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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 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.

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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.

Conditions Studied

Polycystic Ovary Syndrome Disorder of Glucose Regulation

Interventions

  • DRUG Saxagliptin
  • DRUG Metformin XR
  • DRUG Saxagliptin-Metformin XR

Study Locations (1)

Louisiana

  • Woman's Hospital - Baton Rouge

Trial Details

FieldValue
Enrollment Target 38 participants
Start Date 2014-03
Est. Completion 2016-10
Phase Phase 3

Sponsor

Woman's

17 total trials

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What the Registry Record Tells You About NCT02022007

The ClinicalTrials.gov registry entry for NCT02022007 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 17,257-participant average among 30 other Polycystic Ovary Syndrome trials with a reported enrollment target (100% lower). The listed sponsor is Woman's, which has 17 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.