DEPICT-1 and -2 (NCT02268214, NCT02460978) were near identical studies assessing DAPA 5 and 10 mg as add-on to insulin (INS) in T1D. Here we present an analysis of the pooled population from the two studies. Safety data were available for 548, 566 and 532 patients (pts) in the DAPA 5 mg, 10 mg and placebo (PBO) groups, respectively and efficacy data for 530, 529 and 532 pts in each group, respectively. Baseline characteristics were similar between groups. Overall mean (SD) age was 43 (14) years, BMI 28 (5) kg/m2, duration of T1D 20 (12) years and HbA1c 8.5 (0.7)%. At week (week) 24 and 52 DAPA decreased HbA1c, systolic blood pressure (BP) and weight vs. PBO (Table). At week 24, INS dose was decreased with DAPA 5 mg (−8.3%) and 10 mg (−10.5%) but increased with PBO (+1.4%); this pattern was also seen up to week 52. More DAPA vs. PBO pts achieved HbA1c reduction ≥0.5% without severe hypoglycemia (hypo; Table). Safety of DAPA was consistent with previous observations in T1D and T2D. Severe hypo was balanced across groups. Events adjudicated as definite diabetic ketoacidosis (DKA) occurred more frequently with DAPA vs. PBO (in 3.8 vs. 1.1% of pts after 52 weeks); most were of mild or moderate intensity.
In conclusion, over 52 weeks in this large group of pts with T1D, DAPA provided glycemic, weight and BP benefits along with reductions in INS, increased DKA events, but with a low frequency of severe hypo.
P. Dandona: Advisory Panel; Self; AbbVie Inc., AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Intarcia Therapeutics, Inc., Merck & Co., Inc., Novo Nordisk Inc., Sanofi. Research Support; Self; AbbVie Inc., AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk Inc., Sanofi. C. Mathieu: Advisory Panel; Self; Boehringer Ingelheim International GmbH, Eli Lilly and Company, Merck & Co., Inc., Novo Nordisk A/S, Roche Diabetes Care, Sanofi. Speaker's Bureau; Self; AstraZeneca, Novartis AG, Novo Nordisk A/S, Sanofi. M. Phillip: Consultant; Self; Qulab Medical, RSP Systems A/S. Research Support; Self; Bristol-Myers Squibb Company, Dexcom, Inc., JDRF, Lexicon Pharmaceuticals, Inc., Merck & Co., Inc., OPKO. Stock/Shareholder; Self; DreaMed Diabetes, Ltd., NG Solutions Ltd., Nutriteen Professional Ltd. Other Relationship; Self; AstraZeneca, Eli Lilly and Company, Insulet Corporation, Medtronic MiniMed, Inc., Novo Nordisk A/S, Pfizer Inc., Sanofi-Aventis. L. Hansen: Employee; Self; AstraZeneca, MedImmune. Stock/Shareholder; Self; Bristol-Myers Squibb Company, Novo Nordisk A/S. F.A. Thoren: Employee; Self; AstraZeneca. M.F. Scheerer: Employee; Self; AstraZeneca. J. Xu: Employee; Self; AstraZeneca. A. Langkilde: Employee; Self; AstraZeneca. Stock/Shareholder; Self; AstraZeneca.