Efficacy and Safety of Dapagliflozin in Patients With Inadequately Controlled Type 1 Diabetes: The DEPICT-1 52-Week Study

• Published in: Diabetes care Vol. 41; no. 12; pp. 2552 - 2559
• Main Authors: Dandona, Paresh, Mathieu, Chantal, Phillip, Moshe, Hansen, Lars, Tschöpe, Diethelm, Thorén, Fredrik, Xu, John, Langkilde, Anna Maria
• Format: Journal Article
• Language: English
• Published: United States American Diabetes Association 01.12.2018
• Subjects: Adult; Antidiabetics; Benzhydryl Compounds - therapeutic use; Blood Glucose - drug effects; Blood Glucose - metabolism; Body weight; Body weight loss; Clinical outcomes; Control methods; Diabetes; Diabetes mellitus; Diabetes mellitus (insulin dependent); Diabetes Mellitus, Type 1 - blood; Diabetes Mellitus, Type 1 - drug therapy; Double-Blind Method; Drug therapy; Drug Therapy, Combination; Female; Glucose; Glucose monitoring; Glucosides - therapeutic use; Glycated Hemoglobin A - analysis; Glycated Hemoglobin A - metabolism; Health risks; Humans; Hypoglycemia; Hypoglycemic Agents - therapeutic use; Insulin; Insulin - administration & dosage; Insulin - adverse effects; Ketoacidosis; Male; Patients; Placebos; Randomization; Research design; Safety; Treatment Outcome; Weight loss; Weight Loss - drug effects
• ISSN: 0149-5992; 1935-5548
• DOI: 10.2337/dc18-1087

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. 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 (HbA 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. 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 HbA (difference vs. placebo [95% CI] -0.33% [-0.49, -0.17] [-3.6 mmol/mol (-5.4, -1.9)] and -0.36% [-0.53, -0.20] [-3.9 mmol/mol (-5.8, -2.2)], respectively) and body weight (difference vs. placebo [95% CI] -2.95% [-3.83, -2.06] and -4.54% [-5.40, -3.66], 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). 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.