A Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Investigate the Effect of Taspoglutide on Gastric Emptying Measured by a Paracetamol Test After Single Dose and After Multiple Doses in Patients With Type 2 Diabetes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Tmax, log (AUC), log(Cmax)of paracetamol
研究概览
简要总结
This 3 arm, placebo-controlled study will investigate the effect of Taspoglutide on gastric emptying in patients with type 2 diabetes. Patients will be randomized into one of 3 groups to receive a)10mg Taspoglutide sc weekly for 12 weeks b)10mg Taspoglutide sc weekly for 4 weeks followed by 20mg Taspoglutide sc weekly for 8 weeks or c) placebo sc weekly for 12 weeks, with all injections administered in the abdomen.Gastric emptying will be assessed by a paracetamol test at intervals during the study. The anticipated time on study treatment is 3 months, and the target sample size is <100 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, treated with stable oral antidiabetic drug therapy for >=3 months prior to screening;
- •stable weight +/-10% for >=3 months before screening.
排除标准
- •type 1 diabetes mellitus;
- •acute gastrointestinal symptoms at screening and/or day -1;
- •clinically relevant cardiovascular, bronchopulmonary, gastrointestinal or neurological disease.
研究组 & 干预措施
1
干预措施: taspoglutide (Drug)
2
干预措施: taspoglutide (Drug)
3
干预措施: Placebo (Drug)
结局指标
主要结局
Tmax, log (AUC), log(Cmax)of paracetamol
时间窗: Days -1, 1, 5, 29, 33, 78 and 82
次要结局
- Adverse events, laboratory parameters, vital signs(Throughout study)
- renal function (creatinine clearance, urine volume and electrolytes)(Throughout study)
- Multiple dose pharmacokinetics of Taspoglutide(Throughout study)