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

Medientyp: E-Artikel
Titel: Efficacy and Safety of Dapagliflozin in Patients With Inadequately Controlled Type 1 Diabetes: The DEPICT-1 52-Week Study
Beteiligte: Dandona, Paresh; Mathieu, Chantal; Phillip, Moshe; Hansen, Lars; Tschöpe, Diethelm; Thorén, Fredrik; Xu, John; Langkilde, Anna Maria; Proietto, Joseph; Stranks, Stephen; Chen, Roger; O'Neal, David; Pape, Alexia; Forbes, Mark; Morbey, Claire; Luger, Anton; Hanusch, Ursula; Schnack, Christoph; Fliesser-Goerzer, Evelyn; Hoelzl, Bertram; Ebenbichler, Christoph; Prager, Rudolf; Van Gaal, Luc; Vercammen, Chris; [...]
Erschienen: American Diabetes Association, 2018
Erschienen in: Diabetes Care
Sprache: Englisch
DOI: 10.2337/dc18-1087
ISSN: 0149-5992; 1935-5548
Schlagwörter: Advanced and Specialized Nursing ; Endocrinology, Diabetes and Metabolism ; Internal Medicine
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Beschreibung: <jats:sec> <jats:title>OBJECTIVE</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec> <jats:title>RESEARCH DESIGN AND METHODS</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec> <jats:title>RESULTS</jats:title> <jats:p>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] −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).</jats:p> </jats:sec> <jats:sec> <jats:title>CONCLUSIONS</jats:title> <jats:p>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.</jats:p> </jats:sec>
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