Clinical trial · Interventional
Prospective Trial of Metformin - Chemoprevention Role
A Prospective Placebo-control Double-blind Randomized Trial of Metformin in Chemoprevention of Metachronous Colonic Neoplastic Polyps
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical research study is to learn if metformin extended release (ER) can prevent colonic adenomas from becoming cancerous. Metformin ER will be compared to a placebo. Metformin ER is designed to block a protein in tumor cells that is important in tumor growth and blood vessel development. This may cause cell death or reduce the spread of the disease. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectum | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metformin ER | Drug | Metformin | ALIAS |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Metformin ER
- description
- Participants receive two tablets of Metformin ER 500 mg once daily for no more than twelve to eighteen months allowing time for at least one follow up colonoscopy. Dose will be reached in a gradual escalation scheme to improve gastrointestinal tolerance. If participants experience side effects during dose escalation regimen, they will be reduced to one tablet of 500 mg daily, and may continue taking 500 mg daily for the duration of the study.
- interventionNames
- Drug: Metformin ER
- type
- ACTIVE_COMPARATOR
- label
- Placebo
- description
- Control group given matched Placebo once daily for no more than twelve to eighteen months allowing time for at least one follow up colonoscopy.
- interventionNames
- Other: Placebo
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age between 40 and 75 years 2. Polyp features suggesting high risk for recurrence include: piece-meal polypectomy, large (\>10mm) neoplastic polyp, polyp with high grade dysplasia, or substantial number (\>10) of neoplastic polyps. 3. ability to give informed consent 4. Patients should be registered on LAB10-0417 5. Diabetic patients are eligible but they may be excluded if they are taken Metformin, insulin or sulfonylureas Exclusion Criteria: 1. Patients with renal insufficiency defined as serum creatinine \>= 1.4 mg/dl for females and \>= 1.5 mg/dl for males by the manufacturer. 2. Pregnant or nursing women 3. A malignancy currently under active therapy 4. Unstable angina, uncontrolled ischemic cardiac disease or symptomatic congestive heart failure (e.g. Class III or IV New York Heart Association's Functional Classification) 5. Current usage of Metformin 6. Current usage of insulin, sulfonylureas 7. History of lactic acidosis 8. Liver dysfunction including chronic active hepatitis and cirrhosis 9. Inability to give informed consent 10. Other investigational drugs within the past one year or concurrently 11. Known hypersensitivity or intolerance to Metformin 12. Contraindications for repeat colonoscopy 13. Inflammatory bowel disease 14. Rectosigmoiditis of any etiology
References
Publications (0)
Data not yet available