The Efficacy of Canagliflozin Versus Metformin in Women With Polycystic Ovary Syndrome: A Randomized, Open Label Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- HOMA-IR
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •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.
研究组 & 干预措施
SGLT2 inhibitors group
Intervention with SGLT2 inhibitors (100mg/d) for 3 months
干预措施: SGLT2 inhibitors (Drug)
Metformin group
Intervention with metformin (1500-2000mg/d) for 3 months
干预措施: Metformin (Drug)
结局指标
主要结局
HOMA-IR
时间窗: 3 months
Homeostatic model assessment insulin resistance index
次要结局
- CR(3 months)
- WHR(3 months)
- WC(3 months)
- HC(3 months)
- ALT(3 months)
- UA(3 months)
- Menstrual cycles(3 months)
- FBG(3 months)
- FINS(3 months)
- PINS(3 months)
- AST(3 months)
- PBG(3 months)
- FT(3 months)
- LDL-c(3 months)
- HDL-c(3 months)
- TC(3 months)
- PRL(3 months)
- male pattern baldness(3 months)
- TG(3 months)
- TT(3 months)
- LH(3 months)
- FSH(3 months)
- E2(3 months)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(3 months)
- DHEAS(3 months)
- AD(3 months)
- Metabonomics(3 months)
- Ferriman-Gallwey score(3 months)
- SHBG(3 months)
- BMI(3 months)
- acne score(3 months)
- HOMA- ISI(3 months)
研究者
Zhang Manna
Director, Principal Investigator, Clinical Professor
Shanghai 10th People's Hospital