SGLT2 Inhibitors in Patients With PCOS

Tongji University

Status and phase

Completed

Phase 4

Conditions

Polycystic Ovary Syndrome

Treatments

Drug: Metformin

Drug: SGLT2 inhibitors

Study type

Interventional

Funder types

Other

Identifiers

NCT04700839

SGLT2i PCOS

Details and patient eligibility

About

Polycystic ovary syndrome (PCOS) is a common endocrine disorder, with a prevalence of 5% to 15% in premenopausal women. Patients with PCOS presents as abnormal menstruation, ovulation disorders and/or hyperandrogenemia, and often accompanied by insulin resistance and other metabolic abnormalities. Metformin has been clarified as an option in patients with PCOS. However, the clinical responses to metformin are limited and different. Sodium glucose co-transporter 2 (SGLT2) inhibitors are novel drugs for the treatment of type 2 diabetes, with weight loss, reducing insulin resistance and cardiovascular benefits. Limited data is available on the efficacy of SGLT2 inhibitors in patients with PCOS.

Full description

This clinical study aims to determine the safety and efficacy of canagliflozin vs metformin in Polycystic Ovary Syndrome (PCOS) patients with insulin resistance (IR). Methods: A single center, prospective, randomized open-label study (ratio 1:1), non-inferiority trial was conducted in the department of endocrinology, Shanghai Tenth People's Hospital between July 2019 and April 2021. PCOS women aged 18-45 years with IR were enrolled and randomly assigned to either canagliflozin 100 mg (n = 33) or metformin 1500-2000 mg (n = 35) daily for 12 weeks. The primary outcome was changes in HOMA-IR after 12 weeks treatment. The secondary outcomes included changes in anthropometric, menstrual frequency, sex hormone and metabolic parameters.

Enrollment

68 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Fmale aged 18- 45;
Meet Rotterdam criteria;
Insulin Rsistance

Exclusion criteria

Women who are pregnant or have a pregnancy plan within six months; ·Congenital adrenocortical hyperplasia;
Hyperprolactinemia;
Hyperthyroidism or hypothyroidism;
Abnormal liver function (≥ 3 times of the upper limit of normal range);
Abnormal renal function (GFR<60ml/min/1.73m2);
Adrenal or ovarian tumors secreting androgens;
Used contraceptives, metformin, GLP-1RA, SGLT2I, pioglitazone and contraceptives in the last 3 month.