Long-Term Sotagliflozin Safe, Effective as Adjunct Therapy to Insulin in Type 1 Diabetes

A bottle of pills
A bottle of pills
After insulin optimization, participants with type 1 diabetes were randomly assigned to placebo, sotagliflozin 200 mg, or sotagliflozin 400 mg with insulin.
The following article is part of conference coverage from the American Diabetes Association’s 78th Scientific Sessions (ADA 2018) in Orlando,Florida. Endocrinology Advisor’s staff will report on medical research and technological advances in diabetes and diabetes education, conducted by experts in the field. Check back for the latest news from ADA 2018.

ORLANDO — Sotagliflozin has shown efficacy in reducing glycated hemoglobin (HbA1c) and incidence of severe hypoglycemia in patients with type 1 diabetes. This research was presented at the American Diabetes Association’s 78th Scientific Sessions held in Orlando, Florida, June 22-26, 2018.

This double-blind trial took place over 1 year and included 793 adults with type 1 diabetes, 40% of whom received several insulin injections daily and 60% of whom were treated with an insulin pump. Participants were randomly assigned to receive either sotagliflozin 200 mg (n=263), sotagliflozin 400 mg (n=262), or a placebo (n=268).

The sotagliflozin 200 and 400 mg groups showed improvements in HbA1c and self-reported satisfaction at the 24-week mark, as well as decreased weight, HbA1c, bolus insulin, self-reported distress, and fasting plasma glucose at 1 year. Net clinical benefit was more common in the sotagliflozin group vs placebo (<.05). Severe hypoglycemia was most common in placebo, although increased diarrhea, genital mycotic infections, and diabetic ketoacidosis were more common in sotagliflozin 200 and 400 mg groups.

Participants receiving sotagliflozin were treated once per day following a 6-week insulin optimization period. The 3 groups showed similar baseline characteristics. The trial’s primary end point was shift from baseline in HbA1c at 24 weeks. Other end points included weight, HbA1c, changes in bolus insulin and fasting plasma glucose at 1 year, net clinical benefit and participant self-reported outcomes, and the ratio of subjects with HbA1c below 7% who did not experience diabetic ketoacidosis or severe hypoglycemia.

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The study researchers conclude that “[sotagliflozin] 200 and 400 mg were associated with statistically significant [HbA1c] reductions that were sustained (<.05) at Week 52, with an increased (but low) rate of [diabetic ketoacidosis], and a lower incidence of [severe hypoglycemia], when compared with placebo.”

This study was supported by Lexicon Pharmaceuticals. Sotagliflozin is being developed in partnership by Sanofi and Lexicon Pharmaceuticals. Please refer to reference for complete list of authors’ disclosures.

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Buse JB, Garg SK, Rosenstock J, et al. Fifty-two-week efficacy and safety of sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, as adjunct therapy to insulin in adults with type 1 diabetes (inTandem1). Poster presentation at: ADA 2018 78th Scientific Sessions; June 22-26, 2018; Orlando, FL. Abstract 212-OR.