NCT00375492已完成3 期
Effect on Weight Loss of Exenatide Versus Placebo in Subjects With Type 2 Diabetes Participating in a Lifestyle Modification Program
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
- 196
- 试验地点
- 1
- 主要终点
- Change From Baseline in Body Weight
研究概览
简要总结
This trial is designed to compare the effects of twice-daily exenatide and twice-daily placebo on weight loss. This trial will evaluate overweight and obese subjects with type 2 diabetes who have inadequate glycemic control with metformin, sulfonylurea, or metformin plus a sulfonylurea. Subjects will be treated with exenatide or placebo in addition to their current oral antidiabetes agent regimen and participate in a lifestyle modification program.
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 for at least 6 months
- •Have been treated with a stable dose of the following for at least 6 weeks prior to screening: *immediate or extended release metformin, or *a sulfonylurea, or *a fixed-dose sulfonylurea/metformin combination therapy
- •Have an HbA1c of 6.6% to 10.0%, inclusive
- •Have a Body Mass Index (BMI) of 25 kg/m^2 to 39.9 kg/m^2, inclusive
排除标准
- •Are treated with any of the following excluded medications: *exogenous insulin, thiazolidinedione, or alpha-glucosidase inhibitor for more than 1 week within 6 weeks of screening; *Symlin injection at any time; * Byetta injection within 3 months of screening or discontinuation of therapy at any time due to adverse reaction; *drugs that directly affect gastrointestinal motility; *use of a weight loss drug (including those available over the counter) within 3 months of screening; *chronic (lasting longer than 2 weeks) systemic corticosteroids (excluding topical, intranasal, and inhaled preparations) by oral, intravenous, or intramuscular route within 2 months of screening
- •Have conditions contraindicating metformin and/or sulfonylurea use
- •Have had a change in lipid-lowering agents within 6 weeks of screening
- •Have received glucagon-like peptide-1 (GLP-1) analogs, or dipeptidyl peptidase-IV inhibitors (DPP-IV inhibitors) or have previously participated in this study
- •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
研究组 & 干预措施
Group A
Experimental
干预措施: exenatide (Drug)
Group B
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Change From Baseline in Body Weight
时间窗: Baseline, Week 24
Change in body weight from baseline (Week 0) after 24 weeks of treatment (i.e., weight at week 24 minus weight at week 0). Body weight measured in kilograms (k).
次要结局
- Change From Baseline in High Density Lipoprotein (HDL) Cholesterol at Week 24(baseline, Week 24)
- Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24(baseline, Week 24)
- Ratio of Homeostatic Model Assessment-Beta Cell (HOMA-B) at Week 24 to HOMA-B at Baseline(baseline, Week 24)
- Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol at Week 24(baseline, Week 24)
- Change From Baseline in 6-point Self Monitored Blood Glucose (SMBG) Profile at Week 24(baseline, Week 24)
- Change From Baseline in Waist Circumference at Week 24(baseline, Week 24)
- Ratio of Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S) at Week 24 to HOMA-S at Baseline(baseline, Week 24)
- Change From Baseline in Total Cholesterol at Week 24(baseline, week 24)
- Number of Participants With Hypoglycemic Events During the Study(Baseline to 24 weeks)
- Rate of Hypoglycemic Events(24 weeks)
- Ratio of Triglycerides at Week 24 to Triglycerides at Baseline(baseline, Week 24)
研究者
研究点 (1)
Loading locations...
相似试验
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 DiabetesType 2 Diabetes MellitusNCT00516074AstraZeneca54
进行中（未招募）
不适用
A Randomized Trial Comparing Exenatide with Placebo in Subjects with Type 2 Diabetes on Insulin Glargine With or Without Oral Antihyperglycemic Medications - GWCOType 2 Diabetes MellitusEUCTR2008-003843-36-GBEli Lilly and Company260
进行中（未招募）
不适用
A Randomized Trial Comparing Exenatide with Placebo in Subjects with Type 2 Diabetes on Insulin Glargine With or Without Oral Antihyperglycemic Medications - GWCOMedDRA version: 9.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusType 2 Diabetes MellitusEUCTR2008-003843-36-GREli Lilly and Company260
已完成
2 期
A Pilot Study of Effects of Exenatide on Body Weight in Non-Diabetic, Obese PatientsObesityNCT00500370AstraZeneca163
已完成
2 期
Weight Loss Study for Patients With Obesity Due to Craniopharyngioma or Other Brain TumorOverweightObesityCraniopharyngiomaNCT01484873Vanderbilt University Medical Center10