NCT00331851已完成3 期
Liraglutide Effect and Action in Diabetes (LEAD-5): Effect on Glycaemic Control After Once Daily Administration of Liraglutide in Combination With Glimepiride and Metformin Versus Glimepiride and Metformin Combination Therapy, and Versus Insulin Glargine Added to Glimepiride and Metformin Combination Therapy in Subjects With Type 2 Diabetes.A Six-month Randomised, Double-blind, Parallel-group, Multi-centre, Multi-national Trial With an Open-label Treat-to-target Insulin Glargine Control Arm.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 584
- 试验地点
- 117
- 主要终点
- HbA1c
研究概览
简要总结
This trial is conducted in Africa, Asia, Europe and South America. This trial is designed to show the effect of treatment with liraglutide added to existing glimepiride and metformin combination therapy and to compare it with the effects of insulin glargine added to combination therapy of glimepiride and metformin.
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
- •Treatment with oral anti-diabetic drugs for at least 3 months
- •HbA1c: 7.5-10.0 % (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 to 45 kg/m2
排除标准
- •Treatment with insulin within the last 3 months
- •Treatment with any drug that could interfere with the glucose level
- •Any serious medical condition
- •Females who are pregnant, have intention of becoming pregnant or are breastfeeding
结局指标
主要结局
HbA1c
时间窗: after 26 weeks of treatment
次要结局
- Glycaemic control
- body weight
- Safety and tolerability
- Beta-cell function
研究者
研究点 (117)
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