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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: Completed Phase 3 study, sponsored by University of Massachusetts, Worcester.
NCT01334125 is a Phase 3 study that has completed, run by University of Massachusetts, Worcester. The registered enrollment target is 28 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Comparison of the baseline-adjusted differences in HbA1c between the metformin and placebo groups during the trial. Hemoglobin A1c is a marker of glycemic control. The reported values represented means adjusted for baseline values, age, gender, and BMI using repeated measures ANOVA (General Linear Model).
Interventions
- DRUG Placebo
- DRUG Metformin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2011-02 |
| Est. Completion | 2014-12 |
| Phase | Phase 3 |
What the finished NCT01334125 record still lists
NCT01334125 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01334125 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01334125's enrollment target sits among peer trials
28 1935th of 2000 higher than 65 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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