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NCT01881828 · ClinicalTrials.gov registry record · Phase 3
Metformin Therapy for Overweight Adolescents With Type 1 Diabetes
A Phase 3 study, sponsored by Jaeb Center for Health Research.
- Completed
- Registry status
- Phase 3
- Development phase
- 164
- Enrollment target
NCT01881828 is a Phase 3 study that has completed, run by Jaeb Center for Health Research. The registered enrollment target is 164 participants.
The verdict
NCT01881828, a Phase 3 study, has completed, sponsored by Jaeb Center for Health Research.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 164 participants
- Enrollment target
Study Summary
The objective of the proposed research is to evaluate the efficacy and safety of the use of metformin in addition to standard insulin therapy in overweight and obese children and adolescents, age 12-\<20 years, with type 1 diabetes for at least 1 year. Secondary objectives are to assess the effect of metformin on C-peptide levels, a measure of how much insulin is still being produced by the beta cells of the pancreas, and on vascular dysfunction. In addition, an ancillary study is planned to assess if metformin will improve tissue-specific insulin resistance in type 1 diabetes using a hyperinsulinemic euglycemic clamp.
Interventions
- DRUG Metformin (glucophage)
- OTHER oral placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 164 participants |
| Start Date | 2013-09 |
| Est. Completion | 2014-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01881828
The ClinicalTrials.gov registry entry for NCT01881828 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 164 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jaeb Center for Health Research, which has 119 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Metformin (glucophage) is the first listed.
NCT01881828 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01881828 about?
NCT01881828 is a clinical study titled "Metformin Therapy for Overweight Adolescents With Type 1 Diabetes". The objective of the proposed research is to evaluate the efficacy and safety of the use of metformin in addition to standard insulin therapy in overweight and obese children and adolescents, age 12-\<20 years, with type 1 diabetes for at least 1 year. Secondary objectives are to assess the effect o...
What is the current status of trial NCT01881828?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 164 participants. The study started on 2013-09. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01881828?
The interventions under investigation include: Metformin (glucophage) (DRUG), oral placebo (OTHER).
Who is sponsoring clinical trial NCT01881828?
This trial is sponsored by Jaeb Center for Health Research, which has 119 total clinical trials registered on ClinicalTrials.gov.
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