A Double Blind, Placebo-controlled, Dose-ranging Study to Investigate the Effect on Glycemic Control, Safety, Pharmacokinetics and Pharmacodynamics of GLP-1 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
- 306
- 主要终点
- Absolute change from baseline in HbAlc
研究概览
简要总结
This 6 arm study will evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of multiple doses and regimens 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, 5mg, 10mg or 20mg weekly, or 10mg or 20mg every 2 weeks. 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
- •adult patients, 18-75 years of age;
- •type 2 diabetes mellitus, with stable metformin treatment for >=3 months;
- •stable weight +/-10% for >=3 months before screening.
排除标准
- •type 1 diabetes mellitus;
- •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.
研究组 & 干预措施
5
干预措施: taspoglutide (Drug)
1
干预措施: taspoglutide (Drug)
2
干预措施: taspoglutide (Drug)
3
干预措施: taspoglutide (Drug)
4
干预措施: taspoglutide (Drug)
6
干预措施: Placebo (Drug)
结局指标
主要结局
Absolute change from baseline in HbAlc
时间窗: Week 8
次要结局
- Changes in lipid profile(Week 8)
- Absolute change from baseline in FPG, fructosamine, body weight, fasting insulin, C-peptide, glucagon.(Week 8)
- AEs, laboratory parameters, primary pharmacokinetic parameters(Throughout study)