132-LB: The Safety and Efficacy of Canagliflozin in Women with Polycystic Ovary Syndrome: A Randomized Control Trial

Objectives: To determine the safety and efficacy of canagliflozin in Polycystic Ovary Syndrome (PCOS) patients with insulin resistance (IR) and investigate whether canagliflozin was non-inferiority to metformin in PCOS patients with IR. Methods: A randomized open-label study (ratio 1:1) was conducted in the department of endocrinology, Shanghai Tenth people’s Hospital between July 2019 and March 2021. PCOS women aged 18-45 years with IR were enrolled and randomly assigned to either canagliflozin 100 mg (n = 32) or metformin 1500-2000 mg (n = 35) daily for 12 weeks. The primary outcome was the changes in HOMA-IR before and after 12 weeks treatment. The secondary outcome were the changes in anthropometric, body composition, menstrual frequency, hormonal and metabolic parameters. Results: A total of 53 subjects in the canagliflozin (n=27) and metformin group (n=26) have completed follow-up. Both canagliflozin (5.4±4.1 vs. 3.2±1.9; P=0.001) and metformin (4.7±3.5 vs. 3.6±3.0; P=0.009) can significantly improve HOMA-IR after 12 weeks in PCOS patients with IR. There was no significant difference in the changes of HOMA-IR (canagliflozin: −2.3 ± 3.2 vs. metformin: -1.4 ± 2.4; P = 0.222) between the two groups. According to a secondary endpoint analysis, the canagliflozin group resulted in significantly low uric acid than the metformin group. The changes in anthropometric, body composition, menstrual frequency, sex hormone and other metabolic parameters were comparable between two groups. Gastrointestinal reaction (including nausea, vomiting and Diarrhea) (57.14 %) and pruritus vulvae (6.25%) were the main adverse events in the metformin group and Canagliflozin group, respectively. There were none serious adverse events in both groups. Conclusion: Our study showed that canagliflozin was not significantly inferior to metformin in PCOS patients with IR, which suggested SGLT2 inhibitor should be considered as an effective drug in the treatment of patients with PCOS. Disclosure M. Cai: None. Y. Zhang: None. S. Qu: None. M. Zhang: None. Funding National Natural Science Foundation of China (81601269)