Efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes (DEPICT-1): 24 week results from a multicentre, double-blind, phase 3, randomised controlled trial

医学 达帕格列嗪 2型糖尿病 双盲 糖尿病 随机对照试验 梅德林 物理疗法 内科学 替代医学 安慰剂 内分泌学 政治学 病理 法学
作者
Paresh Dandona,Chantal Mathieu,Moshe Phillip,Lars Hansen,Steven C. Griffen,Diethelm Tschöpe,Fredrik Thorén,John Xu,Anna Maria Langkilde,Joseph Proietto,Stephen 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,Thomas Schaum,Diethelm Tschoepe,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 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,Efrain 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,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,Paresh Dandona,Jonathan Wise,David Kayne,William Biggs
出处
期刊:The Lancet Diabetes & Endocrinology [Elsevier]
卷期号:5 (11): 864-876 被引量:252
标识
DOI:10.1016/s2213-8587(17)30308-x
摘要

Summary Background Dapagliflozin is a sodium-glucose cotransporter-2 inhibitor approved for the treatment of type 2 diabetes. We aimed to assess the efficacy and safety of dapagliflozin as an add-on to adjustable insulin in patients with inadequately controlled type 1 diabetes. Methods DEPICT-1 was a double-blind, randomised, parallel-controlled, three-arm, phase 3, multicentre study done at 143 sites in 17 countries. Eligible patients were aged 18–75 years and had inadequately controlled type 1 diabetes (HbA 1c between ≥7·7% and ≤11·0% [≥61·0 mmol/mol and ≤97·0 mmol/mol]) and had been prescribed insulin for at least 12 months before enrolment. After an 8 week lead-in period to optimise diabetes management, patients were randomly assigned (1:1:1) using an interactive voice response system to dapagliflozin 5 mg or 10 mg once daily, given orally, or matched placebo. Randomisation was stratified by current use of continuous glucose monitoring, method of insulin administration, and baseline HbA 1c . The primary efficacy outcome was the change from baseline in HbA 1c after 24 weeks of treatment in the full analysis set, which consisted of all randomly assigned patients who received at least one dose of study drug. An additional 55 patients who were incorrectly and non-randomly allocated to only dapagliflozin treatment groups were included in the safety analysis set. This study was registered with ClinicalTrials.gov, number NCT02268214; data collection for the present analysis was completed on Jan 4, 2017, and a 28 week extension phase is ongoing. Findings Between Nov 11, 2014, and April 16, 2016, 833 patients were assigned to treatment groups and included in safety analyses (dapagliflozin 5 mg [n=277] vs dapagliflozin 10 mg [n=296] vs placebo [n=260]; 778 of these patients were randomly assigned and included in the full analysis set for efficacy analyses (259 vs 259 vs 260; difference due to randomisation error affecting 55 patients). Mean baseline HbA 1c was 8·53% (70 mmol/mol; SD 0·67% [7·3 mmol/mol]). At week 24, both doses of dapagliflozin significantly reduced HbA 1c compared with placebo (mean difference from baseline to week 24 for dapagliflozin 5 mg vs placebo was −0·42% [95% CI −0·56 to −0·28; p vs placebo was −0·45% [−0·58 to −0·31; p vs 36 [12%] vs 39 [15%]), urinary tract infection (19 [7%] vs 11 [4%] vs 13 [5%]), upper respiratory tract infection (15 [5%] vs 15 [5%] vs 11 [4%]), and headache (12 [4%] vs 17 [6%] vs 11 [4%]). Hypoglycaemia occurred in 220 (79%), 235 (79%), and 207 (80%) patients in the dapagliflozin 5 mg, dapagliflozin 10 mg, and placebo groups, respectively; severe hypoglycaemia occurred in 21 (8%), 19 (6%), and 19 (7%) patients, respectively. Adjudicated definite diabetic ketoacidosis occurred in four (1%) patients in the dapagliflozin 5 mg group, five (2%) in the dapagliflozin 10 mg group, and three (1%) in the placebo group. Interpretation Our results suggest that dapagliflozin is a promising adjunct treatment to insulin to improve glycaemic control in patients with inadequately controlled type 1 diabetes. Funding AstraZeneca and Bristol-Myers Squibb.
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