Effect of Liraglutide or Glimepiride Added to Metformin on Glycaemic Control in Subjects With Type 2 Diabetes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 929
- 试验地点
- 1
- 主要终点
- Change in Glycosylated Haemoglobin A1c (HbA1c)
研究概览
简要总结
This trial is conducted in Asia. The trial is designed to compare the effect on glycaemic control of liraglutide or glimepiride added to metformin in subjects with 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
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes
- •Subjects diagnosed with type 2 diabetes and treated with one or more oral antidiabetic drugs (OADs) for the last 3 months
- •HbA1c: 7.0-11.0% (both incl.) for subjects on OAD alone
- •HbA1c: 7.0-10.0 % (both incl.) for subjects on OAD combination therapy
- •BMI less than 45.0 kg/m^2
排除标准
- •Treatment with insulin within the last 3 months prior to the trial
- •Impaired liver or/and renal function
- •Significant cardiovascular disease over the last 6 months
- •Known retinopathy or maculopathy
- •Recurrent major hypoglycaemia or hypoglycaemic unawareness
研究组 & 干预措施
Lira 0.6 + Met
Liraglutide 0.6 mg + metformin + glimepiride placebo
干预措施: liraglutide (Drug)
Lira 0.6 + Met
Liraglutide 0.6 mg + metformin + glimepiride placebo
干预措施: placebo (Drug)
Lira 0.6 + Met
Liraglutide 0.6 mg + metformin + glimepiride placebo
干预措施: metformin (Drug)
Lira 1.2 + Met
Liraglutide 1.2 mg + metformin + glimepiride placebo
干预措施: placebo (Drug)
Lira 1.2 + Met
Liraglutide 1.2 mg + metformin + glimepiride placebo
干预措施: liraglutide (Drug)
Lira 1.2 + Met
Liraglutide 1.2 mg + metformin + glimepiride placebo
干预措施: metformin (Drug)
Lira 1.8 + Met
Liraglutide + metformin + glimepiride placebo
干预措施: placebo (Drug)
Lira 1.8 + Met
Liraglutide + metformin + glimepiride placebo
干预措施: liraglutide (Drug)
Lira 1.8 + Met
Liraglutide + metformin + glimepiride placebo
干预措施: metformin (Drug)
Glim + Met
Glimepiride 4.0 mg + metformin + liraglutide placebo
干预措施: glimepiride (Drug)
Glim + Met
Glimepiride 4.0 mg + metformin + liraglutide placebo
干预措施: metformin (Drug)
Glim + Met
Glimepiride 4.0 mg + metformin + liraglutide placebo
干预措施: placebo (Drug)
结局指标
主要结局
Change in Glycosylated Haemoglobin A1c (HbA1c)
时间窗: week 0, week 16
Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 16 weeks (end of treatment).
次要结局
- Change in Body Weight(week 0, week 16)
- Change in Self-measured Fasting Plasma Glucose(week 0, week 16)
- Change in Beta-cell Function(week 0, week 16)
- 7-point Self-measured Plasma Glucose Profiles(week 0, 8, 12 and 16)
- Change in Fasting Lipid Profile(week 0, week 16)
- Change in Fasting Lipid Profile, APO-B(week 0, week 16)
- Hypoglycaemic Episodes(weeks 0-16)