Memorandum

Conference Preview: EASD 2015 – August 24, 2015

September 14-18, 2015 – Stockholmsmässan Exhibition and Convention Center – Stockholm, Sweden

Primary Conference Agenda

Pre-Conference Events: Industry Agenda

Conference Website

2014 Full report

Hallå! From September 14-18, our team will head across the Atlantic to Stockholm, Sweden to attend the 51st Annual Meeting of the European Association for the Study of Diabetes (EASD). This year’s conference will feature 264 oral presentations (identical to last year in Vienna), 40 symposia (up from 33 last year), 22 corporate symposia (up from 17 last year!), and 1,202 posters (down from 1,323 last year). We’re in for a busy few days …

On the drug side, the presentation of full results from the EMPA-REG OUTCOME trial of Lilly/BI’s SGLT-2 inhibitor Jardiance (empagliflozin) stands to be the highlight of the conference. As a reminder, the companies announced topline results from the trial just last week demonstrating cardiovascular risk reduction with Jardiance vs. placebo, and we are very eager to gain a better understanding of the magnitude and implications of these groundbreaking results (see our initial report for the slew of questions to which we’ll be trying to find the answers). We are also looking forward to new data from a phase 2 trial of J&J’s SGLT-2 inhibitor Invokana (canagliflozin) in type 1 diabetes, which should help provide more clarity on the class’ risk/benefit profile in this population in the face of the recent concerns about ketoacidosis (based on our conversation with the renowned Dr. Irl Hirsch, we’re imagining that the response to SGLT-2s from type 1s is likely more homogenous across type 1s than the response to GLP-1, which we learned a bit more about today – see today’s report on Novo Nordisk opting not to submit liraglutide for type 1 right now). The agenda also includes several sessions on the latest in the insulin and GLP-1 agonist arenas, including a number of presentations on Novo Nordisk’s Xultophy (insulin degludec/liraglutide) and data on Lilly’s controversial basal insulin peglispro and Intarcia’s ITCA 650.

EASD is always lighter on diabetes technology, and this year has just two non-sponsored sessions: an ADA/EASD session on diabetes devices (joint insulin pump statement, Bionic Pancreas, Cambridge team on European closed loop work) and an oral presentation session on devices changing the treatment paradigm. The last two years have seen the biggest device updates in corporate symposia, and this year may be no exception. Abbott, BD, Dexcom, and Roche will all have sessions during EASD, and we’ll be following especially closely for updates on Abbott’s FreeStyle Libre (after one year on the EU market); BD’s FlowSmart infusion set (with partner Medtronic, slated for a 2016 launch); Dexcom’s Gens 5, 6, and new partnership with Google; and Roche’s new Accu-Chek Connect meter and plans on the CGM front.  

The usual packed two-day lineup of corporate and non-commercial symposia preceding the scientific sessions will feature 17 companies and eight organizations, including Abbott, AstraZeneca, BD, Dexcom, BI/Lilly, J&J/Janssen, Merck, Novartis, Novo Nordisk, Roche, Sanofi, and Takeda. Even in slower years, these days are packed and we’ll be very busy during these days in particular. The non-commercial symposia before the meeting will touch on a range of topics in diabetes, from beta cell imaging to global data on diabetes and obesity research.

Below, we have included a list of some of the most notable sessions, organized chronologically – pre-conference industry-sponsored sessions come first, followed by the conference schedule. Please note that times and locations are subject to last minute changes so if you are onsite, please check your schedules to make sure the rooms and times haven’t changed. Unlike at ADA, where all the conference symposia are at 5 am and 8 pm, all the corporate symposia are in the “pre-conference” the weekend before; once the meeting starts, things actually slow down a tiny bit.

See EASD’s very user-friendly virtual meeting portal for the full program, as well as a view count to see how many people have clicked on which sessions (Tuesday’s curiously titled oral session “Sledge Hammers to Crack Nuts,” is currently leading the way with 492 views – how crazy is that! – followed by Wednesday’s “Growing Experience with GLP-1 Receptor Agonists” with 475 views – the race is on!) Also, be sure to check out EASD’s display of who is looking at their website around the world … Gee, we wonder why San Francisco is currently leading the charge?? <grin> We hope to see you next month in Sweden 0r to be keeping you in touch from afar!

Sunday, September 13 (Pre-Conference Day)

  • (2:00 pm – 5:00 pm, Pirart Hall) Non-Commercial Symposium: Immunotherapy for Type 1 Diabetes – Building on Success. Okay – we’re very excited about this session. Dr. Colin Dayan (Cardiff University, UK) will chair this pre-conference overview of promising immunotherapies for type 1 diabetes. Dr. Bart Keymeulen (University Hospital Brussels, Belgium) will provide a look at the future of anti-CD3 therapies – though this area of research suffered a major setback with the negative phase 3 results for Tolerx and GSK’s otelixizumab in 2011, the field has seen revived interest recently from GSK and that’s a big deal. In terms of other type 1 diabetes immunotherapies, Janssen’s Dr. Mark Rigby will present promising evidence on the immunosuppressive drug alefacept (presented at ADA in June), the very highly regarded Dr. Mark Atkinson (University of Florida, Gainesville, FL) will discuss the use of ATG and G-CSF to preserve insulin production in newly-diagnosed type 1 diabetes (promising results on this combination were presented at ADA 2014), and Dr. Mark Peakman will round out the symposium with an overview of CTLA-4 blockade.
  • (2:30 – 5:00 pm, Hodgkin Hall) Non-Commercial Symposium: Development of EU-Wide Pediatric Diabetes Educator Course. This symposium, opened by Dr. Thomas Danne (Kinderkrankenhaus, Hannover, Germany), will review the state of pediatric diabetes in Europe and bring in staff from the EU Pediatric Certified Diabetes Educator Course Project to discuss the project’s development and content. The second half of this symposium will focus on the role of the CDE within diabetes, as providers and parents will come together to discuss their perspectives. Dr. Karin Lange (Hannover Medical School, Hannover, Germany) will follow with what the “future perspective” on CDEs will be. We are glad to see a symposium focused on education and the growing role of the CDE, as our recent coverage of AADE has stressed the need for the field to recognize how we can collaborate with and leverage the skillset of the CDE in the move toward even greater team-based care.
  • (3:00 pm – 6:00 pm, Schmidt Hall) Non-Commercial Symposium: Emerging Issues in Diabetes. Dr. Mahmoud Ibrahim (San Antonio Community Hospital, Rancho Cucamonga, CA) will open this session will a provocatively titled lecture: “Pre-diabetes, when is it worth treating it?” We are big fans of early intervention, and we will be interested to hear the nuance Dr. Ibrahim brings to the discussion. Dr. Carani Sanjeevi (Karolinska Institute, Stockholm, Sweden) will follow by asking whether a proper diabetes diagnosis actually matters – we certainly hope our treatments are tailored enough to make his answer a resounding “YES,” though this does need to get much, much better – the ROI argument isn’t where it needs to be, is it? In addition, Dr. Agostino Consoli (University of Chieti-Pescara, Italy) will address the re-emerging role of glucagon in type 1 and type 2 diabetes, while Dr. Christopher De Block (University of Antwerp, Belgium) will compare and contrast metabolic syndrome and type 2 diabetes.

Monday, September 14 (Pre-Conference Day)

  • (9:00 am – 4:00 pm, Keen Hall) Corporate Symposium: Sanofi – Different Patients, Different Needs: Towards an Integrated Care Approach in Diabetes. In this all-day, Sanofi-sponsored corporate symposium, attendees will be treated to a comprehensive look at individualizing and integrating care for their patients with diabetes. The masterful Dr. Richard Bergenstal (International Diabetes Center, Minneapolis, MN) and Dr. Lars Rydén (Karolinska Institute, Stockholm, Sweden) will chair the program. The day is broadly divided into three categories: optimizing and advancing basal insulin, understanding and managing risk in diabetes care, and expanding the horizons of diabetes care. The wide-ranging topics will include the evolution of basal insulin, intensifying basal insulin therapy, hyper- and hypoglycemia, cardiovascular risk, cholesterol control, individualizing targets, diabetes technology (led by the always charismatic Dr. Steve Edelman), the patient-provider relationship, and integrated care. We expect the basal insulin presentations to include discussion of Sanofi’s newest basal insulin Toujeo (insulin glargine U300), which has received strong reviews since its launch, helped by a significant access help by the company – though the revenue doesn’t show it yet, we’re hopeful for Sanofi on the potential commercial strength of this drug. The diabetes-focused talks will then be followed by a dedicated session on the relevance of PCSK9 inhibition for patients with diabetes – we are very, very eager for this since people with diabetes (who have so much CVD) haven’t been a major focus (at all!) so far from the CV field and we believe these patients stand to benefit enormously (we spoke about this at the FDA Advisory Committee, where we were the one of only two advocates of nearly 20 to speak on the importance of approval for people with diabetes). The session, co-sponsored by Sanofi and Regeneron, follows the recent approval of the companies’ PCSK9 inhibitor Praluent (alirocumab) and likely reflects confidence in the product’s future blockbuster status.
  • (10:00 am – 3:20 pm, Hellerström Hall) Corporate Symposium: Novo Nordisk – Evolving Perspectives in Treating Diabetes and Obesity.
    • Like last year, the first segment of this daylong corporate symposium will focus mainly on obesity. A talk by Dr. Donna Ryan (Pennington Biomedical Research Center, Baton Rouge, LA) on personalizing the choice of obesity medications based on responder analyses promises to be a highlight. Dr. Michael Lean (University of Glasgow, UK) and Dr. Nicholas Finer (University College Hospital, London, UK) will speak more broadly about weight management strategies; Dr. Niels Vrang (Gubra, Hørsholm, Denmark) and Dr. Mansoor Husain (University of Toronto, Ontario, Canada) will focus on the mechanisms of action of GLP-1 agonists; and Dr. Luc Van Gaal (Antwerp University Hospital, Antwerp, Belgium) will discuss secondary outcomes in the SCALE trials for Novo Nordisk’s Saxenda (liraglutide 3.0 mg). Dr. Melanie Davies (University of Leicester, UK) will provide a transition to the more diabetes-focused afternoon session with a talk on managing diabetes in special populations.
    • Hot topics on the agenda for the afternoon session include basal insulin/GLP-1 agonist combinations and the implications of cardiovascular outcomes trials. Dr. Stephen Gough (Harris Manchester College, Oxford, UK) and Dr. John Buse (University of North Carolina, Chapel Hill, NC) will discuss the exciting “dual approach” of GLP-1 agonist/basal insulin combinations on the heels of the impressive DUAL V results for Novo Nordisk’s Xultophy (insulin degludec/liraglutide) presented at ADA. We continue to see these combinations as a potentially transformative class with some of the most compelling data out there. ELIXA investigator Dr. Marc Pfeffer’s (Brigham and Women’s Hospital, Boston, MA) talk on where the field is headed with regard to CVOTs also promises to be a highlight – though he may need to revise his remarks after the just-announced positive results from the EMPA-REG OUTCOME trial for Lilly/BI’s Jardiance (empagliflozin). We are also looking forward to a tag-team talk by Dr. Tim Heise (Profil, Neuss, Germany) and Dr. Christopher Sorli (Billings Clinic, Billings, MT) on “what is new in insulin treatment” – we imagine that Novo Nordisk’s faster-acting insulin aspart and oral insulin programs will be among the topics of discussion.
  • (10:00 am – 12:30 pm, Meyer-Schwickerath Hall) Corporate Symposium: Dexcom – Continuous Glucose Monitoring in 2015. Dexcom’s symposia pretty much always offer new pipeline updates and data, and we hope Mr. Jake Leach (VP of R&D, Dexcom, San Diego, CA) will offer the same in this session. We hope to hear updates on: (i) the FDA approval and launch of the G5 mobile app and new Bluetooth-enabled transmitter (currently under FDA review, with US launch expected this year); (ii) a pre-pivotal study of the 10-day-wear Gen 6 sensor (potential 2017 launch); (iii) a “robust” new data platform coming in 2H15; and (iv) further details on the recently announced collaboration with Google to develop a next-gen, low-cost, bandage-like, disposable CGM. The workshop will also feature Dr. Peter Adolfsson (University of Gothenburg, Sweden) on the clinical use of CGM and Dexcom’s Dr. Claudia Graham on the favorable economics of CGM (a topic she spoke on most recently at ADA 2015).
  • (10:00 am – 12:30 pm, Rahbar Hall B) Corporate Symposium: Pfizer – Translational Pursuits. This Pfizer-sponsored corporate symposium delves into the possibility of hyper-individualized precision medicine in diabetes. Topics include fine-tuning diabetes classification, the role of DNA variation in developing precision medicines, and individualizing targets based on genetics and other factors. We are very excited to see more applications of precision medicine to diabetes, as our sense is that it has received less attention compared to other disease areas in the past. That appears to be changing: President Obama specifically mentioned diabetes as an area of opportunity for the new NIH Precision Medicine Initiative in his 2015 State of the Union address, and we heard updates on several intriguing projects at Rachmiel Levine and ACC earlier this year. In our view, the enormous heterogeneity of the diabetes patient population makes the area an excellent match for precision medicine initiatives.
  • (10:30 am – 4:30 pm, Heding Hall) Corporate Symposium: AstraZeneca – Individualized Patient Care in Type 2 Diabetes: Translating Science to Practice. This all-day symposium includes presentations on a number of important big-picture questions in type 2 diabetes pharmacotherapy, including a talk by Dr. John Wilding (University of Liverpool, UK) on whether weight gain is inevitable, one by Dr. Tina Vilsbøll (Gentofte Hospital, Hellerup, Denmark) on delaying escalation to insulin therapy, and several in the afternoon about the promise of combination therapy. A move toward earlier, more aggressive combination therapy has been a recurring theme at recent AZ events, most notably at an Investor Day last November. We expect that the discussion could touch on the company’s saxagliptin/dapagliflozin (DPP-4 inhibitor/SGLT-2 inhibitor) fixed-dose combination, which is currently under regulatory review and received significant attention during AZ’s 2Q15 update. We are also looking very forward to Dr. Juris Meier’s (St. Josef Hospital, Bochum, Germany) talk on the safety of novel therapies for type 2 diabetes – the bar certainly keeps getting higher. We imagine he could address the ongoing DPP-4 inhibitor/heart failure controversy (which could lead to label changes for AZ’s Onglyza [saxagliptin]) and the recent concerns about ketoacidosis with SGLT-2 inhibitors (that’s barely been an issue in type 2 although of course safety is always very top of mind).
  • (1:30 – 5:00 pm, Heding Hall) Corporate Symposium: Novartis – The Future of Diabetes: Opportunities and Challenges. This afternoon symposium is divided into two parts, the first examining the vision’s opportunities and challenges and the second examining the reality’s opportunities and challenges. Speakers include Dr. Matthias Bluher (University Hospital Leipzig, Leipzig, Germany), Dr. Kamlesh Khunti (University of Leicester, Leicester, UK), Dr. Mark Cooper (Baker IDI Heart and Diabetes Institute, Melbourne, Australia), and Dr. Focke Ziemssen (University of Tuebingen. Tuebingen, Germany). Part two of this symposium will discuss if “optimized diabetes care can be accessible in the future” and if we will “be able to prevent the future.” While the titles remain pretty vague, we can speculate that this event may focus on larger public health issues that perhaps involve cost control, the scalability of diabetes prevention programs, and opportunities of digital health and technology – especially since Novartis has partnered with Google to develop a glucose-sensing contact lens (although it has been a few quarters since we have heard any updates on this, we don’t think that has anything to do with progress or lack thereof – we imagine they’ll be on the quiet side regardless of progress).  
  • (2:00 – 4:05 pm, Peltonen-Palotie Hall) Corporate Symposium: BI and Lilly – Getting to the Heart of Type 2 Diabetes. This cleverly-titled BI and Lilly-sponsored corporate symposium will investigate two literal and figurative “heart”-related considerations in diabetes care – cardiovascular risk and empathy among healthcare professionals. The first half of the program tackles managing cardiovascular risk in type 2 diabetes and the cardiovascular outcomes trials environment – especially timely following the release of positive topline results from the EMPA-REG OUTCOME CVOT for the companies’ SGLT-2 inhibitor Jardiance (empagliflozin). The second half examines the relationship between empathy on the part of healthcare providers and the success of insulin treatment. We love this unexpected pairing of two very important topics! This continues the field’s increased focus on behavior – long may this continue.
  • (2:30 – 5:00 pm, Doniach Hall) Corporate Symposium: MSD – Lessons Learned from the TECOS CV Safety Trial and the Evolving Role of DPP-4 Inhibitors in the Treatment of Patients with Type 2 Diabetes. Chaired by Drs. Rury Holman (University of Oxford, Oxford, UK) and Michel Komajda (University Pierre et Marie Curie, Paris, France), this symposium – sponsored by the international equivalent of Merck, MSD – will first discuss a wide range of issues surrounding DPP-4 inhibitors as speakers will examine previous DPP-4 CVOTs as well as the latest science of the class. Dr. Holman will wrap the session up by presenting on lessons learned from TECOS with regards to the treatment of cardiovascular patients with type 2 diabetes. As a reminder, the full TECOS results were presented at this past ADA, showing spot-on neutrality with Merck’s Januvia (sitagliptin). We will be curious to hear speakers’ insights on how the TECOS results impact how providers will approach the entire DPP-4 inhibitor class regarding the small heart failure signals of SAVOR and EXAMINE (see our coverage of the FDA meeting on these results). In addition, we’ll be interested to hear about what scientific innovations are ongoing or needed in the future to revive this class. As a reminder, phase 3 results of Merck’s once-weekly omarigliptin were presented at last year’s EASD and we hope to hear commentary on the potential advantages these formulations can bring to the DPP-4 class.
  • (2:30 – 5:00 pm, Meyer-Schwickerath Hall) Corporate Symposium: Amgen – Diabetic Dyslipidemia, Cardiovascular Disease, and PCSK9 Inhibition with Evolocumab: Four Key Questions. This symposium will focus on four questions with the first presented by Dr. Neil Poulter (Imperial College London, London, UK) asking if targeting dyslipidemia in diabetes is important. Dr. Ulrich Laufs (University of Saarland, Homburg, Germany) will follow by asking what to do with patients who cannot tolerate a maximum dose of statins. Dr. John Chapman (National Institute for Health and Medical Research, Paris, France) will bring the new hot drug class of PCSK9 inhibitors to the table by asking, “what is PCSK9 and why should you be interested in it?” while Drs. Kausik Ray (Imperial College London, London, UK) and Naveed Sattar (University of Glasgow, Glasgow, Scotland) will close the session with a debate on whether or not LDL-C reduction is more important than glucose lowering in diabetes. With the high cardiovascular risk of people with diabetes, we see all of these as valid questions and important for providers to understand in diabetes management. And with Sanofi/Regeneron’s first-in-class PCSK9 inhibitor Praulent (alirocumab) recently approved (and Amgen’s Repatha [evolocumab] close behind with a PDUFA date of August 27) with an indication for patients with atherosclerotic cardiovascular disease (as an adjunct to maximally tolerated statins), the drug class appears to perhaps already have an impact on a certain patient population in diabetes. We would not be surprised for this class to be more widespread in diabetes within the next five years, as the companies will certainly work on broader indications once more CVOT data are available. For more on the latest in PCSK9 inhibitors, please see our coverage of Praulent’s approval and FDA AdComm meeting.
  • (2:30 – 5:00 pm, Rahbar Hall B) Corporate Symposium: BD – Optimizing Insulin Pump Therapy: Infusion Set Failures and Silent Occlusions. BD has put together a star-studded tech lineup for this symposium. Dr. Lutz Heinemann (Science & Co., Düsseldorf, Germany) will open the session by providing an overview of real-world challenges of insulin infusion set failure before handing off to Dr. Bruce Buckingham (Stanford University, Stanford, CA) to discuss the science of infusion sets. Dr. Buckingham has previously identified sets as the “weak link” in insulin delivery, and we hope to hear his honest views on the clinical impact of BD’s new set. Dr. Thomas Danne (Diabetes Center for Children and Adolescents, Hannover, Germany) will follow with a look a pediatric case studies, before handing off to Dr. Laurence Hirsch (BD, Franklin Lakes, NJ) for an EU introduction to the new BD FlowSmart infusion set – we’ll be most interested to hear any updates or new details on the set, which is still slated to launch in 2016 with commercial partner Medtronic. The session will also discuss the set’s future implications for closing the loop, led by the very smart Dr. Hans de Vries (Academic Medical Center, Amsterdam, Netherlands) and Dr. Aaron Kowalski (JDRF, New York, NY) on tap to discuss “what the future holds.” BD will close out the session with a 15-minute demonstration of the infusion set, which we were impressed with in our test drive at the company’s headquarters in May.
  • (2:30 – 5:00 pm, Loubatière Hall) Corporate Symposium: Janssen – Should SGLT2 Inhibitors Be An Integral Part of a Personalized Treatment Plan for Type 2 Diabetes? Janssen’s corporate symposium will focus on the role of SGLT-2 inhibitors in the treatment of type 2 diabetes after another year of continued strong performance for the company’s market-leading Invokana (canagliflozin). We are particularly looking forward to Dr. Ronan Roussel’s (Cordeliers Research Centre, Paris, France) talk on the non-glycemic effects of SGLT-2 inhibitors and their potential impact on long-term outcomes. We expect Dr. Roussel to discuss the ongoing CREDENCE renal outcomes study investigating a potential renal benefit with Invokana. We are also very curious to hear his take on the just-released positive CVOT results for Lilly/BI’s SGLT-2 inhibitor Jardiance (empagliflozin) and whether he believes they are indicative of a class effect (the answer must surely be it’s too early to know, but we’re keen for any speculation).
  • (2:30 – 5:00 pm, Sterne Hall) Corporate Symposium: Abbott – One year with Flash Glucose Monitoring: Perspectives From Different Stakeholders in Diabetes Care. What’s Next? Abbott has stolen the show with its standing-room-only sessions on FreeStyle Libre at EASD 2013, EASD 2014, ATTD 2014, and ATTD 2015. Now coming up on one year of commercial experience in the EU, we look forward to hearing thoughts on real-world use of the technology – enthusiasm to date has certainly exceeded management’s expectations. Dr. Pratik Choudhary (King’s College London, UK) and Mr. Stephen Dixon will headline the session by discussing the impact of FreeStyle Libre on patient-clinician communication – this should be fascinating, given the challenges of interpreting glucose data and quickly identifying problem areas. We’ve heard Mr. Dixon speak before and we love him. Dr. Katarina Eeg-Olofsson (Uppsala University, Sweden) will present on her clinical experience with Libre, while Dr. Oliver Schubert (Bethany Hospital, Hamburg, Germany) will discuss the utility of the Ambulatory Glucose Profile data downloading software – the high value of this has been an unexpected surprise. As always, we will cross our fingers for an update on the US timeline for a commercial version of Libre. Abbott has been very tight-lipped on this front, though did submit the Pro system (retrospective, blinded) for regulatory approval in the US in 2Q15.
  • (2:30 – 5:00 pm, Bouchardat Hall) Corporate Symposium: Roche – How Much Can technology Support Personalized Diabetes Management? Roche has done some great work on the BGM personalization front, perhaps best exemplified by the company’s recent US launch of the Accu-Chek Connect (BGM and paired smartphone app with a bolus calculator). We expect that the new system will feature heavily in both Dr. Matthias Axel Schweitzer’s (Roche Diagnostics, Mannheim, Germany) update on the future of personalized diabetes therapies and Dr. Fabio Broglio’s (University in Turin, Italy) presentation on real-world experience with the Connect. (The system launched in South Africa, Italy, and Germany in September 2014, and in the US this month) Dr. Ashleigh Walker (LMC Diabetes & Endocrinology, Ontario, Canada) will also deliver a uniquely titled presentation, “Surfing safely in the diabetes app tsunami” (presumably focused on FDA-approved vs. unapproved apps), before Dr. Julia Mader (Medical University of Graz, Austria) will present the never-before-seen findings of the “Accu-Chek Insight EU Study” – the trial is examining glycemic control and human factors in adult patients with type 1 and type 2 diabetes (n=~80-95) in 10-12 sites in Austria, France and the UK. As a reminder, the Insight is a next-gen pump and meter platform, with plans to include pre-filled NovoRapid cartridges. We’re not sure if there will be an update on Roche’s novel CGM sensor; at Roche’s 2015 Analyst Meeting, this product was characterized ~18 months away from commercialization in the EU.
  • (2:30 pm – 5:00 pm, Press Conference Room) Non-Commercial Symposium: Global Data for Diabetes and Obesity Research. This symposium will focus on InterConnect, a resource meant to “change the way that data are used in population research into the causes of diabetes and obesity” as the meeting aims to engage scientists, research funders, and other stakeholders in a new approach of optimizing the use of existing data. Dr. Nick Wareham (University of Cambridge, Cambridge, UK) will open the symposium with a broad introduction and a presentation on how we can understand differences in risk between populations – a key issue when looking at the disparities in minority groups’ prevalence rates. Drs. Wareham and Nita Forouhi (University of Cambridge, Cambridge, UK) will then introduce InterConnect and its vision, while speakers including Dr. Matthias Schulze (Technische Universität München, Muchen, Germany), Dr. Tom Bishop (University of Cambridge, Cambridge, UK), and Dr. Ken Ong (University of Cambridge, Cambridge, UK) will discuss bigger-picture questions on how to bring the analysis to the data and develop “exemplar research questions.” We are excited to hear more about Interconnect, as we see moving towards more scalable and shareable data as incredibly valuable in understanding questions surrounding genetics and population differences. Within the US, similar efforts are also underway with the NIH/industry collaboration of Accelerating Medicines Partnership as well as the NIH’s vision of the Precision Medicine Initiative.
  • (5:00 – 6:00 pm, Pirart Hall) Corporate Symposium: Lilly – Challenges in Comprehensive Lipid Management. We are intrigued to see Lilly hosting a dedicated corporate symposium on lipid management in type 2 diabetes and wonder if this could foreshadow an emphasis on patients with diabetes as a target population for the company’s phase 3 CETP inhibitor evacetrapib (this has been a tough class to move ahead). The subject of dyslipidemia in diabetes is particularly timely given the approval of the first PCSK9 inhibitor (Sanofi/Regeneron’s Praluent [alirocumab]) in the US last month. While the initial indication for the drug is fairly targeted, it will still likely encompass a significant number of patients with diabetes. Lilly has its own PCSK9 inhibitor in phase 2, and management stated during the company’s 2Q15 update that it is currently evaluating its options for the product, recognizing that it would need to show differentiation vs. other products in the class given the fact that it would likely be fourth to market.

Tuesday, September 15

  • (9:00 – 10:30 am, Hellerström Hall) Opening Ceremony, Presidential Address, and 47th Claude Bernard Lecture. EASD president Dr. Andrew Boulton (University of Manchester, UK) will open the conference with what promises to be an inspiring address – he is always so eloquent and has the patient at very top of mind. Dr. Boulton has lauded the EASD for its role in championing better research in Europe in the past, and we expect a similarly rousing perspective this time around. Dr. Hans Haring (University of Tübingen, Germany) will then deliver the annual Claude Bernard Lecture with a focus on “understanding phenotypes of prediabetes.” We suspect that he will highlight various paths to type 2 diabetes and are very curious to hear how he characterizes and differentiates disease progression – much more teaching on this front is a positive and we’re glad that is in store for us all.
  • (10:45 am – 12:15 pm, Hellerström Hall) Oral Presentations: Insulin Analogues: Is Newer Always Better? This session includes three presentations on Lilly’s novel basal insulin peglispro (BIL): results from the IMAGINE 1 study vs. Sanofi’s Lantus (insulin glargine) in type 1 diabetes, data on glycemic variability, and data demonstrating hepato-preferential action in patients with type 1 diabetes. We will be listening closely for any commentary on the liver safety concerns that led Lilly to delay the submission timeline for peglispro until 2017 to conduct additional studies. It is unclear to what extent these concerns have tarnished the product’s reputation in the field – we were somewhat surprised to hear positive commentary on it from two speakers at AADE with no mention of the safety signals. We will also see data on the latest basal insulins from Sanofi (the EDITION JP 1 study of Toujeo [insulin glargine U300]) and Novo Nordisk (a clinical follow-up study of patients switched to Tresiba [insulin degludec]), as well as phase 2a results for Biodel’s ultra-rapid acting U400 insulin BIOD-531.
  • (10:45 am – 12:15 pm, Keen Hall) Oral Presentations: Incretin-Based Therapy – On and Off Conventional Targets. This session of oral presentations is built around non-conventional targets for incretin therapies. Presenters will showcase data on the role of GLP-1 agonists in reducing liver fat content, adipose tissue responses to GLP-1 agonist-induced weight loss, GI adverse events in GLP-1 agonist therapy, effect of GLP-1 agonists on heart rate, pancreatic cancer risk with incretin therapy, and the protective effects of DPP-4 inhibitors against bone loss from TZD use. The incretin/pancreatitis/pancreatic cancer controversy has long subsided since its peak in 2013, particularly since CVOTs of incretin therapies have all been neutral with regard to pancreatic risk. These similarly neutral results from a case-control study in Denmark should hopefully continue to decrease the level of concern. The increased heart rate with GLP-1 agonists remains one of the few nagging concerns with the class, and reviews like this and future outcomes trials should help clarify the level of risk with specific agents.
  • (3:00 – 4:30 pm, Hellerström Hall) Oral Presentations: A Glimpse at Future Diabetes Therapy. This session includes data presentations for three novel insulin candidates. Dr. Melanie Davies (University of Leicester, UK) will reprise her ADA presentation of full results from the IMAGINE 2 study (peglispro vs. Lantus in type 2 diabetes), Dr. Bruce Bode (Atlanta Diabetes Associates, Atlanta, GA) will share results (first presented as a poster at ADA) showing improved postprandial control with Novo Nordisk’s faster aspart, and we will see preclinical data on Hanmi’s once-weekly insulin HM12470. We are also excited to see phase 3 pediatric results for Locemia’s intranasal glucagon, which looks to be the first next-generation glucagon to reach the market – lots of people have been waiting for this. Presentations on Isis’ novel insulin sensitizer ISIS-PTP1BRx and Teijin Pharma’s glucokinase activator TMG-123 will round out the session.
  • (3:00 – 4:30 pm, Heding Hall) Oral Presentations: The Calm Before the Storm – Predicting Metabolic Disease. This session addresses a range of efforts to identify earlier predictors of future diabetes onset for both type 1 and type 2 diabetes. Dr. Ake Lernmark’s (Lund University, Sweden) talk promises to be a highlight – he will present new data from TEDDY study on prenatal risk factors for the first appearance of an islet antibody. We’ve already seen quite a bit of intriguing data from TEDDY – at EASD 2014, we saw data indicating that early probiotic exposure was associated with reduced risk of islet autoimmunity, and Dr. Marian Rewers (University of Colorado, Denver, CO) shared intriguing preliminary data on the role of viruses and gut microbiota in type 1 diabetes at ENDO 2015 in May. Other presentations in this session will present data on type 2 diabetes predictors, genomic risk factors for type 1 and type 2 diabetes in young adults, and markets of coronary artery disease and other diabetes complications.
  • (3:00 – 4:30 pm, Keen Hall) Oral Presentations: The Price of Diabetes Care. We are very much looking forward to this economics-focused session should have serious implications for diabetes reimbursement in the EU. Dr. Stephanie Roze will headline the session with an evaluation of the cost-effectiveness of pump vs. MDI therapy in type 2 patients, looking specifically at clinical and economic benefits in the Netherlands. The session will also feature Dr. Annie Nikolajsen, who will discuss the underappreciated consequences of post-prandial hyperglycemia (e.g., missed work time, reduced productivity), and Dr. Ginger Carls, who will present a retrospective look at adherence and its association with healthcare costs in patients with type 2 diabetes. Meanwhile, Dr. Eleonora Lovato will discuss the importance of incorporating the effects of hypoglycemia into our health economic models and Dr. Michael Willis will address the economic consequences of clinical inertia in treatment intensification for patients with type 2 diabetes.
  • (4:45 – 5:45 pm, Hellerström Hall) 30th Camillo Golgi Lecture: The Eye in Diabetes: A Personal Account. This lecture will be delivered by Dr. Hans-Peter Hammes (University of Heidelberg, Heidelberg, Germany), who has conducted research on the effect of euglycemia on microvascular damage in the eye, the role of advanced glycation end products in diabetic retinopathy, the role of growth factors regulating pericyte recruitment, and more. In addition, Dr. Hammes has been an advocate of the idea that diabetic retinopathy is not an exclusive vascular disease but that it, in fact, involves retinal glia, microglia, and other neuronal cells. We will curious to hear about this framework especially as the science of neuronal systems seems to be increasingly blending into that of diabetes and obesity. While the title of this lecture remains vague, we expect Dr. Hammes to walk attendees through his own lifetime of research on eye complications and we hope to hear him provide his insights on the current status and future of treatment options – see our ADA coverage for recent results on the comparative effectiveness of aflibercept, bevacizumab, and ranibizumab.
  • (4:45 – 5:45 pm, Heding Hall) 9th Albert Renold Lecture: Insights Into the Beta Cell from Patients with Monogenic Diabetes. This lecture will be delivered by Dr. Andrew Hattersley (Peninsula Medical School, Exeter, UK), whose research on monogenic diabetes has described 12 new subtypes of monogenic diabetes. Dr. Hattersley presented on Maturity Onset Diabetes of the Young (MODY) at EASD 2011, as he introduced the condition and discussed diagnostic and treatment options. As monogenic forms of diabetes are becoming increasingly more difficult to diagnose and distinguish from type 1 or type 2 in a growing obese patient population, we hope to hear Dr. Hattersley discuss the cutting-edge science in genetics and physiology that can be translated into more effective clinical guidelines on this front.
  • (6:30 – 9:30 pm, Venue81) Solvable Problems in Diabetes (Sponsored by The diaTribe Foundation). The diaTribe Foundation’s second annual program on "Solvable Problems in Diabetes” will feature the highly respected Professor Ele Ferrannini (University of Pisa School of Medicine, Pisa, Italy) and Professor Rury Holman (University of Oxford, UK) who will discuss some of the most urgent problems and opportunities in diabetes, and what we all must do to bring about change. As a reminder, last year’s inaugural panel featured our own Ms. Kelly Close moderating a conversation with Professor Philip Home (Newcastle University, Newcastle Upon Tyne, UK) and Professor Jens Sandahl Christiansen (Aarhus University, Aarhus, Denmark). The event brought in 120 attendees from medicine, academic, industry, professional and patient advocacy, and government, generating discussion on topics that ranged from utility of long-term cardiovascular outcomes trials to how the speakers would invest $10 billion in diabetes care. Last year’s event sold out in a matter of weeks and despite expanding to a larger venue, we expect this year’s program to be similarly packed. See here for more information and tickets!

Wednesday, September 16

  • (9:00 – 10:30 am, Hellerström Hall) EASD/ESC Symposium: Lessons Learned From Glucose Lowering Trials. This symposium will tackle the vexing question of the relationship between glycemic control and cardiovascular risk. Dr. Darren McGuire (University of Texas Southwestern Medical Center, Dallas, TX) will cover the timely topic of lessons learned from cardiovascular outcomes trials in diabetes. We hope he will offer big-picture commentary on the costs vs. benefits of the 2008 CV Guidance now that five trials have reported results. Dr. Craig Currie (Cardiff Medicentre, Cardiff, UK) will discuss strategies related to glucose lowering and CVD risk, while the great Dr. Stefano Del Prato (University of Pisa, Pisa, Italy) will focus on targets (he’s so smart – do you remember Ms. Jessica Dong’s 2013 most valuable and instructive interview with him?). We assume Dr. Del Prato’s talk will touch upon the still-controversial results from ACCORD – Dr. Pat Rafferty (St. Louis College of Pharmacy, St. Louis, MO) provided a valuable take on this issue at AADE.
  • (10:45 am – 12:15 pm, Hellerström Hall) Oral Presentations: Growing Experience With GLP-1 Receptor Agonists. YES! This session is going to be a can’t-miss. This session offers a wealth of clinical data on GLP-1 agonists, used either alone, in conjunction with other therapies, or in head-to-head studies. We’re particularly eager to hear results from Novo Nordisk’s phase 4 LIRA-LIXI study, a head-to-head comparison trial between Victoza (liraglutide) and Sanofi’s Lyxumia (lixisenatide). We’ve yet to hear an update since Novo Nordisk announced the trial in 3Q13 – at the time, the company expressed confidence that Victoza is in a “different league” in terms of efficacy compared to Lyxumia – we’ll see! Another exciting presentation in this session will showcase results from a sub-study of Lilly’s AWARD-4 trial in which CGM was used to monitor glycemic variability with Trulicity (dulaglutide) vs. Lantus (insulin glargine) – we love seeing CGM data in clinical trials and a greater focus on glycemic variability as an endpoint in addition to A1c. Other talks in this jam-packed session include a meta-analysis of CV events with Trulicity, a randomized trial of liraglutide in combination with multiple daily insulin injections, an exploration of prandial lixisenatide with basal insulin, and a peek into liraglutide’s effect on the reward and satiety centers of the brain.
  • (3:00 – 3:45 pm, Hellerström Hall) EASD / Novo Nordisk Foundation Diabetes Prize for Excellence: Human Metabolic Disease – Lessons Learned From Genetics. This keynote lecture, the first annual one of the Diabetes Prize for Excellence, will be delivered by Dr. Stephen O’Rahilly (University of Cambridge, Cambridge, UK), whose research has been focused on the basic causes of obesity and type 2 diabetes at a molecular level. We will be curious to hear what he has to say as the genetic basis of both diabetes and obesity has been historically challenging to dissect, especially with the conditions’ interconnectedness with the environment. While certain genetic determinants have been identified for small subpopulations (e.g. MC4 in obesity), we hope that Dr. O’Rahilly touches on lessons from genetics that can be applied to a larger patient population and how these can be moved into clinical translation with regards to scalable prevention and early intervention efforts.
  • (4:00 – 5:30 pm, Hellerström Hall) Oral Presentations: Incretin-based Therapy – Novel Agents, New Indications. Highlights from this session include results from the phase 3 FREEDOM-1 trial of Intarcia’s ITCA 650 and a post-hoc phase 2 analysis for Sanofi’s LixiLan (lixisenatide/insulin glargine). We see these products (as well as Novo Nordisk’s basal insulin/GLP-1 agonist combination Xultophy [insulin degludec/liraglutide]) as two of the most exciting recent advances for the GLP-1 agonist class, and both have reported new positive topline results in recent months (from the phase 3 FREEDOM-2 and LixiLan-O trials, respectively). We will also see results from the Steno Diabetes Center’s Lira-1 study of Novo Nordisk’s Victoza (liraglutide) in type 1 diabetes. Results from both this study and Novo Nordisk’s ADJUNCT TWO trial of Victoza in type 1 diabetes came in somewhat below expectations, as news from today showed. Novo Nordisk expects results from the more robust ADJUNCT ONE trial within the next few months, and we’ll see if this has any impact on management’s decision to opt away from FDA submission – that had been expected in 1H16. We assume they will also be key in determining whether other companies feel this area is worth pursuing – if Novo Nordisk opts away from it, which it seems to have, then we doubt any other companies would move toward it, though we could be surprised – it also remains at least a remote possibility that Novo Nordisk will show more positive results in sub-categories of type 1 and may submit for those alone (speculation on our part, to be sure). Other presentations of note in this session include results for Merck’s once-weekly DPP-4 inhibitor omarigliptin (to be submitted in the US by the end of 2015), Hanmi’s once-monthly GLP-1 agonist HM11260C, and LG Life Sciences’ gemigliptin/metformin combination.
  • (4:00 – 5:30 pm, Jacobsohn Hall) Oral Presentations: Management of Cardiovascular Risk Factors. This session includes three presentations of results from observational studies/meta-analyses suggesting increased cardiovascular risk with sulfonylureas compared to other diabetes drugs. We have suspected for some time that this drug class would be unlikely to pass FDA muster in terms of CV safety if it had emerged during the current era of CVOTs and wish there were more incentives for more definitive outcomes studies of the now-generic drugs. We are also looking forward to a presentation by Dr. Richard Bergenstal (International Diabetes Center, Minneapolis, MN) showing neutral cardiovascular effects with peglispro based on MACE rates during phase 2 and 3 studies, and a cohort study presented by Dr. Sanjoy Paul (QIMR Berghofer Medical Research Institute, Brisbane, Australia) suggesting that therapeutic inertia can lead to increased cardiovascular risk in patients with diabetes.
  • (5:45 – 7:15 pm, Hellerström Hall) Symposium: DPP-4 Inhibition – 20 Years of Research. Drs. Mark Cooper (Baker IDI Heart and Diabetes Institute, Melbourne, Australia), Carolyn Deacon (University of Copenhagen, Denmark), and Jens Holst (University of Copenhagen, Denmark) join chairperson Dr. Bo Ahren (Lund University, Sweden) in a session that promises to provide a comprehensive overview of the DPP-4 inhibitor class. Dr. Cooper will begin by reviewing the science behind DPP-4 inhibitors’ glucose lowering mechanism,  Dr. Deacon will discuss the translation of that research into clinical practice, and Dr. Holst will discuss pleiotropic effects. We hope to hear commentary on the various safety controversies that have plagued the class in recent years (namely heart failure and pancreatitis) and the implications of the results from the SAVOR, EXAMINE, and TECOS CVOTs for clinical practice.
  • (5:45 – 7:15 pm, Jacobsohn Hall) Symposium: The Three IMI Diabetes Musketeers – What Have They Delivered? This session includes a separate presentation each on IMIDIA (presented by Dr. Bernard Thorens [University of Lausanne, Lausanne, Switzerland]), DIRECT (presented by Dr. Ewan Pearson [University of Dundee, Dundee, UK]), and SUMMIT (presented by Dr. Leif Groop [Lund University, Lund, Sweden]). As background, the IMI (Innovative Medicines Initiative) formed a public-private consortium called the Innovative Medicines Initiative for Diabetes (IMIDIA) in 2010, which is focused on pancreatic islet cell function and survival to develop biomarkers to improve treatments in diabetes – an important area as biomarkers have been an especially challenging area for diabetes and one in which we see worth investing as the costs of trials needing hard endpoints, such as CVOTs, are becoming unsustainable. The other two “diabetes musketeers” include DIRECT, which aims to examine patient stratification to best personalize treatment, and SUMMIT, which looks at therapies for late-stage micro- and macrovascular complications – see a flyer for these three projects to learn more.
  • (5:45 – 7:15 pm, Doniach Hall) EASD/JDRF Symposium: Can We Make a Better Beta Cell? JDRF’s masterful Chief Scientific Officer, Dr. Richard Insel, co-chairs this joint EASD/JDRF symposium with Dr. Shanta Persaud (King’s College London, UK). The program promises a glimpse into two broad categories of beta cell replacement therapies under investigation: i) promoting pancreatic progenitor cell differentiation into beta cells and ii) stimulating beta cell regeneration. There has been significant recent activity in the stem cell differentiation field with developments from Sanofi/Evotec, ViaCyte, Dr. Doug Melton’s lab at Harvard University (funded in part by JDRF) and the BetaLogics team led by Dr. Tim Kieffer (University of British Columbia, Vancouver, Canada). Dr. Harry Heimberg’s (Vrije Universiteit Brussel, Brussels, Belgium) presentation on beta cell differentiation appears to focus more narrowly on the final step of converting multipotent pancreatic progenitor cells to functional beta cells. We hope that Dr. Heiko Lickert’s (Helmholtz Zentrum München, Neuherberg, Germany) presentation on “targeting beta cells for regenerative therapy” will touch upon the debate over whether adult human beta cells retain the ability to proliferate, which remains a controversial topic in the field.

Thursday, September 17

  • (9:00 – 10:00 am, Hellerström Hall) Dogmata Debate: Is Insulin Resistance Always Bad For You? In this debate, Dr. Ele Ferrannini (University of Pisa School of Medicine, Pisa, Italy) will argue that yes, insulin resistance is always bad for you, while Dr. David Matthews (Oxford Centre for Diabetes, Oxford, UK) will argue for the contrary. We will be curious to hear the arguments for the benefits of insulin resistance since we believe there is limited research on this perspective. Some have suggested that insulin resistance could have offered an evolutionary advantage in the past by facilitating storage of glucose in fat, thus providing a stockpile in times of famine, but we are not familiar with research suggesting any current benefits.
  • (9:00 – 10:00 am, Keen Hall) Debate: Do We Need Triple and Quadruple Therapies? This debate between Dr. Ralph DeFronzo (University of Texas Health Science Center, San Antonio, TX) and Dr. Thomas Pieber (Medical University of Graz, Graz, Austria) promises to be an invigorating start to the day. Not surprisingly, Dr. DeFronzo will be arguing in favor of combination therapies. The data released thus far on his signature triple therapy (metformin + exenatide + pioglitazone) vs. the conventional sequential approach has been compelling, and we have heard several speakers on the conference circuit urge the field to move toward greater use of combination therapy earlier in the treatment algorithm. However, there are convincing arguments on the other side as well, such as concerns about cost and the challenges of managing side effects from multiple medications.
  • (10:15 – 11:45 am, Heding Hall) Oral Presentations: Optimising the Insulin Treatment Paradigm. This collection of oral presentations tackles the many nuances and complexities associated with insulin regimens in type 1 and type 2 diabetes. Topics range from pump use in patients with type 2 diabetes, timing and dosing of insulin, the comparative effectiveness of different post-basal insulin intensification therapies, the importance of single-patient data when determining insulin therapy regimens, and real-world efficacy and safety data on basal-bolus vs. basal-only regimens. We’re particularly interested in Dr. Angel Rodriguez’s (Lilly, Madrid, Spain) data on the administration of basal insulin peglispro (BIL) in the morning vs. the evening – we’ll be keeping an ear out for any thoughts on the road ahead for peglispro following its regulatory submission delay due to safety concerns earlier this year.
  • (3:30 – 5:00 pm, Hellerström Hall) Oral Presentations: Understanding the Effects of SGLT Inhibitors. Dr. Thomas Pieber (Medical University of Graz, Austria) kicks off this session with data from the EASE-1 trial on the A1c-lowering effects of Lilly/BI’s Jardiance (empagliflozin) in type 1 diabetes (presented as poster 1213-P at ADA). Jardiance and the SGLT-2 inhibitor class as a whole has received significant attention – positive and negative – in the last few months. Jardiance recently demonstrated a positive effect on CV outcomes in patients with type 2 diabetes, but SGLT-2 inhibitors have been implicated in rising concerns over euglycemic DKA, particularly in patients with type 1 diabetes. We’ll be interested to see if any mention of those safety concerns makes it into Dr. Pieber’s presentation. Later in the session, SGLT inhibitor guru Dr. William Cefalu (Pennington Biomedical Research Center, Baton Rouge, LA) will showcase phase 2 data (first presented at ADA) on Lexicon’s late-stage SGLT-1/2 dual inhibitor sotagliflozin while Dr. Anna Solini (University of Pisa, Italy) will discuss the SGLT-1 and GLUT-2 modulating effects of SGLT-2 inhibitor dapagliflozin (AZ’s Farxiga). Other presentations in the session include a look at dapagliflozin’s effects on glucagon secretion and albuminuria and canagliflozin’s (J&J’s Invokana) effects on A1c and body weight when combined with GLP-1 agonists and DPP-4 inhibitors – particularly relevant given that both of J&J’s competitors have SGLT-2 inhibitor/DPP-4 inhibitor combinations on the market (Lilly/BI’s Glyxambi [empagliflozin/linagliptin]) or under review (AZ’s saxagliptin/dapagliflozin).
  • (3:30 – 5:00 pm, Keen Hall) Oral Presentations: Devices Changing Treatment Paradigm. Standouts in this session include Dr. Hans de Vries presenting overnight closed-loop data, and Dr. Doris Zane discussing intermediate, one-year results from a pre-clinical investigation of Intarcia’s implantable exenatide pump in rats. As a reminder, Intarcia just announced topline results from the phase 3 FREEDOM-2 study demonstrating significantly greater A1c reductions (1.5% vs. 0.8%; p<0.001) and weight loss (4 kg vs. 1.3 kg; p<0.001) with its new technology vs. Merck’s Januvia (sitagliptin). Also in this session, Dr. Henrik Andersen will discuss Steno Diabetes Center’s investigation of the long-term effect of shifting patients from MDI to pump therapy. As we understand it, the group’s six-year follow-up demonstrated improvements in A1c without weight gain – to what extent is the big question, given the higher cost of pumps and what is presumably an observational study (where there may be selection bias). In looking to the future, the session will also feature Dr. Pamela Maffioli and Dr. Hanne-Charlotte Andersen separately discussing the effect of sensor-augmented pump therapy on glycemic control, the latter with a focus on the human factors.
  • (5:15 – 6:45 pm, Hellerström Hall) Symposium: Results of the EMPA-REG OUTCOME Study. This session promises to be the absolute highlight of the conference – we hope the organizers have overflow rooms prepared! Lilly/BI’s topline results announcement disclosed only that the trial demonstrated CV risk reduction with Jardiance (empagliflozin) vs. placebo, so this full results presentation will be key in clarifying the magnitude and implications of the results. In the session, Dr. Silvio Inzucchi (Yale University, New Haven, CT) will present the primary results, Dr. Christoph Wanner (University Hospital Würzburg, Würzburg, Germany) will present the efficacy results, and Dr. David Fitchett (University of Toronto, Ontario, Canada) will discuss safety – we will be particularly interested to see the rates of ketoacidosis given the recent concerns with the SGLT-2 inhibitor class though we note most of the concern has surrounded type 1 off-label use. We will then hear commentary from the highly respected Dr. Bernard Zinman (University of Toronto, Ontario, Canada) and discussant Dr. Hertzel Gerstein (McMaster University, Hamilton, Ontario, Canada) on the implications of the results. We hope to hear discussion of the potential for other SGLT-2 inhibitor CVOTs to produce similarly positive results, the likelihood of the class becoming the standard second-line therapy for type 2 diabetes, and how these results influence the broader debate over the appropriateness of the 2008 CV Guidance.
  • (5:15 – 6:45 pm, Keen Hall) EASD/ADA Symposium: Devices. This star-studded session on the safety of medical devices will build on the provocative session on this topic from EASD 2014. Dr. Lutz Heinemann will headline the session by presenting the ADA/EASD Statement on Insulin Pumps, first presented at the EASD Diabetes Technology Meeting in February. Dr. Steven Russell (Massachusetts General Hospital, Boston, MA) will also provide an update on the Bionic Pancreas, where we’ll hope to hear more on the recently started insulin-only and bi-hormonal glycemic target studies. The session will also feature Dr. Lalantha Leelarathna from the Cambridge team, who will provide a comprehensive overview of European efforts in the closed-loop field.
  • (7:00 – 8:30 pm, Meyer-Schwickerath Hall) Corporate Symposium: Lilly/BI – EMPA-REG Outcome: Implications for Management of Patients with Type 2 Diabetes. The discussion of the groundbreaking EMPA-REG OUTCOME results will continue with this corporate symposium immediately following the results presentation. After a presentation by trial investigator Dr. Zinman, much of the session will be devoted to a panel discussion by some of the biggest names in the diabetes/CVD field: Dr. Lars Ryden (Karolinska Institute, Stockholm, Sweden), Dr. Sanjay Kaul (Cedars-Sinai Medical Center, Los Angeles, CA), Dr. Lawrence Leiter (University of Toronto, Toronto, Ontario, Canada), and Dr. Naveed Sattar (University of Glasgow, Glasgow, UK). We hope to hear commentary on how speakers feel the results will impact Jardiance alone relative to the SGLT-2 inhibitor class as a whole, whether they will be enough to make SGLT-2 inhibitors the standard second-line therapy for type 2 diabetes, and the prospects of future CVOTs for diabetes drugs showing cardioprotection.
  • (7:00 – 8:30 pm, Loubatière Hall) Corporate Symposium: Novo Nordisk – GLP-1 Receptor Agonists: Liraglutide 3.0 mg in Weight Management. This symposium will discuss the role of GLP-1 agonists within obesity and review data from the SCALE trials, specifically those of the phase 2 studies as well as the key results of SCALE Obesity and Prediabetes, SCALE Maintenance, and SCALE Diabetes presented by Drs. Nick Finer (University College London, London, UK), Carel Le Roux (University College Dublin, Dublin, Ireland), and Tina Vilsboll (University of Copenhagen, Copenhagen, Denmark). As a reminder, all of these results have been presented within the past couple years – see each trial’s results from last year’s EASD for more. As background, Novo Nordisk’s Saxenda (liraglutide 3.0 mg) was launched earlier this year in April, although the company’s 2Q15 update showed a modest post-launch trajectory in terms of prescription volume. We will be most interested to hear what issues will be brought up during the panel discussion now that the drug is on the market, as providers deal with Saxenda’s high costs (though the drug has made some recent formulary wins) and should now have had some real-life experience prescribing alongside Victoza (liraglutide 1.8 mg). Novo Nordisk is, not surprisingly, the only presence for obesity with regards to corporate symposiums at EASD this year – we continue to hope that the company is able to revive the obesity pharmacotherapy’s slow momentum in the context of other obesity companies’ challenges.
  • (7:00 – 8:30 pm, Kimmelstiel Hall) Corporate Symposium: MSD – The TECOS CV Safety Trial and the Lessons Learned for Treatment of Patients with Type 2 Diabetes and Cardiovascular Disease. The highlight of this session will be Dr. Rury Holman’s (University of Oxford, Oxford, UK) presentation of new data from TECOS. We hope these might be subgroup analyses that could provide more insight on whether the results – for the primary endpoint, heart failure, or other secondary outcomes – were entirely neutral across the board as they appeared to be based on the primary results presentation at ADA. The session also includes significant time for Q&A and faculty discussion with speakers Dr. Niko Marx (University of Ulm, Ulm, Germany), Dr. Juris Meier (St. Josef Hospital, Bochum, Germany), Dr. Richard Gilbert (University of Toronto, Toronto, Ontario, Canada), and Dr. Holman. We especially hope to hear discussion of how the neutral heart failure results contribute to the ongoing controversy for the DPP-4 inhibitor class. Our sense is that the results should largely rule out the hypothesis of a class effect, but we have heard varying opinions on the relative likelihood of divergent drug-specific effects, chance findings in one of the trials, or another explanation.
  • (7:00 – 8:30 pm, Elite Hotel Marina Tower) Corporate Symposium: Lilly – The Patient in Mind: New Perspectives on Injectable Therapy for Type 2 Diabetes. Lilly’s second Thursday night corporate symposium dives into the use of injectable therapies – insulin and GLP-1 agonists – in type 2 diabetes. The highly regarded Dr. Michael Nauck (Diabeteszentrum Bad Lauterberg, Bad Lauterberg im Harz, Germany) will do triple-duty as the chair, the discussion moderator, and a presenter in this session. He will be joined by Drs. Melanie Davies (University of Leicester, UK) and Francesco Giorgino (University of Bari Aldo Moro, Bari, Italy). Together they will offer a patient-focused take on injectable therapies in terms of the transition, persistence and preference, and whether once-weekly GLP-1 agonists (e.g., Lilly’s Trulicity [dulaglutide]) can alter current perspectives on injectables. The feedback on Trulicity thus far from patients and providers has been very positive according to Lilly management, and we think that the convenience of once-weekly administration and the user-friendly delivery device should continue to spur growth of the GLP-1 agonist class and make the concept of injectable therapy for type 2 diabetes seem less daunting.

Friday, September 18

  • (9:00 – 10:00 am, Hellerström Hall) Michael Berger Debate: Do We Need Fixed Combinations of GLP-1 Analogues and Insulin? Dr. Henning Beck-Nielsen (Odense University Hospital, Denmark) chairs this sure-to-be lively debate between Drs. Stephen Gough (Oxford Centre of Diabetes Endocrinology and Metabolism, Oxford, UK) and Leszek Czupryniak (Medical University of Lodz, Poland) on the need for fixed-dose combinations of GLP-1 agonists and insulins. This timely debate occurs just as Novo Nordisk’s Xultophy (insulin degludec/liraglutide) is launching across European markets, but recently received a “no additional benefit” ruling from IQWiG. We have found the clinical trial data on Xultophy very compelling and were very disappointed by the IQWiG ruling,  so we will be particularly interested to hear Dr. Czupryniak’s arguments on the negative side of the debate.
  • (12:45 pm – 2:15 pm, Hellerström Hall) Symposium: Combination of Insulin Degludec/Liraglutide (IDegLira) – Key Results From the DUAL Programme. This dedicated symposium on the results of the DUAL phase 3 program for Novo Nordisk’s Xultophy (insulin degludec/liraglutide) illustrates the enormous impact this product is expected to have on the treatment paradigm for type 2 diabetes. Yeah – this will be packed. Dr. David Russell-Jones (Royal Surrey County Hospital, Guildford, UK) will review the results of the various trials, Dr. John Buse (University of North Carolina, Chapel Hill, NC) will discuss the product’s role in individualized therapy and improving outcomes, and Dr. Juris Meier will speak more broadly about the concept of combining hormones/proteins.
  • (12:45 pm – 2:50 pm, Keen Hall) Rising Star Symposium. Four up-and-coming investigators will discuss a broad array of basic science research in this perennial session: the genetics of polygenic insulin resistance (Robert Scott); dissecting the metabolic role of p53 (Ruben Nogueiras); shedding light on beta cell function using photopharmacology and optogenetics (David Hodson); and insulin and the human brain (Martin Heni).
  • (12:45 pm – 1:45 pm, Jacobsohn Hall) Symposium: Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS). Dr. Holman will present again on the TECOS results in the last day’s afternoon alongside Dr. Robert Josse (St. Michael’s Hospital, Toronto, Ontario, Canada) who will provide an “update on TECOS safety data.” While we do not expect Dr. Holman to present any new information, we will have our ears turned towards Dr. Josse to see if he provides any additional analyses or insights from the full results we heard at ADA. Specifically, we are curious as to if he will comment on the small imbalances in pancreatic adverse events that went both ways.
  • (1:50 pm – 2:50 pm, Jacobsohn Hall) Symposium: ELIXA Trial in Perspective. Dr. Michael Nauck (Diabeteszentrum Bad Lauterberg, Bad Lauterberg im Harz, Germany) chairs this in-depth look at the cardiovascular and glucometabolic perspectives on the ELIXA CVOT for Sanofi’s Lyxumia (lixisenatide). As a reminder, full ELIXA results were presented at ADA 2015 and were resoundingly neutral overall. At the ADA presentation, Dr. Hertzel Gerstein (McMaster University, Hamilton, Ontario, Canada) provided an informative perspective on the trial, adding a positive spin to many of the neutral results from the study – he returns to EASD to comment on the glucometabolic context of the ELIXA results and we expect his talk will largely be an expansion of his ADA commentary. Dr. Kenneth Dickstein (University of Bergen, Norway) will join him to provide addition context for the cardiovascular results.
  • (12:45 pm – 1:45 pm, Doniach Hall) Symposium: Trending Topics in SGLT-2 Inhibition. The conference will wrap up on a high note with the presentation of new data from a phase 2 trial of J&J’s Invokana (canagliflozin) in type 1 diabetes by Dr. Robert Henry (UCSD, San Diego, CA) and an update from Dr. Anne Peters (USC, Los Angeles, CA) on the risk of ketoacidosis with the class, including the rates seen in the Invokana trial. We hope that results from this and other robust trials of SGLT-2 inhibitors in type 1 diabetes can help clarify how the many potential benefits in this population (weight loss, blood pressure reductions, reduced glycemic variability, lower insulin doses) stack up against the risk of ketoacidosis.

 

-- by Melissa An, Adam Brown, Helen Gao, Varun Iyengar, Emily Regier, and Kelly Close