A Multicenter, Randomized, Open-label, Active-controlled Study to Compare the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Insulin Glargine in Insulin-naïve Type 2 Diabetic Patients Inadequately Controlled With Metformin and Sulphonylurea Combination Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,072
- 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 insulin glargine in patients with insulin-naive type 2 diabetes mellitus inadequately controlled with metformin and sulphonylurea combination therapy. Patients will be randomized to receive taspoglutide (10 mg once weekly, or 10mg once weekly for 4 weeks followed by 20mg once weekly) or insulin glargine (starting dose 10 IU/day) in a ratio of 1:1:1 in addition to continued prestudy metformin treatment. The anticipated time on study treatment is 2+ years, and the target sample size if 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 treated with a stable dose of metformin and sulphonylurea for at least 12 weeks;
- •C-peptide (fasting) >=1.0ng/mL;
- •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;
- •symptomatic poorly controlled diabetes;
- •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
insulin glargine
insulin glargine starting dose 10 IU daily in addition to continued prestudy metformin treatment
干预措施: insulin glargine (Drug)
insulin glargine
insulin glargine starting dose 10 IU daily in addition to continued prestudy metformin treatment
干预措施: metformin (Drug)
taspoglutide 10 mg
taspoglutide 10 mg once weekly in addition to continued prestudy metformin treatment
干预措施: metformin (Drug)
taspoglutide 10 mg
taspoglutide 10 mg once weekly in addition to continued prestudy metformin treatment
干预措施: taspoglutide (Drug)
taspoglutide 10 mg/20 mg
taspoglutide 20 mg once weekly (after 4 weeks of taspoglutide 10 mg once weekly) in addition to continued prestudy metformin treatment
干预措施: metformin (Drug)
taspoglutide 10 mg/20 mg
taspoglutide 20 mg once weekly (after 4 weeks of taspoglutide 10 mg once weekly) in addition to continued prestudy metformin treatment
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
- Change from baseline in fasting plasma glucose; change from baseline in body weight; responder rates for HbA1c (target <=7.0%, <=6.5%); incidence of hypoglycemia; change from baseline in lipid profile.(24 weeks)
- Relative change in glucose, insulin, C-peptide and glucagon during a meal tolerance test.(24 weeks)
- Safety: Adverse events, vital signs, physical examination, clinical laboratory tests, ECG and anti-taspoglutide antibodies(Throughout study)