A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Effect of Taspoglutide Compared to Placebo, in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 373
- 主要终点
- Absolute change from baseline in HbA1c
研究概览
简要总结
This 3 arm study will assess the efficacy, safety and tolerability of taspoglutide compared to placebo in patients with type 2 diabetes mellitus inadequately controlled with diet and exercise. Patients will be randomized to one of 3 treatment arms: taspoglutide 10mg sc once weekly, taspoglutide 20mg sc once weekly (after 4 weeks of taspoglutide 10mg sc once weekly) or placebo. After the first 24 weeks patients on placebo will be switched to taspoglutide 10mg once weekly or taspoglutide 20mg once weekly (after 4 weeks of taspoglutide 10mg once weekly). The anticipated time on study treatment is 1 year, and the target sample size is 100-500 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
- 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
- •adult patients, 18-80 years of age;
- •drug naive patients with type 2 diabetes uncontrolled with diet and exercise;
- •tested negative for anti-glutamic acid decarboxylase (anti-GAD) antibodies;
- •C-peptide (fasting) >=1.0ng/mL
- •HbA1c >=6.5% and <=10.0% at screening;
- •BMI >=25 (>23 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 mellitus or acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma in the previous 6 months;
- •evidence of clinically significant diabetic complications;
- •symptomatic poorly controlled diabetes;
- •myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the previous 6 months;
- •known hemoglobinopathy or chronic anemia.
研究组 & 干预措施
placebo
干预措施: placebo (Drug)
taspoglutide 10mg sc
干预措施: taspoglutide (Drug)
taspoglutide 10mg/20mg sc
干预措施: taspoglutide (Drug)
结局指标
主要结局
Absolute change from baseline in HbA1c
时间窗: 24 weeks
次要结局
- Safety: Adverse events, vital signs, physical examination, clinical laboratory tests, ECG and anti-taspoglutide antibodies.(Throughout study)
- Responder rates for HbA1c (target <=7.0%, <=6.5%); relative change in glucose, insulin, C-peptide and glucagon during a meal tolerance test; beta cell function.(24 weeks)
- Change from baseline in fasting plasma glucose; change from baseline in body weight.(24 weeks)