Portal de Periódicos da CAPES

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

2018; American Diabetes Association; Volume: 41; Issue: 12 Linguagem: Inglês

10.2337/dc18-1087

1935-5548

Paresh Dandona, Chantal Mathieu, Moshe Phillip, Lars Hansen, Diethelm Tschöpe, Fredrik Thorén, John Xu, Anna Maria Langkilde, Joseph Proietto, Stephen N Stranks, Roger Chen, David N. O’Neal, Alexia Pape, Mark Forbes, Claire Morbey, Anton Luger, Ursula Hanusch, Christoph Schnack, Evelyn Fliesser-Goerzer, Bertram Hoelzl, Christoph Ebenbichler, Rudolf Prager, Luc Van Gaal, Chris Vercammen, André Scheen, Chantal Mathieu, Francis Duyck, Frank Nobels, Johannes Ruige, Naresh Aggarwal, Vincent Woo, Bruno St-Pierre, R Dumas, Irene Hramiak, Thomas G. Elliott, Troels Krarup Hansen, Jan Erik Henriksen, Jeppe Gram, A. S. Lihn, Jens Meldgaard Bruun, Juha Saltevo, Jyrki Taurio, Jorma Strand, Timo T. Valle, Sakari Nieminen, Kirsi H. Pietiläinen, Bruno Guerci, Samy Hadjadj, Bertrand Cariou, Bruno Vergès, Sophie Borot, A. Penfornis, Diethelm Tschöpe, Thomas Schaum, Cornelia Marck, Thomas Horacek, Ludger Rose, Gerhard Klausmann, Joerg Luedemann, Steffi Appelt, Ulrich Aigner, R Goebel, Thomas Behnke, Anette‐Gabriele Ziegler, Eva Péterfai, Zsuzsanna Kerenyi, Tamás Oroszlán, G Kiss, L. Könyves, Gyorgyi Piros, Moshe Phillip, Ofri Mosenzon, Naim Shehadeh, Faiad Adawi, Julio Wainstein, Francesco Dotta, PierMarco Piatti, Stefano Genovese, Agostino Consoli, Paolo Di Bartolo, Edoardo Mannucci, Carla Giordano, Annunziata Lapolla, Carlos Aguilar, Alberto Esteban Bazzoni Ruiz, Guillermo Mondragon Ramirez, Emilia Pelayo Orozco, Carlos Alejandro Stobschinski de Alba, Carlos Eduardo Medina Pech, Jose Garza Ruiz, Leobardo Sauque Reyna, Guillermo Llamas Esperón, Luis Alejandro Nevarez Ruiz, Maricela Vidrio Velázquez, Fernando Flores Lozano, José Gerardo González‐González, Pedro Alberto García-Hernández, Roberto Araujo Silva, Efraín Villeda-Espinosa, Cristina Mistodie, Daniela Popescu, Ciprian Constantin, Alina Nicolau, Bogdan Popa, Romulus Timar, Cristian Serafinceanu, Ella Pintilei, Alfonso Soto, Marga Giménez, Juan Francisco Merino-Torres, Cristóbal Morales, P Mezquita, Johan Jendle, Bengt-Olov Tengmark, Jan W. Eriksson, Magnus Löndahl, Björn Eliasson, Anthony Gunstone, Simon Heller, Ken Darzy, Peter Mansell, Melanie J. Davies, Rory Reed, Duncan L. Browne, Hamish Courtney, Wayne Turner, Mark Blagden, Rory J. McCrimmon, Paresh Dandona, Richard M. Bergenstal, Wendy Lane, Kathryn Jean Lucas, Alexander White, Shichun Bao, Judith L. White, Curtis Jantzi, Neda Rasouli, William Ervin, Lorena Lewy-Alterbaum, Yehuda Handelsman, Bresta Miranda-Palma, Alan Cleland, Raymond Fink, Helena W. Rodbard, Samer Nakhle, Craig Greenberg, Alan B. Schorr, Harold Bays, Debra L. Simmons, E. Klein, Laurie A. Kane, Norman Fishman, Eli Ipp, Satish K. Garg, Anuj Bhargava, Michelle Zaniewski Singh, Julio Rosenstock, James Thrasher, Mark Warren, Laura Young, Vanita R. Aroda, Jeremy Pettus, David R. Liljenquist, Robert S. Busch, Jonathan Wise, David Kayne, William Biggs,

Diabetes Management and Research

OBJECTIVE 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 (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. 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 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). CONCLUSIONS 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.