The Effect of Dulaglutide on Major Cardiovascular Events in Patients with Type 2 Diabetes: Researching Cardiovascular Events with a Weekly INcretin in Diabetes (REWIND)
The purpose of this trial is to assess the effect of once-weekly 1.5-mg dulaglutide on CV outcomes when added to the existing antihyperglycemic regimen of patients with type 2 diabetes. The primary objective is to test the hypothesis that a once-weekly injection of 1.5-mg dulaglutide reduces the occurrence of the composite primary endpoint of death from cardiovascular (CV) causes, nonfatal myocardial infarction (MI), or nonfatal stroke when added to glucose-lowering regimen of patients with type 2 diabetes, compared to the addition of a once-weekly placebo injection. The secondary efficacy objectives are to assess the effects of add-on therapy with 1.5-mg dulaglutide compared to placebo on the occurrence of :
- the composite microvascular endpoint of diabetic retinopathy requiring laser therapy, vitrectomy for diabetic retinopathy, development of clinical proteinuria, a 30% decline in estimated glomerular filtration rate (eGFR), or need for chronic renal replacement therapy.
- each component of the composite primary endpoint.
- all-cause mortality.
- heart failure (HF) requiring hospitalization .
Study Design: Phase 3, event-driven, multicenter, international, randomized, double-blind, placebo-controlled, parallel study.
Intervention: Dulaglutide, 1.5 mg administered subcutaneously once weekly.
Length of Study: 8 years.
# of Patients: 9600.
Patient Populations: Men or women ≥50 years old with type 2 diabetes (HbA1c ≤9.5%) treated with various antihyperglycemic regimens who are at high risk for CV events.
Available upon study completion.
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