Design of DEVOTE (Trial Comparing Cardiovascular Safety of Insulin Degludec vs Insulin Glargine in Patients With Type 2 Diabetes at High Risk of Cardiovascular Events) - DEVOTE 1.
DEVOTE was designed to evaluate the cardiovascular safety of insulin degludec (IDeg) vs insulin glargine U100 (IGlar) in patients with T2D at high risk of cardiovascular events. DEVOTE is a phase 3b, multicenter, international, randomized, double-blind, active comparator-controlled trial, designed as an event-driven trial that would continue until 633 positively adjudicated primary events were accrued. The primary end point was the time from randomization to a composite outcome consisting of the first occurrence of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. Patients with T2D at high risk of cardiovascular complications were randomized 1:1 to receive either IDeg or IGlar, each added to background therapies. This trial was designed to demonstrate statistical noninferiority of IDeg vs IGlar for the primary end point. DEVOTE enrolled 7,637 patients between October 2013 and November 2014 at 436 sites in 20 countries. Of these, 6,506 patients had prior cardiovascular disease or chronic kidney disease, and the remainder had multiple cardiovascular risk factors. DEVOTE was designed to provide conclusive evidence regarding the cardiovascular safety of IDeg relative to IGlar in a high-risk population of patients with T2D.
University of Texas Southwestern Medical Center, Dallas, TX. Electronic address: smarso@gmail.com.
Steven P
SP
Marso
University of Texas Southwestern Medical Center, Dallas, TX.
Darren K
DK
McGuire
Samuel Lunenfeld Research Institute, Mount Sinai Hospital, University of Toronto, Toronto, ON, Canada.
Bernard
B
Zinman
International Centre for Circulatory Health, Imperial College London, London, UK.
Neil R
NR
Poulter
University of Washington, Seattle, WA.
Scott S
SS
Emerson
Medical University of Graz, Graz, Austria.
Thomas R
TR
Pieber
Florida Hospital Translational Research Institute for Diabetes and Metabolism and Sanford Burnham Prebys Medical Discovery Institute, Orlando, FL.
Richard E
RE
Pratley
Novo Nordisk A/S, Søborg, Denmark.
Poul-Martin
PM
Haahr
Novo Nordisk A/S, Søborg, Denmark.
Martin
M
Lange
Novo Nordisk A/S, Søborg, Denmark.
Kirstine Brown
KB
Frandsen
Novo Nordisk A/S, Søborg, Denmark.
Rasmus
R
Rabøl
University of North Carolina School of Medicine, Chapel Hill, NC.
John B
JB
Buse
D000368:Aged; D000789:Angina, Unstable / Q000453:epidemiology; D002318:Cardiovascular Diseases / Q000401:mortality*; D015897:Comorbidity; D003327:Coronary Disease / Q000453:epidemiology; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000453:epidemiology / Q000378:metabolism; D004311:Double-Blind Method; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006333:Heart Failure / Q000453:epidemiology; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D000069036:Insulin Glargine / Q000627:therapeutic use*; D049528:Insulin, Long-Acting / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000453:epidemiology; D016016:Proportional Hazards Models; D051436:Renal Insufficiency, Chronic / Q000453:epidemiology; D012307:Risk Factors; D020521:Stroke / Q000453:epidemiology
D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D000069036:Insulin Glargine; D049528:Insulin, Long-Acting; C517652:hemoglobin A1c protein, human; C571886:insulin degludec