TY - JOUR
T1 - 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
AU - Marso, Steven P
AU - McGuire, Darren K
AU - Zinman, Bernard
AU - Poulter, Neil R.
AU - Emerson, Scott S.
AU - Pieber, Thomas R.
AU - Pratley, Richard E.
AU - Haahr, Poul Martin
AU - Lange, Martin
AU - Frandsen, Kirstine Brown
AU - Rabøl, Rasmus
AU - Buse, John B.
N1 - Funding Information:
Dr Darren McGuire has received personal fees from Boehringer-Ingelheim, Janssen Research and Development LLC, Sanofi-Aventis Group, Genentech Inc, Merck Sharp and Dohme, Daiichi Sankyo Inc, Lilly USA, Novo Nordisk, GlaxoSmithKline, Takeda Pharmaceuticals North America, Bristol-Myers Squibb, AstraZeneca, Orexigen, Lexicon, Eisai, Regeneron, Janssen, Merck, Pfizer, and Genfit; personal fees from University of Oxford, Duke Clinical Research Institute, Partners HealthCare, and the Cleveland Clinic Foundation; and nonfinancial support from Gilead Sciences.
Funding Information:
Prof Bernard Zinman has received grant support from Boehringer-Ingelheim, AstraZeneca and Novo Nordisk; and consulting fees from AstraZeneca, Boehringer-Ingelheim, Eli Lilly, Janssen, Merck, Novo Nordisk, and Sanofi Aventis.
Funding Information:
Dr Scott S. Emerson has received personal fees related to Data Monitoring Committees from CTIBioPharma, Arena Pharmaceuticals, SFJ Pharmaceuticals, BioMarin, Medivation, Biom'up, Dynavax, Genentech, GlaxoSmithKline, Janssen Research, Novartis, Pfizer, Roche, Sarepta, and Xoma; personal fees related to other statistical consulting from AstraZeneca, Celltrion, Sarepta, Sprout, Sanofi, Collegium Pharmaceutical, and Intercept; and research grant support from NHLBI.
Funding Information:
Dr Richard Pratley's services were paid for directly to Florida Hospital, a nonprofit organization. Sponsor AstraZeneca paid for the speaker and consultant. Sponsor Boehringer-Ingelheim paid for the consultant. Sponsor Gilead Sciences paid for the research grant. Sponsor GlaxoSmithKline paid for the consultant. Sponsor Hanmi Pharmaceutical Co, Ltd paid for the consultant. Sponsor Lilly paid for the research grant. Sponsor Merck paid for the research grant and consultant. Novo Nordisk paid for the research grant, speaker, honoraria, and consultant. Sponsor Sanofi-Aventis US, LLC paid for the research grant. Sponsor Takeda paid for the research grant and consultant.
Funding Information:
Dr John Buse reports grant and consultation fees to the University of North Carolina (UNC) under contract and travel/meals/lodging for contracted activities from Novo Nordisk during the conduct of the study; grants and fees for consultation to UNC under contract and travel/meals/lodging for contracted activities from Eli Lilly, GI Dynamics, Amylin, Orexigen, Merck, Novo Nordisk, Transtech Pharma, AstraZeneca, Takeda, Sanofi, and Lexicon; fees for consultation to UNC under contract and travel/meals/lodging for contracted activities from Hoffmann-La Roche, Bristol-Myers Squibb, Liposcience, Elcelyx, Metavention, Dance Biopharm Inc, and Quest; grants from Medtronic Minimed, Tolerex, Osiris, Halozyme, Pfizer, Johnson & Johnson, Andromeda, Boehringer-Ingelheim, GlaxoSmithKline, Astellas, MacroGenics, Intarcia Therapeutics, and Scion NeuroStim; stock options in PhaseBio outside the submitted work; and is or has been a member of a variety of nonprofit boards: American Diabetes Association, DiabetesSisters, Taking Control of Your Diabetes, AstraZeneca Healthcare Foundation, Bristol-Myers Squib Together on Diabetes Foundation, and the National Diabetes Education Program.
Funding Information:
This trial was sponsored by Novo Nordisk (Bagsvaerd, Denmark). We thank the trial investigators, trial staff, and trial participants for their participation and Watermeadow Medical (sponsored by Novo Nordisk) for providing submission support.
PY - 2016/9/1
Y1 - 2016/9/1
N2 - 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.
AB - 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.
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U2 - 10.1016/j.ahj.2016.06.004
DO - 10.1016/j.ahj.2016.06.004
M3 - Article
C2 - 27595693
AN - SCOPUS:84979555894
VL - 179
SP - 175
EP - 183
JO - American Heart Journal
JF - American Heart Journal
SN - 0002-8703
ER -