Phase 3 Study of Liraglutide in Individuals With Type 2 Diabetes Using Insulin
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Change in A1c
研究概览
简要总结
Liraglutide is a GLP1 agonist used in the treatment of Type 2 diabetes and is is asociated with improved blood glucose control, weight loss and low rates of hypoglycemia when used alone or in combination with metformin. Liraglutide has not been extensively tested in people with type 2 diabetes who are taking relatively large doses of insulin (>50 U/day). Often these patients are insulin resistant and despite using large doses of insulin are not able to achieve glucose targets. The rationale for this study is to assess if the addition of liraglutide in addition to usual care versus placebo can improve blood glucose levels in people not achieving a target HbA1C of less than 7.0%.
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
- Triple (Participant, Care Provider, 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
- •BMI≤45 kg/m2
- •A1c ≥7.5% and ≤10.5%
排除标准
- •type 1 diabetes
- •symptoms of poorly controlled diabetes
- •eGFR <50 ml/min/1.73m2
研究组 & 干预措施
liraglutide
liraglutide 1.8 mg injected once daily
干预措施: liraglutide (Drug)
Placebo injection
干预措施: placebo injection (Drug)
结局指标
主要结局
Change in A1c
时间窗: Baseline to 24 wks
次要结局
- Percentage of patients experiencing hypoglycemia(Baseline and 24 weeks)
- Change in Systolic Blood pressure(Baseline and 24 weeks)
- Change in diastolic blood pressure(Baseline and 24 weeks)
- Change in waist circumference(Baseline and 24 weeks)
- Change in body weight(Baseline and 24 weeks)
- Change in heart rate(Baseline and 24 weeks)
- Change in lipid profile(Baseline and 24 weeks)
- Diabetes Treatment Satisfaction(Baseline, 12 weeks and 24 weeks)
- Percentage of patients achieving A1C < or equal to 7%(Baseline and 24 weeks)
- Change in fasting blood glucose(Baseline adn 24 weeks)
- Occurence of undetected hypoglycemia as measured by continuous glucose monitoring(Baseline, 12 weeks and 24 weeks)
- Postprandial glucose reduction through measurement of 7 point glucose profile(Baseline, 4 weeks, 12 weeks and 24 weeks)
研究者
Dr. Vincent Woo
Assistant Professor
University of Manitoba