NCT00085969已完成2 期
A Phase 2, Randomized, Triple-Blind, Placebo-Controlled, Multicenter Study to Examine the Effect of Exenatide Monotherapy on Glucose Control in Subjects With Type 2 Diabetes Mellitus
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
- 99
- 试验地点
- 22
- 主要终点
- Change in HbA1c (glycosylated hemoglobin) from Baseline to Day 28
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of a 28-day regimen of exenatide (AC2993), given as a monotherapy to subjects with type 2 diabetes mellitus.
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
- •Subject has type 2 diabetes mellitus treated with diet and exercise modification alone or in combination with one oral antidiabetic agent for no longer than 4 years.
排除标准
- •Subject has a clinically significant history or presence of any of the following conditions: (a) Hepatic disease, (b) Renal disease, (c) Central nervous system disease, (d) Gastrointestinal disease (e) Pulmonary disease (f) Hematologic disease.
- •Subject is currently treated with any of the following excluded medications: (a) Metformin/sulfonylurea combination therapy (b) Thiazolidinediones (c) Insulin as outpatient therapy (d) Regular use of drugs that directly affect gastrointestinal motility (e) Regular use of systemic corticosteroids by oral, intravenous (IV), or intramuscular (IM) route, or potent, inhaled, intrapulmonary, or intranasal steroids known to have a high rate of systemic absorption (f) Regular use of medications with addictive potential such as opiates, narcotics and tranquilizers (g) Antineoplastic agents (h) Transplantation medications (i) Prescription weight-loss medications.
研究组 & 干预措施
A1 - Placebo 0.04 mL twice daily
Placebo Comparator
干预措施: Placebo 0.04 mL twice daily (Drug)
A2 - Placebo 0.04 mL once daily
Placebo Comparator
干预措施: Placebo 0.04 mL once daily (Drug)
A3 - Placebo 0.08 mL once daily
Placebo Comparator
干预措施: Placebo 0.08 mL once daily (Drug)
B - Exenatide 10 mcg twice daily
Experimental
干预措施: B - Exenatide 10 mcg twice daily (Drug)
C - Exenatide 10 mcg once daily
Experimental
干预措施: C - Exenatide 10 mcg once daily (Drug)
D - Exenatide 20 mcg once daily
Experimental
干预措施: Exenatide 20 mcg once daily (Drug)
结局指标
主要结局
Change in HbA1c (glycosylated hemoglobin) from Baseline to Day 28
时间窗: Baseline, Day 28
Change in HbA1c from Baseline Visit 3 (Day 1) to study termination (Day 28)
次要结局
- Change in body weight from Baseline to Day 14 and to Day 28(Baseline, Day 14, Day28)
- Change in fasting plasma glucose concentration from Baseline to Day 14 and to Day 28(Baseline, Day 14, Day 28)
- Change in serum fructosamine concentration from Baseline to Day 14 and to Day 28(Baseline, Day 14, Day 28)
- Change in postprandial blood glucose concentrations from Baseline to Day 28(Baseline, Week 28)
研究者
研究点 (22)
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