NCT01617434已完成3 期
The Effect of Liraglutide Versus Placebo When Added to Basal Insulin Analogues With or Without Metformin 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
- 451
- 试验地点
- 1
- 主要终点
- Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 26
研究概览
简要总结
This trial is conducted in Asia, Europe and North and South America. The aim of the trial is to investigate the effect of liraglutide versus placebo when added to basal insulin analogues with or without metformin in subjects with type 2 diabetes.
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
- •Diagnosed with type 2 diabetes for at least 180 days prior to screening and treated with stable basal insulin analogue dose of minimum 20 U/day with or without stable metformin equal to or above 1500 mg/day for at least 8 weeks prior to screening (defined as insulin adjustments less than 10% during the past 8 weeks as assessed by the investigator)
- •HbA1c (glycosylated haemoglobin A1c) 7.0-10.0% (both inclusive)
- •Body mass index (BMI) 20-45 kg/m^2 (both inclusive)
排除标准
- •Female of child-bearing potential who is pregnant, breast-feeding or intending to become pregnant
- •Recurrent severe hypoglycaemic episodes or hypoglycaemic unawareness
- •Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria in a period of 12 weeks prior to screening
- •Impaired liver or renal function
- •Uncontrolled treated or untreated hypertension (systolic blood pressure (SBP) equal to or above 180 mmHg and/or diastolic blood pressure (DBP) equal to or above 100 mmHg)
- •Any clinically significant disorder, except for conditions associated with type 2 diabetes history which in the investigator's opinion could interfere with results of the trial
- •Known or suspected abuse of alcohol or narcotics
研究组 & 干预措施
Liraglutide
Experimental
干预措施: liraglutide (Drug)
Placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 26
时间窗: Week 0 to Week 26
The estimated mean change from baseline in HbA1c after 26 weeks of treatment.
次要结局
- Number of Subjects Achieving HbA1c Below 7.0% (American Diabetes Association [ADA] Target)(At Week 26)
- Change in Mean Self-Measured Plasma Glucose (SMPG) of 7-Point Profile From Baseline to Week 26(Week 0 to Week 26)
- Number of Subjects Achieving HbA1c Below or Equal to 6.5% (American Association of Clinical Endocrinologists [AACE] Target)(At Week 26)
- Number of Minor Hypoglycaemic Episodes During The Randomised Treatment Period(Week 0 to Week 26 + 7 days follow up)
- Number of Adverse Events (AEs) During The Randomised Treatment Period(Week 0 to Week 26 + 7 days follow up)
- Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26(Week 0 to Week 26)
- Change in Body Weight From Baseline to Week 26(Week 0 to Week 26)
- Number of Severe Hypoglycaemic Episodes During The Randomised Treatment Period(Week 0 to Week 26 + 7 days follow up)
研究者
研究点 (1)
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