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

Abstract

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 (HbA 1c 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 HbA 1c (difference vs. placebo [95% CI] 20.

Sodium‐glucose co‐transporter inhibitors, their role in type 1 diabetes treatment and a risk mitigation strategy for preventing diabetic ketoacidosis: The STOP DKA Protocol

“…With the overarching goal of expanding the type 1 diabetes toolbox beyond insulin, several multinational phase 3 trials in type 1 diabetes cohorts were conducted using the SGLT2 inhibitors dapagliflozin (DEPICT Programme) and empagliflozin (EASE Programme), as well as the dual SGLT1/2 inhibitor sotagliflozin (inTandem Programme). Given that the detailed results of these research programmes have already been published, only the salient points of each will be discussed.…”

“…The dapagliflozin‐focused DEPICT phase 3 programme consisted of two studies: DEPICT‐1 (24‐wk short‐term study +28‐wk extension) and DEPICT‐2 (24 wk) . The populations of these two studies had comparable baseline age, duration of type 1 diabetes, and HbA1c levels (Table S1).…”

“…While the DEPICT‐1 participants were predominantly white (95%) with 60% of the cohort recruited in Europe and 27% in North America, 78% of the DEPICT‐2 population was white and 20% Asian, with approximately 34%, 35% and 19% of the group enrolled in Europe, North America and Japan, respectively . The HbA1c entry criterion was ≥58 to ≤91 mmol/mol (≥7.5% to ≤10.5%) and approximately three‐quarters of both cohorts had an HbA1c level ≥ 58 to <75 mmol/mol (≥7.5% to <9.0%) at randomization . Only individuals with a calculated creatinine clearance of ≥60 mL/min/1.73 2 were included.…”

“…Only individuals with a calculated creatinine clearance of ≥60 mL/min/1.73 2 were included. Although the DEPICT‐1 cohort used more insulin than the DEPICT‐2 population, the ratio of participants using continuous subcutaneous insulin infusion (CSII) to MDI was similar in both groups with one in three using CSII and two in three using MDI …”

Pharmacokinetics and pharmacodynamics of dapagliflozin in combination with insulin in Japanese patients with type 1 diabetes

“…Data from the DEPICT‐1 and DEPICT‐2 studies at 24 weeks showed that dapagliflozin was associated with a significant reduction in HbA1c, total daily insulin dose and body weight, as well as with improvements in several continuous glucose‐monitoring parameters in patients with T1D . Participants in the DEPICT‐1 study also showed improvement in glycaemic control up to 52 weeks following dapagliflozin administration …”