October 1-5, 2018; Berlin, Germany; Preview – Draft

Our team will be flying to Berlin, Germany to attend the 54^th annual meeting of the European Association for the Study of Diabetes (EASD), taking place October 1-5, 2018. Pre-conference sessions kick off on Monday, October 1 and boast an incredible 12 industry symposia. In total, the meeting features 28 corporate-sponsored symposia – wow! This meeting is jam-packed with new data, including readouts of the CARMELINA CVOT for DPP-4 Tradjenta (Lilly/BI) and the HARMONY-Outcomes trial for discontinued GLP-1 Tanzeum (GSK), plus much-anticipated data on dual agonists (Lilly’s newly-phase 3 GIP/glucagon combo) and ultra-rapid insulins (Lilly, Adocia). SGLT-2s are heavily featured in the program, and outcomes beyond A1c – from cardio- and renal-protection to hypoglycemia to glycemic variability – are also well-represented. Be sure to register here and view the full agenda for more details. Let us know if we should keep an eye out for you!

Conference Website

Registration

Agenda

Monday, October 1 (Pre-Conference Day)

• (9:00 AM – 4:00 PM, Langerhans Hall) Glycemic Control and Beyond: Shifting The Paradigm in Diabetes Care (Sponsored by Novo Nordisk). With numerous positive CVOTs now reported, a multitude of renal protection studies for new diabetes therapies underway, and outcomes beyond A1c taking center stage in clinical trials, we are witnessing a movement (some would say paradigm shift – it’s probably not that quite yet) from glucose-centric to outcome-based diabetes care. This is incredibly exciting, and it’s certainly fitting that Novo Nordisk is sponsoring a corporate symposium devoted to this changing dynamic. This seven-hour (!) session will be chaired by the highly-respected Dr. Rury Holman and we expect it to touch on Novo Nordisk’s entire suite of diabetes therapies. The morning is primarily dedicated to insulin, featuring a talk on glycemic variability by Dr. Tim Heise (Profil GmbH, Neuss, Germany) – who argued at ADA that next-gen mealtime insulins offer tangible postprandial glucose improvements despite lacking A1c and hypoglycemia data – as well as a co-hosted speech on hypoglycemia by what should be such a great team of Dr. Bernard Zinman (University of Toronto, Canada) and Prof. Simon Heller (University of Sheffield, Sheffield, UK). That talk alone makes this so well worth attending! Following a coffee break we’ll hear from Dr. Liana Billings (NorthShore University, Evanston, IL) on combining proteins with insulin for intensified treatment (we are not sure what to expect here – we had assumed basal/GLP-1 combos) as well as Dr. Mark Evans (University of Cambridge, Cambridge, UK) and former ADA president Dr. John Buse (UNC, Chapel Hill, NC) on mealtime insulins, notably Novolog and Fiasp. The remainder of the day is focused solely on GLP-1 agonists and CV outcomes, including a comparison of Novo Nordisk’s Ozempic (once-weekly semaglutide) vs. Lilly’s Trulicity (once-weekly dulaglutide), for which SUSTAIN 7 offers comparative glycemic and weight loss data – however, only the former has demonstrated CV benefit so far (SUSTAIN-6). The REWIND CVOT for Trulicity is expected to read out in 4Q18 – all eyes will be on these results. We’ll also be interested to hear about what has changed in all of these fields since last year, when Novo Nordisk sponsored a similarly-themed symposium at EASD 2017. Of note, Novo Nordisk’s CVOT plan for semaglutide (both Ozempic and phase 3 oral semaglutide) has seriously shifted of late, and we’ll be keen to hear what speakers in the afternoon make of those changes.

• (9:00 AM – 3:45 PM, Koch Hall) Illuminating The Path of Care for a Multifaceted Disease (Sponsored by Sanofi). In keeping with its title, Sanofi’s all-day symposium kicks off with a keynote on the heterogeneity of diabetes by the revered Dr. James Gavin (Emory University, Atlanta, GA). To start, we’ll hear from Dr. Richard Bergenstal (International Diabetes Center, Minneapolis, MN) and Dr. Alice Cheng (St. Michael’s Hospital, Toronto, CA) on the past, present, and future of basal insulins, including the emerging field of glucose-responsive insulins and an analysis of Sanofi’s BRIGHT study, which was presented at ADA, demonstrating a 26% risk reduction for hypoglycemia (<70 mg/dl) during the titration phase (first 12 weeks) with Sanofi’s Toujeo (insulin glargine U300) compared to Novo Nordisk’s Tresiba (insulin degludec). Between weeks 13-24, there was no significant difference in hypoglycemia between the two insulins. Bucketing data into 12-week segments like this was new to us, and we’ll be interested to hear Dr. Cheng’s take on the study design as well as the overt implication of hypoglycemia reduction with Toujeo compared to Tresiba. From our view, both next-generation basal insulins are so much better than Lantus or Levemir. Finishing off the morning will be what should be an interesting discussion on methodology and RCTs, including talks from Dr. Vicki Seyfert-Margolis (MyOwnMed, Bethesda, MD) on big data, and Dr. Luigi Meneghini (UT Southwestern Medical Center, Dallas, TX), Dr. Stewart Harris (Western University, Ontario, Canada), and Dr. John Wilding (University of Liverpool, Liverpool, UK). The afternoon will be divided into three sessions, each focusing on a different high-risk patient group and the Sanofi therapy that can be used to mitigate risk: (i) Patients uncontrolled on basal insulins (focusing on Sanofi’s basal insulin/GLP-1 agonist combination Soliqua); (ii) patients with type 1 who need further intervention (focusing on Lexicon/Sanofi’s SGLT-1/2 dual inhibitor, sotagliflozin); and (iii) patients at high risk of CV disease (focusing on Regeneron/Sanofi’s PCSK9 inhibitor, Praluent).

• (9:30 AM – 16:30 PM, Virchow Hall) Tomorrow’s Management of Diabetes, Today (Sponsored by AstraZeneca). AstraZeneca’s extensive, day-long symposium chronicles the development of diabetes management, beginning with a recap of previous innovation and ending with a call-to-action to improve modern management of type 2 diabetes by former ADA president Dr. John Buse (UNC, Chapel Hill, NC). Along the way, we’ll hear panels on GLP-1 agonists (AZ’s Bydureon BCise just received EU commission approval), SGLT-2 inhibitors (AZ’s Farxiga has driven >90% of the company’s growth for the past two quarters), individualized drug selection for patients, and CV disease in diabetes. Regarding that last topic, we’re particularly intrigued to hear from Dr. Jochen Seufert (Albert-Ludwigs-Universität Freiburg, Freiburg, Germany) and Dr. Martin Cowie (Imperial College London, London, UK) on “Diabetes – Cardiovascular Disease in the Presence of Hyperglycemia?” The inextricable link between diabetes and CV disease is well-acknowledged, but we’ve also heard compelling arguments against the notion that CV disease is exacerbated by hyperglycemia itself ­(from Drs. Ralph DeFronzo and James Gavin) – rather, they most arise from common pathophysiological defects. In the afternoon, Dr. David Russell-Jones’ (Royal Surrey County Hospital, Guildford, UK) talk on the risk vs. return on SGLT-2 inhibitors promises to be riveting, given that the side-effects of the class have been thrust back into the spotlight as of late. A cohort study recently presented at ESC demonstrated a ~doubled risk of amputations with SGLT-2s compared to GLP-1s (even though only 1% of the sample was taking Invokana), and the FDA recently required that a new warning for a serious bacterial infection be included on the labels for all SGLT-2 containing therapies.

• (10:00 AM – 12:30 PM, Behring Hall) The Cardiorenal Connection: Mineralocorticoid Receptor Inhibition in Diabetes (Sponsored by Bayer). Interestingly, Bayer has dedicated the entirety of its sole symposium to its phase 3 mineralocorticoid receptor (MR) antagonist for diabetic kidney disease, finerenone (of course, other MCRAs are already on the market). The session begins with chair Dr. Mark Cooper (Baker Heart and Diabetes Institute, Melbourne, Australia) delineating the link between kidney and CV disease in diabetes followed by the pathological connection of the two as explained by Dr. Richard Gilbert (University of Toronto, Toronto, Canada). Dr. David Cherney (Toronto General Hospital Research Institute, Toronto, Canada) and Dr. Mikhail Kosiborod (Mid America Heart Institute of Saint Luke's Hospital, Kansas City, MO) will then filter the facts on the cardiorenal connection to get to the “heart of the matter.” Most notably, Dr. Cooper will conclude the session with expectations from phase 3 trials of finerenone. During Bayer’s 2Q18 call, no updates were given on the FIGARO-DKD (n=6,400) and FIDELIO-DKD (n=4,800) trials evaluating finerenone vs. placebo in people with DKD, which are expected to complete in February 2020 and October 2019, respectively. We find it important to note that finerenone is not the only therapy approaching approval for the treatment of DKD; the CREDENCE trial for J&J’s SGLT-2 inhibitor Invokana (canagliflozin) in patients with DKD was recently stopped over a year early due to overwhelmingly positive results. We could not be more thrilled by this recent uptick of interest in DKD treatment – a notoriously challenging disease to treat. While the burden of the DKD is vast (8.2 million people in the US), no new indications have been approved for this condition in the past 18 years (since high blood pressure medications irbesartan and losartan in 2000).

• (10:00 AM – 12:30 PM, Rapoport Hall) From Science to Reality: Understanding the Silent Side of Severe Hypoglycemia (Sponsored by Lilly). This symposium, dedicated to severe hypoglycemia, is highlighted by a superstar panel discussion with Dr. Pratik Choudhary (King’s College, London, UK), author Chris Cebollero (Christian Hospital, St. Louis, MO), Prof. Thomas Danne (Hannover Medical School, Germany), Prof. Brian Frier (University of Edinburgh, UK), musician Ms. Crystal Bowersox, and Prof. Frank Snoek (VU University Medical Center Amsterdam, Netherlands). Prior to discussion, we’ll hear from Ms. Bowersox (an American Idol runner-up!) on her personal challenges with severe hypoglycemia, as well as clinical cases presented by Professor Danne and Dr. Choudhary. We’ll be listening closely for any mentions of Lilly’s nasal glucagon, which was just filed with FDA and EMA in 2Q18 – the first next-gen glucagon for which regulatory submission was announced (Xeris’ Glucagon Rescue Pen closely followed). Notably, Lilly is sponsoring three symposia on Monday, all dedicated to outcomes beyond A1c!

• (10:00 AM – 11:50 AM, Ehrlich Hall) Improving Outcomes in Type 2 Diabetes: Focus on Cardiovascular and Renal Safety (Sponsored by PeerVoice – BI/Lilly Diabetes Alliance). This beyond A1c-themed symposium kicks off with Dr. Naveed Sattar (University of Glasgow, Glasgow, UK) weighing the evidence for CV outcomes in type 2 diabetes. As a reminder, we heard Dr. Sattar express cautious optimism on CV complication prevention in high-income countries at WCPD 2018, noting especially that an increased lifespan means more comorbidities. Dr. Merlin Thomas (Baker IDI, Melbourne, Australia) will follow with an overview of the link between kidney disease and type 2 diabetes. Tying these subjects together will be Dr. Per-Henrik Groop (University of Helsinki, Helsinki, Finland), who will provide a clinical perspective on the impact of novel therapies on CV and renal outcomes and lead a concluding panel discussion. For context, the sponsor of this symposium, PeerVoice, is an independent medical education firm, but this specific activity is supported by a grant from the BI/Lilly diabetes alliance. As such we will be interested to see exactly which CV and renal data is presented.

• (2:30 PM – 4:30 PM, Hirsch Hall) Reducing Cardiovascular Mortality in Patients with Type 2 Diabetes: A New Clinical Mandate? (Sponsored by BI/Lilly). We can’t wait for this one. As we enter an empowering age of outcomes beyond A1c (hypoglycemia, CV benefits, renal protection) in clinical trials, we’re interested to see how the building wealth of information is being applied in clinics – and if patients are even learning what cardioprotection is. The symposium is co-chaired by Dr. Stefan Anker (Charité University, Berlin, Germany) and Dr. Silvio Inzucchi (Yale, New Haven, CT), who recently presented a new treatment algorithm for type 2 diabetes based on CV and renal risk factors rather than A1c. Excitingly, Dr. Inzucchi is set for a talk on the driving factors behind type 2 diabetes treatment decisions, and we’re eager to hear his expanded thoughts. The session also features Dr. Mikhail Kosiborod (Saint Luke's Hospital, Kansas City, MO) and Dr. Merlin Thomas (Baker IDI, Melbourne, Australia) who will present on emerging evidence in type 2 diabetes patient care and ongoing clinical trials with SGLT-2 inhibitors, respectively. Dr. Kosiborod, a cardiologist, has emerged as a prominent advocate for greater use of SGLT-2 inhibitors and GLP-1 agonists for cardioprotection in people with diabetes, as well as for greater cooperation and interaction between the fields of cardiology and endocrinology. Indeed, he’s presented an algorithm for choosing diabetes therapy based on a patient’s CV status (CODHy 2018), highlighted the benefit of SGLT-2s on heart failure in particular (ADA 2018), and also postulated that GLP-1s should offer cardioprotection in primary prevention populations (AACE 2018). We expect these presenters to offer insight on how SGLT-2s in particular are expanding beyond glucose-lowering and the type 2 populatio

• (2:30 PM – 5:00 PM, Heubner Hall) Focus on the Future: Latest Scientific and Clinical Understanding for the Treatment of Patients with Type 2 Diabetes (Sponsored by Merck). This jam-packed session features eight back-to-back short presentations on a wide-variety of topics. The session will kick off with Dr. Jonathan Campbell (Duke, Durham, NC) providing an overview of recent advancements in alpha and beta cells, followed by an overview of the COMPOSIT trials given by Dr. Juan Frias (National Research Institute, Los Angeles, CA), which demonstrated a 0.15% greater A1c reduction (p=0.006) in patients with moderate renal dysfunction taking Merck’s Januvia (sitagliptin) compared to AZ’s Farxiga (dapagliflozin) after 24 weeks. Dr. Jens Juul Holst (University of Copenhagen, Copenhagen, Denmark) – who discovered the GLP-1 hormone – will then give an overview of the glucagon hormone, followed by a talk on Merck/Pfizer’s SGLT-2 inhibitor Steglatro (ertugliflozin) – the newest therapy to the class – by Dr. Sam Dagogo-Jack (University of Tennessee, Knoxville, Tennessee). We’ll be listening very closely for any mentions of the ongoing VERTIS CVOT for Steglatro in both Dr. Dagogo-Jack’s talk as well as Dr. Matthew Cavender’s (University of North Carolina, Chapel Hill, NC) follow-up on SGLT-2 inhibitor use in patients with diabetes and established CV disease. It is difficult to overstate the importance of VERTIS: Without compelling CV results, we can’t easily imagine the product gaining significant market access without offering substantial rebates. While some say they can’t imagine many providers being eager to prescribe it, either, we are sure they would for the right reasons. For context, Lilly/BI’s Jardiance already has a CV indication, J&J has submitted an sNDA for an indication for Invokana (Variation application just approved in the EU), and AZ’s DECLARE trial for Farxiga will report topline results by the end of the year. The session closes with a keynote by Dr. Michael Nauck (Diabeteszentrum, Bad Lauterberg, Germany) on the mechanisms behind DPP-4 and SGLT-2 inhibitors – we hope he also brings many of his opinions!

• (2:30 PM – 5:00 PM, Rubner Hall) Introduction to Dexcom G6 Continuous Glucose Monitoring as the Leader in Technology, Accuracy and Performance (Sponsored by Dexcom). Dexcom VP of R&D Mr. Jake Leach will review the latest advancements available with the Dexcom G6, likely drawing from his presentation at Dexcom’s G6 ADA product theater, during which he detailed how Dexcom factory calibrates the sensor. As a reminder, the G6 was cleared by the FDA as an iCGM in March and received its CE mark in June. Per Dexcom’s early August call, G6 is in its full US launch, and an international launch was expected in 2H18; hopefully we’ll get a more concrete update in this symposium on where/when launches will occur. (UK and Ireland were expected to be first, starting in June.) Dr. Guido Freckmann (Institut für Diabetes-Technologie, Ulm, Germany) will compare the Dexcom G6 to Abbott’s FreeStyle Libre, highlighting accuracy and performance differences relevant to clinical practice. Dexcom is marketing a G6 overall MARD of 9.0% (9.8% in adults and 7.7% in pediatrics) based on the results of the smaller automatic applicator study (n=62), while Abbott’s 14-day approval press release touts a MARD of 9.4% (FDA’s SSED notes a 10.1% MARD). We assume Dr. Freckmann has done his own head-to-head study, in line with the work he has previously done on glucose meters. A separate talk in the symposium will be dedicated to the G6 accuracy and performance (speaker TBD), likely covering the labeling and pivotal study as we heard at ADA. Dr. Freckmann may also mention the iHart CGM study comparing the G5 to FreeStyle Libre in type 1s with hypoglycemia unawareness, although we don’t think anyone would argue with the value of high-risk patients using CGM alarms.

• (2:30 PM – 5:00 PM, Ehrlich Hall) Integrated Personalized Diabetes Management: Connecting the Dots to Improve Outcomes (Sponsored by Roche). We’re very excited to hear from Harvard’s Dr. Frank Doyle on the translation of artificial pancreas systems into clinical practice. Roche is involved in the NIH-funded iDCL Protocol 2 with Senseonics and TypeZero, slated to begin testing patients in an EU pivotal trial in 3Q18. Given Dexcom’s acquisition of TypeZero in August, we’re not quite sure what this might mean for the trial and its inclusion of Senseonics’ Eversense XL CGM. (Will they move to another algorithm – perhaps the Harvard zone MPC? Will they swap in Dexcom CGM?) Dr. Doyle is likely to discuss his work enhancing AID algorithms, including an adaptation based on multiple zones and trust indices, which generated a time-in-range that he claimed at ATTD may have set a “new high water mark” for his own work (88%). Similar to the Roche corporate symposium at last year’s EASD, the event will heavily feature the company’s digital ecosystem, including Senseonics’ Eversense CGM. The Roche OUS distribution agreement with Senseonics expires at the end of this year, but Senseonics management expressed confidence on the company’s 2Q18 call that both sides are interested in a renewal. Dr. Dorothee Deiss (Endokrinologikum am Gendarmenmarkt, Berlin Germany), who spoke at the FDA Advisory Committee open public hearing in support of the Eversense approval in the US, will detail the clinical benefits of the 180-day Eversense XL. The XL is available in all OUS markets and per 2Q18 expectations, Senseonics hopes to submit an IDE this month to begin an Eversense XL US clinical trial this fall. We were also interested to see a focus on prediabetes and prevention in the session’s agenda. Dr. Luc Van Gaal (Antwerp Hospital, Antwerp, Belgium) will detail how to best motivate lifestyle changes and weight loss for those with prediabetes, while prevention expert and co-director of the Leicester Diabetes Center Professor Kamlesh Khunti will discuss how the interplay between therapy, data, and tech is critical in improving outcome. In June, Professor Khunti advocated for the UK’s National Health Service to address the rising public health crisis of prediabetes and type 2 diabetes with structured diabetes education programs. We’re pleased to see this critical topic afforded much-warranted attention by industry, and we hope to see structured diabetes education programs put into frictionless formats that are easy to consume, low/no-cost to patients, and with sufficient marketing dollars behind them.

•  (2:30 PM – 5:00 PM, Behring Hall) At the Forefront: Piecing Together Recent Type 2 Diabetes Evidence (Sponsored by Takeda). This Takeda-sponsored symposium will kick off with the Great Dr. Ele Ferrannini (UT San Antonio, San Antonio, TX) providing an overview from 10,000 feet of the type 2 diabetes epidemic, identifying treatment gaps now and in the future. We’re very excited to hear from cardiologist Dr. Robert Chilton (UT San Antonio, San Antonio, TX), who will provide insight into recent data from the EXAMINE trial investigating the CV safety for Takeda’s Nesina (alogliptin). While the trial originally read out in 2013, finding CV safety for Nesina (although trending towards placebo), Dr. Chilton’s session title deems EXAMINE to be, “an evolving story,” and we’re excited to hear what this entails. From our view, the EXAMINE data trend positively on CV death, though the results were neutral on three-point MACE (HR=0.96, upper bound 95% CI: 1.16). Interestingly, the symposium includes a talk by Dr. Vivian Fonseca (Tulane, New Orleans, LA) on the multiple clinical benefits of alogliptin/pioglitazone, Takeda’s DPP-4/TZD combination therapy (Incresync outside of the US, Oseni in the US). We’ve heard little about this therapy since it was approved in 2013, but were interested to hear about its benefits beyond A1c. Lastly, Dr. Sanjay Rajagopalan (UH Cleveland Medical Center, ) will compare and contrast the CV data for Takeda’s therapies with other recent CVOT data. 

• (2:30 PM – 5:00 PM, Rapoport Hall) Technical and Clinical Advances in Flash Glucose Monitoring (Sponsored by Abbott). Dr. Kristin Castorino (William Sansum Diabetes Center, Santa Barbara, CA) will discuss improvements in FreeStyle Libre accuracy, perhaps touching on the recent approval of the 14-day version in the US – as a reminder, the press release noted an improved MARD of 9.4%, utilizing a slightly different methodology than FDA’s SSED (MARD: 10.1%). At the time, Abbott shared that the company is working to address the disparities with FDA – we’ll be listening for updates on this front, as well as any comment son improving hypoglycemia accuracy, where Libre still lags behind competitors. Dr. Ides Colin (Mons-Hainaut Hospital, Mons, Belgium) will provide commentary on the utility of alarms in CGM, perhaps addressing the iHart CGM study comparing Dexcom’s G5 and Abbott’s FreeStyle Libre. Hopefully, Dr. Colin will detail for which patients CGM alarms are best suited, rather than attempting to make a broader claim. Of course, given Abbott’s plans for a next-gen FreeStyle Libre with continuous communication, the products will become more comparable in the not-too-distant future – indeed, Bigfoot’s Mr. Jeffrey Brewer hinted at Friends For Life that the next-gen FreeStyle Libre with Bluetooth is coming “sooner than people realize.” Dr. Simone von Sengbusch (Pediatric Diabetology Working Group, Munster, Germany) will provide a consensus statement from Germany on the incorporation of trend arrows in insulin dosing decisions and Dr. Cliff Bailey (Aston University, Birmingham, UK) will discuss results from a meta-analysis demonstrating A1c reduction with FreeStyle Libre use.

Tuesday, October 2

• (7:30 AM – 9:30 AM, Spener Hall) Diabetes Prevention on Demand: What Strategies. This symposium will kick off the first full day of conference activities at EASD 2018. Of note, Dr. Silvia Turroni (University of Bologna, Italy) will present on the role of the gut microbiome in type 2 diabetes—we’ve seen increasing research focus into this field (check out Dr. Eran Spegal’s cool talk on this subject from AADE 2018 here) in the past few years and are excited to hear from Dr. Turroni, who has specialized in research of the microbiome in various populations. Dr. Rafael Gabriel will also present on strategies to implement for diabetes prevention–we’re glad to see prevention be one of the first topics discussed at EASD!

• (9:15 AM – 10:00 AM, Langerhans Hall) 50^th Claude Bernard Lecture: Prevention of Type 2 Diabetes: The Dream that Came True. The esteemed Dr. Jaana Lindström will give a talk reviewing diabetes prevention strategies and successes over the years. We couldn’t be more excited to hear from this pioneer in diabetes prevention, whose work on developing the Diabetes Risk Score and groundbreaking research (cited over 11,000 times!) on lifestyle interventions as a prevention strategy has dramatically influenced the field

• (10:15 AM – 11:45 AM, Heubner Hall) Oral Presentation 4: The Adipose Tissue: From Biology to Intervention Studies. Six different talks in this session will focus on factors influencing adipose tissue regulation and differentiation. We will be sure to cover a talk in this session given by researchers from University of Gothenburg, Sweden, discussing an observational study on gastric bypass study in patients with obesity and type 2 diabetes. 

• (12:oo PM – 1:00 PM, Langerhans Hall) HARMONY-Outcomes. We’re on the edge of our seats for results to be presented from HARMONY, the CVOT for GSK’s now discontinued GLP-1 Tanzeum (albiglutide). Presenters will include Duke University’s Dr. Adrian Hernandez (introduction and background) and Dr. Jennifer Green (study design and methods), Università di Pisa’s Dr. Stefano Del Prato (glycemic and renal outcomes), and University of Glasgow’s Dr. John McMurray (CV outcomes). Importantly, HARMONY results could go a long way in answering some outstanding question on a potential class effect that GLP-1s may offer in the way of cardioprotection. As a reminder, both LEADER (liraglutide) and SUSTAIN (semaglutide) have indicated cardioprotection for their respective GLP-1s, while EXSCEL (exenatide) and ELIXA (lixisenatide) both only showed CV safety (although EXSCEL was famously this close to showing CV superiority). Positive HARMONY results could be a major asset for another party to swoop in looking to take over commercialization and distribution of Tanzeum, now that GSK has discontinued it. We’ll also be on the lookout for safety results presented, especially concerning GI side effects and rates of diabetic retinopathy.

• (12:00 PM – 1:00 PM, Poster Hall) Poster Session 1: Diabetes Health Burden. This poster session, the first of many at EASD 2018, will include eight different posters on the health burden of diabetes. We’re especially interested in analyzing a poster by the Health Economics & Outcomes Research group from Novo Nordisk, which looks at the prevalence of CV disease and treatment patterns in patients with type 2 diabetes in a real world setting. We’re also excited to see two posters on the Maastricht study being presented, which is an extensive phenotyping study on the determinants of type 2 diabetes based off a population cohort of 10,000 patients tracked for 5-7 years.

• (12:00 PM – 1:00 PM, Poster Hall) Poster Session 49: Novel Aspects of SGLT-2 inhibitors. Be sure to check out this poster session, which will include ten posters on the effects of SGLT-2 inhibitors in traditionally less-studied areas, including stem cells, NAFLD, and bariatric surgery. A poster on dapagliflozin preserving renal vasodilating capacity will surely be interesting as well, especially in light of CREDENCE results showing renal-protection for canagliflozin and the outstanding question of whether this represents a class-wide effect for SGLT-2 inhibitors.

• (12:00 PM – 1:00 PM, Poster Hall) Poster Session 61: GLP-1 Receptor Agonists: Do Age and Ethnicity Matter? This session will be highlighted by two post-hoc analyses of the SUSTAIN trials for semaglutide (Novo Nordisk’s Ozempic)—one focusing on the elderly patient subgroup, while the other will include analysis by race and ethnicity. We were thrilled to see a SUSTAIN 6 post-hoc analysis of patients across the spectrum baseline CVD risk at ESC 2018 and look forward to similar learnings at this session. There will also be a similar analysis of liraglutide treatment in elderly patients based off of the LEADER trial.

• (12:00 PM – 1:00 PM, Poster Hall) Poster Session 67: Artificial Insulin Delivery and Insulin Pump Therapy. This packed poster session leads with data from the AID ski camp study out of Dr. Boris Kovatchev’s team at UVA. At ATTD, Dr. Kovatchev shared remarkable data testing the integrated Tandem X2/Dexcom G6/TypeZero system in 13-18 year-olds (n=25): time-in-range (70-180 mg/dl) increased from 50% on SAP to a whopping 73% on closed loop, translating to six more hours in range! The next phase of the trial was slated to test the system in 6-12 year-olds, so we’re hoping to see data from this younger cohort. We’ll also see data from the Cambridge group’s fully automated closed loop system in type 2 diabetes patients on hemodialysis. At ADA, Dr. Lia Bally (Inselspital Bern University Hospital) presented very encouraging results from a multi-system, 15-day RCT (n=136) of the system in inpatient type 2 diabetes. As the only group to our knowledge that is currently running studies to bring closed therapy to the inpatient settings, we’re rooting for Cambridge’s success. Adam was recently in the hospital for a ruptured appendix and was truly horrified at the hospital’s knowledge of diabetes care; more on that to come in diaTribe.

•  (1:15 PM – 2:15 PM, Poster Hall) Poster Session 44: Are SGLT-2 Inhibitors Effective and Safe in Type 1 Diabetes? This session will be jam-packed with intriguing posters that we can’t wait to see given the ongoing swirling debate around SGLT-2 use in type 1 diabetes. The session will include an analysis of the inTandem1 and inTandem2 studies showing that sotagliflozin (SGLT-1/2 dual inhibitor) use as an adjunct therapy in type 1 patients leads to increased time-in-range measured by CGM. As a reminder, sotagliflozin is currently awaiting a decision from both FDA and EMA on potential approval for type 1 patients. Moreover, we’ll get to see pooled analyses of the DEPICT-1 and DEPICT-2 studies of dapagliflozin. Most importantly, we hope to see more data and further discussion surrounding DKA risk with this use of SGLT-2 inhibitors in type 1 patients. In our view, the benefits of this therapy in type 1 patients are undeniable—many studies have shown their efficacy in lowering A1c, body weight, and insulin doses—but key questions regarding safety remain unanswered.

• (1:15 PM – 2:15 PM, Poster Hall) Poster Session 50: SGLT-2 Inhibitors: What Do the CVOTs Tell Us? Nine different posters will be presented in this session, and four of them will focus on analyses of the CANVAS study. Notably, we are eager to see poster 662, discussing CV and renal outcomes for patients in the CANVAS program being improved indiscriminately across different body mass indexes. Two posters will also highlight the EMPA-REG OUTCOME trial, with one focusing on kidney outcomes for patients in the trial with or without heart failure at baseline. Excitingly, another poster on empagliflozin, this time showing that it reduces mortality and hospitalization for heart failure for patients with or without a history of myocardial infarction or stroke at baseline, will also be presented.  

• (1:15 PM – 2:15 PM, Poster Hall) Poster Session 56: Metabolic Effects of Novel, Dual and Triple Incretin Agonists. This session will zoom in on metabolic interactions of dual and triple agonists currently in development. We’ll be sure to check out poster 718 which will present dose escalation data on AZ’s GLP-1/glucagon dual agonist MEDI0382. AZ specifically highlighted this candidate in their 2Q18 call, signaling enthusiasm for the potential of this candidate. To our knowledge, this candidate is being considered for multiple indications, including type 2 diabetes and NASH. Full phase 2b results for MEDI0382 are expected in 1H19. Generally, we remain excited about the potential of dual (and triple agonists)—in our view, these agents could represent the next revolution within type 2 diabetes pharmacotherapy, if they can demonstrate meaningful improvements over existing GLP-1 agonists. The competitive landscapes for both GLP-1/GIP and GLP-1/glucagon dual agonists are robust. We’ll be especially excited to see phase 2 data being presented here at EASD on Lilly’s GIP/glucagon candidate; this candidate has already been pushed into phase 3, making it the first dual agonist to achieve this milestone.

• (1:15 PM – 2:15 PM, Poster Hall) Poster Session 68: Faster Acting Insulins: State of the Art. Eight posters will be presented in this session, with half of them focusing on Adocia’s BioChaperone technology. Adocia recently announced topline results for its phase 1 BioChaperone pramlintide + human insulin combo—in this context, we’ll be sure to see poster 811, which will detail BioChaperone technology applied to pramlintide and prandial insulin combinations. Data will also be presented on Lilly’s ultra-rapid lispro (URLi) in a comparison with lispro in type 2 patients; this candidate is now in phase 3 studies expected to complete in August 2019.

• (1:15 PM – 2:15 PM, Poster Hall) Poster Session 74: Cost Effectiveness In Diabetes Therapies. This session will delve into answering the question of how cost-effective newer, more efficacious classes of diabetes therapies such as SGLT-2 inhibitors and GLP-1 receptor agonists really are. Poster 862, sponsored by Merck, will compare the long-term cost effectiveness of sitagliptin vs. SGLT-2 inhibitor combination therapy. Poster 863, sponsored by BI, will present a cost-effectiveness analysis of empagliflozin when compared to standard of care and DPP-4 treatment based off of CVOT data. Poster 867, sponsored by Novo Nordisk, will emphasize the importance of incorporative CV benefits of once-weekly semaglutide (Ozempic) in estimates of health benefits of for type 2 patients. We agree with this general theme of reframing cost analysis of these newer drug classes in this session. Although they are undoubtedly pricier than other available drugs, these analyses can help better understand whether the myriad benefits (superior glucose lowering, weight loss, potential CV and renal protection) they provide justify higher up-front costs over the long term.

• (1:15 PM – 2:15 PM, Poster Hall) Poster Session 80: Causes and Consequences of Hypoglycemia. This session will explore risk factors for hypoglycemia (such as physical activity, psychological distress, quality of life) along with health consequences of these events. Dr. Rich Bergenstal and researchers from Novo Nordisk will present data from Poster 911, which uses real world CGM data in type 1 patients to show that reducing glycemic variability decreases time in hypoglycemia independent of mean glucose – excellent! The data set, taken from Novo Nordisk/Glooko’s Cornerstones4Care app, uses the same data from a poster shared at ADA (but adds Dr Bergenstal as an author and presents the data more clearly, at least in the abstract). Data like these emphasize the importance of CGM variability metrics, which add so much over mean glucose alone.

• (2:30 PM – 4:00 PM, Langerhans Hall) Oral Presentation 7: New Insights from Clinical Trials with Incretin-Based Therapies. Dr. Francesco Giorgino (University of Bari, Bari, Italy) will chair this session focusing on new insights from clinical trials involving GLP-1s and SGLT-2s. A highlight of this session will surely be a presentation lead by Dr. John Buse (University of North Carolina, Chapel Hill, USA) on the potential impact of differential drop-in of open-label medications in the EXSCEL trial. We’re also excited to hear from Dr. Martin Haluzik (Institute for Clinical and Experimental Medicine, Prague, Czech Republic) who will present data from PIONEER 1 regarding efficacy and safety of oral semaglutide monotherapy in type 2 diabetes . Full data from PIONEER 1 was presented at ADA earlier this year; we’ll be on the lookout for any new insights on oral semaglutide, specifically concerning the fasting requirement for patients along with rates of GI side effects.

• (2:30 PM - 4:00 PM) Oral Presentation 10: Where, When and Hows of Rapid Acting Insulins. As it stands, two ultra-rapid-acting postprandial insulins are available on the market (Novo Nordisk’s Fiasp (faster-acting insulin aspart) and MannKind’s inhalable Afrezza) and one more is hot on their heels (Adocia/Tonghua Dongbao’s phase 3-ready BioChaperone Lispro). In this powerhouse session, we’ll hear updates on all three. First, Mr. Frank Pompilio (MannKind, Los Angeles, CA) will present a secondary analysis of the AFFINITY-1 trial for Afrezza, which indicated a 26% risk reduction for hypoglycemia compared to Novo Nordisk’s injectable NovoLog (insulin aspart). Mr. Gregory Meiffren (Adocia, Lyon, France) will follow with PK/PD data comparing BC Lispro to Fiasp and Novolog, and Prof. Christophe De Block (University of Antwerp, Antwerp Belgium) will round out the three with results from a hypoglycemia study comparing Novo Nordisk’s Fiasp and NovoLog. As a tech-bonus, we’ll hear from Prof. Eric Renard (Centre Hospitalier Universitaire de Montpellier, Montpellier, France) on the long-term safety and efficacy of intraperitoneal insulin infusion via implanted pumps in patients with type 1 diabetes. For background, Dr. Renard, a leading thinker in implantable (and external) pump and sensor technology, moderated a breakout session on clinical trial design for intraperitoneal insulin therapy at the JDRF-Helmsley Closed Loop Intra-Peritoneal Infusion Workshop last year in New York.

•  (4:15 PM – 5:15 PM, Langerhans Hall) 33^rd Camillo Golgi Lecture: Diabetic Complications – An Alternative View on Diabetes. We can’t wait to hear Dr. Peter Nawroth (University of Heidelberg, Germany) present an “alternative view on diabetes complications.” Dr. Nawroth is an expert in diabetes complications and reactive metabolites; we’ll be curious to see his take on how these two areas intertwine. Dr. Nawroth’s recent work has included looking at how targeting the accumulation and effects of the endogenous reactive metabolite methylglyoxal (MG) may provide a novel more effective method of treating diabetic neuropathy.

• (4:15 PM – 5:55 PM, Koch Hall) Rising Star Symposium. Don’t miss this year’s Rising Star Symposium, which always serves as an inspiration to all who attend. Four young researchers in diabetes will present on their research, spanning the link between brown adipose tissue and metabolic disease, new genes causing beta cell dysfunction, VEGF-A signaling, and insulin granules.
  

Wednesday, October 3

• (8:30 AM – 10:00 AM, Langerhans Hall) Update and New Findings from the Restoring Insulin Secretion (RISE) Study. We’ll be on the edge of our seats to hear updates on the RISE study. Dr. Kristen Nadeau (Barbara Davis Center for Childhood Diabetes, Aurora, Colorado, United States) will speak on new analyses of RISE baseline measures and pediatric medication study outcomes. Dr. Anny Xiang (University of Southern California Keck School of Medicine, Los Angeles, California, United States) will present on background and design on the study, while Dr. Thomas Buchanan (University of Southern California Keck School of Medicine, Los Angeles, California, United States) will present results and interpretation of this section. Finally, Dr. Roy Taylor (University of New Castle, United Kingdom) will offer commentary on the study. Notably, we heard an update on RISE Peds at ADA earlier this year, which depressingly highlighted a rapid decline in beta cell function among youth with type 2 diabetes despite metformin and/or insulin glargine treatment. We do wonder if new analyses on various subgroups in the broader study population will offer any promising insights.

• (8:30 AM – 10:00 AM, Koch Hall) EASD/JDRF Symposium: Looking into the Future: Developing New Interventions for Type 1 Diabetes. This engaging symposium will feature three different presentations focusing on novel approaches for type 1 treatment. Dr. Carla Greenbaum (University of Washington, Seattle, WA) will kick off the session by discussing prevention trials for type 1 diabetes. She will review the TrialNet Oral Insulin Study, which showed mixed results in terms of oral insulin administration delaying onset of type 1 diabetes. The TrialNet study seemed to indicate that monotherapy alone will not prevent or delay type 1 diabetes onset; consequently, many ongoing trials for type 1 prevention involve combination therapies (see our landscape here). We’re particularly excited to hear the always thought-provoking Dr. Jay Skyler (University of Miami, FL) finish up the session with a talk centered on “hope and hype” in type 1 diabetes prevention and treatment.

• (10:15 AM – 11:45 AM, Langerhans Hall) Oral Presentation 13: GLP-1 Receptor Agonists, SGLT-2 inhibitors and the Kidney: New Lessons from Large Clinical Trials. These series of oral presentations will highlight analyses of CV outcomes in patients that have renal dysfunction and are taking GLP-1s or SGLT-2s. We will get to hear analyses of subgroups with renal dysfunction or kidney disease in the EXSCEL study (exenatide), the LEADER trial (liraglutide), AWARD-7 trial (dulaglutide), ELIXA study (lixisenatide), and SUSTAIN 6 trial (semaglutide). In light of the CREDENCE study showing that Invokana (canagliflozin) has significant renal protection effects, researchers will surely be on the lookout for how other SGLT-2 inhibitors (and GLP-1s) may affect renal outcomes. As a reminder, CREDENCE was stopped early after showing that a significantly reduced risk for adverse renal outcomes in a population of 4,401 patients with DKD.

• (10:15 AM – 11:45 AM, Koch Hall) Oral Presentation 15: Technological Advances in the Treatment of Diabetes. USC’s Dr. Anne Peters will present sure-to-be-fascinating results from a Helmsley Charitable Trust-supported study of non-diabetes children and adults on the Dexcom G6. This multicenter study was conducted to provide a suggested “normal range” of sensor glucose levels that could then be used for comparison in clinical trials. These results could be instrumental in supporting Beyond A1c efforts, since defining what is a “normal” time-in-range in someone without diabetes could help inform benchmark efforts in diabetes. We’ll also hear results from the Cambridge group’s multi-center, multi-national, parallel study in type 1s six-years and older investigating closed-loop (Medtronic 640G/Enlite 3) on the Cambridge control algorithm vs. SAP over 12 weeks of unrestricted living – it will be outstanding to hear another long-term study on AID. Also in this session is a Medtronic abstract featuring authors Drs. Bob Vigersky and Fran Kaufman on a provider-facing decision support system using retrospective CGM data and ADA/AACE guidelines to provide therapy recommendations for patients with type 2 diabetes. Decision support was a major theme at Medtronic’s analyst meeting in June, but this is the first data that we are seeing to this end. Lastly, the great Dr. Bruce Buckingham will present PROLOG results on Tandem’s Basal-IQ, first presented at ATTD; presumably we will see post-hoc analyses split out by prior diabetes device use.

•  (12:00 PM – 1:00 PM, Langerhans Hall) UKPDS. We definitely will not want to miss this symposium on one of the field’s most important landmark trials, UKPDS. Dr. Rury Holman (University of Oxford, United Kingdom) will start the session by reviewing the past 40 years, and Dr. Alastair Gray (University of Oxford, United Kingdom) will follow up by providing insights from the UKPDS outcomes model. Dr. David Matthews (University of Oxford, United Kingdom) will close the session by taking a step back and putting UKPDS in perspective—what effect has this landmark study had, how is it currently influencing care, and what will its impact be in the future? These are questions that Dr. Matthews will surely look to provide some commentary on, and we can’t wait to learn from his insights!

• (1:15 PM – 2:15 PM, Langerhans Hall) SGLT2 and DPP-4 Inhibitors: New Avenues to Protect the Kidney. We’re excited to hear results presented on the DELIGHT trial during this symposium. As a reminder, the exploratory DELIGHT trial (n=459) completed in April 2018 and investigated Farxiga (dapagliflozin) vs. Qtern (dapagliflozin/saxagliptin) in patients with diabetes and DKD. Dr. Carol Pollock (University of Sydney, Sydney, Australia) will specifically present DELIGHT results looking at effects of dapagliflozin and dapagliflozin/saxagliptin treatments on renal outcomes in the study’s population. We have heard thought leaders opine that renal protection is likely to be a class effect for SGLT-2 inhibitors; DELIGHT results (although certainly small in scale) will add another importance piece in completing this puzzle. The potential for DPP-4 inhibitor combinations in modulating this effect is also enticing, and something we’ll be on the lookout for in this presentation. Finally, Dr. Michael Nauck (St. Josef Hospital, Bochum, Germany) will offer his commentary on these results.

• (2:30 PM – 4:00 PM, Langerhans Hall) Oral Presentation 19: SGLT-2 Inhibitors: New Mechanisms and Clinical Evidence. This session of oral presentations will surely be jam packed with incredible learnings. A talk from Dr. John Buse’s group will look, a real-world analysis  looking at canagliflozin versus other antihyperglycemic agents on the risk of below-knee amputations in over 700,000 US patients. The amputation signal seen in CANVAS remains a contested topic among thought leaders, especially on its generalizability to a class effect for SGLT-2 inhibitors as a whole. At ESC 2018, we heard a “very provocative” presentation on an observational study showing a significantly increased risk for amputations with patients using SGLT-2 inhibitors (only 1% of which were on canagliflozin). We hope that this analysis at EASD will shed some more light on the nuance behind amputation rates with canagliflozin treatments. We will also get to hear results from a nationwide observational study conducted by a team of researchers from Sweden and Norway; the study looks at the risk of CV disease and mortality with SGLT-2 inhibitors vs. bolus insulin as an add-on to stable basal insulin in type 2 patients. Positive results here could further expand the patient population that HCPs feel comfortable using SGLT-2 inhibitors with and could further strengthen evidence for cardioprotection as a class effect for these agents. In this same vein, a team of researchers will also present work showing that empagliflozin treatment reduces mortality and hospitalization risk for heart failure irrespective of baseline CV risk—wow! We hope that these results are the first step in a path that includes other trials (such as the readout of the much anticipated DECLARE study) showing that SGLT-2 inhibitors can be used in primary prevention populations for heart failure – and primary prevention of type 2. As a reminder, EMPA-REG demonstrated CV benefit of empagliflozin in a patient population with established CV risk.

• (2:30 PM – 4:00 PM, Koch Hall) Oral Presentation 21: Predicting Complications. This session will feature six rapid fire 15-minute presentations, all with a focus on the prediction of various complications associated with prediabetes and diabetes. A highlight of this session will be a discussion of the Hoorn Diabetes Care System Cohort led by a team of researchers from The Netherlands. This team will argue that the updated mean HbA1c level is more strongly related to mortality than a single HbA1c measurement, helping to further prioritize a shift away from putting too much stock into one A1c reading. We will also be sure to listen in on a talk representing research from a multinational group of researchers that uses multiplex proteomics for prediction of major CV events in patients with type 2 diabetes.

• (5:30 PM – 6:30 PM, Langerhans Hall) PIONEER Trial. This symposium will serve as an informative overview of the genesis and development of the PIONEER trials for studying Novo Nordisk’s oral semaglutide candidate. The esteemed Dr. Daniel Drucker (Mount Sinai Hospital, Toronto, Canada) will discuss barriers associated with the drug development process of oral peptide delivery; all previous peptide GLP-1 therapies have been administered through injections directly into the bloodstream. For sure, oral peptide delivery is a daunting challenge, as these peptides must survive harsh pH conditions in the gut along with an abundance of enzymes primed to digest large peptides. Dr. Melanie Davies (University of Leicester, UK) will follow by detailing the process of taking the conception of an oral formulation of semaglutide to the creation of the PIONEER program, which now involves 10 separate trials. Dr. Vanita Aroda (Brigham and Women’s Hospital, Boston, Massachusetts, United States) will then present on the PIONEER 1 program and presumably overview results discussing efficacy and safety of oral semaglutide when compared to placebo. As a reminder, PIONEER 1 full results were presented at ADA 2018, showing remarkable glucose-lowering efficacy without hypoglycemia or weight gain. Shortly thereafter, Dr. Steven Bain (Swansea University Medical School, Swansea, United Kingdom) will provide an overview of the future of the PIONEER program. PIONEER 2, 3, 4, and 5 have already had topline results released, and topline results from PIONEER 6 (CVOT) are expected by year’s end. See a full breakdown here. Finally, Dr. Clifton Bailey (Aston University, Birmingham, United Kingdom) will close the session by providing commentary on the PIONEER program.

• (5:30 PM – 6:30 PM, Virchow Hall) Hypoglycemia: Definition to Prevention. This hour-long symposium will feature two talks on the evolution of how we view hypoglycemia and efforts to mitigate its prevalence. Dr. Simon Heller (The University of Sheffield, Sheffield, United Kingdom) will track how the definition of hypoglycemia has changed over time to its current manifestation, while Dr. Carol Wysham (University of Washington, Seattle, Washington, United States) will discuss the role of newer insulin analogues in reducing hypoglycemic events.

• (5:30 PM – 6:30 PM, Koch Hall) EASD/ESC Symposium: Cardiorenal Protection with SGLT-2 Inhibitors: A Benefit for All and Also Outside Diabetes? This symposium will surely be notable, and one that you don’t want to miss if you have an interest in the evolving intersection of diabetes therapies in cardiology and nephrology. In this session, Dr. Faiez Zannad (University of Lorraine, Nancy, France) will first overview cardioprotective effects of SGLT-2 inhibitors. We hope to hear Dr. Zannad wade into the debate on whether cardioprotection represents a class effect for SGLT-2 inhibitors (the growing consensus appears to be yes), and whether this benefit extends to patients without diabetes as well. At ESC 2018, we frequently heard cardiologists challenge the status quo and question whether SGLT-2 inhibitors are in reality cardioprotective drugs first and diabetes drugs second—we’d love to hear Dr. Zannad, who is a cardiologist, offer up a hot take on this as well. Dr. Paola Fioretto (University of Padova, Padova, Italy) will then discuss renal protection in terms of SGLT-2 inhibitors and patients without diabetes. Surely, the upcoming Dapa-CKD and EMPA-KIDNEY studies, both which enroll patients with CKD (and not necessarily with diabetes), will be crucial in writing this story of the emergence of diabetes drugs in wider populations. 

• (5:30 PM – 6:30 PM, Hirsch Hall) Michael Berger Debate: Improving Glucose Control in Type 1 Diabetes: Sensors vs. Pumps. Cambridge’s Dr. Roman Hovorka and Joslin’s Dr. Elena Toschi will battle it out on the big stage, providing lively discourse on one of the most popular topics in diabetes technology – which is more effective in type 1 diabetes management, CGM or pump therapy? Dr. Hovorka will argue in favor of pumps, while Dr. Toschi will present a case for CGM. We look forward to what we’re sure will be a thought-provoking discussion. We’re of the opinion that both devices are incredibly beneficial, but if only one could be selected, we’d urge CGM first and adding a pump second. (But would ask not to have to choose!) The devices are different – one is for informing therapy, while one is for delivering therapy, and the synergy between them (with automated algorithms) is going to be even greater than their individual, siloed use. Perhaps the biggest question facing the field is going to be patient selection and treatment cadence, especially with connected pens coming to market (Companion Medical’s InPen launched in the US in December and is slated to rollout to the EU in 2019). Who should get MDI/CGM/decision support vs. pump/CGM with hybrid closed loop automation?

•  (6:45 PM – 8:15 PM, Rapoport Hall) Innovation Within Insulin Management of Type 1 Diabetes (Sponsored by Novo Nordisk). Dr. David Russell-Jones’ (Royal Surrey County Hospital, Guildford, UK) will chair Novo Nordisk’s Wednesday symposium on the frontier of insulin development in type 1 diabetes. The session will begin with Dr. Bernard Zinman (University of Toronto, Canada), who will provide an overview of basal insulins – presumably with a focus on Novo Nordisk’s next-gen Tresiba. Of note, the FDA recently approved a label update for Tresiba, which now includes data from DEVOTE (40% risk reduction for severe hypoglycemia with Tresiba vs. standard care Lantus); the EMA added DEVOTE to the European label in 3Q17. Dr. Elmar Jaeckel (Medizinische Hochschule Hannover, Hannover, Germany) and Dr. David Klonoff (UCSF, San Francisco, CA) will then turn the discussion to mealtime insulins, including a perspective on next-gen mealtime insulins (Novolog and Fiasp) in pumps. Closing out the session will be Novo Nordisk’s own Dr. Ken Coppieters (Type 1 Diabetes Center, Søborg, Denmark) looking to future treatment options beyond insulin for type 1 diabetes.

• (6:45 PM – 8:15 PM, Ehrlich Hall) Fighting the Prediabetes Pandemic (Sponsored by Merck KGaA). Hat’s off to Merck for shedding light on the prediabetes epidemic (more than 84 million Americans per CDC estimates) with this corporate symposium. The session features Dr. José Silva-Nunes (Centro Hospitalar de Lisboa Central, Lisbon, Portugal) on the facts and figures of the prediabetes epidemic (we’ll keep our ears open for updates to the CDC’s estimates), Dr. Marinella Temprosa (George Washington University, Washington DC, US) on how to curb prediabetes onset with lifestyle, and Dr. Guangwei Li (China-Japan Friendship Hospital, Beijing, China) on medication recommendations for pre-diabetes. Of note, Dr. Temprosa compellingly argued for metformin as a cost-effective solution to the growing global prediabetes epidemic during a similar Merck-sponsored corporate symposium at EASD 2017 and is the PI of the Biomarkers for Outcomes in the Diabetes Prevention Program – a sub-study of the NIDDK-sponsored DPP. Surely this study will arise given her talk is centered on lifestyle and prediabetes, and we’re eager to hear any new results.

• (7:00 PM – 8:00 PM, Spener Hall) SGLT-2 Inhibitors – Why Would You Not Use One? (Sponsored by AstraZeneca). This jam-packed AZ symposium features a star-studded lineup of KOLs, starting with general background from Dr. Mikhail Kosiborod (Mid America Heart Institute of Saint Luke's Hospital, Kansas City, MO), who presented CVD-REAL 2 results at ACC 2018, which revealed a 49% risk reduction on all-cause death and a 36% risk reduction on hospitalization for heart failure for patients initiated on any SGLT-2 inhibitor (although 75% of SGLT-2 exposure in this real-world study was to AZ’s dapagliflozin). Dr. Richard Holt (University of Southampton, Southampton, UK), will follow with a practical assessment of diabetes therapies in 2018, presumably with an emphasis on how SGLT-2 inhibitors measure up to the competition. Prior to a concluding discussion (which is scheduled for nearly half of the hour-long symposium!), Dr. Juris Meier (Ruhr-Universitat Bochum, Bochum, Germany) will break down the barriers currently preventing optimal treatment for those with diabetes.

Thursday, October 4

• (8:30 AM – 10:00 AM, Langerhans Hall) Comparative Effectiveness of Cardiovascular Outcomes in New Users of SGLT2 Inhibitors (CVD-REAL). CVD-REAL, which reported results in 2017, represented the largest real-world study of SGLT-2 inhibitors on heart failure and hospitalization. Observational in nature, CVD-REAL demonstrated significant reductions in heart failure hospitalization risk when compared to other glucose-lowering agents, along with significant reduction in all-cause mortality as well. These promising results aligned with those seen in CVOTs for this class of agents and strengthened the promise of SGLT-2 inhibitors in paving a new path of diabetes care beyond A1c. We are excited to hear further analyses of this important trial during this session. Dr. Matthew Cavender (University of North Carolina, Chapel Hill, North Carolina, United States) will overview the study’s design along with primary and secondary findings, while Dr. Kare Birkeland (University of Oslo, Oslo, Norway) will delve into the regional impacts seen across the six different countries that patients were enrolled from in the study. Dr. Kamlesh Khunti (University of Leicester, Leicester, United Kingdom) will then take on the exciting task of integrating findings from CVD-REAL with existing CVOT data. We have heard thought leaders in the past comment that the wide distribution of SGLT-2 products used and the compelling risk reductions for death and heart failure hospitalizations in CVD-REAL  point toward a class effect--will Dr. Khunti echo these thoughts? In our view, real-world data like the one presented in this study are essential along with CVOTs in order to generate a more complete picture for patients and providers. Moving along, one of the highlights of this session will surely be the great Dr. Mikhail Kosiborod (Saint Luke’s Mid-America Heart Institute, Kansas City, Missouri, United States), who is the lead researcher for CVD-REAL, discuss the clinical implications of the trial and potential future directions. We hope Dr. Kosiborod gives his opinion on how CVD-REAL has affected prescribing practices and perhaps how it has influenced future real-world studies in its vein. Finally, Dr. Eleuterio Ferrannini (University of Pisa, Pisa, Italy) will provide general commentary on the study and subsequent analyses of its results.

• (8:30 AM – 10:00 AM, Virchow Hall) EASE Programme: Empagliflozin as an Adjunct to Insulin in Type 1 Diabetes. This presentation of full results for the EASE program is surely bound to be one of the most highly-anticipated at EASD 2018. At ADA 2018, we got a brief taste of EASE results in the form of very high topline results that did not include specific numbers. As a reminder, the EASE program randomized 1,680 type 1 patients to either empagliflozin or placebo treatment. Topline results at ADA 2018 showed that EASE-2 (n=720) and EASE-3 (n=960) both met their primary endpoint of superior A1c reductions with the SGLT-2 vs. placebo after 26 weeks, and very notably, the 2.5 mg empagliflozin dose used in EASE-3 demonstrated significant glycemic efficacy (and weight loss efficacy) without a significant spike in DKA. Of course, DKA risk with SGLT-2 adjunct therapy in type 1 patients remains a hot button issue. We could not be further on the edge of our seats to see full results for EASE, especially to analyze more data concerning lower doses of empagliflozin (2.5 mg) that allegedly provide nearly all of the benefits of higher doses of treatment without the usual increase in DKA risk. These results at ADA 2018 seemed far too good to believe--but if the full results confirm this, then wow!! The always entertaining Dr. Jay Skyler (University of Miami, Miami, Florida, United States) will kick off the session by advocating for the need for adjunct therapies in type 1 patients. Dr. Julio Rosenstock (University of Texas, Dallas, Texas, United States) will present on the efficacy of empagliflozin treatment, Dr. Bruce Perkins (University of Toronto, Toronto, Canada) will importantly present on safety results with a focus on hypoglycemia, Dr. Lori Laffel (Joslin Diabetes Center, Boston, Massachusetts, United States) will give advice on how to translate these results into clinical practice, and finally Dr. Thomas Pieber (Medical University of Graz, Graz, Austria) will provide commentary on the results. Boy oh BOY we can’t wait for this!!

• (8:30 AM – 10:00 AM, Koch Hall) EASD/EASL Symposium: Diabetes and NAFLD. We’re excited to see this session tackle the growing intersection of diabetes and NAFLD. Dr. Laurent Castera (Hopital Beaujon, Clichy, France) will start the session with a discussion of best practices concerning how to diagnose and monitor patients with NAFLD. As with many conditions, early diagnosis and treatment of NAFLD remains a key component of successful patient outcomes, and we’re glad that Dr. Castera will emphasize this right off the bat in this session. Next, Dr. Christopher Byrne (University Hospital Southampton, Southampton, United Kingdom) will present on the liver and extra-hepatic complications of NAFLD, such as cardiovascular disease and cancer (in fact, the majority of deaths related to NAFLD are a result of these extra-hepatic complications). Finally, Dr. Hannele Yki-Jarvinen (University of Helsinki, Helsinki, Finland) will discuss how diabetes plays into NAFLD disease progression and various treatment options. Specifically, she will focus on how lifestyle and pharmacological treatments can be used in NAFLD and diabetes.  

• (10:15 AM – 11:45 AM, Langerhans Hall) Oral Presentation 25: Hypoglycemia: Consequences and prevention. Ms. Julia Hermann (Ulm University, Germany) will present real-world data from the DPV registry to determine outcomes (A1c, severe hypoglycemia, and DKA) in pediatric subjects during the first year following initiation of CGM. We’ll also hear from Lilly’s Dr. Jeffrey Suico on the efficacy of nasal glucagon to treat hypoglycemia in adults with type 1 diabetes. Lilly submitted nasal glucagon to both FDA and EMA as of the company’s 2Q18 call, marking the first regulatory submission to come out of the next-gen glucagon competitive landscape. Interestingly, Zealand’s market research has shown that patients prefer an easy-to-use pen rather than nasal spray for glucagon; of course, what matters more for uptake here is what caregivers/HCPs will find easier (they would be the ones administering it) and where pricing/payer contracts end up.

•  (10:15 AM – 11:45 AM, Heubner Hall) Oral Presentation 28: Novel Drug Therapies: Moving Beyond GLP-1. In this session, we’ll get some rapid fire updates on various novel drug therapies for diabetes, with an emphasis on emerging dual and triple agonists. A team of Sanofi-sponsored researchers from Italy and Germany will present on SAR425899, a dual GLP-1/GCGR agonist that is currently in phase 2 for obesity studies. We’ll be sure to be on the lookout for commentary on tolerability concerns for this agent, which Sanofi fears may cause delays in its progression into phase 3. We’re also excited to learn more about Hanmi’s GLP-1/GIP/glucagon triple agonist; Hanmi representatives will present here on potential neuroprotective effects of their agent that have been observed in various disease models. For context, the last we heard about this candidate was in the context of its addition to basal insulin; data on this combination was presented at ADA 2018, showing impressive glucose lowering and weight loss in diabetic animal models. For sure, many of the candidates presented in this session are far away from clinical significance; nevertheless, we remain excited about the robust potential of these novel agents and what they could represent for the future of diabetes therapeutics.

• (12:00 PM – 1:00 PM, Virchow Hall) Single and Combined Stimulation of GIP and GLP-1 Receptors in the Treatment of Type 2 Diabetes. This exciting session features the highly-anticipated phase 2b results for Lilly’s injectable GIP/GLP-1 dual-agonist candidate; given that Lilly recently announced a webcast to discuss these results following the EASD presentation, we’re expecting good news though that is speculative. To kick off the proceedings, Dr. David D’Alessio (Duke, Durham, NC) will provide background on GIP/GLP-1 dual agonists, followed by presentation of the results from Dr. Juan Frias (National Research Institute, Los Angeles, CA) and commentary from Dr. Matthias Tschöp (Helmholtz Zentrum Munchen, Munich, Germany). Importantly, this candidate is the first dual-agonist for diabetes to reach phase 3, with trials set to start in late 2018 or early 2019. For context, our GIP/GLP-1 competitive landscape includes a handful of other phase 1 and preclinical candidates (including GIP/GLP-1/glucagon tri-agonists from Novo Nordisk and Sanofi), while the larger GLP-1/glucagon competitive landscape features four promising phase 2 candidates. What’s more, during Lilly’s 2Q18 call Head of Diabetes and SVP Mr. Enrique Conterno emphasized the company’s “high bar for any type of next-generation incretin,” and Lilly has previously explained how critical it is for this candidate to demonstrate superiority vs. existing GLP-1 agonists, so we have high expectations for the phase 2 data. We’re very excited to see Lilly moving quickly on this candidate – if everything goes as planned, we’d estimate it could be approved by 2021 – and, pending the phase 2 readout, we’re also curious about the therapy’s potential in obesity. For reference, the candidate, LY3298176, completed a phase 2 trial (n=300) in type 2 diabetes in March 2018, in which it was compared to both placebo and dulaglutide (Trulicity).
• (1:15 PM – 2:15 PM, Langerhans Hall) Glycaemic Analyses from the CAMELLIA-TIMI 61 Trial. We got a small taste of glycemic data from the CAMELLIA-TIMI CVOT for Arena/Eisai’s obesity therapy Belviq (lorcaserin) just last month at ESC 2018, and we’re eager for more. As a reminder, the study indicated non-inferiority for Belviq vs. placebo on three-point MACE, raising questions about the relationship between weight loss and CV outcomes (albeit with only ~4 lbs treatment difference at 3.3 years). With respect to glycemic data from the study, incident diabetes was the only individual outcome presented that was significantly impacted by Belviq vs. placebo, with the former conferring a significant 19% relative risk reduction for new-onset diabetes vs. placebo - wow! As far as we know, this is the only outcome of the study that demonstrated superiority, and not just non-inferiority, of Belviq compared to placebo. As such, we’re intrigued to hear how Arena/Eisai’s obesity therapy may fare in other glycemic metrics. As for the schedule, Dr. Darren McGuire (UT Southwestern, Dallas, TX) will first provide background on obesity and pharmacologic weight-loss, followed by Dr. Erin Bohula (Brigham and Women’s Hospital, Boston, MA), who will rehash the CV data of CAMELLIA. The session will finish strong with Dr. Benjamin Scirica (Brigham and Women’s Hospital, Boston, MA) presenting full metabolic data.

• (1:15 PM – 2:15 PM, Poster Hall) Poster Session 66: Multiple Facets of Continuing Glucose Monitoring. The most-viewed abstract in this session is a real-world analysis from the UK examining the clinical impact of FreeStyle Libre in 2,211 users – the abstract indicates very positive outcomes on reducing A1c and patient satisfaction. This session also includes a Medtronic poster with real-world data from 1,183 children <15 years-old on the Guardian Connect CGM using predictive alerts. As a reminder, the Guardian Connect was approved in the US in March for use in 14-75 year-olds, so we’ll be eager to see if these results might support an expanded US pediatric indication. We’ll also see data on a new formula to determine eA1c from a three-month average of interstitial glucose measured by FreeStyle Libre in type 1s, as well as an accuracy assessment comparing the WaveForm Cascade CGM vs. FreeStyle Libre over 14 days. At ADA, we saw a poster comparing the WaveForm Cascade to the Dexcom G5, finding seven-day MARD vs. YSI to be similar between the Cascade system calibrated once-daily (10.4%) and G5 calibrated twice-daily (11.0%). As of that poster, a CE mark submission was planned for 3Q18-4Q18, with an EU launch as a 14-day CGM ambitiously expected for 1Q19. This session’s Dexcom poster associating several A1c ranges with CGM-derived parameters – pooling DIAMOND Phase 1 and Phase 2, REPLACE-BG, and HypoDE – appears to be the same as the poster we saw at ADA.

• (2:30 PM – 4:00 PM, Langerhans Hall) Oral Presentation 31: Nephropathy: Bedside and Back to Bench. Headlining these presentations on kidney disease in diabetes will be a secondary, pooled analysis of the DEVOTE CVOT comparing Novo Nordisk’s next-gen basal insulin Tresiba (insulin degludec) to standard of care, Sanofi’s Lantus (insulin glargine). For context, 85% of the enrolled population in the study had established cardiovascular disease or chronic kidney disease and the remaining 14% and 15% had cardiovascular risk factors. When considering this entire population, Tresiba demonstrated non-inferiority for the three-point MACE and a significant 40% risk reduction in severe hypoglycemia compared to Lantus. The catch for the secondary analysis being presented here? Only those with established chronic kidney disease will be considered. In context of the shifting paradigm towards outcomes beyond A1c in diabetes care, it is important that next-generation therapies confer additional benefits on top of better glycemic control compared to previous standards of care. Needless to say, we’re eager to see the results.
• (5:15 PM – 6:15 PM, Langerhans Hall) Cardiovascular and Renal Microvascular Outcome Study with Linagliptin in Patients with Type 2 Diabetes Mellitus (CARMELINA). What a session this promises to be. We’ve been eagerly awaiting full results from CARMELINA (CVOT for Lilly/BI’s DPP-4 inhibitor Tradjenta) since the study’s topline readout in July, which found non-inferiority to placebo on the three-point MACE. While this result was not unexpected - the TECOS (Merck’s Januvia), EXAMINE (Takeda’s Nesina), and SAVOR-TIMI (AZ’s Onglyza) CVOTs have all been published, and each found non-inferiority for a DPP-4 vs. placebo on three-point MACE - there are several endpoints that could seriously differentiate Tradjenta from other DPP-4 inhibitors. Firstly, it’ll be important for CARMELINA to establish Tradjenta’s safety for heart failure hospitalization, as SAVOR-TIMI showed increased risk on this endpoint with Onglyza. for heart failure hospitalization associated with Onglyza. We’re also especially curious about the renal data from this CVOT. Lilly/BI have been promoting Tradjenta as the only DPP-4 inhibitor available that doesn’t have to be dose-adjusted with falling eGFR, and CARMELINA results that show long-term renal safety could play in to this strategy. Moreover, data suggesting renal protection could be game-changing – at EASD 2017, Dr. Per-Henrik Groop pointed to smaller, shorter trials that have hinted at Tradjenta’s renal benefits, and he noted that CARMELINA will be more telling, because the renal effects of linagliptin are believed to work via a longer-term, anti-fibrotic mechanism. This session will be chaired by Dr. Julio Rosenstock (Dallas Diabetes Research Center, Dallas, Texas). Dr. Robert Toto (UT Southwestern, Dallas, TX) will present study design, Dr. Steven Kahn (University of Washington, Seattle, WA) will go through baseline characteristics and metabolic outcomes, Dr. Darren McGuire (UT Southwestern, Dallas, TX) will present the CV outcomes, Dr. Vlado Perkovic (George Institute for Global Health, Sydney, Australia) will provide the renal outcomes, Dr. Mark Cooper (Baker Heart and Diabetes Institute, Melbourne, Australia) will present hypoglycemia and safety results, and Dr. Bernard Zinman (University of Toronto, Canada) will tie it all together.

• (5:15 PM – 6:15 PM, Virchow Hall) New Approaches to Diabetes Risk in Urban Areas. In so many of the presentations we attend at diabetes conferences, we see “environmental factors” referenced only briefly in an introductory slide on the causes of the diabetes epidemic, before the presenter goes on to discuss some aspect of diabetes pharmacotherapy or technology. While there are undoubtedly conferences about urban infrastructure that we’re not attending, and while of course drug and device solutions are vital in improving diabetes care for patients today, slowing the long-term rise in diabetes prevalence clearly will also require broader changes to our environment. Perhaps the most impressive example of an initiative to make these changes is Novo Nordisk’s Cities Changing Diabetes program, which seeks to map urban diabetes through data collection, best practices development and dissemination, and coordination and encouragement in multiple respects among multiple stakeholders. The 16-city program now touches ~120 million people worldwide on every (inhabitable) continent apart from Australia. In this exciting symposium we will hear from two of the programs directors. First, Prof. David Napier (UCL, London, UK) will provide insight into how to approach action research on urban diabetes, followed by Mr. Steffen Nielsen (Novo Nordisk, Bagsværd, Denmark) who will dive into how public-private partnerships, such as Cities Changing Diabetes, can move the needle on urban diabetes.

•  (6:30 PM – 8:00 PM, Langerhans Hall) CARMELINA: Translating State-of-the-Art Science into Tailored Type 2 Diabetes Management in Clinical Practice (Sponsored by BI/Lilly). Oh boy what a session this promises to be. Full results from CARMELINA (CVOT for Lilly/BI’s DPP-4 inhibitor Tradjenta) are set to be presented immediately prior to this symposium – which features over an hour of panel discussion and Q&A. As a reminder, the topline readout of CARMELINA showed non-inferiority to placebo on the three-point MACE, the same as all other DPP-4 CVOTs. However, we’re especially curious about the renal data from this CVOT. Lilly/BI have been promoting Tradjenta as the only DPP-4 inhibitor available that doesn’t have to be dose-adjusted with falling eGFR, and CARMELINA results that show long-term renal safety could play in to this strategy. Moreover, data suggesting renal protection could be game-changing – at EASD 2017, Dr. Per-Henrik Groop pointed to smaller, shorter trials that have hinted at Tradjenta’s renal benefits, and he noted that CARMELINA will be more telling, because the renal effects of linagliptin are believed to work via a longer-term, anti-fibrotic mechanism. As for symposium structure, Dr. Darren McGuire (UT Southwestern, Dallas, TX) will briefly review the results, followed by a discussion and Q&A session featuring Prof. Melanie Davies (University of Leicester, Leicester, UK), Dr. Per-Henrik Groop (University of Helsinki, Helsinki, Finland), and Dr. McGuire, narrated by Dr. Bernard Zinman (University of Toronto, Toronto, Canada).

• (6:30 PM – 8:00 PM, Frerichs Hall) Empowering Patients to Take Control of Insulin Titration (Sponsored by Sanofi). This patient-centered symposium will kick off with Dr. Francesco Giorgino (Università degli Studi di Bari Aldo Moro, Bari, Italy) delineating the importance of starting off on the right foot with insulin titration, followed by two, 15-minute sessions on data behind titration: (i) Dr. Javier Ampudia-Blasco (Hospital Clínico Universitario de Valencia, Valencia, Spain) on differences in titration between insulins; and (ii) Dr. Robert Ritzel (Klinnikum Bogenhausen, Munich, Germany) on next-gen basal insulins. Our best guess is that both sessions will focus on the BRIGHT study, which was presented at ADA and found that Sanofi’s Toujeo offered less hypoglycemia risk vs. Novo Nordisk’s Tresiba during the study’s titration period (first 12 weeks), although there was no difference overall in the 24-week study period. 2009 Diabetes Educator of the Year Ms. Lori Berard (University of Manitoba, Manitoba, Canada) and Dr. Stewert Harris (Schulich School, London, Canada) will wrap up the session with advice on how to empower patients in the difficult task of insulin titration.

• (6:30 PM – 8:00 PM, Spener Hall) Connected Self-Monitoring of Blood Glucose – “A Future Perspective” (Sponsored by LifeScan). We were interested to see a LifeScan corporate symposium – the BGM business has been very quiet since J&J accepted Platinum’s bid to acquired the business for ~$2.1 billion in June. (Transaction to close by the end of 2018.) We’re eager to hear any updates on how LifeScan will be managed under Platinum; as of March, J&J Diabetes Care President Ms. Valerie Asbury was slated to continue leading LifeScan. LifeScan Director of Marketing Mr. David DeJonghe’s presentation is intriguingly titled “Revealing the Future.” With the right investment, we’re cautiously optimistic that LifeScan can recover, especially because CGM is still many years away from standard of care in type 2 diabetes. While the OneTouch Reveal app is very highly-rated on the App Store (4.7/5 stars; 18,600 ratings) and Google Play (3.9/5 stars; 6,664 ratings), and the OneTouch Verio Flex integration with WellDoc could bring valuable education and support to type 2s, staying afloat as a BGM company amidst rising CGM popularity in the highest-frequency testers is no easy task. Might LifeScan consider acquiring a CGM to broaden its portfolio? We’re also excited to hear from LifeScan’s Dr. Mike Grady, who will detail the latest clinical evidence for BGM accuracy. Both the OneTouch Verio and OneTouch Ultra2 did not quite pass DTS’ BGM Surveillance Program, and we imagine Dr. Grady will reiterate the brand’s strict standards and focus on quality. UCSD’s Dr. Steve Edelman will detail the value of connected BGM, while Bournemouth University’s Professor Katharine Barnard will provide insight on selecting the right BGM for the right patient.

• (6:30 PM – 8:00 PM, Rapoport Hall) Overcoming the Challenges of Weight Management in Clinical Practice (Sponsored by Novo Nordisk). Novo Nordisk’s Saxenda (liraglutide 3.0 mg), the shining bright spot in the obesity landscape, will be the star of this symposium, which begins with Dr. Carel le Roux (University College Dublin, Dublin, Ireland) on how the GLP-1 receptor functions as a target for weight management. Obesity expert Dr. Arya Sharma (University of Alberta, Edmonton, Canada) will follow with an assessment of weight management in clinical practice, and psychologist Dr. Michael Vallis (Dalhousie University, Halifax, Canada) will close with strategies to sustain behavior change. For context, Dr. Vallis gave a riveting speech at Diabetes Canada 2017 on overcoming clinical inertia and “psychological insulin resistance” – the feelings of fear and reluctance surrounding the initiation of insulin therapy – through motivational communication.

• (6:30 PM – 8:00 PM, Ehrlich Hall) High CV Risk Populations Who May Benefit the Most from PCSK9 Inhibitor Therapy: Highlights from the Most Recent ODYSSEY Outcomes Data (Sponsored by Sanofi/Regeneron). This symposium will take a deep dive into the most recent data from ODYSSEY, the CVOT for Sanofi/Regeneron’s PCSK9 inhibitor Praluent (alirocumab) in patients with acute coronary syndrome, which revealed a significant 15% relative risk reduction on a primary composite MACE endpoint and an observational endpoint of all-cause death compared to placebo. An interesting question came up during the initial readout at ACC 2018 comparing ODYSSEY to FOURIER (CVOT for Amgen’s PCSK9 inhibitor Repatha). For context, the latter enrolled a healthier study population, yet results between the two are nearly identical. Should we have expected a greater risk reduction with a sicker population and longer follow-up in ODYSSEY? To be sure, we’ll be listening intently for any comparison of the two CVOTs during this symposium, which features Dr. Ulrich Laufs (University of Saarland, Homburg, Germany), Dr. Helen Colhoun (University of Edinburgh, Edinburgh, UK), and Dr. Klaus Parhofer (Ludwig Maximilians University of Munich, Munich, Germany).

• (6:30 PM – 8:00 PM, Tiburtius Hall) New Insights for Clinician Choices in the Treatment of Patients with Type 2 Diabetes (Sponsored by Merck). This is a shorter version of Merck’s Monday symposium (2:30 PM – 5:00 PM, Heubner Hall), featuring Dr. Michael Nauck (University of Copenhagen, Copenhagen, Denmark), Dr. Oliver Schnell (Ludwig Maximilians University, Munich, Germany), Dr. Ronan Roussel (Centre de Recherche des Cordeliers, Paris, France), Dr. Richard Pratley (Florida Hospital Diabetes Institute, Orlando, FL), and Dr. Ronald Goldenberg (NYU, New York, New York).

• (7:00 – 9:00 PM, Wasserwerk Berlin) The diaTribe Foundation’s Fifth Annual “Solvable Problems in Diabetes” event. Get tickets here! This not-to-miss program will feature KU Leuven’s Prof. Chantal Mathieu and Portsmouth Hospitals NHS Trust’s Dr. Partha Kar in conversation with our own Adam Brown. We expect a big focus on diabetes technology and use of CGM, novel models of diabetes care, use of SGLT-2’s in type 1 diabetes, HCP challenges in Europe, and much more from these two type 1 diabetes experts. Read our coverage from last year’s event here. Be sure to register here!

Friday, October 5

• (8:00 AM – 9:30 AM, Langerhans Hall): Management of Hyperglycemia in Type 2 Diabetes: ADA-EASD Consensus Report 2018. Following the presentation of the draft Consensus Report at ADA 2018, we’re looking forward to hearing how public comments and suggestions might have affected the writing committee’s recommendations in this update to the 2015 consensus report. At ADA, the audience praised the recommendation of GLP-1 agonists as first-line injectable therapy (before basal insulin, except in certain cases), but audience members were somewhat critical that SGLT-2s were not recommended for renal protection, as they were for heart failure treatment. We’ll keep a close eye on how public comments may have swayed the recommendations in one direction or the other. Of high note, Oxford’s Dr. David Matthews and ADA’s Dr. Will Cefalu will discuss implications from the EASD and ADA perspectives. Drs. John Buse and Melanie Davies chair the writing committee and will be joined by committee members Drs. David D’Alessio, Judith Fradkin, Walter Kernan, Chantal Mathieu, Geltrude Mingrone, Peter Rossing, Apostolos Tsapas (Dr. Deborah Wexler is also a committee member).

• (8:30 AM – 9:30 AM, Virchow Hall): The Lancet Commission on Diabetes: Practical Strategies to Conquer Diabetes. Within this symposium, we’re most interested in a talk from CDC’s Dr. Edward Gregg on the prioritization of diabetes prevention across country income levels. We’re very curious to hear what Dr. Gregg views as the most effective diabetes prevention strategies, but also how a prevention program’s effectiveness might vary depending on a country’s development. We’ll also hear a review of societal prevention policies aligned with WHO and UN guidelines, featuring examples from low- and middle-income countries, as well as a talk on team-based prevention, detection, and treatment.

• (8:30 AM – 9:30 AM, Koch Hall) Digital Diabetes Health: From Now to the Future. Dr. David Klonoff (Mills-Peninsula Health Services, San Mateo, CA) will provide an overview of the use of digital health to increase adherence. Also in this session, Dr. Ricard Bellazi (University of Pavia, Italy) will detail how to leverage data mining to improve diabetes outcomes.

• (8:30 AM – 9:30 AM, Heubner Hall) Deconvoluting Big Data: Seeing the Trees in the Forest. Professor Ewan Pearson (University of Dundee, UK) will discuss the use of genomics and big data in stratifying diabetes. At WCPD, Prof. Pearson referenced the Lancet D&E paper describing five subtypes of diabetes and asserted that these subgroups are not actually very distinct; rather the data resemble a cloud. Still, he found it conceptually useful to map patients within “pathophysiological space” to better understand molecular mechanisms and risk of complications. We’re looking forward to further detail on this interesting topic. Dr. Annika Rosengren (University of Gothenburg, Sweden) will discuss tactics for translating big data into clinical application. At the Helmsley Charitable Trust/JDRF Meeting on Big Data in August, we heard ample discussion on several applications for big data in diabetes, including primary prevention, diagnosis, treatment, and reduction of healthcare costs. We’ve been hearing lots of talk on this front and hope to see some actual output soon.

• (12:15 PM – 1:45 PM, Langerhans Hall): Main Results from the Large EU-Project PREVIEW: PREVention of Diabetes Through Lifestyle Intervention and Population Studies in Europe and Around the World. This symposium includes the primary results from PREVIEW, a multi-national diabetes prevention project in people with prediabetes aiming to identify the “most efficient lifestyle pattern” for prevention of type 2 diabetes. PREVIEW includes both an RCT (n=2,500) in children and adults and large population studies focused on diet, exercise, and a variety of lifestyle and background factors. On Friday, we’ll see the main results from both arms of the program, alongside a talk on the role of the brain and behavior in the development of type 2 diabetes. We’re always looking to better understand behavior, prevention, and the relationship between the two, so we’re very much looking forward to any insight to be gained from this session.

• (12:15 PM – 1:45 PM, Heubner Hall) EASD/AASD Symposium: Tackling Diabetes at a Whole System Level. Diabeter’s founder Dr. Henk Veeze will hopefully provide an update on the Medtronic-owned chain of Dutch clinics with an advanced integrated care model that delivers value-based medicine. Last we heard at ATTD, Diabeter cares for 2,500 patients, up from just 200 a decade ago, and is beginning to take care of adults (past the age of 25) who don’t want to age out of the unique Diabeter model. At the HCT/JDRF Big Data in Type 1 workshop in August, JDRF’s Dr. Aaron Kowalski lauded Diabeter as a model for value-based care, advocating that the US needs to “rip off the band-aid” and build a healthcare system so that when it comes time to plug in solutions, the right ones can be selected for the right reasons. We’ll be very interested to hear more on how Diabeter is pushing health systems around the world towards value-based care.

• (12:15 PM – 1:45 PM, Virchow Hall): Combination Therapy for Type 2 Diabetes: Challenges and Controversies. Dr. David Matthews will chair a session including talks from Dr. Stefano Del Prato on early-initiation of combination therapy, Dr. Tina Vilsbøll on fixed-ratio vs. free combinations, and Dr. Matthias Tschöp on dual and tri-agonists. We expect Dr. Del Prato will focus heavily on Dr. Ralph DeFronzo’s EDICT trial, which put metformin/exenatide/pioglitazone combination therapy up against metformin/insulin/SUs; six-year results just presented at ADA 2018 were very positive. Dr. DeFronzo said at Keystone 2018 that, if designed today, he would test a GLP-1/SGLT-2/pioglitazone combo, so we’ll also be looking for Dr. Del Prato’s thoughts on this more aggressive combination regimen. We’re also very much looking forward to Dr. Vilsbøll’s thoughts on barriers to fixed-ratio combination uptake: In our view, the added convenience and remarkable efficacy offered by Novo Nordisk’s Xultophy and Sanofi’s Soliqua are a huge win for patients. However, we’re also aware of limitations in how high doses can be titrated and the fixedness of the ratio between the two components/which agents can be combined, which we understand many providers find off-putting; we’re sure Dr. Vilsbøll will have additional insight to share – she is an extraordinarily gifted speaker. Finally, we’ll be interested to hear Dr. Tschöp’s take on the balance of safety and efficacy with dual and tri-agonists: While Lilly has expressed very high enthusiasm about its phase 3 GIP/GLP-1 dual agonist (phase 2 results to be presented on Thursday), Sanofi saw significant tolerability issues with its GLP-1/glucagon dual agonist. What profile would represent a meaningful improvement over GLP-1 agonists?

• (12:15 PM – 1:45 PM, Hirsch Hall): Cures for Diabetes? In a fairly broad session, we’ll hear from UK’s Dr. Colin Dayan about immunotherapy for type 1 diabetes – to date, a field that has seen more challenges than victories but also one that holds great promise. Dr. Dayan’s current research is on antigen-specific immunotherapy; what benefit might this approach offer? Dr. Fatima Bosch will address gene therapy for type 2 diabetes, a proposition that we understand to be remarkably complicated, given the high number of genetic variants contributing to type 2 diabetes risk. Additionally, Dr. Andrew Schaefer will discuss mitochondrial donation and mitochondrial diabetes.

• (12:15 PM – 1:45 PM, Koch Hall): Diabetes and the Mind: Psychological Aspects. This powerhouse session features Dr. Bill Polonsky on identifying and addressing diabetes distress and Professor Thomas Danne on the importance of glycemic variability, as well as Dr. Frans Pouwer on the impact of depression and anxiety on glycemic control. Given Professor Danne’s prominent leadership on the front of adjunct therapies for type 1 diabetes, we’re very excited to get his full take on the impact glycemic variability has on both patient experiences and outcomes. Fueled by the outcomes beyond A1c movement, the rise of CGM, and growing use of non-insulin therapies in people with type 1 diabetes, the issue of glycemic variability continues to receive ever-increasing attention. At Keystone 2018, Dr. Irl Hirsch called for a dedicated outcomes trial of glycemic variability in type 1. Moreover, based on the data available to far, SGLT inhibitors in type 1 seem to offer an impressive benefit on time-in-range despite arguably less striking effects on A1c. How might Professor Danne weigh this time-in-range benefit against the increased risk of DKA that comes with these agents, particularly from a psychological perspective?

--by Ann Carracher, Martin Kurian, Peter Rentzepis, Maeve Serino, Adam Brown, and Kelly Close