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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

Diabetes, Obesity and Metabolism Apr 26, 2020

Mathieu C, Rudofsky G, Phillip M, et al. - In adults with type 1 diabetes (T1D) and inadequate glycemic control, researchers tested the long‐term safety and effectiveness of dapagliflozin as an adjunct to adjustable insulin. DEPICT‐2 (Dapagliflozin Evaluation in Patients with Inadequately Controlled T1D) was a placebo‐controlled, double‐blind, multicenter, Phase III study of T1D adults (HbA1c 7.5–10.5%) randomized (1:1:1) to receive dapagliflozin 5 mg, 10 mg, or placebo. The safety and effectiveness of dapagliflozin over 52 weeks were exploratory endpoints in this extension to DEPICT‐2. Of the randomized 813 candidates, 88.2% completed the study. In adults with T1D, dapagliflozin resulted in long‐term reductions in HbA1c and body weight, but increased risk of diabetic ketoacidosis relative to placebo.

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