Long-Term Efficacy and Safety of Dapagliflozin in Patients with Inadequately Controlled Type 1 Diabetes—The DEPICT-1 Study

In the short term (24-week) period of the Phase 3 study DEPICT-1, treatment with the SGLT2 inhibitor dapagliflozin (DAPA) as adjunct to adjustable insulin (INS) improved glycemic control and was well-tolerated in patients with inadequately controlled T1D (HbA1c 7.5-10.5%) ( Lancet Diabetes Endocrinol . 2017;5:864-76). Here we describe the 28-week extension of DEPICT-1, assessing the 52-week efficacy and safety of DAPA in patients who completed the 24-week period. 747 patients in the DAPA 5 mg (n=250), 10 mg (n=270), or placebo (PBO; n=227) plus INS groups entered the long-term period (90% of the randomized patients); 85% completed the study. Reductions in HbA1c and body weight were maintained in the DAPA groups vs. PBO over 52 weeks (Table). The moderate decrease in HbA1c with DAPA was accompanied by a more substantial dose-dependent reduction in body weight. Total events of adjudicated definite DKA increased in the long-term period, with more in the DAPA groups vs. PBO at Week 52. Most were mild or moderate, with the primary cause related to missed insulin doses or pump failure. Adverse events (AEs), serious AEs, and hypoglycemic events were balanced between groups (Table). In conclusion, DAPA plus INS provided a sustained reduction in HbA1c and body weight, and was well-tolerated, but increased events of DKA over 52 weeks in patients with inadequately controlled T1D. Disclosure P. Dandona: Advisory Panel; Self; AstraZeneca. Consultant; Self; AstraZeneca. Research Support; Self; AstraZeneca. C. Mathieu: Research Support; Self; Novo Nordisk A/S. Advisory Panel; Self; Novo Nordisk A/S. Speaker9s Bureau; Self; Novo Nordisk A/S. Research Support; Self; Sanofi. Speaker9s Bureau; Self; Sanofi. Advisory Panel; Self; Sanofi. Research Support; Self; Merck Sharp u0026 Dohme Corp.. Speaker9s Bureau; Self; Merck Sharp u0026 Dohme Corp.. Advisory Panel; Self; Merck Sharp u0026 Dohme Corp.. Research Support; Self; Eli Lilly and Company. Speaker9s Bureau; Self; Eli Lilly and Company. Advisory Panel; Self; Eli Lilly and Company. Research Support; Self; Novartis AG. Speaker9s Bureau; Self; Novartis AG. Advisory Panel; Self; Novartis AG, Bristol-Myers Squibb Company. Speaker9s Bureau; Self; AstraZeneca. Advisory Panel; Self; AstraZeneca, Pfizer Inc., Janssen Pharmaceuticals, Inc., Boehringer Ingelheim GmbH. Speaker9s Bureau; Self; Boehringer Ingelheim GmbH. Advisory Panel; Self; Hanmi Pharmaceutical. Research Support; Self; Roche Diagnostics Corporation. Advisory Panel; Self; Roche Diagnostics Corporation. Research Support; Self; Medtronic. Advisory Panel; Self; Medtronic, MannKind Corporation. Research Support; Self; Intrexon. Advisory Panel; Self; Intrexon, Dianax, UCB, Inc.. Research Support; Self; Abbott. M. Phillip: Other Relationship; Self; Sanofi, Medtronic MiniMed, Inc., Novo Nordisk A/S. Speaker9s Bureau; Self; Eli Lilly and Company. Research Support; Self; Merck u0026 Co., Inc., Bristol-Myers Squibb Company, Kamada, Lexicon Pharmaceuticals, Inc.. Other Relationship; Self; DreaMed Diabetes, Ltd.. Speaker9s Bureau; Self; Abbott. L. Hansen: Employee; Self; MedImmune. D. Tschoepe: Advisory Panel; Self; AstraZeneca. Speaker9s Bureau; Self; AstraZeneca. Advisory Panel; Self; Amgen Inc.. Speaker9s Bureau; Self; Amgen Inc.. Advisory Panel; Self; Eli Lilly and Company. Speaker9s Bureau; Self; Eli Lilly and Company. Advisory Panel; Self; Novo Nordisk A/S. Speaker9s Bureau; Self; Novo Nordisk A/S. Advisory Panel; Self; Servier. Speaker9s Bureau; Self; Servier, Sanofi, Novartis Pharmaceuticals Corporation. Research Support; Self; AstraZeneca, Bayer AG, Eli Lilly and Company, Novo Nordisk A/S, Novartis Pharmaceuticals Corporation, Sanofi. F.A. Thoren: Employee; Self; AstraZeneca. J. Xu: Employee; Self; AstraZeneca. A. Langkilde: Employee; Self; AstraZeneca. Stock/Shareholder; Self; AstraZeneca.