Liraglutide Effect and Action in Diabetes (LEAD-3): Effect on Glycemic Control of Liraglutide Versus Glimepiride in Type 2 Diabetes
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 746
- 试验地点
- 1
- 主要终点
- Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 52
研究概览
简要总结
This trial is conducted in North America (the United States of America (USA) and Mexico).
The trial is designed to evaluate the effects of treatment with liraglutide versus glimepiride in subjects with type 2 diabetes. The trial is a 52-week randomised, double-blind trial period plus a 52-week open-label extension (week 104) followed by an additional 156-week continued open-label extension. The total duration of the treatment period is planned to be 260 weeks (5 years).
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
- •TTreatment with diet/exercise or with not more than half maximal dose of oral anti-diabetic drugs alone for at least 2 months
- •Diet/exercise treated subjects with HbA1c between 7.0% and 11%, inclusive
- •OAD (oral anti-diabetic drug) treated subjects with HbA1c between 7.0% and 10%, inclusive
- •Body Mass Index (BMI) less than or equal to 45 kg/m^2
排除标准
- •Treatment with insulin for the last 3 months, except short-term treatment for intercurrent illness
- •Treatment with any drug that could interfere with the glucose level (besides use of a single anti-diabetic compound)
- •Any serious medical condition
研究组 & 干预措施
Lira 1.8
Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195).
干预措施: liraglutide (Drug)
Lira 1.8
Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195).
干预措施: placebo (Drug)
Lira 1.2
Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195).
干预措施: liraglutide (Drug)
Lira 1.2
Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195).
干预措施: placebo (Drug)
Glimepiride - 1
Glimepiride 8 mg once daily + liraglutide placebo 200 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195).
干预措施: glimepiride (Drug)
Glimepiride - 1
Glimepiride 8 mg once daily + liraglutide placebo 200 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195).
干预措施: placebo (Drug)
Glimepiride - 2
Glimepiride 8 mg once daily + liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195).
干预措施: glimepiride (Drug)
Glimepiride - 2
Glimepiride 8 mg once daily + liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195).
干预措施: placebo (Drug)
结局指标
主要结局
Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 52
时间窗: week 0, week 52
Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 52 weeks (end of double-blind period)
Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 104
时间窗: week 0, week 104
Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 104 weeks (end of 52-week extension)
Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 156
时间窗: week 0, week 156
Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 156 weeks
次要结局
- Change in Fasting Plasma Glucose at Week 104(week 0, week 104)
- Change in Body Weight at Week 52(week 0, week 52)
- Change in Body Weight at Week 104(week 0, week 104)
- Change in Body Weight at Week 156(week 0, week 156)
- Change in Fasting Plasma Glucose at Week 52(week 0, week 52)
- Change in Fasting Plasma Glucose at Week 156(week 0, week 156)
- Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 52(week 0, week 52)
- Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 104(week 0, week 104)
- Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 156(week 0, week 156)
- Change in Prandial Increments of Plasma Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 52(week 0, week 52)
- Change in Prandial Increments of Plasma Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 104(week 0, week 104)
- Change in Prandial Increments of Plasma Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 156(week 0, week 156)
- Hypoglycaemic Episodes(weeks 104-195)