Long-term (52-week) efficacy and safety of dapagliflozin as adjunct to insulin therapy in Japanese patients with type 1 diabetes: Subgroup analysis of the DEPICT-2 study.

AIMS Dapagliflozin, an SGLT2 inhibitor used to treat type 2 diabetes, can improve glycemic control and attenuate weight gain associated with insulin therapy in patients with type 1 diabetes (T1D) without increasing hypoglycemic risk, as demonstrated in the DEPICT-2 study. We examined the long-term efficacy and safety of dapagliflozin in the Japanese sub-population of DEPICT-2. MATERIALS AND METHODS T1D patients were randomized to dapagliflozin 5 mg (n = 55), dapagliflozin 10 mg (n = 41), or placebo (n = 58) plus insulin for a 24-week double-blind period followed by a 28-week single-blind extension phase. RESULTS From baseline to 24 weeks, dapagliflozin reduced HbA1c compared with placebo (mean change of -0.58% and -0.80% for 5 mg and 10 mg, respectively), and a HbA1c reduction was observed up to 52 weeks. Compared with placebo, dapagliflozin 5 mg and 10 mg increased the proportion of patients achieving ≥0.5% reductions in HbA1c without severe hypoglycemia events and reduced glycemic variability assessed via continuous glucose monitoring. Both dapagliflozin doses decreased body weight and total daily insulin dose at 24 weeks compared with placebo; these reductions were maintained up to 52 weeks. Diabetic ketoacidosis occurred in both dapagliflozin groups (one and two cases, respectively) but not with placebo. CONCLUSIONS Efficacy and safety results from the Japanese sub-population of DEPICT-2 were generally consistent with those from the overall population, indicating that long-term dapagliflozin adjunct to insulin therapy improves glycemic control without increased risk of hypoglycemia but with a risk of diabetic ketoacidosis in Japanese patients with T1D. This article is protected by copyright. All rights reserved.