Liraglutide as Add on Therapy on Metformin in Women With Polycystic Ovary Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The number of good responders to combined treatment regarding body weight
研究概览
简要总结
The purpose of this study was to determine whether combined treatment with liraglutide and metformin is more effective than metformin as monotherapy in the treatment of obese women with polycystic ovary syndrome (PCOS). We anticipated greater changes in body weight in patients on combined treatment than in those on monotherapy.
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 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years old to menopause
- •polycystic ovary syndrome (NICHD criteria)
- •BMI of 30 kg/m² or higher
排除标准
- •type 1 or type 2 diabetes mellitus
- •history of carcinoma
- •Cushing's syndrome or congenital (non-classic) adrenal hyperplasia
- •personal or family history of MEN 2
- •significant cardiovascular, kidney or hepatic disease
- •the use of medications known or suspected to affect reproductive or metabolic functions
- •the use of statins, within 90 days prior to study entry
研究组 & 干预措施
metformin
In the metformin group metformin was initiated at a dose of 500 mg once per day and increased by 500 mg every 3 days up to 1000 mg BID per os.
干预措施: Metformin (Drug)
combined
In the metformin and liraglutide group metformin was initiated at a dose of 500 mg once per day and increased by 500 mg every 3 days up to 1000 mg BID per os. At the same time liraglutide was initiated at a dose of 0.6 mg injected sc once per day and increased to 1.2 mg/day after 1 week.
干预措施: Glucophage tablets and Victoza (Drug)
结局指标
主要结局
The number of good responders to combined treatment regarding body weight
时间窗: up to 12 weeks of clinical trial
Change in body weight
时间窗: up to 12 weeks of clinical trial
次要结局
- Change in body mass index (BMI).(up to 12 weeks of clinical trial)
- Change in waist circumference(up to 12 weeks of clinical trial)
研究者
Andrej Janez
professor, MD, PhD
University Medical Centre Ljubljana