NCT00135330已完成3 期
An Evaluation of the Metabolic Effects of Exenatide, Rosiglitazone, and Exenatide Plus Rosiglitazone in Subjects With Type 2 Diabetes Mellitus Treated With Metformin
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
- 137
- 试验地点
- 1
- 主要终点
- Change in ASIiAUC During a Hyperglycemic Clamp Test.
研究概览
简要总结
This protocol is designed to evaluate the metabolic effects of adding exenatide, rosiglitazone, or both to an existing regimen of metformin in subjects with inadequate glycemic control.
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
- None
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
- •HbA1c of 6.8% to 10.0%, inclusive.
- •Body mass index (BMI) of 25 kg/m^2 to 40 kg/m^2, inclusive.
排除标准
- •Have participated in this study previously, or have received exenatide, pramlintide acetate, GLP-1 analogs, or dipeptidyl peptidase-IV (DPP-IV) inhibitors
- •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 study start. This criterion includes drugs that have not received regulatory approval for any indication at the time of study start.
- •Treated with any of the following medications:
- •Thiazolidinedione within 5 months of screening;
- •Sulfonylurea within 3 months of screening;
- •Metformin/sulfonylurea combination therapy within 3 months of screening;
- •Alpha-glucosidase inhibitor within 3 months of screening;
- •Meglitinide within 3 months of screening;
- •Insulin for more than 1 week within the 3 months prior to screening.
- •Symlin (pramlintide acetate) injection or Byetta (exenatide) injection at any time
- •Chronic (more than 2 weeks) or recent (within 4 weeks of study start) use of a drug that directly affects gastrointestinal motility
- •Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within the 4 weeks immediately preceding study start
- •Regular use of a medication with addictive potential such as an opiate, narcotic, or tranquilizer
- •Systemic antineoplastic agent
- •Systemic transplantation medication
- •Drugs for weight loss, including over-the-counter medications, within the 4 months prior to study start
研究组 & 干预措施
Exenatide Arm
Experimental
干预措施: exenatide (Drug)
Exenatide plus Rosiglitazone Arm
Experimental
干预措施: exenatide (Drug)
Exenatide plus Rosiglitazone Arm
Experimental
干预措施: rosiglitazone (Drug)
Rosiglitazone Arm
Experimental
干预措施: rosiglitazone (Drug)
结局指标
主要结局
Change in ASIiAUC During a Hyperglycemic Clamp Test.
时间窗: 20 weeks
Change in insulin incremental area under the concentration-time curve (ASIiAUC) from baseline to week 20. ASIiAUC is a measure of beta-cell function.
次要结局
- Change in Incremental for Postprandial C-peptide During Meal Challenge Test (MCT).(Week 20)
- Hypoglycemia Rate Per 30 Days Per Patient(20 weeks)
- Pedal Edema Score(20 weeks)
- Change in Fasting Total Cholesterol.(Week 20)
- Change in Fasting Triglycerides(Week 20)
- Change in Body Fat Mass During a Meal Challenge Test (MCT)(20 weeks)
- Change in Waist Circumference(20 weeks)
- Change in AUC for Glucose During a Meal Challenge Test (MCT).(Week 20)
- Change in Insulin Sensitivity Index as Measured by M-value.(Week 20)
- Change in Insulin AUC in the First Stage From Baseline to Endpoint.(Week 20)
- Change in Insulin iAUC From Baseline to Endpoint.(Week 20)
- Ratio (Value at Endpoint Divided by Value at Baseline) of AUC for Insulin During a Meal Challenge Test (MCT).(Week 20)
- Change in Incremental for Postprandial Insulin During Meal Challenge Test (MCT).(Week 20)
- Change in HbA1c(Week 20)
- Change in Fasting Proinsulin(Week 20)
- Change in Body Weight(Week 20)
- Change in Percent Body Fat During a Meal Challenge Test (MCT)(20 weeks)
- Change in Hip Circumference(20 weeks)
- Change in Waist-to-hip Ratio(20 weeks)
- Incidence of Hypoglycemia Events(20 weeks)
- Change in Fasting Serum Glucose Concentration.(Week 20)
- Change in Fasting C-peptide(Week 20)
- Change in Fasting Insulin(Week 20)
- Change in Fasting HDL Cholesterol(Week 20)
- Change in Fasting LDL Cholesterol(Week 20)
- Change in Lean Body Mass During a Meal Challenge Test (MCT)(20 weeks)
- Change in AUC for C-peptide During a Meal Challenge Test (MCT).(Week 20)
- Change in Incremental for Postprandial Glucose During a Meal Challenge Test (MCT).(Week 20)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
The Effect of Exenatide on Weight and Hunger in Obese, Healthy WomenImpaired Glucose ToleranceObesityNCT00456885Beth Israel Deaconess Medical Center41
已完成
4 期
Bioenergetic Alterations After Exenatide AdministrationHealthyNCT00623545University of Wisconsin, Madison28
Unknown
不适用
Effects of Exenatide on Obesity and/or Diabetes Mellitus Due to Hypothalamic DamageHypothalamic ObesityDiabetes MellitusNCT01783717Huashan Hospital10
进行中（未招募）
不适用
The effect of Exenatide on satiety, metabolic parameters and regional brain activation in response to nutrient ingestion in Type 2 diabetes.The brain?s response to food ingestion can be imaged and preliminary data suggest that these responses are different in the obese and insulin resistant. We will investigate the hypothesis that Exenatide will normalize neuronal activation in brain regions concerned with food seeking behaviour, appetite control and reward motivated behaviours (pre-frontal cortex, amygdala and insula) in response to nutrient ingestion in Type 2 diabetes.EUCTR2007-005534-36-GBKing's College Hospital60
撤回
4 期
Pilot Study of Exenatide Pharmacokinetics and Pharmacodynamics in Gestational DiabetesGestational DiabetesNCT00572689Georgetown University