Design and Baseline Characteristics of Participants in the Researching cardiovascular Events with a Weekly INcretin in Diabetes (REWIND) Trial of Dulaglutide's Cardiovascular Effects

BACKGROUND: Dulaglutide, a synthetic once-weekly, injectable human glucagon-like peptide 1 (GLP1) analogue lowers blood glucose, body weight, appetite, and blood pressure. Its effect on cardiovascular outcomes is unknown.METHODS: People with type 2 diabetes, aged 50 or older, a HbA1c ≤9.5%, and either a previous cardiovascular (CV) event, evidence of CV disease or ≥ 2 CV risk factors were randomly allocated to a weekly subcutaneous injection of either dulaglutide (1.5 mg) or placebo and followed within the Researching cardiovascular Events with a Weekly INcretin in Diabetes (REWIND) trial every 3 to 6 months. The primary cardiovascular outcome is the first occurrence of the composite of cardiovascular death or non-fatal MI or nonfatal stroke. Secondary outcomes include 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. Follow-up will continue until the accrual of 1200 confirmed primary outcomes.RESULTS: Recruitment of 9901 participants (mean age 66, 46% women) occurred in 370 sites located in 24 countries over a period of 2 years. The mean duration of diabetes was 10 years, mean baseline HbA1c was 7.3 %, and 31% had prior cardiovascular disease.CONCLUSION: The REWIND trial's international scope, high proportion of women, high proportion of people without prior cardiovascular disease, and inclusion of participants whose mean baseline HbA1c was 7.3% suggests that its cardiovascular and safety findings will be directly relevant to the typical middle-aged patient seen in general practice throughout the world.