Developing, Planning and Conducting an Interim Analysis: Lessons From the DEVOTE Cardiovascular Outcomes Trial (Trial Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Patients With Type 2 Diabetes at High Risk of Cardiovascular Events)

2019 ◽  
Vol 53 (2) ◽  
pp. 279-286
Author(s):  
Hanne Theilgaard ◽  
◽  
Inger Mollerup ◽  
Ida Carøe Helmark ◽  
Lars Endahl ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
High Risk ◽  
Insulin Glargine ◽  
Interim Analysis ◽  
Cardiovascular Events ◽  
Cardiovascular Outcomes ◽  
Insulin Degludec ◽  
Cardiovascular Safety

scholarly journals Series: Cardiovascular outcome trials for diabetes drugs Degludec and DEVOTE

2021 ◽  
Author(s):  
Miles Fisher
Keyword(s):  
Type 2 Diabetes ◽  
Insulin Glargine ◽  
Insulin Degludec ◽  
Cardiovascular Outcome ◽  
Diabetic Patients ◽  
Cardiovascular Safety ◽  
Vascular Events ◽  
Cardiovascular Outcome Trials ◽  
Cardiovascular Outcome Trial

DEVOTE (Trial Comparing Cardiovascular Safety of Insulin Degludec versus Insulin Glargine in Patients with Type 2 Diabetes at High Risk of Cardio-vascular Events) was an FDA-mandated cardiovascular outcome trial and was the first – and at present the only – completed trial comparing two insulins. DEVOTE compared insulin degludec and insulin glargine (U100) in 7,637 people with type 2 diabetes with established cardiovascular disease, chronic kidney disease, or both, and older diabetic patients with increased cardiovascular risk. DEVOTE demonstrated non-inferiority for major cardiovascular events (MACE), a composite of death from cardiovascular causes, non-fatal myocardial infarction and non-fatal stroke, with a pre-specified non-inferiority margin of 1.3. At 24 months the mean HbA1c was similar in the two groups. Mean fasting plasma glucose was significantly lower in the degludec group than in the glargine group, and pre-specified severe hypoglycaemia was also significantly lower in the degludec group. DEVOTE satisfied the FDA cardiovascular safety requirements for new antidiabetic therapies.

Short-Term Cost-Effectiveness of Insulin Degludec vs. Insulin Glargine 100 Units/mL for Patients with Type 2 Diabetes at High Risk of Hypoglycemia in DEVOTE

2018 ◽  
Vol 42 (5) ◽  
pp. S60 ◽  
Author(s):  
Vincent Woo ◽  
Bernard Zinman ◽  
Thomas R. Pieber ◽  
Richard F. Pollock ◽  
Jens Gundgaard ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Cost Effectiveness ◽  
High Risk ◽  
Insulin Glargine ◽  
Insulin Degludec ◽  
Short Term
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