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Saxagliptin + Metformin Compared to Saxagliptin or Metformin Monotherapy in PCOS Women With Impaired Glucose Homeostasis

NCT02022007 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2017-06-28

Study results available
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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

  • Polycystic Ovary Syndrome
  • Disorder of Glucose Regulation

Interventions

DRUG

Metformin XR

Start 2 pills (2 pills of 500 mg =1000mg XR) for 3 weeks Increase to 4 pills as tolerated (4 pills of 500 mg XR =2000 mg XR) for remainder of study

DRUG

Saxagliptin

Start 1 pill (5 mg)) for 3 weeks Remain at 1 pill (5mg dose) for remainder of study

DRUG

Saxagliptin-Metformin XR

Start 1 pill (2.5 mg/ 1000mg XR) for 3 weeks Increase to 2 pills as tolerated (5mg/2000 mg XR) for remainder of study

Sponsors & Collaborators

Principal Investigators

  • Karen Elkind-Hirsch, Ph.D. · Woman's Hospital, Louisiana

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
42 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2016-08-31
Completion
2016-10-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02022007 on ClinicalTrials.gov