Improved time in range and glycemic variability with sotagliflozin in combination with insulin in adults with type 1 diabetes: A pooled analysis of 24-week continuous glucose monitoring data from the IntanDEM program

Thomas Danne, Bertrand Cariou, John B. Buse, Satish K. Garg, Julio Rosenstock, Phillip Banks, Jake A. Kushner, Darren K. McGuire, Anne L. Peters, Sangeeta Sawhney, Paul Strumph

Research output: Contribution to journalArticle

16 Scopus citations

Abstract

OBJECTIVE To evaluate effects of the dual sodium–glucose cotransporter (SGLT) 1 and SGLT2 inhibitor sotagliflozin in combination with insulin on glucose time in range (TIR) and glucose excursions, postprandial glucose (PPG), and other glycemic metrics in adults with type 1 diabetes using masked continuous glucose monitoring (CGM). RESEARCH DESIGN AND METHODS Data sets from the inTandem1 (clinical trial reg. no. NCT02384941) and inTandem2 (clinical trial reg. no. NCT02421510) double-blind randomized trials evaluating sotagliflozin versus placebo in adults with type 1 diabetes treated with optimized insulin were pooled for analyses of masked CGM data from a subset of participants in each trial. The pooled cohort included patients randomized to receive placebo (n = 93), sotagliflozin 200 mg (n = 89), or sotagliflozin 400 mg (n = 96). The primary outcome was change from baseline to week 24 in glucose TIR (3.9–10.0 mmol/L [70–180 mg/dL]). Secondary end points included time below and above the target range and 2-h PPG level assessed after a standardized mixed meal. RESULTS Mean percentage of glucose TIR/percentage time spent at <3.9 mmol/L (<70 mg/dL) during week 24 was 51.6%/5.9%, 57.8%/5.5%, and 64.2%/5.5% with placebo, sotagliflozin 200 mg, and sotagliflozin 400 mg, respectively, which corresponded to a placebo-adjusted change from a baseline of +5.4%/20.3% (P = 0.026; +1.3/20.1 h/day) for sotagliflozin 200 mg and +11.7%/20.1% (P < 0.001; +2.8/20.02 h/day) for sotagliflozin 400 mg. Placebo-adjusted PPG reductions were 1.9 6 0.7 mmol/L (35 6 13 mg/dL; P = 0.004) and 2.8 6 0.7 mmol/L (50 6 13 mg/dL; P < 0.001) with sotagliflozin 200 and 400 mg, respectively. CONCLUSIONS Combined with optimized insulin in type 1 diabetes, sotagliflozin significantly increased glucose TIR without increasing time spent at <3.9 mmol/L and reduced PPG, thereby improving glycemic control.

Original languageEnglish (US)
Pages (from-to)919-930
Number of pages12
JournalDiabetes care
Volume42
Issue number5
DOIs
StatePublished - May 1 2019

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Advanced and Specialized Nursing

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