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.

Presentations

Available upon study completion.

Main Publications (A full listing of PHRI publications can be found in the 'Media & Publictions' section)