Researching Cardiovascular Events With a Weekly Incretin in Diabetes (REWIND)

Lilly

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2; Cardiovascular Disease

Treatments: Drug: Placebo; Drug: Dulaglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01394952

13438

H9X-MC-GBDJ (Other Identifier)

Details and patient eligibility

About

The purpose of this trial is to assess whether dulaglutide can reduce major cardiovascular events and other serious outcomes in persons with type 2 diabetes, when added to their anti-hyperglycemic regimen.

Enrollment: 9,901 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes with Hemoglobin A1c equal to or less than 9.5% (equal to or less than 81 mmol/mol)
• Anti-hyperglycemic drug naive or treated with up to 2 oral hyperglycemic drugs with or without a glucagon-like peptide-1analog or basal insulin, or basal insulin alone
• On stable antihyperglycemic regimen for at least 3 months
• Age equal to or greater than 50 years with established clinical vascular disease, or age equal to or greater than 55 years and subclinical vascular disease or age equal to or greater than 60 years and at least 2 or more cardiovascular risk factors

Exclusion criteria

• Uncontrolled diabetes requiring immediate therapy
• History of severe hypoglycemia in past year
• Acute coronary or cerebrovascular event within past 2 months
• Planned or anticipated revascularization procedure
• History of pancreatitis, hepatic insufficiency , chronic renal failure or of C-cell thyroid disorder
• Pregnancy or planned pregnancy during the trial period
• Completed or withdrawn from any study investigating dulaglutide

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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9,901 participants in 2 patient groups, including a placebo group

1.5 mg Dulaglutide

Experimental group

Description:

Administered once weekly, subcutaneously

Treatment:

Drug: Dulaglutide

Placebo

Placebo Comparator group

Description:

Administered once weekly, subcutaneously

Treatment:

Drug: Placebo