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NCT01329016 · ClinicalTrials.gov registry record · Phase 1
Glyburide and Metformin for Gestational Diabetes Mellitus (GDM)
A Phase 1 study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- Completed
- Registry status
- Phase 1
- Development phase
- 177
- Enrollment target
NCT01329016: Completed Phase 1 study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
NCT01329016 is a Phase 1 study that has completed, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 177 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (195% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01329016, a Phase 1 study, has completed, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 177 participants
- Enrollment target
Study Summary
This is a pharmacokinetic and pharmacodynamic study evaluating glyburide, metformin, and combination treatment for gestational diabetes mellitus.
Primary Outcome
(1) Determination of metformin dosage in pregnancy needed to produce comparable concentrations to the approved dosage range in non-pregnant women. (2)To compare metformin apparent oral clearance in pregnant and non-pregnant women. (3)To evaluate the effect of GLY monotherapy, MET monotherapy, and GLY-MET combination on insulin sensitivity, beta-cell responsivity index and disposition index (response vectors) describing the mechanism and magnitude of effect.
Interventions
- DRUG Metformin
- DRUG Glyburide
- DRUG Glyburide-Metformin combination
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 177 participants |
| Start Date | 2011-07 |
| Est. Completion | 2015-02-28 |
| Phase | Phase 1 |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
What the finished NCT01329016 record still lists
NCT01329016 is an interventional study that assigns participants to a tested intervention. The registered 177 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (195% higher).
The record links to 0 conditions, and to 3 interventions - of which Metformin is the first listed.
NCT01329016 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01329016 about?
NCT01329016 is a clinical study titled "Glyburide and Metformin for Gestational Diabetes Mellitus (GDM)". This is a pharmacokinetic and pharmacodynamic study evaluating glyburide, metformin, and combination treatment for gestational diabetes mellitus.
What is the current status of trial NCT01329016?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 177 participants. The study started on 2011-07. Estimated completion is 2015-02-28.
What interventions are being tested in trial NCT01329016?
The interventions under investigation include: Metformin (DRUG), Glyburide (DRUG), Glyburide-Metformin combination (DRUG).
Who is sponsoring clinical trial NCT01329016?
This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01329016's enrollment target sits among peer trials
177 313th of 2000 higher than 1,685 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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