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. Issue 9 (22nd May 2020)

• Record Type: Journal Article
• Authors: Mathieu, Chantal; Rudofsky, Gottfried; Phillip, Moshe; Araki, Eiichi; Lind, Marcus; Arya, Niki; Thorén, Fredrik; Scheerer, Markus F.; Iqbal, Nayyar; Dandona, Paresh
• Is Part Of: Diabetes, obesity & metabolism. Volume 22:Issue 9(2020)
• Page Start: 1516
• Page End: 1526
• Publication Date: 2020-05-22
• Subjects: dapagliflozin, DEPICT‐2, SGLT2 inhibitor, type 1 diabetes; Diabetes -- Periodicals; Obesity -- Periodicals; Metabolism -- Disorders -- Periodicals; Clinical pharmacology -- Periodicals; 616.462
• DOI: 10.1111/dom.14060
• Languages: English
• ISSNs: 1462-8902

Abstract

Abstract: Aim: To 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 Methods: Dapagliflozin 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. Results: Of 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. Conclusions: Dapagliflozin led to long‐term reductions in HbA1c and body weight in adults with T1D, but increased DKA risk compared with placebo.