NCT00641056已完成3 期
Efficacy of Once-Weekly Exenatide Long-Acting Release and Once-Daily Insulin Glargine in Patients With Type 2 Diabetes Treated With Metformin Alone or in Combination With Sulfonylurea
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
- 467
- 试验地点
- 1
- 主要终点
- Change in HbA1c From Baseline to Week 26
研究概览
简要总结
The purpose of this study is to compare the effects of 2.0 mg exenatide once weekly and insulin glargine, titrated to glucose targets using the algorithm described by Yki- Järvinen et al.(2007), with respect to glycemic improvements, body weight, fasting lipids, safety, and tolerability.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has type 2 diabetes and at least 18 years of age at screening.
- •Hemoglobin A1c (HbA1c) of 7.1% to 11.0%, inclusive, at screening.
- •Body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive, at screening.
- •Have a history of stable body weight (not varying by >5% for at least 3 months prior to screening).
- •Have been treated with metformin(Met) for at least 3 months and have been taking a stable dose for at least 8 weeks prior to screening OR
- •Have been treated with metformin(Met) for at least 3 months and have been taking a stable dose for at least 8 weeks prior to screening and have been treated with SU for at least 3 months and have been taking a stable dose of at least an optimally effective dose of brand of SU for 8 weeks prior to screening.
排除标准
- •Have had a clinically significant 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; or is expected to require coronary artery bypass surgery or angioplasty during the course of the study.
- •Have clinical signs or symptoms of liver disease, acute or chronic hepatitis.
- •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 had greater than three episodes of major hypoglycemia within 6 months prior to screening.
- •Have any contraindication for the oral antidiabetic agent which they use.
- •Have a known allergy or hypersensitivity to insulin glargine, exenatide once weekly, or excipients contained in these agents.
- •Are known to 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 for longer than 2 weeks with any of the following excluded medications within 3 months prior to screening:
- •Thiazolidinediones (e.g., Actos® [pioglitazone] or Avandia® [rosiglitazone])
- •Alpha-glucosidase inhibitors (e.g., Glyset® [miglitol] or Precose® [acarbose])
- •Meglitinides (e.g., Prandin® [repaglinide] or Starlix® [nateglinide]).
- •Byetta® (exenatide BID formulation)
- •Dipeptidyl peptidase (DPP)-4 inhibitors (e.g., Januvia™ [sitagliptin], Galvus® [vildagliptin])
- •Symlin® (pramlintide acetate).
- •Have had an organ transplant.
- •Have donated blood within 30 days of screening.
- •Have previously completed or 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
1
Experimental
干预措施: Exenatide Once Weekly (Drug)
2
Active Comparator
干预措施: Insulin Glargine (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
次要结局
- Percentage of Patients Achieving HbA1c <=7.0% at Week 26(Baseline, Week 26)
- Change in Body Weight (BW) From Baseline to Week 26(Baseline, Week 26)
- Change in High-density Lipoprotein Cholesterol (HDL) From Baseline to Week 26(Baseline, Week 26)
- Percentage of Patients Achieving HbA1c <=6.5% at Week 26(Baseline, Week 26)
- Change in Total Cholesterol From Baseline to Week 26(Baseline, Week 26)
- Change in Blood Pressure From Baseline to Week 26(Baseline, Week 26)
- Change in Fasting Serum Glucose (FSG) From Baseline to Week 26(Baseline, Week 26)
- Ratio of Triglycerides at Week 26 to Baseline(Baseline, Week 26)
- Assessment on Event Rate of Treatment-emergent Hypoglycemic Episodes(Baseline to Week 26)
研究者
研究点 (1)
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