NCT00382239已完成2 期
A Dose Response Study to Assess the Effect on Glucose Control and Safety and Tolerability of LY2148568 in Japanese Patients With Type 2 Diabetes Who Are Treated With Oral Antidiabetic(s) But Not Well Controlled
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 12
研究概览
简要总结
This study will examine the response of several doses of LY2148568 (exenatide) and assess the effect on glucose control and safety and tolerability in Japanese patients with type 2 diabetes.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with type 2 diabetes.
- •Have a body weight of >=50 kg.
排除标准
- •Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
- •Have participated in this study previously, or any other study using exenatide or other GLP-1 analogs.
- •Are treated with any exogenous insulin within 3 months of screening.
- •Are continuously treated with any of the following excluded medications within 3 months of screening (more than 7 days per 1 month): *drugs that directly affect gastrointestinal motility, including Nauzelin® (domperidone), Primperan®/Terperan® (metoclopramide), Ganaton® (itopride), Acenalin® (cisapride), Gasmotin® (mosapride), or Cerekinon® (trimebutine).
- •Have characteristics contraindicating for concomitant medication, according to product-specific label.
- •Have severe allergy or hypersensitivity to any drug.
研究组 & 干预措施
Exenatide 5 mcg/exenatide 10 mcg
Experimental
干预措施: exenatide (LY2148568) (Drug)
Exenatide 5 mcg/exenatide 5 mcg
Experimental
干预措施: exenatide (LY2148568) (Drug)
Exenatide 2.5 mcg/exenatide 2.5 mcg
Experimental
干预措施: exenatide (LY2148568) (Drug)
Placebo/placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 12
时间窗: Baseline, Week 12
Assess dose response effect on glucose control as measured by HbA1c among four doses (2.5 μg, 5 μg, 10 μg, and placebo) of subcutaneous injection of exenatide, twice daily before meals in the morning and evening, for 12 weeks
次要结局
- Proportion of subjects achieving HbA1c <7% at Week 12(12 weeks)
- Changes in fasting blood glucose from Visits 3 to 7(Baseline, Week 12)
- Change in Serum lipids from Baseline to Week 12(Baseline, Week 12)
- Changes in body weight, waist size and waist/hip ratio from Baseline to Week 12(Baseline, Week 12)
研究者
研究点 (1)
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