Liraglutide Effect and Action in Diabetes (LEAD-2): Effect on Glycaemic Control After Once Daily Administration of Liraglutide in Combination With Metformin Versus Metformin Monotherapy Versus Metformin and Glimepiride Combination Therapy in Subjects With Type 2 Diabetes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,091
- 试验地点
- 1
- 主要终点
- Change in Glycosylated A1c (HbA1c) at Week 26
研究概览
简要总结
This trial is conducted in Europe, Oceania, Africa, Asia and South America. This trial is designed to show the effect of treatment with liraglutide when adding to existing metformin therapy and to compare it with the effects of metformin monotherapy and combination therapy of metformin and glimepiride. Two trial periods: A 6 month (26 weeks) randomised, double-blinded period followed by an 18 months open-label extension, in total 2 years (104 weeks).
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
- •Subjects diagnosed with type 2 diabetes and treated with oral anti-diabetic drugs (OADs) for at least 3 months
- •HbA1c: 7.0-11.0 % (both incl.) in subjects on OAD monotherapy. 7.0-10.0 % (both incl.) in subjects on OAD combination therapy
- •Body Mass Index (BMI) less than or equal 40 kg/m2
排除标准
- •Subjects treated with insulin within the last three months
- •Subjects with any serious medical condition
- •Females of child bearing potential who are pregnant, breast-feeding or have the intention of becoming pregnant or not using adequate contraceptive methods
- •Subjects using any drug (except for OADs), which in the Investigator's opinion could interfere with the glucose level (e.g. systemic corticosteroids)
研究组 & 干预措施
Lira 0.6 + Met
Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day
干预措施: liraglutide (Drug)
Lira 0.6 + Met
Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day
干预措施: metformin (Drug)
Lira 0.6 + Met
Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day
干预措施: placebo (Drug)
Lira 1.2 + Met
Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day
干预措施: metformin (Drug)
Lira 1.2 + Met
Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day
干预措施: placebo (Drug)
Lira 1.2 + Met
Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day
干预措施: liraglutide (Drug)
Lira 1.8 + Met
Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day
干预措施: metformin (Drug)
Lira 1.8 + Met
Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day
干预措施: placebo (Drug)
Lira 1.8 + Met
Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day
干预措施: liraglutide (Drug)
Met Mono
Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo
干预措施: metformin (Drug)
Met Mono
Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo
干预措施: placebo (Drug)
Met + Glim
Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo
干预措施: metformin (Drug)
Met + Glim
Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo
干预措施: glimepiride (Drug)
Met + Glim
Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo
干预措施: placebo (Drug)
结局指标
主要结局
Change in Glycosylated A1c (HbA1c) at Week 26
时间窗: week 0, week 26
Percentage point change in Glycosylated A1c (HbA1c) from baseline (week 0) to 26 weeks (end of randomisation)
Change in Glycosylated A1c (HbA1c) at Week 104
时间窗: week 0, week 104
Change in glycosylated A1c (HbA1c) baseline (week 0) to 104 weeks (end of randomisation)
次要结局
- Change in Body Weight at Week 26(week 0, week 26)
- Change in Body Weight at Week 104(week 0, week 104)
- Change in Fasting Plasma Glucose (FPG) at Week 26(week 0, week 26)
- Change in Fasting Plasma Glucose (FPG) at Week 104(week 0, week 104)
- Change in Mean Prandial Increments of Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 26(week 0, week 26)
- Change in Mean Prandial Increments of Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 104(week 0, week 104)
- Change in Mean Post Prandial Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 26(week 0, week 26)
- Change in Mean Post Prandial Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 104(week 0, week 104)
- Change in Beta-cell Function at Week 26(week 0, week 26)
- Change in Beta-cell Function at Week 104(week 0, week 104)
- Hypoglycaemic Episodes at Week 26(weeks 0-26)
- Hypoglycaemic Episodes at Week 104(weeks 0-104)