NCT02915198

Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes

CSP #2002 - Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes (VA-IMPACT)

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 7,410 (estimated)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research will help us to learn if the medicine called metformin reduces the risk of death, heart attacks, and/or strokes in Veterans who have pre-diabetes and heart or blood vessel problems.

Detailed description

CSP #2002 is a multicenter, prospective, randomized, double blind, secondary prevention trial to test the hypothesis that treatment with metformin, compared with placebo, reduces mortality and cardiovascular morbidity in Veterans with pre-diabetes and established atherosclerotic cardiovascular disease. Qualifying patients have pre-diabetes defined by HbA1c, fasting blood glucose, or oral glucose tolerance test criteria; clinically evident coronary, cerebrovascular, or peripheral arterial atherosclerotic cardiovascular disease; and estimated glomerular filtration rate of at least 45 mL/min/1.73 m2; and do not fulfill any exclusion criteria. Patients who are eligible and agree to participate are randomly assigned to treatment with metformin XR (titrated to a maximum dose of 2000 mg daily based on safety and tolerability) or matching placebo. All patients receive counseling on therapeutic lifestyle recommendations. CSP #2002 had a Pilot Phase trial from 2/2019 to 1/2021 and was approved for the full-scale trial, with Full-scale study launch in 04/2023.

Conditions

• Prediabetic State
• Atherosclerosis
• Metformin

Interventions

Type	Name	Description
DRUG	Metformin XR	The study medication dose may be increased by a step-wise fashion up to a maximum of 4 tablets per day.
DRUG	Placebo	For patients \< 80 years of age at the time of a study visit, and with most recent eGFR 45 mL/min/1.73 m2, study medication dose may be increased in a stepwise fashion to a maximum of 4 tablets daily, corresponding to metformin XR 2000 mg or matching placebo. For patients 80 years of age or with most recent 30 eGFR \< 45 mL/min/1.73 m2, the maximum dose of study medication is 2 tablets daily, corresponding to metformin XR 1000 mg or matching placebo

Timeline

• Start date: 2023-04-03
• Primary completion: 2029-09-28
• Completion: 2029-09-28
• First posted: 2016-09-26
• Last updated: 2025-12-17

Locations

40 sites across 1 country: United States

Regulatory

• FDA-regulated drug study