A Double-blind, Placebo-controlled Titration Study to Investigate the Tolerability, Safety and Pharmacodynamic Profile of a GLP-1 Analogue in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 133
- 主要终点
- Percentage of patients withdrawn because of gastrointestinal effects
研究概览
简要总结
This 4 arm study will evaluate the tolerability, efficacy and pharmacodynamics of different doses of a GLP-1 analogue in patients with type 2 diabetes who are treated with a stable dose of metformin. Patients will be randomized to receive either subcutaneous placebo, or subcutaneous GLP-1 analogue (at a dose of 20mg, or a starting dose of 20mg escalating to either 30mg or 40mg), weekly. All patients will continue on their existing metformin treatment regimen throughout the study. The anticipated time on study treatment is <3 months, 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male,and post-menopausal or surgically sterilized female, patients, 18-75 years of age;
- •type 2 diabetes mellitus, with stable metformin treatment for >=3 months;
- •HbA1c >=7.0% and <=9.5% at screening;
- •stable weight +/-10% for >=3 months before screening.
排除标准
- •type 1 diabetes mellitus;
- •clinically significant gastrointestinal disease;
- •treatment with any anti-hyperglycemic medication other than metformin monotherapy during last 3 months;
- •use of weight-lowering medications in the last 3 months;
- •uncontrolled hypertension;
- •previous exposure to GLP-1 or GLP-1 analogues.
研究组 & 干预措施
Placebo
sc weekly
干预措施: Placebo (Drug)
Taspoglutide 20mg
sc weekly
干预措施: Taspoglutide 20mg (Drug)
Taspoglutide 20mg-30mg
sc weekly
干预措施: Taspoglutide 20mg-30mg (Drug)
Taspoglutide 20mg-40mg
sc weekly
干预措施: Taspoglutide 20mg-40mg (Drug)
结局指标
主要结局
Percentage of patients withdrawn because of gastrointestinal effects
时间窗: Week 9
次要结局
- Mean changes in 24h blood glucose Area Under the Curve (AUC), Fasting Plasma Glucose (FPG), fructosamine, Hemoglobin A1c (HbA1c), body weight, Adverse Events (AEs), laboratory parameters.(Week 9)