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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SGLT2 inhibitors group | Experimental | Intervention with SGLT2 inhibitors (100mg/d) for 3 months |
|
| Metformin group | Active Comparator | Intervention with metformin (1500-2000mg/d) for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SGLT2 inhibitors | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| HOMA-IR | Homeostatic model assessment insulin resistance index | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| WHR | Waist/hip Ratio | 3 months |
| WC | Waist Circumference (cm） | 3 months |
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Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shen Qu, Dr | Shang hai Tenth People's Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Tenth People' Hospital | Shanghai | Shanghai Municipality | 200072 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30866088 | Result | Javed Z, Papageorgiou M, Deshmukh H, Rigby AS, Qamar U, Abbas J, Khan AY, Kilpatrick ES, Atkin SL, Sathyapalan T. Effects of empagliflozin on metabolic parameters in polycystic ovary syndrome: A randomized controlled study. Clin Endocrinol (Oxf). 2019 Jun;90(6):805-813. doi: 10.1111/cen.13968. Epub 2019 Apr 2. | |
| 41401816 | Derived |
| Label | URL |
|---|---|
| Efficacy of canagliflozin versus metformin in women with polycystic ovary syndrome: A randomized, open-label, noninferiority trial | View source |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| ID | Term |
|---|---|
| D000077203 | Sodium-Glucose Transporter 2 Inhibitors |
| D000068896 | Canagliflozin |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D007004 | Hypoglycemic Agents |
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|
|
| Metformin | Drug | Metformin is a classic drug for the treatment of polycystic ovary syndrome, which can improve the degree of insulin resistance in PCOS patients. |
|
| HC |
Hip Circumference（cm） |
| 3 months |
| Menstrual cycles | annual number of menstrual cycles | 3 months |
| FBG | fasting blood-glucose in mmol/L | 3 months |
| PBG | postprandial blood-glucose in mmol/L | 3 months |
| FINS | fasting serum insulin in mU/L | 3 months |
| PINS | Postprandial insulin in mU/L | 3 months |
| ALT | alanine aminotransferase in U/L | 3 months |
| AST | Aspartate aminotransferase in U/L | 3 months |
| UA | Uric acid in umol/L | 3 months |
| CR | Creatinine in umol/L | 3 months |
| LDL-c | low-density lipoprotein cholesterol in mmol/L | 3 months |
| HDL-c | high-density lipoprotein cholesterol in mmol/L | 3 months |
| TC | Total Cholesterol in mmol/L | 3 months |
| TG | Triglyceride in mmol/L | 3 months |
| TT | total testosterone in nmol/L | 3 months |
| LH | Luteinizing hormone in IU/L | 3 months |
| FSH | follicle-stimulating hormone in IU/L） | 3 months |
| E2 | Estradiol in pmol/L、PRL(Prolactin in uIU/ml) | 3 months |
| PRL | Prolactin in uIU/ml | 3 months |
| Metabonomics | the change of Metabonomics after the treatment | 3 months |
| Ferriman-Gallwey score | Ferriman-Gallwey score、acne, male pattern baldness | 3 months |
| acne score | male pattern baldness | 3 months |
| male pattern baldness | male pattern baldness | 3 months |
| HOMA- ISI | Homeostatic model assessment insulin sensitivity index | 3 months |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Adverse events and Safety data in two treatment groups. | 3 months |
| BMI | body mass index in kg/m^2 | 3 months |
| SHBG | sex hormone binding globulin in nmol/L | 3 months |
| FT | Free testosterone in pg/ml | 3 months |
| DHEAS | Dehydroepiandrosterone Sulfate in ug/dl | 3 months |
| AD | Androstenedione in ng/ml | 3 months |
| Yan Q, Cai M, Wang N, Wu W, Zhang H, Zhu Y, Luo J, Zhang M, Li J. Circulating Profiles of the Bile Acid Metabolomics in Patients With Polycystic Ovary Syndrome Treated With Metformin or Canagliflozin. Pharmacotherapy. 2026 Feb;46(2):e70092. doi: 10.1002/phar.70092. Epub 2025 Dec 16. |
| Effects of empagliflozin on metabolic parameters in polycystic ovary syndrome: a randomized controlled study | View source |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D045505 | Physiological Effects of Drugs |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |