Overview

This trial is active, not recruiting.

Conditions cardiovascular disease, diabetes mellitus, type 2
Treatments dulaglutide, placebo
Phase phase 3
Sponsor Eli Lilly and Company
Start date July 2011
End date July 2018
Trial size 9622 participants
Trial identifier NCT01394952, 13438, H9X-MC-GBDJ

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
Administered subcutaneously, weekly for up to 8 years
dulaglutide LY2189265
Administered subcutaneously
(Placebo Comparator)
Administered subcutaneously, weekly for up to 8 years
placebo
Administered subcutaneously

Primary Outcomes

Measure
Time from randomization to first occurrence of cardiovascular death, non fatal myocardial infarction, or non fatal stroke (a composite cardiovascular outcome)
time frame: From randomization to study completion (average duration of follow up of 6.5 years)

Secondary Outcomes

Measure
Time to first occurrence after randomization of the composite microvascular endpoint
time frame: From randomization to study completion (average duration of follow up of 6.5 years)
Time to first occurrence after randomization of first hospitalization for unstable angina
time frame: From randomization to study completion (average duration of follow up of 6.5 years)
Time to first occurrence after randomization of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke, individually
time frame: From randomization to study completion (average duration of follow up of 6.5 years)
Time to all cause mortality
time frame: From randomization to study completion (average duration of follow up of 6.5 years)
Time to first occurrence after randomization of heart failure requiring hospitalization or an urgent heart failure clinic visit
time frame: From randomization to study completion (average duration of follow up of 6.5 years)

Eligibility Criteria

Male or female participants at least 50 years old.

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

Additional Information

Official title The Effect of Dulaglutide on Major Cardiovascular Events in Patients With Type 2 Diabetes: Researching Cardiovascular Events With a Weekly INcretin in Diabetes (REWIND)
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.