Long-term efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes (the DEPICT-2 study): 52-week results from a randomized controlled trial.

Abstract

AimTo investigate the long‐term efficacy and safety of dapagliflozin as an adjunct to adjustable insulin in adults with type 1 diabetes (T1D) and inadequate glycaemic control.Materials and MethodsDapagliflozin Evaluation in Patients with Inadequately Controlled Type 1 Diabetes (DEPICT‐2) was a placebo‐controlled, double‐blind, multicentre, phase III study of adults with T1D (HbA1c 7.5%‐10.5%) randomized (1:1:1) to receive dapagliflozin 5, 10 mg, or placebo. The efficacy and safety of dapagliflozin over 52 weeks were exploratory endpoints in this extension to DEPICT‐2.ResultsOf 813 participants randomized, 88.2% completed the study. From baseline to 52 weeks, dapagliflozin 5 and 10 mg were associated with reduction in HbA1c (difference [95% CI] vs. placebo: −0.20% [−0.34, −0.06] and −0.25% [−0.38, −0.11], respectively) and adjusted mean percentage change in body weight (difference [95% CI] vs. placebo: −4.42% [−5.19, −3.64] and −4.86% [−5.63, −4.08], respectively). Serious adverse events were reported in the dapagliflozin 5, 10 mg, and placebo groups (32 [11.8%], 19 [7.0%] and 16 [5.9%], respectively). The proportion of hypoglycaemic events was similar across groups; severe hypoglycaemia was uncommon. More participants with events adjudicated as definite diabetic ketoacidosis (DKA) were in the dapagliflozin 5 and 10 mg groups versus placebo (11 [4.1%], 10 [3.7%] and 1 [0.4%], respectively); the majority of events were mild or moderate in severity and all were resolved with treatment.ConclusionsDapagliflozin led to long‐term reductions in HbA1c and body weight in adults with T1D, but increased DKA risk compared with placebo.