DEPICT-1 Trial: Efficacy and Safety of Dapagliflozin in Patients With Inadequately Controlled Type 1 Diabetes

September 14, 2017. This 24-week double-blind, multicenter, randomized controlled trial evaluated the safety and efficacy of the sodium-glucose cotransporter-2 inhibitor dapagliflozin in patients with type 1 diabetes (T1D) not adequately controlled on insulin therapy. Patients were randomly assigned to receive dapagliflozin 5 mg or 10 mg, or placebo. The primary endpoint was A1C reduction from baseline. At 24 weeks, the mean A1C difference from baseline vs placebo was -0.42% and -0.45% for dapagliflozin 5 and 10 mg, respectively (P<0.0001 for both). The most common adverse events (AEs) observed were hypoglycemia, nasopharyngitis, urinary tract infection, upper respiratory tract infection, and headache; rates of all of these AEs were similar for patients receiving either dapagliflozin or placebo. Diabetic ketoacidosis occurred in 1% and 2% of patients receiving dapagliflozin 5 mg or 10 mg, respectively, and in 1% of patients on placebo. The authors concluded that dapagliflozin appears to be a promising adjunctive therapy for patients with T1D. These findings were presented at the European Association for the Study of Diabetes meeting and simultaneously published online. Follow this link to read the full article.