Memorandum
AACE/ACE will host a two-day meeting on October 24-25, 2015 in Dallas, TX to review the current knowledge and draft clinical recommendations regarding the risk of DKA with SGLT-2 inhibitors. We are very impressed that this top-rate professional organization is all over this! The meeting will convene top experts in the field and promises a deep dive into the science behind the phenomenon, including presentations on carbohydrate restriction from Dr. Ele Ferrannini (University of Pisa, Italy) and the pathophysiology of DKA from Dr. Ralph DeFronzo (UT Health Science Center, San Antonio, TX). Dr. Julio Rosenstock (UT Southwestern, Dallas, TX) will summarize the common features of the phenomenon, Dr. Bob Henry (UCSD, San Diego, CA) will present data from clinical studies in type 1 and type 2 diabetes, and Dr. Anne Peters (USC, Los Angeles, CA) will present an in-depth case discussion – we are very glad to see Dr. Peters so highly involved as she is the one who alerted the diabetes community to this phenomenon last January. Also on the agenda is an opportunity for providers, patients, and manufacturers to share their views in a town hall-format, with representatives from Janssen, AZ, BI, and Lexicon all scheduled to participate – Close Concerns/The diaTribe Foundation has also been asked for its perspective, and we very much appreciated the patient focus, to which AACE is always so attuned, in our view. The risk of DKA (often euglycemic DKA) with SGLT-2 inhibitors has attracted significant attention in the field since Dr. Irl Hirsch (University of Washington, Seattle, WA) and Dr. Peters first drew attention to it at ENDO in March (following Dr. Peters’ warnings earlier in the year), and the FDA and EMA are both currently reviewing the issue. The latest data presented at EASD bolstered the hypothesis that this is mostly a concern for patients with type 1 diabetes: rates of DKA in the EMPA-REG OUTCOME trial of Lilly/BI’s Jardiance (empagliflozin) in type 2 diabetes were very low (<0.1%) and balanced between groups, while a phase 2 study in type 1 diabetes found rates of 5%-10% with J&J’s Invokana (canagliflozin) vs. no events with placebo. We will be back soon with a detailed preview of the impressive agenda for this meeting.
-- by Helen Gao, Emily Regier, and Kelly Close