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Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes

2016-09-26 22:23:21 | BioPortfolio

Summary

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

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 patients with pre-diabetes and established atherosclerotic cardiovascular disease. Qualifying patients have pre-diabetes defined by HbA1c, fasting blood glucose, and/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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Prediabetic State

Intervention

Metformin XR, Placebo

Location

VA Eastern Colorado Health Care System, Denver, CO
Denver
Colorado
United States
80220

Status

Not yet recruiting

Source

VA Office of Research and Development

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-09-26T22:23:21-0400

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Medical and Biotech [MESH] Definitions

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