completed

The REWIND trial recruited 9901 middle-aged people with type 2 diabetes, a mean HbA1c of 7.3% and additional cardiovascular risk factors, and allocated them to weekly subcutaneous injections of either dulaglutide (1.5 mg) or placebo.

Primary endpoint:

Time to first occurrence (after randomization) of the composite endpoint of death from CV causes, nonfatal MI, or nonfatal stroke.

Secondary endpoints:

Each component of the primary composite cardiovascular outcome, a composite clinical microvascular outcome comprising retinal or renal disease, hospitalization for unstable angina, heart failure requiring hospitalization or an urgent heart failure visit, and all-cause mortality.

During more than five years of follow-up, dulaglutide reduced the risk of cardiovascular events in people with and without prior cardiovascular disease.

Based on the results of the REWIND study, the Food and Drug Administration (FDA) in the United States, in February 2020, approved dulaglutide for reducing the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes who have multiple cardiovascular risk factors – with or without established cardiovascular disease.

REWIND_ADA 2019 - Download PDF
Study Type

Interventional - Drug

Study Design

Phase 3, randomized, double-blind, placebo-controlled, parallel

NO. of Countries

24

NO. of Sites

404

NO. of Participants

9901

Study Period

2011-2018

Sponsor

Eli Lilly

Eli Lilly

VIDEO: Hertzel Gerstein discusses the key takeaways from the REWIND trial.

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