A Double-blind, Crossover, Randomized, Placebo-controlled Study to Investigate the Effect of Two Different Doses of Taspoglutide IRF Administered as Continuous Subcutaneous Infusion on First- and Second-phase Insulin Secretion in Type 2 Diabetic Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 主要终点
- Incremental area under insulin concentration time curve relative to basal insulin concentration
研究概览
简要总结
This crossover study will assess the effect of 2 doses of Taspoglutide on first- and second-phase insulin secretion in patients with type 2 diabetes. Patients will receive a continuous subcutaneous infusion of a)the Immediate Release Formulation (IRF)of Taspoglutide 300 micrograms/day for 2 days followed by Taspoglutide 800 micrograms/day for 2 days or b)saline placebo for 2+2 days. After a washout period of 10-15 days, patients will be crossed-over for further treatment;those receiving Taspoglutide in period 1 will receive placebo in period 2, and vice versa. On days 2 and 4 of each period, insulin secretion patterns will be assessed. 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
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients, 18-65 years of age;
- •type 2 diabetes mellitus;
- •treated with diet and exercise alone, or in combination with stable metformin for at least 3 months prior to screening.
排除标准
- •type 1 diabetes mellitus;
- •type 2 diabetes duration of <3 months;
- •treatment with any oral anti-hyperglycemic medication other than metformin monotherapy during last 3 months;
- •treatment with insulin for >7 days within 6 months prior to screening.
研究组 & 干预措施
1
干预措施: Placebo (Drug)
1
干预措施: taspoglutide (Drug)
结局指标
主要结局
Incremental area under insulin concentration time curve relative to basal insulin concentration
时间窗: First 10 minutes after glucose bolus
次要结局
- Adverse events, laboratory parameters(Throughout study)
- Incremental area under insulin concentration time curve relative to basal insulin concentration(10-120 minutes after glucose bolus)