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Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes

NCT02915198 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 7410

Last updated 2025-12-17

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Gregory G. Schwartz, PhD MD · Rocky Mountain Regional VA Medical Center, Aurora, CO

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-03
Primary Completion
2029-09-28
Completion
2029-09-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02915198 on ClinicalTrials.gov