NCT00701935终止2 期
Effect of Exenatide on Abdominal Fat Distribution in Patients With Type 2 Diabetes Pretreated With Metformin
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Percentage Change in Abdominal Visceral Fat From Baseline to 6 Months
研究概览
简要总结
A multicenter, randomized, double-blind, placebo-controlled trial will assess the effects of twice-daily subcutaneous injection with exenatide versus treatment with matching placebo injection on abdominal visceral fat content.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 18 and 85 years of age, inclusive.
- •Patients with type 2 diabetes
- •Patients have been treated with metformin, at a stable dose for at least 3 months prior to Visit 1
- •Patients have HbA1c of 7.0% to 8.9%, inclusive.
- •Patients have a body mass index >27 kg/m2 and <40 kg/m2 and meet local CT scan body weight requirements. For South Asian, Japanese, and Chinese patients, a body mass index >=25 kg/m2 is acceptable as the lower limit.
- •Patients have a history of stable body weight (not varying by >2 kg in the 3 months prior to Visit 1).
- •Medications for the treatment of high blood pressure are stable with respect to treatment regimen for 4 weeks prior to Visit
- •Stable regimen of lipid-lowering agents for 6 weeks prior to Visit 1.
排除标准
- •Have received treatment in the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
- •Have an active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
- •Have a history of renal transplantation, or are currently receiving renal dialysis.
- •Have had a clinically significant history of cardiac disease or presence of active cardiac disease within 1 year prior to Visit 1, including myocardial infarction, clinically significant arrhythmia, unstable angina, moderate to severe congestive heart failure, coronary artery bypass surgery, or angioplasty; or is expected to require coronary artery bypass surgery or angioplasty during the course of the study.
- •Have known hemoglobinopathy or clinically significant, chronic anemia.
- •Known or are likely to become transfusion dependent during the study.
- •Have active, symptomatic proliferative retinopathy.
- •Are receiving chronic treatment for gastrointestinal disease with a drug directly affecting gastrointestinal motility. (i.e. metoclopramide, cisapride, and chronic use of macrolide antibiotics)
- •Have severe gastrointestinal disease, including gastroparesis.
- •Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 months immediately prior to Visit
- •Have taken exenatide, liraglutide or any other GLP-1 receptor agonist in the past 6 months, either in a clinical study or as commercially available medication. Patients with known allergy to exenatide should be excluded.
- •Have used any prescription or over the counter drug to promote weight loss within 3 months prior to Visit 1, or intend to use such a drug during the study. (Examples: Xenical [orlistat], Meridia [sibutramine], Acutrim [phenylpropanolamine], Acomplia [rimonabant]).
- •Have participated in a structured weight loss program within 3 months prior to Visit 1, or intend to participate in such a plan during this study.
- •Have been treated for longer than 2 weeks with any of the following excluded medications within 3 months prior to Visit 1: Insulin; Thiazolidinediones; Alpha-glucosidase inhibitors; Sulfonylureas; Oral DPP-IV inhibitors; Meglitinides.
- •Are taking warfarin, or a coumarol derivative.
研究组 & 干预措施
1
Placebo Comparator
干预措施: placebo (Drug)
2
Experimental
干预措施: exenatide (Drug)
结局指标
主要结局
Percentage Change in Abdominal Visceral Fat From Baseline to 6 Months
时间窗: baseline, 6 months
Percentage change in abdominal visceral fat
次要结局
- Change in HbA1c From Baseline to 6 Months(baseline, 6 months)
- Change in Diastolic Blood Pressure From Baseline to 6 Months(baseline, 6 months)
- Percentage Change in Subcutaneous Abdominal Fat From Baseline to 6 Months(baseline, 6 months)
- Change in Systolic Blood Pressure From Baseline to 6 Months(baseline, 6 months)
- Change in Total Cholesterol From Baseline to 6 Months(baseline, 6 months)
- Percentage Change in Total Abdominal Fat From Baseline to 6 Months(baseline, 6 months)
- Change in Fasting Plasma Glucose From Baseline to 6 Months(baseline, 6 months)
- Change in High-Density Lipoprotein (HDL) Cholesterol From Baseline to 6 Months(baseline, 6 months)
- Change in Weight From Baseline to 6 Months(baseline, 6 months)
- Percentage of Patients With HbA1c <=7.0% at 6 Months(6 months)
- Change in Triglycerides From Baseline to 6 Months(baseline, 6 months)
- Assessment of Event Rate of Treatment- Emergent Hypoglycemic Event(baseline, 6 months)
研究者
研究点 (1)
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