A Multicenter, Randomized, Double Blind (Double Dummy), Active Controlled Study to Compare the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Pioglitazone in Type 2 Diabetes Patients Inadequately Controlled on Therapy With Sulfonylurea or Metformin Plus Sulfonylurea
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 756
- 主要终点
- Absolute change from baseline in HbA1c
研究概览
简要总结
This double-blind, double-dummy 3 arm study will evaluate the efficacy, safety and tolerability of taspoglutide versus pioglitazone in patients with type 2 diabetes mellitus inadequately controlled with sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy. After an initial screening period, patients will be randomized to one of 3 groups, to receive a)taspoglutide 10mg sc weekly, b)taspoglutide 20mg sc weekly after 4 weeks of taspoglutide 10mg sc weekly or c)pioglitazone 45mg/day po after 4 weeks of pioglitazone 30mg/day po.The anticipated time on study treatment is 24 months, 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
- Double (Participant, Investigator)
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 mellitus;
- •treated with stable sulfonylurea monotherapy or metformin + sulfonylurea for >=12 weeks prior to screening;
- •HbA1c >=7.0% and <=10% at screening;
- •stable weight +/-5% for >=12 weeks prior to screening.
排除标准
- •type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes;
- •clinically significant diabetic complications;
- •clinically symptomatic gastrointestinal disease;
- •>3 episodes of severe hypoglycemia within 6 months before screening.
研究组 & 干预措施
pioglitazone
干预措施: pioglitazone (Drug)
taspoglutide 10mg
taspoglutide 10mg sc weekly
干预措施: taspoglutide (Drug)
taspoglutide 10mg/20mg
taspoglutide 20mg sc weekly after 4 weeks of taspoglutide 10mg sc weekly
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
- Adverse events; laboratory parameters; cardiovascular events(At each clinic visit up to 106 weeks)
- Proportion of patients achieving target HbA1c <=6.5%, <=7%(weeks 24, 52 and 104)
- Absolute/percentage change from baseline in body weight; responder rate for body weight; absolute/percentage change from baseline in waist and hip circumference;absolute/percentage change from baseline in fasting plasma glucose(weeks 24, 52 and 104)