Efficacy and Safety of Dapagliflozin in Patients With Inadequately Controlled Type 1 Diabetes: The DEPICT-1 52-Week Study
Author:
Dandona Paresh1ORCID, Mathieu Chantal2ORCID, Phillip Moshe34, Hansen Lars5, Tschöpe Diethelm6, Thorén Fredrik7, Xu John8, Langkilde Anna Maria7, Proietto Joseph, Stranks Stephen, Chen Roger, O'Neal David, Pape Alexia, Forbes Mark, Morbey Claire, Luger Anton, Hanusch Ursula, Schnack Christoph, Fliesser-Goerzer Evelyn, Hoelzl Bertram, Ebenbichler Christoph, Prager Rudolf, Van Gaal Luc, Vercammen Chris, Scheen Andre, Mathieu Chantal, Duyck Francis, Nobels Frank, Ruige Johannes, Aggarwal Naresh, Woo Vincent, St-Pierre Bruno, Dumas Richard, Hramiak Irene, Elliott Thomas, Hansen Troels Krarup, Henriksen Jan Erik, Gram Jeppe, Lihn Aina, Bruun Jens, Saltevo Juha, Taurio Jyrki, Strand Jorma, Valle Timo, Nieminen Sakari, Pietilainen Kirsi, Guerci Bruno, Hadjadj Samy, Cariou Bertrand, Verges Bruno, Borot Sophie, Penfornis Alfred, Tschöpe Diethelm, Schaum Thomas, Marck Cornelia, Horacek Thomas, Rose Ludger, Klausmann Gerhard, Luedemann Joerg, Appelt Steffi, Aigner Ulrich, Goebel Rolf, Behnke Thomas, Ziegler Anette-Gabriele, Peterfai Eva, Kerenyi Zsuzsanna, Oroszlan Tamas, Kiss Gyula G., Konyves Laszlo, Piros Gyorgyi, Phillip Moshe, Mosenzon Ofri, Shehadeh Naim, Adawi Faiad, Wainstein Julio, Dotta Francesco, Piatti Piermarco, Genovese Stefano, Consoli Agostino, Di Bartolo Paolo, Mannucci Edoardo, Giordano Carla, Lapolla Annunziata, Aguilar Carlos, Bazzoni Ruiz Alberto Esteban, Mondragon Ramirez Guillermo, Orozco Emilia Pelayo, Stobschinski de Alba Carlos Alejandro, Medina Pech Carlos Eduardo, Garza Ruiz Jose, Sauque Reyna Leobardo, Llamas Esperon Guillermo, Nevarez Ruiz Luis Alejandro, Velazquez Maricela Vidrio, Flores Lozano Fernando, Gonzalez Gonzalez Jose Gerardo, Garcia-Hernandez Pedro Alberto, Araujo Silva Roberto, Villeda-Espinosa Efrain, Mistodie Cristina, Popescu Daniela, Constantin Ciprian, Nicolau Alina, Popa Bogdan, Timar Romulus, Serafinceanu Cristian, Pintilei Ella, Soto Alfonso, Gimenez Margarita, Merino Juan, Morales Cristobal, Mezquita Pedro, Jendle Johan, Tengmark Bengt-Olov, Eriksson Jan, Londahl Magnus, Eliasson Bjorn, Gunstone Anthony, Heller Simon R., Darzy Ken, Mansell Peter, Davies Melanie, Reed Rory, Browne Duncan, Courtney Hamish, Turner Wayne, Blagden Mark, McCrimmon Rory, Dandona Paresh, Bergenstal Richard, Lane Wendy, Lucas Kathryn, White Alexander, Bao Shichun, White Judith, Jantzi Curtis, Rasouli Neda, Ervin William, Lewy-Alterbaum Lorena, Handelsman Yehuda, Miranda-Palma Bresta, Cleland Alan, Fink Raymond, Rodbard Helena, Nakhle Samer, Greenberg Craig, Schorr Alan, Bays Harold, Simmons Debra, Klein Eric, Kane Laurie, Fishman Norman, Ipp Eli, Garg Satish, Bhargava Anuj, Singh Michelle Zaniewski, Rosenstock Julio, Thrasher James, Warren Mark, Young Laura, Aroda Vanita, Pettus Jeremy, Liljenquist David, Busch Robert, Wise Jonathan, Kayne David, Biggs William,
Affiliation:
1. Department of Medicine, State University of New York at Buffalo, Buffalo, NY 2. Clinical and Experimental Endocrinology, Universitair Ziekenhuis (UZ) Gasthuisberg, University of Leuven, Leuven, Belgium 3. Institute for Endocrinology and Diabetes, Schneider Children’s Medical Center of Israel, Petah Tikva, Israel 4. Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel 5. Bristol-Myers Squibb, Princeton, NJ 6. Department for Endocrinology, Diabetology and Gastroenterology, Heart and Diabetes Centre, Bad Oeynhausen, Germany, and Ruhr University Bochum, Bochum, Germany 7. AstraZeneca, Gothenburg, Sweden 8. AstraZeneca, Gaithersburg, MD
Abstract
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.
Funder
AstraZeneca Bristol-Myers Squibb
Publisher
American Diabetes Association
Subject
Advanced and Specialized Nursing,Endocrinology, Diabetes and Metabolism,Internal Medicine
Cited by
180 articles.
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