Randomized, Active Controlled, Open Label Study to Compare Taspoglutide vs Exenatide as add-on Treatment to Metformin and/or Thiazolidinediones in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,189
- 主要终点
- Change in HbA1c
研究概览
简要总结
This 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared with exenatide in patients with type 2 diabetes mellitus inadequately controlled with metformin, thiazolidinedione or a combination of both. Patients will be randomized to receive taspoglutide (10mg once weekly or 10mg once weekly for 4 weeks followed by 20mg once weekly) or exenatide (5 micrograms twice daily for 4 weeks followed by 10 micrograms twice daily) in a ratio of 1:1:1 in addition to continued prestudy metformin and thiazolidinedione either alone or in combination. The anticipated time on study treatment is 3+ years, and the target sample size is >500 individuals.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients, 18-75 years of age;
- •type 2 diabetes receiving metformin and/or pioglitazone or rosiglitazone for at least 12 weeks;
- •HbA1c >=7.0% and <=10% at screening;
- •BMI >=25kg/m2 (>23kg/m2 for Asians) and <=45kg/m2 at screening;
- •stable weight +/- 5% for at least 12 weeks prior to screening.
排除标准
- •history of type 1 diabetes, diabetes resulting from pancreatic injury or secondary forms of diabetes;
- •history of acute metabolic diabetic complications within the previous 6 months;
- •evidence of clinically significant diabetic complications;
- •known proliferative diabetic retinopathy;
- •myocardial infarction (MI), coronary artery bypass surgery, post-transplantation cardiomyopathy (PTCM) or stroke within the past 6 months;
- •any abnormality in clinical laboratory test or ECG, which precludes safe involvement in the study as judged by the investigator;
- •known hemoglobinopathy or chronic anemia;
- •clinically significant gastrointestinal disease.
研究组 & 干预措施
exenatide
干预措施: exenatide (Drug)
taspoglutide 10mg
干预措施: taspoglutide (Drug)
taspoglutide 10mg/20mg
干预措施: taspoglutide (Drug)
结局指标
主要结局
Change in HbA1c
时间窗: 24 weeks
次要结局
- Fasting body weight(24 weeks)
- Proportion of patients reaching target HbA1c <=7.0%, <=6.5%(24 weeks)
- Beta cell function (proinsulin/insulin ratio)(24 weeks)
- Relative change in glucose, insulin, C-peptide and glucagon values during a meal tolerance test in a subset of patients.(24 weeks)