NCT00676338已完成3 期
Safety and Efficacy of Exenatide Once Weekly Injection Versus Metformin, Dipeptidyl Peptidase-4 Inhibitor, or Thiazolidinedione as Monotherapy in Drug-Naive 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
- 820
- 试验地点
- 2
- 主要终点
- Change in HbA1c From Baseline to Week 26
研究概览
简要总结
This study will compare the effects of 2.0 mg exenatide once weekly injection as monotherapy to 3 active comparators(metformin, dipeptidyl peptidase-4 inhibitor, and thiazolidinedione) in drug naive patients with type 2 diabetes treated with diet and exercise.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •have type 2 diabetes and are treated with diet and exercise alone.
- •at least 18 years of age.
- •HbA1c between 7.1% and 11.0%, inclusive.
- •Body mass index (BMI) of 23 kg/m2 to 45 kg/m2, inclusive.
- •Have a history of stable body weight (not varying by >5% for at least 3 months prior to screening).
排除标准
- •Have history of cardiac disease or presence of active cardiac disease within the year prior to inclusion in the study including myocardial infarction, clinically significant arrhythmia, unstable angina, moderate to severe congestive heart failure, coronary artery bypass surgery, or angioplasty
- •Have a history of renal transplantation or are currently receiving renal dialysis
- •Have 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 history of severe GI disorder (e.g., gastroparesis)
- •Have a history of acute or chronic pancreatitis.
- •Have active proliferative retinopathy.
- •Have been treated with drugs that promote weight loss (e.g., Xenical®[orlistat], Meridia® [sibutramine], Acomplia® [rimonabant], Acutrim® [phenylpropanolamine], or similar over-the-counter medications) within 3 months of screening.
- •Have been treated with any antidiabetic agent for more than 7 days within 3 months prior to screening.
- •Have had an organ transplant.
- •Have previously completed or discontinued study drug in this study, withdrawn from this study or any other study investigating exenatide once weekly.
- •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.
- •Are currently enrolled in any other clinical study.
研究组 & 干预措施
Sitagliptin
Active Comparator
干预措施: sitagliptin (Drug)
Exenatide Once Weekly
Experimental
干预措施: exenatide once weekly (Drug)
Metformin
Active Comparator
干预措施: metformin (Drug)
Pioglitazone
Active Comparator
干预措施: pioglitazone (Drug)
结局指标
主要结局
Change in HbA1c From Baseline to Week 26
时间窗: Baseline, Week 26
Change in HbA1c from baseline to Week 26.
Percentage of Patients Achieving HbA1c <=7% at Week 26
时间窗: Baseline, Week 26
Percentage of patients achieving HbA1c \<=7% at Week 26 (for patients with baseline HbA1c \>7%).
次要结局
- Change in Fasting Serum Glucose (FSG) From Baseline to Week 26(Baseline, Week 26)
- Change in Fasting Total Cholesterol (TC) From Baseline to Week 26(Baseline, Week 26)
- Change in Fasting High-Density Lipoprotein (HDL) From Baseline to Week 26(Baseline, Week 26)
- Assessment on Event Rate of Treatment-Emergent Minor Hypoglycemic Events(Baseline to Week 26)
- Change in Systolic Blood Pressure From Baseline to Week 26.(Baseline, Week 26)
- Change in Diastolic Blood Pressure From Baseline to Week 26.(Baseline, Week 26)
- Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Events(Baseline to Week 26)
- Change in Body Weight From Baseline to Week 26(Baseline, Week 26)
- Ratio of Fasting Triglycerides at Week 26 to Baseline(Baseline, Week 26)
研究者
研究点 (2)
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