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NCT03467763 · ClinicalTrials.gov registry record · Phase 4
Trial of an Intervention to Improve Metformin Persistence and Adherence
A Phase 4 study, sponsored by Weill Medical College of Cornell University.
- Completed
- Registry status
- Phase 4
- Development phase
- 13
- Enrollment target
NCT03467763 is a Phase 4 study that has completed, run by Weill Medical College of Cornell University. The registered enrollment target is 13 participants.
The verdict
NCT03467763, a Phase 4 study, has completed, sponsored by Weill Medical College of Cornell University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 13 participants
- Enrollment target
Study Summary
Metformin is a safe and effective first-line drug for type 2 diabetes that is also widely recommended for weight loss and diabetes prevention. But, metformin is associated with gastrointestinal and other side effects which prevent its use in 10-20% of patients and appear to limit the usable dose in others. This study is an N-of-1 trial design that will recruit 20 previously metformin-intolerant patients for re-challenge with metformin in a double-blind scenario. In this setting, 'intolerant' means either unable to take metformin at all, or unable to increase the dose past 1,000 mg despite the treating physician's recommendation to do so. Patients will be assigned to take their baseline medication regimen plus 2 weeks of 250 mg per day of metformin extended release, followed by 500 mg metformin XR, 750 mg, and 1,000 mg metformin XR with each treatment period separated by a 2-week course of placebo. Initial treatment, placebo or metformin XR, will be decided randomly. At the end of each two-week treatment period, participants will complete questionnaires assessing overall satisfaction with the medication, gastrointestinal symptoms, and adherence. Six months after the conclusion of the intervention, patients will be asked if they are continuing metformin at a higher dose than upon entry to the trial. This trial has two aims. First, to test the hypothesis that medication satisfaction will be the same during periods of placebo treatment and during periods of treatment with the active drug. The second aim is to test the hypothesis that \> 30% of metformin-intolerant patients in an N of 1 crossover trial are able to tolerate higher-dose metformin at 6-months.
Interventions
- DRUG Placebo oral capsule
- DRUG Metformin Extended Release Oral Tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2018-02-09 |
| Est. Completion | 2020-08-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03467763
The ClinicalTrials.gov registry entry for NCT03467763 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Weill Medical College of Cornell University, which has 701 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo oral capsule is the first listed.
NCT03467763 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03467763 about?
NCT03467763 is a clinical study titled "Trial of an Intervention to Improve Metformin Persistence and Adherence". Metformin is a safe and effective first-line drug for type 2 diabetes that is also widely recommended for weight loss and diabetes prevention. But, metformin is associated with gastrointestinal and other side effects which prevent its use in 10-20% of patients and appear to limit the usable dose in ...
What is the current status of trial NCT03467763?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 13 participants. The study started on 2018-02-09. Estimated completion is 2020-08-01.
What interventions are being tested in trial NCT03467763?
The interventions under investigation include: Placebo oral capsule (DRUG), Metformin Extended Release Oral Tablet (DRUG).
Who is sponsoring clinical trial NCT03467763?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
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