NCT00518882已完成3 期
Effect of Liraglutide or Exenatide Added to a Background Treatment of Metformin, Sulphonylurea or a Combination of Both on Glycaemic Control in Subjects With Type 2 Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 467
- 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 and the United States of America (USA). The aim of this trial is to compare the effect on glycaemic control of liraglutide or exenatide when added to subject's ongoing OAD (oral anti-diabetic drug) treatment of either metformin, sulphonylurea or a combination of both in subjects with type 2 diabetes. Two trial periods: A 26 week randomised, followed by a 52 week extension (14 + 38 weeks) where all subjects received liraglutide + OAD after previous randomisation to either liraglutide or exenatide, both combined with OAD treatment.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes
- •Stable treatment with Oral Anti-Diabetic Drugs (metformin, sulphonylurea or a combination of both) for at least 3 months at the discretion of the Investigator
- •HbA1C equal to or greater than 7.0% and equal to or lower than 11.0%
- •Body Mass Index (BMI) equal to or lower than 45.0 kg/m2
排除标准
- •Previous treatment with insulin
- •Treatment with any anti-diabetic drug other than metformin and sulphonylurea
- •Any previous exposure to exenatide or liraglutide
- •Impaired liver or/and renal function
- •History of any significant cardiac events
- •Known retinopathy or maculopathy requiring acute treatment
- •Recurrent major hypoglycaemia or hypoglycaemic unawareness
研究组 & 干预措施
Liraglutide
Experimental
Liraglutide 1.8 mg once daily + subject's own OAD treatment
干预措施: liraglutide (Drug)
Exenatide
Active Comparator
Exenatide 10 mcg twice daily + subject's own OAD treatment
干预措施: exenatide (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)
次要结局
- Change in Glycosylated A1c (HbA1c), Weeks 26-78(week 26, week 78)
- Change in Fasting Plasma Glucose, Weeks 26-78(week 26, week 78)
- Change in Mean Prandial Increment of Plasma Glucose After Lunch, Weeks 26-78(week 26, week 78)
- Change in Mean Prandial Increment of Plasma Glucose After Dinner, Weeks 26-78(week 26, week 78)
- Change in Mean Prandial Increment of Plasma Glucose After Dinner at Week 78(week 0, week 78)
- Change in Mean Postprandial Increment of Plasma Glucose After Lunch at Week 26(week 0. week 26)
- Change in Low-density Lipoprotein-cholesterol at Week 78(week 0, week 78)
- Change in Glycosylated A1c (HbA1c) at Week 78(week 0, week 78)
- Change in Body Weight at Week 26(week 0, week 26)
- Change in Body Weight, Weeks 26-78(week 26, week 78)
- Change in Fasting Plasma Glucose at Week 26(week 0, week 26)
- Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 26(week 0, week 26)
- Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 26(week 0, week 26)
- Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 78(week 0, week 78)
- Change in Body Weight at Week 78(week 0, week 78)
- Change in Fasting Plasma Glucose at Week 78(week 0, week 78)
- Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 26(week 0, week 26)
- Change in Mean Prandial Increment of Plasma Glucose After Dinner at Week 26(week 0, week 26)
- Change in Mean Prandial Increment of Plasma Glucose After Breakfast, Weeks 26-78(week 26, week 78)
- Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 78(week 0, week 78)
- Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 78(week 0, week 78)
- Change in Mean Postprandial Increment of Plasma Glucose After Dinner at Week 26(week 0, week 26)
- Change in Mean Postprandial Increment of Plasma Glucose After Breakfast at Week 78(week 0, week 78)
- Change in Mean Postprandial Increment of Plasma Glucose After Lunch at Week 78(week 0, week 78)
- Change in Beta-cell Function at Week 26(week 0, week 26)
- Change in Total Cholesterol at Week 26(week 0, week 26)
- Change in Total Cholesterol, Weeks 26-78(week 26, week 78)
- Change in Low-density Lipoprotein-cholesterol, Weeks 26-78(week 26, week 78)
- Change in Very Low-density Lipoprotein-cholesterol at Week 26(week 0, week 26)
- Change in Free Fatty Acid at Week 26(week 0, week 26)
- Change in Mean Postprandial Increment of Plasma Glucose After Breakfast at Week 26(week 0, week 26)
- Change in Mean Postprandial Increment of Plasma Glucose After Dinner, Weeks 26-78(week 26, week 78)
- Change in Total Cholesterol at Week 78(week 0, week 78)
- Change in Mean Postprandial Increment of Plasma Glucose After Breakfast, Weeks 26-78(week 26, week 78)
- Change in Mean Postprandial Increment of Plasma Glucose After Lunch, Weeks 26-78(week 26, week 78)
- Change in Beta-cell Function, Weeks 26-78(week 26, week 78)
- Change in Beta-cell Function at Week 78(week 0, week 78)
- Change in Low-density Lipoprotein-cholesterol at Week 26(week 0, week 26)
- Change in High-density Lipoprotein-cholesterol, Weeks 26-78(week 26, week 78)
- Change in Mean Postprandial Increment of Plasma Glucose After Dinner at Week 78(week 0, week 78)
- Change in Very Low-density Lipoprotein-cholesterol, Weeks 26-78(week 26, week 78)
- Change in High-density Lipoprotein-cholesterol at Week 78(week 0, week 78)
- Change in Triglyceride at Week 26(week 0, week 26)
- Change in Apolipoprotein B at Week 26(week 0, week 26)
- Hypoglycaemic Episodes at Week 26(weeks 0-26)
- Change in Very Low-density Lipoprotein-cholesterol at Week 78(week 0, week 78)
- Change in High-density Lipoprotein-cholesterol at Week 26(week 0, week 26)
- Change in Triglyceride at Week 78(week 0, week 78)
- Change in Triglyceride, Weeks 26-78(week 26, week 78)
- Change in Apolipoprotein B, Weeks 26-78(week 26, week 78)
- Change in Free Fatty Acid, Weeks 26-78(week 26, week 78)
- Change in Free Fatty Acid at Week 78(week 0, week 78)
- Change in Apolipoprotein B at Week 78(week 0, week 78)
- Hypoglyceamic Episodes, Weeks 26-78(weeks 26-78)
研究者
研究点 (1)
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