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New treatment option for Prediabetic State
Official title Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes
ClinicalTrials.gov ID: NCT02915198
What this study is testing
What is Metformin XR?
Metformin XR is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for prediabetic state.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Pre-diabetes: This condition is fulfilled by HbA1c of at least 5.7%, but less than 6.5%; or two measurements of fasting plasma glucose (on separate...
- Established atherosclerotic cardiovascular disease: Qualifying participants must have evidence of atherosclerotic disease in at least one of the...
- History of myocardial infarction at least one month prior to randomization.
- History of percutaneous coronary intervention or coronary artery bypass surgery at least one month prior to randomization.
- Angiographic evidence of coronary stenosis of at least 50% in at least two major epicardial coronary arteries. Cerebrovascular disease is fulfilled...
You likely can't join if
- Treatment with metformin or other anti-diabetic medication within 12 months of randomization. Note: In the absence of a diagnosis of diabetes...
- Treatment with systemic glucocorticoids within 3 months of randomization
- Fasting plasma glucose greater than 130 mg/dL measured between screening and randomization visits, or any plasma glucose 180 mg/dL or HbA1c 7.0%...
- Total CO2 below the local laboratory lower limit of normal on most recent blood chemistry panel
- Current treatment with cimetidine, vandetanib, or a systemic treatment with a carbonic anhydrase inhibitor.
- Cirrhosis, active hepatitis, or jaundice at time of randomization, or total bilirubin \> 2 times upper limit of normal
See the full eligibility criteria
- Pre-diabetes: This condition is fulfilled by HbA1c of at least 5.7%, but less than 6.5%; or two measurements of fasting plasma glucose (on separate days) of 100-125 mg/dL; or a 2-hour plasma glucose level of 140-199...
- Established atherosclerotic cardiovascular disease: Qualifying participants must have evidence of atherosclerotic disease in at least one of the following vascular beds: coronary, cerebrovascular, or peripheral arterial...
- History of myocardial infarction at least one month prior to randomization.
- History of percutaneous coronary intervention or coronary artery bypass surgery at least one month prior to randomization.
- Angiographic evidence of coronary stenosis of at least 50% in at least two major epicardial coronary arteries. Cerebrovascular disease is fulfilled by at least one of criteria (1) through (4):
- Documented prior ischemic stroke (at least one month prior to randomization),
- Carotid artery stenosis 50% and history of transient ischemic attack or transient ischemic visual symptoms attributable to the identified lesion(s),
- Asymptomatic carotid stenosis of at least 70% luminal diameter,
- History of carotid revascularization (surgical or catheter-based). Peripheral arterial disease: Fulfilled by at least one of the following:
- History of aorto-iliac or peripheral artery intervention (surgical or catheter based) for limb ischemia, or amputation for limb ischemia,
- Symptoms of intermittent claudication with ankle:brachial index less than or equal to 0.85. 3\. Renal function: Estimated glomerular filtration rate at least 45 mL/min/1.73 m2. 4\. Informed consent has been fully...
- Treatment with metformin or other anti-diabetic medication within 12 months of randomization. Note: In the absence of a diagnosis of diabetes, inpatient treatment with insulin or treatment with an SGLT2 inhibitor (e.g...
- Treatment with systemic glucocorticoids within 3 months of randomization
- Fasting plasma glucose greater than 130 mg/dL measured between screening and randomization visits, or any plasma glucose 180 mg/dL or HbA1c 7.0% measured within 12 months of randomization.
- Total CO2 below the local laboratory lower limit of normal on most recent blood chemistry panel
- Current treatment with cimetidine, vandetanib, or a systemic treatment with a carbonic anhydrase inhibitor.
- Cirrhosis, active hepatitis, or jaundice at time of randomization, or total bilirubin \> 2 times upper limit of normal
- Binge or heavy alcohol consumption within 6 months of randomization
- Severe anemia (hemoglobin \< 10 g/dL)
- Prior history of intolerance to metformin
- Myocardial infarction, coronary revascularization procedure, or stroke within 1 month of randomization
- Uncontrolled hypertension at screening assessment (systolic blood pressure 180 mm Hg or diastolic blood pressure 110 mm Hg
- Acute or decompensated congestive heart failure
- Expected survival less than study duration
- Participants considered to be unable, unwilling, or unreliable to meet protocol requirements
- Impaired decision-making capacity, defined by any history of dementia or cognitive impairment
- Concurrent participation in another research study involving a assigned by chance comparison of drug or device treatments, unless specifically excepted.
- Pregnant, intent to become pregnant during the trial, or lactating
- Women of childbearing potential who are not using a highly effective method of contraception
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Little Rock, Arkansas, United States
- Loma Linda, California, United States
- Long Beach, California, United States
- Palo Alto, California, United States
- San Diego, California, United States
- West Los Angeles, California, United States
- Aurora, Colorado, United States
- West Haven, Connecticut, United States
- Bay Pines, Florida, United States
- Gainesville, Florida, United States
- Miami, Florida, United States
- Decatur, Georgia, United States
- Honolulu, Hawaii, United States
- Chicago, Illinois, United States
- Hines, Illinois, United States
- Iowa City, Iowa, United States
- Lexington, Kentucky, United States
- Baltimore, Maryland, United States
+ 20 more site(s).
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Tucson, Arizona, United States; Little Rock, Arkansas, United States; Loma Linda, California, United States; Long Beach, California, United States; Palo Alto, California, United States and 34 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.