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NCT01856907 · ClinicalTrials.gov registry record · Phase 4
Sitagliptin + Metformin Compared to Metformin Monotherapy and Placebo in Women With a Recent GDM
A Phase 4 study, sponsored by Woman's.
- Completed
- Registry status
- Phase 4
- Development phase
- 36
- Enrollment target
NCT01856907: Completed Phase 4 study, sponsored by Woman's.
NCT01856907 is a Phase 4 study that has completed, run by Woman's. The registered enrollment target is 36 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01856907, a Phase 4 study, has completed, sponsored by Woman's.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 36 participants
- Enrollment target
Study Summary
Gestational diabetes mellitus (GDM) is defined as "any degree of glucose intolerance with onset or first recognition during pregnancy." GDM is one of the most frequent metabolic disorders occurring during pregnancy. Approximately 7% of all pregnancies in the United States are complicated by gestational diabetes resulting in more than 200,000 cases annually. There is epidemiologic evidence associating GDM with insulin resistance, glucose intolerance, and type 2 diabetes (DM2). Among all the risk factors of diabetes mellitus, the experience of gestational diabetes is the strongest one. Systematic reviews of older studies conclude that 35-60% women with gestational diabetes will develop type 2 diabetes at rates much greater than control groups who did not have glucose intolerance during pregnancy. Studies are needed for optimal postpartum and long-term health of women who have had GDM. Recent evidence suggests that incretin-based therapies may be useful for the treatment of DM2 because continuous administration of glucagon-like peptide 1 (GLP-1) produces substantial improvements in glucose control and ß-cell function in subjects with DM2. Inhibition of dipeptidyl peptidase-4 (DPP-4) increases the concentration of GLP-1 and may potentially delay disease progression in GDM considering the ß-cell function improvement in DM2 and ß-cell mass shown to increase in animal models. This study will examine if combination sitagliptin (a DPP-4 inhibitor)-plus metformin is more effective than metformin alone or placebo in improving metabolic parameters, specifically the impact on β-cell function, in prior GDM women with glucose abnormalities.
Primary Outcome
Normalization of glucose in patients with abnormal glucose levels is defined as a fasting glucose level of \<100 mg/dL and a 2-hour glucose level following a 75 gram oral glucose load of \<140 mg/dL
Interventions
- DRUG Metformin
- DRUG Placebo pill
- DRUG Sitagliptin-Metformin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2013-09-28 |
| Est. Completion | 2017-09-28 |
| Phase | Phase 4 |
What the finished NCT01856907 record still lists
NCT01856907 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 3 interventions - of which Metformin is the first listed.
NCT01856907 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01856907 about?
NCT01856907 is a clinical study titled "Sitagliptin + Metformin Compared to Metformin Monotherapy and Placebo in Women With a Recent GDM". Gestational diabetes mellitus (GDM) is defined as "any degree of glucose intolerance with onset or first recognition during pregnancy." GDM is one of the most frequent metabolic disorders occurring during pregnancy. Approximately 7% of all pregnancies in the United States are complicated by gestatio...
What is the current status of trial NCT01856907?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 36 participants. The study started on 2013-09-28. Estimated completion is 2017-09-28.
What interventions are being tested in trial NCT01856907?
The interventions under investigation include: Metformin (DRUG), Placebo pill (DRUG), Sitagliptin-Metformin (DRUG).
Who is sponsoring clinical trial NCT01856907?
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 NCT01856907's enrollment target sits among peer trials
36 1490th of 2000 higher than 495 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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