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

• Status: Completed
• Trial end date: 2018-08-21
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Dulaglutide; Immunoglobulin Fc Fragments; Incretins

Criteria

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• Completed or withdrawn from any study investigating dulaglutide