Table 2.
Title: | Investigation of Metformin in Prediabetes on Atherosclerotic Cardiovascular OuTcomes (VA‐IMPACT) |
---|---|
Design: | Multicentre, prospective, randomized, double‐blind |
Patients: | Required to have: |
Prediabetes: HbA1c ≥5.7%, <6.5% (≥39, <48 mmol/mol) and/or Fasting plasma glucose 100–125 mg/dL (5.6–6.9 mmol/L) and/or 2 h post‐load glucose 140–199 mg/dL (7.8–11.1 mmol/L) after a 75 g oral glucose tolerance test |
|
Pre‐existing cardiovascular or cerebrovascular disease | |
Key exclusions: | Glucose‐lowering therapy |
Estimated glomerular filtration rate <45 mL/min/1.73m2 | |
Known intolerance to metformin | |
Pregnancy, planning pregnancy or lactating | |
Treatments: | Metformin XR (up to 2000 mg/day) |
Placebo | |
Outcomes: | Primary: Death, non‐fatal myocardial infarction (MI), stroke, hospitalization for unstable angina, or symptom‐driven coronary revascularization |
Secondary: Death, MI or stroke | |
Primary endpoint, peripheral arterial disease event or hospitalization for congestive heart failure | |
Incidence of all components of the primary endpoint including recurrent or multiple events in the same participant | |
Each component of the primary outcome measure, peripheral arterial disease events and hospitalization for congestive heart failure | |
New or recurrent malignancy or death from a malignancy | |
New diagnosis of type 2 diabetes (American Diabetes Association criteria) |
Note: Compiled from information presented in reference.59