drugset / Trial / NCT04973891

CANA/Met in Non-diabetic Women With PCOS

NCT04973891

Phase 1/2 Completed 52 enrolled Shengjing Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

Polycystic ovary syndrome (PCOS), which is associated with hyperinsulinaemia, hyperandrogenaemia, impaired glucose metabolism and aberrant adipokines production from the adipose tissue, is a heterogeneous reproductive and endocrine disorder.Currently, metformin, a classical and common insulin sensitizer that can reduce both hyperinsulinemia and hyperandrogenemia, is widely used for patients with PCOS. SGLT-2 inhibitor, a novel glucose-lowering medication, have been shown to have positive effects on reducing body weight, blood pressure and cardiovascular events in individuals with diabetes mellitus. However, evidences related to its management in non-diabetic PCOS women are limited. Hence, we want to give canangliflozin combined with metformin to women with PCOS to see its effect on insulin resistance.

Timeline

Start
2021-04-07
Primary completion
2021-07-08
Completion
2022-03-08

Drugs

EvaluationDrugModalityDoseRoute
Subject CANAGLIFLOZIN ANHYDROUS Small molecule 100 mg
Comparator Metformin Small molecule 1000 mg