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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 4.5 years
Awards & highlights
VA-IMPACT Trial Summary
This trial will help researchers learn if metformin reduces the risk of death, heart attacks, or strokes in patients who have pre-diabetes and heart or blood vessel problems.
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.Check my eligibility
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.See study design
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.
VA-IMPACT Trial 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.
VA-IMPACT Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time in days to death, non-fatal myocardial infarction, stroke, hospitalization for unstable angina, or symptom-driven coronary revascularization
Secondary outcome measures
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
VA-IMPACT 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
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,611 Previous Clinical Trials
3,297,874 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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What medical conditions commonly necessitate Metformin XR?
"Metformin XR has been successfully utilized to manage type 1 diabetes mellitus, exercise-induced hyperglycemia, and diabetic ketoacidosis."
Answered by AI
Are enrollments still open for this trial?
"This research has ceased patient recruitment. After first being posted on January 1st 2023, the trial was last updated on October 5th 2022. Alternatively, if you are looking for other clinical trials involving metformin there are currently 318 studies accepting enrolment and 170 Metformin XR-related investigations recruiting participants."
Answered by AI
How many facilities are currently overseeing this scientific experiment?
"Patients are being recruited at Louis Stokes VA Medical Center, Cleveland oh in Ohio; Wm. Jennings Bryan Dorn VA Medical Center, Columbia sc in South carolina; and VA Long Beach Healthcare System, Long beach ca in California amongst 40 other research centres."
Answered by AI
Are there any other precedents of Metformin XR being utilized in clinical experiments?
"George Washington University first conducted research into Metformin XR back in 2002, with 19247 trials since then. Currently, 170 active studies are recruiting from centres based out of Cleveland, Ohio."
Answered by AI
What is the capacity of participants for this experiment?
"This research is no longer soliciting new patients. The study was originally posted on January 1st 2023 and the information was most recently updated October 5th 2022. If you are considering alternative studies, there are currently 318 trials actively enrolling people with metformin and 170 investigations seeking participants for Metformin XR."
Answered by AI
Is Metformin XR a reliable medication for individuals to take?
"The medical team at Power has evaluated the safety of Metformin XR to be a 3, as it is approved for use in Phase 4 clinical trials."
Answered by AI
Who else is applying?
What state do they live in?
North Carolina
Florida
Georgia
What site did they apply to?
VA Palo Alto Health Care System, Palo Alto, CA
Miami VA Healthcare System, Miami, FL
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
0
Why did patients apply to this trial?
I have Atherosclerosis and 101 fasting glucose on two occasions. My last calcium scoring test came back as 910....first one 12 yrs ago was over 500.
PatientReceived 2+ prior treatments
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