A Trial Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Subjects With Type 2 Diabetes at High Risk of Cardiovascular Events (DEVOTE)

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: insulin glargine; Drug: insulin degludec

Study type: Interventional

Funder types: Industry

Identifiers

NCT01959529

2013-002371-17 (EudraCT Number)

U1111-1141-7614 (Other Identifier)

EX1250-4080

JapicCTI-142464 (Registry Identifier)

Details and patient eligibility

About

This trial is conducted globally. The aim of this trial is to compare cardiovascular safety of insulin degludec versus insulin glargine in subjects with type 2 diabetes at high risk of cardiovascular events.

Enrollment: 7,637 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: - Type 2 diabetes - Age above or equal to 50 years with predefined previous cardiovascular disease(s) or renal disease or age above or equal to 60 years with predefined cardiovascular risk factors - HbA1c (glycosylated haemoglobin) above or equal to 7.0% or HbA1c below 7.0% and current insulin treatment corresponding to above or equal to 20 U of basal insulin per day - One or more oral or injectable antidiabetic agent(s) Exclusion Criteria: - An acute coronary or cerebrovascular event in the previous 60 days - Planned coronary, carotid or peripheral artery revascularisation - Chronic heart failure NYHA (New York Heart Association) class IV - Current or past (within the last 5 years) malignant neoplasms (except basal cell and squamous cell skin carcinoma)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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7,637 participants in 2 patient groups

Insulin degludec (IDeg)

Experimental group

Description:

All subjects will continue their current antidiabetic therapy except for the basal insulin component (if any) that will be replaced by the investigational product.

Treatment:

Drug: insulin degludec

Insulin glargine (IGlar)

Active Comparator group

Description:

All subjects will continue their current antidiabetic therapy except for the basal insulin component (if any) that will be replaced by the investigational product.

Treatment:

Drug: insulin glargine