Efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes: The DEPICT-1 52-week study

behalf of the DEPICT-1 Investigators

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Abstract

OBJECTIVE This study evaluated the long-term safety and efficacy of dapagliflozin as an adjunct to adjustable insulin in patients with type 1 diabetes and inadequate glycemic control. RESEARCH DESIGN AND METHODS DEPICT-1 (Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes) was a randomized (1:1:1), double-blind, placebo-controlled phase 3 study of dapagliflozin 5 mg and 10 mg in patients with type 1 diabetes (HbA1c 7.5-10.5% [58-91 mmol/mol]) (NCT02268214). The results of the 52-week study, consisting of the 24-week short-term and 28-week extension period, are reported here. RESULTS Of the 833 patients randomized into the study, 708 (85%) completed the 52-week study. Over 52 weeks, dapagliflozin 5 mg and 10 mg led to clinically significant reductions in HbA1c (difference vs. placebo [95% CI] 20.33% [20.49, 20.17] [23.6 mmol/mol (25.4, 21.9)] and 20.36% [20.53, 20.20] [23.9 mmol/mol (25.8, 22.2)], respectively) and body weight (difference vs. placebo [95% CI] 22.95% [23.83, 22.06] and 24.54% [25.40, 23.66], respectively). Serious adverse events were reported in 13.4%, 13.5%, and 11.5% of patients in the dapagliflozin 5 mg, 10 mg, and placebo groups, respectively. Although hypoglycemia events were comparable across treatment groups, more patients in the dapagliflozin groups had events adjudicated as definite diabetic ketoacidosis (DKA; 4.0%, 3.4%, and 1.9% in dapagliflozin 5 mg, 10 mg, and placebo groups, respectively). CONCLUSIONS Over 52 weeks, dapagliflozin led to improvements in glycemic control and weight loss in patients with type 1 diabetes, while increasing the risk of DKA.

Original languageEnglish
Pages (from-to)2552-2559
Number of pages8
JournalDiabetes Care
Volume41
Issue number12
DOIs
StatePublished - 1 Dec 2018

Funding

FundersFunder number
Bristol-Myers Squibb
AstraZeneca
Servier

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