Saxagliptin + Metformin Compared to Saxagliptin or Metformin Monotherapy in PCOS Women With Impaired Glucose Homeostasis
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.
Timeline
- Start
- 2014-03
- Primary completion
- 2016-08
- Completion
- 2016-10
Outcome
Met primary endpoint
paper SAXA-MET statistically superior to MET PMID 28228317 ↗
paper IS-SI and menstrual regularity were significantly better with SAXA-MET vs. MET treatment. PMID 28228317 ↗
registry MEAN Saxagliptin-Metformin XR: 532 (Standard Deviation 347) index NCT02022007 ↗
registry analysis (superiority or other test); Metformin XR vs Saxagliptin vs Saxagliptin-Metformin XR; p = .02; ANOVA NCT02022007 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Metformin | Small molecule | 2000 mg | — |
| Subject | SAXAGLIPTIN ANHYDROUS | Small molecule | 5 mg | Oral |