A Multicenter, Randomized, Double-dummy, Placebo and Active-controlled Study to Assess the Safety, Tolerability and Effect of Taspoglutide on Glycemic Control Compared to Sitagliptin and Placebo in Patients With Type II Diabetes Mellitus Inadequately Controlled With Metformin.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 666
- 主要终点
- Mean changes in HbA1c
研究概览
简要总结
This 4 arm study will assess the efficacy, safety and tolerability of taspoglutide compared to sitagliptin and placebo in patients with type 2 diabetes mellitus inadequately controlled with metformin. Patients will be randomized to receive taspoglutide (10mg once weekly or 10mg once weekly for 4 weeks followed by 20mg once weekly), sitagliptin 100mg once daily or placebo, in a ratio of 2:2:2:1, in addition to their continued prestudy metformin treatment. After 24 weeks of treatment, patients on active treatment will continue on the same treatment and 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 2+ 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
- 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 receiving metformin (>=1500mg/day) for at least 12 weeks;
- •HbA1c >=7.0% 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;
- •clinically symptomatic gastrointestinal disease;
- •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
Once daily oral administration of placebo (matching sitagliptin). Once weekly sc injection of placebo (matching taspoglutide). Continued treatment with metformin at prescribed doses.
干预措施: Metformin (Drug)
Placebo
Once daily oral administration of placebo (matching sitagliptin). Once weekly sc injection of placebo (matching taspoglutide). Continued treatment with metformin at prescribed doses.
干预措施: Placebo (matching sitagliptin) (Drug)
Placebo
Once daily oral administration of placebo (matching sitagliptin). Once weekly sc injection of placebo (matching taspoglutide). Continued treatment with metformin at prescribed doses.
干预措施: Placebo (matching taspoglutide) (Drug)
Sitagliptin
Once daily oral administration of 100 mg of sitagliptin. Once weekly sc injection of placebo (matching taspoglutide). Continued treatment with metformin at prescribed doses.
干预措施: Metformin (Drug)
Sitagliptin
Once daily oral administration of 100 mg of sitagliptin. Once weekly sc injection of placebo (matching taspoglutide). Continued treatment with metformin at prescribed doses.
干预措施: Placebo (matching taspoglutide) (Drug)
Sitagliptin
Once daily oral administration of 100 mg of sitagliptin. Once weekly sc injection of placebo (matching taspoglutide). Continued treatment with metformin at prescribed doses.
干预措施: Sitagliptin (Drug)
Taspoglutide 10 mg
Once weekly subcutaneous (sc) injection of 10 mg of taspoglutide. Once daily oral administration of placebo (matching sitagliptin). Continued treatment with metformin at prescribed doses.
干预措施: Metformin (Drug)
Taspoglutide 10 mg
Once weekly subcutaneous (sc) injection of 10 mg of taspoglutide. Once daily oral administration of placebo (matching sitagliptin). Continued treatment with metformin at prescribed doses.
干预措施: Placebo (matching sitagliptin) (Drug)
Taspoglutide 10 mg
Once weekly subcutaneous (sc) injection of 10 mg of taspoglutide. Once daily oral administration of placebo (matching sitagliptin). Continued treatment with metformin at prescribed doses.
干预措施: Taspoglutide (Drug)
Taspoglutide up-titrated to 20 mg
Once weekly sc injection of 10 mg of taspoglutide for the first 4 weeks, then up-titrated to once weekly sc injection of 20 mg of taspoglutide from week 5 onwards. Once daily oral administration of placebo (matching sitagliptin). Continued treatment with metformin at prescribed doses.
干预措施: Metformin (Drug)
Taspoglutide up-titrated to 20 mg
Once weekly sc injection of 10 mg of taspoglutide for the first 4 weeks, then up-titrated to once weekly sc injection of 20 mg of taspoglutide from week 5 onwards. Once daily oral administration of placebo (matching sitagliptin). Continued treatment with metformin at prescribed doses.
干预措施: Placebo (matching sitagliptin) (Drug)
Taspoglutide up-titrated to 20 mg
Once weekly sc injection of 10 mg of taspoglutide for the first 4 weeks, then up-titrated to once weekly sc injection of 20 mg of taspoglutide from week 5 onwards. Once daily oral administration of placebo (matching sitagliptin). Continued treatment with metformin at prescribed doses.
干预措施: Taspoglutide (Drug)
结局指标
主要结局
Mean changes in HbA1c
时间窗: 24 weeks
次要结局
- Change from baseline in fasting plasma glucose; change from baseline in body weight; responder rates for HbA1c (target <=7.0%, <=6.5%); responder rates for body weight; change from baseline in lipid profile; beta cell function.(24 weeks)
- Safety: Adverse events, vital signs, physical examination, clinical laboratory tests, ECG and anti-taspoglutide antibodies.(Throughout study)