At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Metabolic and Endocrine Effects of Combination of Metformin and DPP-4 Inhibitor Saxagliptin Compared to Saxagliptin or Metformin XR Monotherapy in Patients With PCOS and Impaired Glucose Regulation: A Single-blinded Randomized Pilot Study
In Brief
A Phase 3 clinical trial evaluating Metformin XR, Saxagliptin, and 1 other intervention for Polycystic Ovary Syndrome and Disorder of Glucose Regulation. Completed, enrolled 38 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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
Start 1 pill (5 mg)) for 3 weeks Remain at 1 pill (5mg dose) for remainder of study
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