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NCT01334125 · ClinicalTrials.gov registry record · Phase 3
Adjunctive Metformin Therapy in Double Diabetes
A Phase 3 study, sponsored by University of Massachusetts, Worcester.
- Completed
- Registry status
- Phase 3
- Development phase
- 28
- Enrollment target
NCT01334125 is a Phase 3 study that has completed, run by University of Massachusetts, Worcester. The registered enrollment target is 28 participants.
The verdict
NCT01334125, a Phase 3 study, has completed, sponsored by University of Massachusetts, Worcester.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 28 participants
- Enrollment target
Study Summary
The significance of this project is to investigate the effects of adjunctive metformin therapy in children and adolescents with double diabetes. Double diabetes describes a clinical state where an individual possesses features of both type 1 and type 2 diabetes. There is a paucity of data on the role of adjunctive metformin therapy in children and adolescents with double diabetes. To help fill this knowledge gap, the investigators propose a randomized, double-blind, placebo-controlled trial of metformin in double diabetes. Specifically, the investigators will evaluate changes in hemoglobin A1c and anthropometry in patients with a diagnosis of type 1 diabetes who also have features of type 2 diabetes or metabolic syndrome as well as patients with type 2 diabetes who possess diabetes-associated autoantibodies. This will help determine the safety profile, and efficacy of adjunctive metformin therapy in these subjects.
Interventions
- DRUG Placebo
- DRUG Metformin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2011-02 |
| Est. Completion | 2014-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01334125
The ClinicalTrials.gov registry entry for NCT01334125 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Massachusetts, Worcester, which has 240 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01334125 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01334125 about?
NCT01334125 is a clinical study titled "Adjunctive Metformin Therapy in Double Diabetes". The significance of this project is to investigate the effects of adjunctive metformin therapy in children and adolescents with double diabetes. Double diabetes describes a clinical state where an individual possesses features of both type 1 and type 2 diabetes. There is a paucity of data on the rol...
What is the current status of trial NCT01334125?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 28 participants. The study started on 2011-02. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01334125?
The interventions under investigation include: Placebo (DRUG), Metformin (DRUG).
Who is sponsoring clinical trial NCT01334125?
This trial is sponsored by University of Massachusetts, Worcester, which has 240 total clinical trials registered on ClinicalTrials.gov.
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