Efficacy and Safety of Dapagliflozin in Patients With Inadequately Controlled Type 1 Diabetes: The DEPICT-1 52-Week Study
Authors: Dandona Paresh , Mathieu Chantal , Phillip Moshe , Hansen Lars , Tschöpe Diethelm , Thorén Fredrik , Xu John , Langkilde Anna Maria ,   DEPICT-1 Investigators, 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 
Published: October 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.