NCT04213677已完成3 期
Efficacy and Safety of Dapagliflozin in Polycystic Ovary Syndrome: a Multicentre, Randomized, Placebo-controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Improvement in insulin resistance over 12 weeks
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of dapagliflozin on improving insulin resistance and hyperandrogenemia in obesity women with polycystic ovary syndrome.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •women aged 18 to 45 years;
- •Subjects with PCOS diagnosed by according to the Rotterdam criteria;
- •BMI ≥24 kg/m2 and/ or Homeostatic model assessment of insulin resistance (HOMA-IR) with a cutoff ≥2.5;
- •No pregnancy plan within the next 6 months;
排除标准
- •Congenital adrenal hyperplasia such as 21-hydroxylase deficiency, hyperprolactinemia, Cushing syndrome, androgen-producing tumors of the adrenal gland or ovary;
- •Other endocrine diseases include poorly controlled thyroid diseases (hyperthyroidism or hypothyroidism), acromegaly, type 2 diabetes;
- •Patients with a history of acute / chronic infection, severe cardio-cerebrovascular diseases and acute / chronic pancreatitis;
- •Taking any antidiabetic medication that would affect insulin resistance or hyperandrogenemia (i.e. TZD, GLP-1RA, DPP-4i, metformin) in the past one month;
- •Taking letrozole, clomiphene, oral contraceptive, glucocorticoid, gonadotropin, gonadotropin releasing hormone agonist, anti-androgen drug (spironolactone, cycloproterenone acetate, Flutamide etc.) and/or other drugs for PCOS in the past three months;
- •History of recurrent urinary tract infection;
- •History of malignant tumor;
- •Currently participating in weight loss programs or weight change in the past 3 months (> 5% current body weight) or have a history of gastrointestinal surgery.
- •Serious liver dysfunction or chronic kidney disease (AST or ALT > 3 times the upper limit of normal, or eGFR<30 ml/min/1.73 m2);
- •Women who are pregnant or plan to become pregnant;
- •Subject is, in the judgment of the Investigator, unlikely to comply with the protocol or has any severe concurrent medical or psychological condition that may affect the interpretation of efficacy or safety data;
- •Participation in other clinical trial in the 4 weeks before randomization;
- •Patients who are unwilling or unable to give informed consent.
研究组 & 干预措施
Dapagliflozin
Experimental
Dapagliflozin (Participants will receive dapagliflozin 10mg po qd).
干预措施: Dapagliflozin (Drug)
Placebo
Placebo Comparator
Placebo (Participants will receive placebo po qd)
干预措施: Placebo (Drug)
结局指标
主要结局
Improvement in insulin resistance over 12 weeks
时间窗: Baseline and 12 weeks
Change in insulin resistance assessed by insulin sensitivity index(HOMA-IR)
Improvement in serum androgen level over 12 weeks
时间窗: Baseline and 12 weeks
Change in androgen level assessed by free testosterone index(FAI)
次要结局
- Change in serum free testosterone(FT)(Baseline to 12 week)
- Net change in BMI(Baseline to 12 week)
- Net change in glucose(Baseline to 12 week)
- Change in AUC (area under a curve) of glucose and insulin during the oral glucose tolerant test (OGTT)(Baseline to 12 week)
- Net change in androstenedione(AD) level(Baseline and 12 weeks)
- Net change in waist circumference(Baseline to 12 week)
- Net Change in liver fat(Baseline to 12 week)
- Net change in body weight(Baseline to 12 week)
- Change in serum sex hormone binding globulin(SHBG)(Baseline to 12 week)
- Net change in total testosterone (TT) level(Baseline and 12 weeks)
- Net change in dehydroepiandrosterone-sulfate(DHEAS) level(Baseline and 12 weeks)
- Net change in luteinzing hormone(LH) level(Baseline and 12 weeks)
- Change in ovulation rate assessed by serum progesterone(Baseline to 12 week)
研究者
Huijie Zhang
Professor
Nanfang Hospital, Southern Medical University
研究点 (1)
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