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Diabetic Ketoacidosis and Related Events With Sotagliflozin Added to Insulin in Adults With Type 1 Diabetes: A Pooled Analysis of the inTandem 1 and 2 Studies.

  • Peters, Anne L1
  • McGuire, Darren K2
  • Danne, Thomas3
  • Kushner, Jake A4
  • Rodbard, Helena W5
  • Dhatariya, Ketan6
  • Sawhney, Sangeeta7
  • Banks, Phillip7
  • Jiang, Wenjun7
  • Davies, Michael J7
  • Lapuerta, Pablo7
  • 1 Keck School of Medicine of the University of Southern California, Los Angeles, CA [email protected]
  • 2 University of Texas Southwestern Medical Center at Dallas, Dallas, TX.
  • 3 Kinder Krakenhaus auf der Bult, Diabetes Zentrum für Kinder and Jugendliche, Hannover, Germany. , (Germany)
  • 4 McNair Interests, Houston, TX.
  • 5 Endocrine and Metabolic Consultants Research Center, Rockville, MD.
  • 6 Norfolk and Norwich University Hospitals National Health Service Foundation Trust, Norwich, U.K.
  • 7 Lexicon Pharmaceuticals, Inc., The Woodlands, TX.
Published Article
Diabetes care
Publication Date
Sep 14, 2020
DOI: 10.2337/dc20-0924
PMID: 32928957


To evaluate the incidence and risk factors for diabetic ketoacidosis (DKA) and related adverse events (AEs) in adults with type 1 diabetes treated with sotagliflozin adjunctive to insulin. Data from two identically designed, 52-week, randomized studies were pooled and analyzed for DKA, changes in β-hydroxybutyrate (BHB), and percentage of patients with BHB >0.6 and >1.5 mmol/L. The patients were administered placebo, sotagliflozin 200 mg, or sotagliflozin 400 mg once daily. A total of 191 ketosis-related AEs were reported, and 98 underwent adjudication. Of these, 37 events (36 patients) were adjudicated as DKA, with an exposure-adjusted incidence rate of 0.2, 3.1, and 4.2 events per 100 patient-years for placebo, sotagliflozin 200 mg, and sotagliflozin 400 mg. No patient died of a DKA event. From a baseline BHB of ∼0.13 mmol/L, sotagliflozin treatment led to a small median increase over 52 weeks (≤0.05 mmol/L at all time points). Of sotagliflozin-treated patients, approximately 47% and 7% had ≥1 BHB measurement >0.6 mmol/L and >1.5 mmol/L, respectively (vs. 20% and 2%, respectively, of placebo-treated patients). Subsequent to the implementation of a risk mitigation plan, annualized DKA incidence was lower versus preimplementation in both the sotagliflozin 200 and 400 mg groups. In patients with type 1 diabetes, confirmed DKA incidence increased when sotagliflozin was added to insulin compared with insulin alone. A lower incidence of DKA was observed following the implementation of an enhanced risk mitigation plan, suggesting that this risk can be managed with patient education. © 2020 by the American Diabetes Association.

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