Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Nutritional and Metabolic Diseases

Syndrome

Polycystic Ovary Syndrome

Insulin Resistance

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Hypoglycemic Agents

All Drugs and Chemicals

Insulin

Insulin, Globin Zinc

Metformin

Sodium-Glucose Transporter 2 Inhibitors

Canagliflozin

Intervention with SGLT2 inhibitors (100mg/d) for 3 months

Intervention with metformin (1500-2000mg/d) for 3 months

Sodium-glucose cotransporters inhibitors (SGLT2i) are novel hypoglycemic drugs with unique hypoglycemic mechanisms, which are completely independent of islet β-cell function or insulin sensitivity. Previous studies have shown that SGLT2i may improve IR by inhibiting glucotoxicity, reducing body weight, reducing inflammation, improving islet β-cell function, and reducing oxidative stress.

SGLT2 inhibitors

Metformin is a classic drug for the treatment of polycystic ovary syndrome, which can improve the degree of insulin resistance in PCOS patients.

Shen Qu, Dr

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.

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.

SGLT2 Inhibitors in Patients With PCOS

The Efficacy of Canagliflozin Versus Metformin in Women With Polycystic Ovary Syndrome: A Randomized, Open Label Trial

Homeostatic model assessment insulin resistance index

low-density lipoprotein cholesterol in mmol/L

high-density lipoprotein cholesterol in mmol/L

Estradiol in pmol/L、PRL(Prolactin in uIU/ml)

the change of Metabonomics after the treatment

Ferriman-Gallwey score、acne, male pattern baldness

Homeostatic model assessment insulin sensitivity index

Adverse events and Safety data in two treatment groups.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
SGLT2 Inhibitors in Patients With PCOS	NCT04700839	Polycystic Ovar...	SGLT2 inhibitor... Metformin	18 Years - 45 Years	Shanghai 10th People's Hospital
SGLT2 Inhibitors in Patients With PCOS	NCT04700839	Polycystic Ovar...	SGLT2 inhibitor... Metformin	18 Years - 45 Years	Shanghai 10th People's Hospital
SGLT2 Inhibitors in Patients With PCOS	NCT04700839	Polycystic Ovar...	SGLT2 inhibitor... Metformin	18 Years - 45 Years	Shanghai 10th People's Hospital

Spots Global Cancer Trial Database for insulin resistance (ir)