The Impact of Liraglutide on Glucose Tolerance and the Risk of Type 2 Diabetes in Women With Previous Gestational Diabetes Mellitus
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Change in glucose tolerance
研究概览
简要总结
It is well-known that women with previous gestational diabetes mellitus are in risk of developing type 2 diabetes later in life; approximately half of the women develop overt type 2 diabetes within the first 10 years after pregnancy. Knowing this, we want to examine the effect of the type 2 diabetes medicine, liraglutide (Victoza), in women with previous gestational diabetes with the aim of reducing the risk of developing type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Liraglutide
1.8 mg liraglutide, subcutaneous, once-daily for five years
干预措施: Liraglutide (Drug)
Placebo
Placebo, subcutaneous, once-daily for one year
干预措施: Placebo (Drug)
结局指标
主要结局
Change in glucose tolerance
时间窗: from baseline to 52 wks, 53 wks, 260 wks, and 261 wks
Changes in glucose is measured by area under the curve for the plasma glucose excursion following a 4-hour 75 g oral glucose tolerance test (OGTT)
次要结局
- Deterioration in glycaemic status(from baseline to 52 wks, 53, wks, 260 wks, and 261 wks)
研究者
Tina Vilsboll
Dr. Tina Vilsbøll, DMSc
University Hospital, Gentofte, Copenhagen