This small phase 2 study evaluated the use of sotagliflozin, a dual sodium–glucose cotransporter 1 (SGLT1) and SGLT2 inhibitor, as an adjunct to insulin therapy in young adults with poorly controlled type 1 diabetes (HbA1c ≥75 mmol/mol [9.0%]).
Participants were randomised to 12 weeks of either sotagliflozin 400 mg (n=43) or placebo (n=42), in addition to investigator-led insulin therapy to achieve HbA1c targets of 53 mmol/mol (7.0%). At 12 weeks, the primary outcome, least squares mean HbA1c, fell in both the sotagliflozin and placebo groups (by 14 mmol/mol and 11 mmol/mol, respectively); however, the difference between the groups was not significant.
Compared with placebo, significant reductions in postprandial glucose (mean difference, 3.1 mmol/L) and body weight (mean difference, 2.37 kg) were observed with sotagliflozin, and more participants achieved target HbA1c with sotagliflozin than with placebo (16.3% vs 2.4%). However, because significance was tested hierarchically and the study did not meet its primary endpoint, these findings cannot demonstrate true statistical significance.
The incidence of documented and severe hypoglycaemia was similar in the two groups, and there was no incidence of diabetic ketoacidosis (DKA) associated with sotagliflozin.
This study was limited by the short duration, small sample size and lack of significance for the primary endpoint. However, the authors conclude that sotagliflozin may be a useful adjunct to insulin therapy in terms of glycaemic control and weight loss, with a reassuring safety profile in a population that has a high risk of DKA.
Bode BW, Cengiz E, Wadwa RP et al (2020) Effects of sotagliflozin combined with intensive insulin therapy in young adults with poorly controlled type 1 diabetes: the JDRF Sotagliflozin Study. Diabetes Technol Ther 8 Jul [epub ahead of print]. https://doi.org/10.1089/dia.2020.0079
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