Effect of Liraglutide in Combination With Sulfonylurea (SU) 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
- 264
- 试验地点
- 1
- 主要终点
- Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment
研究概览
简要总结
This trial is conducted in Japan. The trial aims for comparison of the effect on glycaemic control of liraglutide in combination with sulphonylurea agent (SU) compared to SU monotherapy, as assessed by HbA1c after 24 weeks and 52 weeks in subjects with type 2 diabetes. Liraglutide will be compared to placebo, in combination with SU. Trial has a randomisation period of 24 weeks followed by a 28 week extension period, in total 52 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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes
- •Diet/exercise therapy with sulfonylurea (SU) for at least eight weeks
- •HbA1c greater than or equal to 7.0% and less than 10.0%
- •BMI less than 35 kg/m2
排除标准
- •Treatment with insulin within the last 12 weeks
- •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
研究组 & 干预措施
SU Mono - 2
Liraglutide placebo 0.9 mg + sulphonylurea
干预措施: sulfonylurea (Drug)
0.6 mg + SU
Liraglutide 0.6 mg + sulphonylurea
干预措施: sulfonylurea (Drug)
0.6 mg + SU
Liraglutide 0.6 mg + sulphonylurea
干预措施: liraglutide (Drug)
0.9 mg + SU
Liraglutide 0.9 mg + sulphonylurea
干预措施: sulfonylurea (Drug)
0.9 mg + SU
Liraglutide 0.9 mg + sulphonylurea
干预措施: liraglutide (Drug)
SU Mono - 1
Liraglutide placebo 0.6 mg + sulphonylurea
干预措施: sulfonylurea (Drug)
结局指标
主要结局
Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment
时间窗: after 24 weeks of treatment
次要结局
- Fasting Plasma Glucose After 52 Weeks of Treatment(after 52 weeks of treatment)
- Mean PG in 7-point Plasma Glucose Profile After 24 Weeks of Treatment(after 24 weeks of treatment)
- Mean PG in 7-point Plasma Glucose Profile After 52 Weeks of Treatment(after 52 weeks of treatment)
- Postprandial Glucose AUC After 52 Weeks of Treatment(after 52 weeks of treatment)
- Glycosylated Haemoglobin A1c (HbA1c) After 52 Weeks of Treatment(after 52 weeks of treatment)
- Postprandial Glucose AUC After 24 Weeks of Treatment(after 24 weeks of treatment)
- Fasting Plasma Glucose After 24 Weeks of Treatment(after 24 weeks of treatment)
- Hypoglycaemic Episodes(over 52 weeks of treatment)
- Body Weight After 52 Weeks of Treatment(after 52 weeks of treatment)
- Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 24 Weeks of Treatment(after 24 weeks of treatment)
- Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 52 Weeks of Treatment(after 52 weeks of treatment)
- Body Weight After 24 Weeks of Treatment(after 24 weeks of treatment)