Effect of Metformin, a Drug Used to Treat Diabetes, vs Placebo (NCT05949008) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Effect of Metformin, a Drug Used to Treat Diabetes, vs Placebo
United States150 participantsStarted 2023-11-22
Plain-language summary
Metformin is a drug used to treat patients with diabetes. The aim of this study is to examine the effect of Metformin along with a low-calorie diet on obese and/or overweight adults with an increased waist measurement. In addition, the study also aims to look at the effect of the drug vs. placebo on quality of life and physical activity.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female, age ≥ 18 years at the time of signing informed consent.
* Body Mass Index (BMI) ≥ 27 kg/m2
* Waist circumference \>40" for men, and \>35" for women
Exclusion Criteria:
* A self-reported change in body weight \> 5 kg (11 lbs) within 90 days before screening irrespective of medical records
* Diagnosed with T2D (HbA1c \>7.5 (53 mmol/mol)
* Current use of insulin or oral medication of metformin, SU, SGLT2i, glitazone, DPP4 or GLP-1 agonist injections as single agent therapy or combination oral agents.
* Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of \< 45 mL/min/1.73 m2 (\< 60 ml/min/1.73 m2 in subjects treated with SGLT2i) according to CKDEPI creatinine equation as defined by KDIGO 201242 by the central laboratory at screening
* History of thyroid disease, but not taking medication or medication dosage changed one or more times over last 6 months (History of thyroid disease and on a stable dose of prescription medication for 6 months or longer is acceptable).
* History or lactic acidosis
* Liver problems
* Congestive heart failure
* History of alcoholism
* Recent surgery
* Heart attack, severe infection or stroke
* Any unstable medical conditions or terminal diagnosis
* Pregnancy or lactation
* Allergy and intolerance to metformin
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is testing metformin — a drug already approved for type 2 diabetes — for weight loss in people with obesity and NIDDM, can you help me understand whether I might be able to get metformin for weight management outside of a trial, versus needing to enroll here?
2The trial is Phase 4, which means metformin's safety is already well established — but is its effectiveness specifically for a 5% or greater body weight reduction proven enough that this would be a better path than other weight loss options you'd recommend for my situation?
3Since this trial is no longer recruiting new participants, does that mean this option is completely off the table for me, or is there any way to find out if similar studies are still open?
4The trial is measuring whether participants can lose at least 5% of their body weight — how does that target compare to what my doctor would consider a meaningful or realistic goal given my current weight and health?
5Given that I have both type 2 diabetes and obesity, are there standard treatments or newer medications already available — like GLP-1 receptor agonists — that my doctor might recommend instead of, or alongside, what this trial is investigating?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants who achieve body weight reduction ≥5% from baseline