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. 2020 Feb 18;22(6):904–915. doi: 10.1111/dom.13984

Table 2.

Overview of the ongoing VA‐IMPACT trial (NCT02915198)

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