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NCT02022007 · ClinicalTrials.gov registry record · Phase 3
Saxagliptin + Metformin Compared to Saxagliptin or Metformin Monotherapy in PCOS Women With Impaired Glucose Homeostasis
A Phase 3 study of Polycystic Ovary Syndrome and Disorder of Glucose Regulation, sponsored by Woman's.
- Completed
- Registry status
- Phase 3
- Development phase
- 38
- Enrollment target
- 1
- Study location
NCT02022007: Completed Phase 3 study of Polycystic Ovary Syndrome and Disorder of Glucose Regulation, sponsored by Woman's.
NCT02022007 is a Phase 3 study of Polycystic Ovary Syndrome and Disorder of Glucose Regulation that has completed, run by Woman's. The registered enrollment target is 38 participants, below the 17,257-participant average among 30 other Polycystic Ovary Syndrome trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02022007, a Phase 3 study of Polycystic Ovary Syndrome and Disorder of Glucose Regulation, has completed, sponsored by Woman's.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 38 participants
- Enrollment target
- 1
- Study location
Study Summary
The objective of the present proposal is to compare the clinical, endocrine and metabolic effects of therapy with combination saxagliptin and metformin to saxagliptin and metformin monotherapy in women with PCOS and prediabetic hyperglycemia (IFG, IGT or IFG/IGT). Saxagliptin is an oral dipeptidyl peptidase IV (DPP-4) inhibitor whose mechanism of action is to prolong the duration of blood glucagon-like peptide (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) levels by inhibiting their degradation and thereby augmenting insulin secretion. This study will serve as a pilot investigation to open perspectives for future studies to explore the potential of combining anti-diabetic drugs with different mechanisms of action in in patients with PCOS and impaired glucose regulation (IGR), especially ones for whom standard treatment with metformin is less effective.
Primary Outcome
Glucose metabolic secretory status after drug treatment (normal, impaired or diabetic). We used the American Diabetes Association (ADA) definition of impairment which is fasting glucose greater than 100 mg/dL and/or 2 hour glucose greater than 140 mg/dL.
Conditions Studied
Interventions
- DRUG Saxagliptin
- DRUG Metformin XR
- DRUG Saxagliptin-Metformin XR
Study Locations (1)
Louisiana
- Woman's Hospital - Baton Rouge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2014-03 |
| Est. Completion | 2016-10 |
| Phase | Phase 3 |
What the finished NCT02022007 record still lists
NCT02022007 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 17,257-participant average among 30 other Polycystic Ovary Syndrome trials with a reported enrollment target (100% lower).
The record links to 2 conditions, with Polycystic Ovary Syndrome appearing as the primary indexed condition, and to 3 interventions - of which Saxagliptin is the first listed.
NCT02022007 reports a single indexed study location in Louisiana.
Frequently Asked Questions
What is clinical trial NCT02022007 about?
NCT02022007 is a clinical study titled "Saxagliptin + Metformin Compared to Saxagliptin or Metformin Monotherapy in PCOS Women With Impaired Glucose Homeostasis". The objective of the present proposal is to compare the clinical, endocrine and metabolic effects of therapy with combination saxagliptin and metformin to saxagliptin and metformin monotherapy in women with PCOS and prediabetic hyperglycemia (IFG, IGT or IFG/IGT). Saxagliptin is an oral dipeptidyl p...
What is the current status of trial NCT02022007?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 38 participants. The study started on 2014-03. Estimated completion is 2016-10.
What conditions does trial NCT02022007 study?
This clinical trial studies the following conditions: Polycystic Ovary Syndrome, Disorder of Glucose Regulation.
What interventions are being tested in trial NCT02022007?
The interventions under investigation include: Saxagliptin (DRUG), Metformin XR (DRUG), Saxagliptin-Metformin XR (DRUG).
Who is sponsoring clinical trial NCT02022007?
This trial is sponsored by Woman's, which has 17 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02022007 being conducted?
This trial has 1 study location across Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Polycystic Ovary Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02022007's enrollment target sits among peer trials
38 23rd of 30 higher than 8 of 30 other Polycystic Ovary Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Polycystic Ovary Syndrome 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.
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