Benefit:Risk Profile of Dapagliflozin 5 mg in the DEPICT-1 and -2 Trials in Individuals with Type 1 Diabetes and BMI ≥27 kg/m2.

AIM The DEPICT-1 and -2 studies (NCT02268214, NCT02460978) evaluated the efficacy and safety of dapagliflozin in individuals with type 1 diabetes who were receiving intensive insulin therapy. This post-hoc analysis investigated the safety and efficacy of dapagliflozin in individuals with BMI ≥27 kg/m2 . METHODS Changes in HbA1c and body weight, percent change in daily insulin dose and proportion of participants achieving HbA1c reduction ≥0.5% without severe hypoglycaemia were evaluated at Weeks 24 and 52. Changes in mean interstitial glucose, mean amplitude of glycaemic excursions, and time in target glycaemic range were evaluated at Week 24. Safety was assessed until Week 56. RESULTS Week-52 adjusted mean (SE) change from baseline for HbA1c was -0.26% (0.05) with dapagliflozin versus +0.08% (0.05) with placebo and for body weight was -2.74 kg [0.25] with dapagliflozin versus +0.81 kg [0.26] with placebo. Mean [SE] percent change in daily insulin dose was -10.5% (1.23) with dapagliflozin versus -1.4% (1.36) with placebo. Time spent in target glycaemic range increased by 2.2 hours/day versus placebo. Dapagliflozin was well tolerated, with lower proportion of participants experiencing diabetic ketoacidosis (dapagliflozin, 1.7%; placebo, 1.0%) than dapagliflozin 5 mg receiving participants in the pooled DEPICT populations. CONCLUSIONS Compared with the pooled DEPICT population, the benefit:risk profile of adjunct dapagliflozin therapy was more favourable in individuals with T1D with BMI ≥27 kg/m2 due to the reduced risk of diabetic ketoacidosis in this population. This article is protected by copyright. All rights reserved.