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NCT01234649 · ClinicalTrials.gov registry record · Phase 3
Combined Liraglutide and Metformin Therapy in Women With Previous Gestational Diabetes Mellitus (GDM)
A Phase 3 study, sponsored by Woman's.
- Completed
- Registry status
- Phase 3
- Development phase
- 153
- Enrollment target
NCT01234649: Completed Phase 3 study, sponsored by Woman's.
NCT01234649 is a Phase 3 study that has completed, run by Woman's. The registered enrollment target is 153 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01234649, a Phase 3 study, has completed, sponsored by Woman's.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 153 participants
- Enrollment target
Study Summary
A diagnosis of gestational diabetes mellitus (GDM)has significant implications for the future health of the mother. GDM is often the culmination of years of unrecognized and unmodified diabetes risk factors that lead to overt and occult clinical manifestations during pregnancy. Systematic reviews of older studies conclude that 35-60% women with gestational diabetes will develop type 2 diabetes (DM2) at rates much greater than control groups who did not have glucose intolerance during pregnancy. Liraglutide may potentially delay disease progression in GDM considering the beta -(ß-)cell function improvement in DM2 and ß-cell mass shown to increase in animal models. This study will examine if the addition of liraglutide to metformin therapy is more effective than metformin alone in improving insulin sensitivity and normalizing insulin secretion in at-risk overweight/obese women with prior GDM.
Primary Outcome
IS-SI in liraglutide-metformin (LIRA-MET) therapy compared to metformin alone (PLacebo-MET)
Interventions
- DRUG Metformin XR plus placebo
- DRUG Metformin XR plus liraglutide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 153 participants |
| Start Date | 2011-08-11 |
| Est. Completion | 2019-06-14 |
| Phase | Phase 3 |
What the finished NCT01234649 record still lists
NCT01234649 is an interventional study that assigns participants to a tested intervention. The registered 153 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Metformin XR plus placebo is the first listed.
NCT01234649 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01234649 about?
NCT01234649 is a clinical study titled "Combined Liraglutide and Metformin Therapy in Women With Previous Gestational Diabetes Mellitus (GDM)". A diagnosis of gestational diabetes mellitus (GDM)has significant implications for the future health of the mother. GDM is often the culmination of years of unrecognized and unmodified diabetes risk factors that lead to overt and occult clinical manifestations during pregnancy. Systematic reviews of...
What is the current status of trial NCT01234649?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 153 participants. The study started on 2011-08-11. Estimated completion is 2019-06-14.
What interventions are being tested in trial NCT01234649?
The interventions under investigation include: Metformin XR plus placebo (DRUG), Metformin XR plus liraglutide (DRUG).
Who is sponsoring clinical trial NCT01234649?
This trial is sponsored by Woman's, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01234649's enrollment target sits among peer trials
153 1510th of 2000 higher than 488 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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