Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes

Conditions

• Atherosclerosis
• Metformin
• Prediabetic State

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Metformin XR — DRUG
  The study medication dose may be increased by a step-wise fashion up to a maximum of 4 tablets per day.
• Placebo — DRUG
  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

Study Details

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.

Key Dates

Start date

Apr 3, 2023

Status verified

Dec 2025

Primary completion

Sep 28, 2029

Completion

Sep 28, 2029

Study Design

Enrollment

7,410 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Metformin
  Participants receive initial treatment with metformin XR 500 mg 1 tablet daily, with stepwise titration to a maximum dose of 2000 mg (4 tablets) daily.
• Placebo Comparator: Placebo
  Participants receive initial treatment with 1 tablet daily of placebo (for metformin XR), with stepwise titration to a maximum of 4 tablets daily.

Primary Outcome Measure

Time in days to death, non-fatal myocardial infarction, stroke, hospitalization for unstable angina, or symptom-driven coronary revascularization [ Time Frame: through study completion, an average of 4.5 years ]

Central Contacts

• Gregory G Schwartz, PhD MD
  (720) 723-6070
  [email protected]
• Kevin Gropp
  (720) 857-5659
  [email protected]

Locations (40)

Find similar trials in Phoenix, AZ

Related Studies

• Causes and Natural History of Dyslipidemias
  Recruiting · National Heart, Lung, and Blood Institute (NHLBI) · Bethesda, Maryland
• Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
  Recruiting · National Heart, Lung, and Blood Institute (NHLBI) · Washington D.C., District of Columbia
• Study of the Effect of Innate on the Inflammatory Response to Endotoxin
  Recruiting · National Institute of Environmental Health Sciences (NIEHS) · Research Triangle Park, North Carolina
• New Heart Imaging Techniques to Evaluate Possible Heart Disease
  Recruiting · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Bethesda, Maryland