A Multi-center, Randomized, Open-label, Active-controlled Study to Compare the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Insulin Glargine in Insulin-naive Type 2 Diabetic Patients Inadequately Controlled With Metformin and Sulphonylurea Combination Therapy.
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 370
- 主要终点
- Glycemic control assessed by HbA1c
研究概览
简要总结
This randomized, open-label, parallel arm study will compare the safety, tolerability and effect on glycemic control of taspoglutide versus insulin glargine in insulin-naïve patients with type 2 diabetes mellitus inadequately controlled on merformin and sulfonylurea combination therapy. Patients will be randomized to receive either taspoglutide 10mg subcutaneously (sc) weekly, or taspoglutide 10mg sc weekly for 4 weeks followed by 20mg sc weekly, or insulin glargine at an initial dose of 10 international units sc daily. Metformin treatment will be continued in all patients throughout the study, whereas sulfonylurea will be discontinued before starting study treatment. Anticipated time on study treatment is 24 weeks, with an option to continue the assigned treatment for another 28 weeks. Target sample size is 500-600 patients.
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 mellitus, treated with stable dose of metformin and sulfonylurea for >/= 12 weeks prior to screening
- •HbA1c 7-10% at screening
- •body weight stable (+/-5%) for >/= 12 weeks prior to screening
- •fasting C-peptide >/=1ng/ml
- •treatment-naïve for insulin
排除标准
- •diagnosis or history of type 1 diabetes mellitus or secondary forms of diabetes
- •acute metabolic diabetic complications or evidence of clinically significant diabetic complications
- •clinically symptomatic gastrointestinal disease
- •history of chronic pancreatitis or acute idiopathic pancreatitis
- •>3 episodes of severe hypoglycemia within 6 months prior to screening
- •miocardial infarcion, unstable angina pectoris, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within 6 months prior to screening
- •any treatment with exenatide, exendin analogues, GLP-1 or its analogues
研究组 & 干预措施
1
干预措施: metformin (Drug)
1
干预措施: taspoglutide (Drug)
2
干预措施: metformin (Drug)
2
干预措施: taspoglutide (Drug)
3
干预措施: insulin glargine (Drug)
3
干预措施: metformin (Drug)
结局指标
主要结局
Glycemic control assessed by HbA1c
时间窗: week 24
次要结局
- Fasting plasma glucose, incidence of hypoglycemia, proportion of patients achieving target HbA1c(week 24)
- Body weight, lipid profile (triglycerides, total cholesterol, LDL and HDL cholesterol, LDL/HDL ratio)(week 24)
- Safety and tolerability: Adverse events (including hypoglycemia), vital signs, laboratory parameters(throughout study, laboratory assessments weeks 12, 24, 32 and 52)
- Meal tolerance test (in a subset of patients): Glucose, insulin, C-peptide, glucagon values(week 24)