NCT00516074已完成3 期
A Study to Assess the Effect of Exenatide Treatment on Mean 24-Hour Heart Rate in Patients With Type 2 Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Change in Mean 24-hour Heart Rate From Baseline to Endpoint
研究概览
简要总结
This study will explore the effect of exenatide (given twice a day) versus placebo (given twice a day) treatment on change in mean 24-hour heart rate over a 12 week period of drug exposure in 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
- 18 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.
- •Treated with metformin and/or a thiazolidinedione.
- •HbA1c between 6.5% and 9.5%, inclusive.
- •Body Mass Index (BMI) > 25 kg/m^2 and < 40 kg/m^2.
排除标准
- •Have previously received exenatide or glucagon-like peptide-1 analogs.
- •Have participated in an interventional medical, surgical, or pharmaceutical study (a study in which an experimental, drug, medical, or surgical treatment was given) within 30 days of screening. This criterion includes drugs that have not received regulatory approval for any indication at the time of study entry.
- •Receiving beta blockers.
- •Receiving treatment with a drug directly affecting gastrointestinal motility, including but not limited to Reglan® (metoclopramide), Propulsid® (cisapride), and chronic macrolide antibiotics.
- •Have received treatment with systemic glucocorticoid therapy by oral, intravenous (IV), or intramuscular (IM) route within 6 weeks of screening, or are regularly treated with potent, inhaled intranasal steroids that are known to have a high rate of systemic absorption or bronchodilators.
- •Have been treated with drugs that promote weight loss (for example, Adipex® [phentermine], Acomplia® [rimonabant], Xenical® [orlistat], Meridia® [sibutramine], Acutrim® [phenylpropanolamine], or similar over-the-counter medications) within 3 months of screening.
- •Have been treated for longer than 2 weeks with any of the following excluded medications within 3 months prior to screening: *Insulin; *Alpha-glucosidase inhibitors (for example, Glyset® [miglitol] or Precose® [acarbose]); *Meglitinides (for example, Prandin® [repaglinide] or Starlix® [nateglinide]); *Sulfonylureas (for example, Glucotrol® [glipizide] or Micronase® [glyburide]); *Dipeptidyl peptidase IV (DPP-IV) inhibitors (for example, Januvia™ [sitagliptin])
- •Have donated blood within 60 days of screening.
研究组 & 干预措施
Exenatide Arm
Experimental
This arm will receive 5mcg exenatide for 4 weeks, and then 10mcg exenatide for the remaining 8 weeks of the study.
干预措施: exenatide (Drug)
Placebo Arm
Placebo Comparator
This arm will receive placebo injection (volume equivalent to the exenatide injection in the experimental arm).
干预措施: placebo (Drug)
结局指标
主要结局
Change in Mean 24-hour Heart Rate From Baseline to Endpoint
时间窗: 12 weeks
Change from baseline to endpoint in average heart rate measured over 24 hours by an ambulatory blood pressure monitor.
次要结局
- Change in Nighttime (2400-0600) Heart Rate From Baseline to Endpoint(12 weeks)
- Change in Mean 24 Hour Diastolic Blood Pressure From Baseline to Endpoint(12 weeks)
- Change in Mean 24 Hour Systolic Blood Pressure From Baseline to Endpoint(12 weeks)
- Change in Daytime Heart Rate From Baseline to Endpoint(12 weeks)
- Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint(12 weeks)
研究者
研究点 (1)
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