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Biguanide
Metformin for Prediabetes (VA-IMPACT Trial)
Phase 4
Recruiting
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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 mg/dL following a 75 g glucose load oral glucose tolerance test.
Renal function: Estimated glomerular filtration rate at least 45 mL/min/1.73 m2.
Must not have
Cirrhosis, active hepatitis, or jaundice at time of randomization, or total bilirubin > 2 times upper limit of normal
Prior history of intolerance to metformin
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 4.5 years
Awards & highlights
Summary
This trial is testing whether metformin can lower the risk of death, heart attacks, and strokes in people with pre-diabetes and heart or blood vessel issues. Metformin is a drug that helps control blood sugar levels and has been used to treat type 2 diabetes mellitus for more than 60 years. The study involves patients who have pre-diabetes and existing heart or blood vessel problems, aiming to see if metformin can provide additional health benefits.
Who is the study for?
This trial is for adults with pre-diabetes (HbA1c between 5.7% and 6.5%, or specific fasting glucose levels) who also have a history of heart disease, such as past heart attacks or strokes, and evidence of atherosclerosis. They should not have used metformin recently, be pregnant, or have severe health issues like liver disease, uncontrolled high blood pressure, recent heart events within the last month.
What is being tested?
The study tests if Metformin XR can reduce the risk of death or cardiovascular events like heart attacks and strokes in people with pre-diabetes and existing heart problems compared to a placebo (a pill without active medication). Participants will randomly receive either Metformin XR or placebo.
What are the potential side effects?
Metformin may cause side effects such as digestive upset (nausea, diarrhea), vitamin B12 deficiency over time which could lead to anemia or nerve damage if untreated, and rarely a serious condition called lactic acidosis.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood sugar levels indicate I have pre-diabetes.
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My kidneys work well enough (filtration rate is okay).
Select...
I have a history of heart issues, including a heart attack, surgery, or significant artery blockage.
Select...
My blood sugar levels indicate I have pre-diabetes.
Select...
My kidneys work well enough (filtration rate is okay).
Select...
I have heart or blood vessel disease due to plaque buildup.
Select...
I have had surgery or a procedure to open my carotid artery.
Select...
I have heart or blood vessel disease due to plaque buildup.
Select...
I have a narrowed carotid artery and have had symptoms like a mini-stroke.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have cirrhosis, active hepatitis, jaundice, or a bilirubin level more than twice the normal limit.
Select...
I have had a bad reaction to metformin before.
Select...
I am not using a highly effective birth control method.
Select...
I am currently taking cimetidine, vandetanib, or a medication that affects body acidity.
Select...
My blood sugar levels are within the specified limits.
Select...
I have a history of dementia or cognitive issues affecting my decision-making.
Select...
I have worsening heart failure symptoms.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 4.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 4.5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Time in days to death, non-fatal myocardial infarction, stroke, hospitalization for unstable angina, or symptom-driven coronary revascularization
Secondary study objectives
Time in days to Cardiovascular Outcomes
Time in days to Diabetes Outcome
Time in days to Oncologic Outcome
Side effects data
From 2016 Phase 4 trial • 532 Patients • NCT0225296514%
Diarrhoea
6%
Abdominal Distension
6%
Nausea
3%
Dizziness
2%
Abdominal Discomfort
2%
Gastrooesophageal Reflux Disease
2%
Vomiting
2%
Hepatic Function Abnormal
2%
Decreased Appetite
2%
Abdominal Pain Upper
2%
Abdominal Pain
2%
Constipation
2%
Upper Respiratory Tract Infection
1%
Hyperhidrosis
1%
Fatigue
1%
Hepatic Steatosis
1%
Dyslipidaemia
1%
Blood uric Acid Increased
1%
Urinary tract Infection
1%
Palpitations
1%
Protein Urine Present
1%
Hyperuricaemia
1%
Hypoglycaemia
1%
Dyspepsia
1%
Frequent Bowel Movements
1%
Hyperlipidaemia
1%
Asthenia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Metformin IR
Metformin XR
Metformin IR to XR
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: MetforminExperimental Treatment1 Intervention
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.
Group II: PlaceboPlacebo Group1 Intervention
Participants receive initial treatment with 1 tablet daily of placebo (for metformin XR), with stepwise titration to a maximum of 4 tablets daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin XR
2013
Completed Phase 4
~9220
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for atherosclerosis, such as metformin, work by decreasing hepatic glucose production, reducing intestinal absorption of glucose, and improving insulin sensitivity. These mechanisms help lower blood glucose levels, which is crucial for preventing endothelial dysfunction and the formation of atherosclerotic plaques.
Additionally, treatments like statins reduce LDL cholesterol and have anti-inflammatory effects, further preventing plaque formation and progression. Managing blood glucose and lipid levels is essential for reducing the risk of cardiovascular events in atherosclerosis patients.
Effects of tolbutamide and glyburide on glucose and acetate incorporation into aortic lipids of the dog.
Effects of tolbutamide and glyburide on glucose and acetate incorporation into aortic lipids of the dog.
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,656 Previous Clinical Trials
3,354,060 Total Patients Enrolled
4 Trials studying Atherosclerosis
773 Patients Enrolled for Atherosclerosis
Gregory G. Schwartz, PhD MDStudy ChairRocky Mountain Regional VA Medical Center, Aurora, CO
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My blood sugar levels indicate I have pre-diabetes.My kidneys work well enough (filtration rate is okay).Your recent blood test showed a lower level of CO2 than what is considered normal at the local laboratory.You have been drinking a lot of alcohol or binge drinking within the past 6 months.You have very low levels of hemoglobin in your blood.I have a history of heart issues, including a heart attack, surgery, or significant artery blockage.I have had a stroke, carotid artery issues, or carotid surgery in the past.I have not taken systemic steroids in the last 3 months.I do not have cirrhosis, active hepatitis, jaundice, or a bilirubin level more than twice the normal limit.I have had a bad reaction to metformin before.My kidneys work well enough (filtration rate is okay).I have had surgery or a procedure for poor blood flow in my limbs, or I have symptoms of leg cramps when walking.My blood sugar levels indicate I have pre-diabetes.I had a heart attack more than a month ago.I have heart or blood vessel disease due to plaque buildup.I am able and willing to follow the study's requirements.I have had surgery or a procedure to open my carotid artery.I have been diagnosed with peripheral arterial disease.I have a history of stroke or brain blood flow problems.I am not using a highly effective birth control method.You are not expected to live as long as the study will last.I am currently taking cimetidine, vandetanib, or a medication that affects body acidity.My blood sugar levels are within the specified limits.I have heart or blood vessel disease due to plaque buildup.I have a history of dementia or cognitive issues affecting my decision-making.I have worsening heart failure symptoms.I have taken metformin or other diabetes medication in the last year.Your blood pressure is too high and not controlled with medication.I have not had a heart attack, heart surgery, or stroke in the last month.I have been diagnosed with coronary artery disease.I have a narrowed carotid artery and have had symptoms like a mini-stroke.
Research Study Groups:
This trial has the following groups:- Group 1: Metformin
- Group 2: Placebo
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Atherosclerosis Patient Testimony for trial: Trial Name: NCT02915198 — Phase 4
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