Efficacy and Safety of Dapagliflozin in Patients With Inadequately Controlled Type 1 Diabetes: The DEPICT-1 52-Week Study
Authors: Paresh Dandona, Chantal Mathieu, Moshe Phillip, Lars Hansen, Diethelm Tschöpe, Fredrik Thorén, John Xu, Anna Maria Langkilde, Joseph Proietto, Stephen Stranks, Roger Chen, David 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, Andre Scheen, Chantal Mathieu, Francis Duyck, Frank Nobels, Johannes Ruige, Naresh Aggarwal, Vincent Woo, Bruno St-Pierre, Richard Dumas, Irene Hramiak, Thomas Elliott, Troels Krarup Hansen, Jan Erik Henriksen, Jeppe Gram, Aina Lihn, Jens Bruun, Juha Saltevo, Jyrki Taurio, Jorma Strand, Timo Valle, Sakari Nieminen, Kirsi Pietilainen, Bruno Guerci, Samy Hadjadj, Bertrand Cariou, Bruno Verges, Sophie Borot, Alfred Penfornis, Diethelm Tschöpe, Thomas Schaum, Cornelia Marck, Thomas Horacek, Ludger Rose, Gerhard Klausmann, Joerg Luedemann, Steffi Appelt, Ulrich Aigner, Rolf Goebel, Thomas Behnke, Anette-Gabriele Ziegler, Eva Peterfai, Zsuzsanna Kerenyi, Tamas Oroszlan, Gyula G. Kiss, Laszlo Konyves, 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 Esperon, Luis Alejandro Nevarez Ruiz, Maricela Vidrio Velazquez, Fernando Flores Lozano, Jose Gerardo Gonzalez Gonzalez, Pedro Alberto Garcia-Hernandez, Roberto Araujo Silva, Efrain Villeda-Espinosa, Cristina Mistodie, Daniela Popescu, Ciprian Constantin, Alina Nicolau, Bogdan Popa, Romulus Timar, Cristian Serafinceanu, Ella Pintilei, Alfonso Soto, Margarita Gimenez, Juan Merino, Cristobal Morales, Pedro Mezquita, Johan Jendle, Bengt-Olov Tengmark, Jan Eriksson, Magnus Londahl, Bjorn Eliasson, Anthony Gunstone, Simon R. Heller, Ken Darzy, Peter Mansell, Melanie Davies, Rory Reed, Duncan Browne, Hamish Courtney, Wayne Turner, Mark Blagden, Rory McCrimmon, Paresh Dandona, Richard Bergenstal, Wendy Lane, Kathryn Lucas, Alexander White, Shichun Bao, Judith White, Curtis Jantzi, Neda Rasouli, William Ervin, Lorena Lewy-Alterbaum, Yehuda Handelsman, Bresta Miranda-Palma, Alan Cleland, Raymond Fink, Helena Rodbard, Samer Nakhle, Craig Greenberg, Alan Schorr, Harold Bays, Debra Simmons, Eric Klein, Laurie Kane, Norman Fishman, Eli Ipp, Satish Garg, Anuj Bhargava, Michelle Zaniewski Singh, Julio Rosenstock, James Thrasher, Mark Warren, Laura Young, Vanita Aroda, Jeremy Pettus, David Liljenquist, Robert Busch, Jonathan Wise, David Kayne, William Biggs
Journal: Diabetes Care (2018)

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.