The Effect of Exenatide on Insulin Requirement, Weight and Inflammation in Obese Type 2 Diabetic Subjects on Insulin
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Fasting Insulin
研究概览
简要总结
Exenatide has been shown to result in better glycemic control in type II diabetes patients. Obesity and diabetes are states of increased inflammation; exenatide is expected to lead to decreased inflammation by virtue of better glycemic control and weight loss.
The purpose of this study is to determine if the addition of Exenatide to diabetic patients will reduce the requirements of insulin particularly the short acting insulin. Exenatide may also lead to decreased inflammation by virtue of better glycemic control and weight loss, or an independent effect.
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
- Single (Participant)
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
- •Males or females 20-75 years of age inclusive.
- •Type 2 diabetes
- •On insulin therapy
- •HbA1c ≥7.5% and ≤ 9%
- •BMI ≥ 30 kg/m2
- •Subjects on statins, ACE inhibitors, metformin, thiazolidinediones and antioxidants will be allowed as long as they are on stable doses of these compounds and the dosage in not changed during the study.
排除标准
- •Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks
- •Pregnancy
- •Hepatic disease (abnormal LFT's)
- •Use of DPP4 inhibitors.
- •Renal impairment (serum creatinine > 1.5)
- •Participation in any other concurrent clinical trial
- •Any other life-threatening, non-cardiac disease
- •Uncontrolled hypertension (BP > 160/100 mm of Hg)
- •Congestive Heart Failure.
- •Use of an investigational agent or therapeutic regimen within 30 days of study
研究组 & 干预措施
exenatide 5 mcg
exenatide 5 mcg
干预措施: exenatide 5 mcg (Drug)
exenatide 10 mcg
exenatide 10 mcg
干预措施: exenatide 10 mcg (Drug)
placebo
placebo
干预措施: placebo (Drug)
结局指标
主要结局
Fasting Insulin
时间窗: after 24 hours fast at baseline and 12 weeks
To compare the fasting insulin level at the end of 12 weeks in patients on exenatide subcutaneously twice daily (5 or 10 mcg/injection) as compared to controls in insulin treated obese type 2 diabetic patients.
次要结局
- Weight(value at 12 weeks minus value at baseline)
- HbA1c(value at 12 weeks minus value at baseline)
- Intranuclear NFκB Binding Activity(measured after 6 hours of a single dose of placebo or exenatide treatment for value measured at 12 weeks minus baseline)