Saxagliptin + Metformin Compared to Saxagliptin or Metformin Monotherapy in PCOS Women With Impaired Glucose Homeostasis
Status:
Completed
Trial end date:
2016-10-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Woman's
Collaborator:
AstraZeneca
Treatments:
Biguanides Dipeptidyl-Peptidase IV Inhibitors Metformin Saxagliptin