NCT01029886已完成3 期
Safety and Efficacy of Exenatide Once Weekly Versus Liraglutide in Subjects With Type 2 Diabetes and Inadequate Glycemic Control Treated With Lifestyle Modification and Oral Antidiabetic Medications
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
- 912
- 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
No head to head comparisons between exenatide once weekly and liraglutide have been performed. Therefore, the purpose of this study is to compare exenatide once weekly to once-daily liraglutide with regard to HbA1c, body weight, subject-reported outcomes, and other clinical benefits. The study includes a 26-week treatment period and a safety follow-up visit 10 weeks after the final study drug dose.
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
- •Diagnosed with type 2 diabetes
- •Have suboptimal glycemic control as evidenced by an HbA1c measurement at study start 7.1% and 11.0%, inclusive
- •Have a body mass index (BMI) ≤45 kg/m^2
- •Have been treated with lifestyle modification (diet and exercise) and with one of the following single oral antidiabetic agents (OADs) or combinations of OADs administered at maximum tolerated dose:
- •metformin
- •metformin plus an SU
- •metformin plus pioglitazone
排除标准
- •Have any contraindication, allergy, or hypersensitivity for the study drug (exenatide once weekly or liraglutide), exenatide twice daily, the OAD(s) being used, or the excipients contained in these agents
- •If taking metformin and have a contraindication to metformin use
- •Have been treated within 8 weeks of study start with systemic glucocorticoid therapy by oral, intravenous, intra-articular, or intramuscular route
- •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 study start
- •Have taken any of the following excluded medications for more than 1 week within the 3 months prior to study start, or have taken any of the following excluded medications within 1 month prior to study start:
- •Alpha-glucosidase inhibitors (e.g., Glyser® [miglitol] or Precose® [acarbose])
- •Meglitinides (e.g., Prandin® [repaglinide] or Starlix® [nateglinide])
- •Avandia® (rosiglitazone)
- •Dipeptidyl peptidase (DPP)-4 inhibitors (e.g., Januvia™ [sitagliptin], Galvus® [vildagliptin], Onglyza™ [saxagliptin])
- •Symlin® (pramlintide acetate)
- •Have donated blood within 30 days prior to study start or have had a blood transfusion or severe blood loss within 3 months prior to study start
- •Have at any time, including a clinical trial, taken exenatide once weekly, exenatide twice daily, liraglutide, or any other GLP-1 receptor agonist or GLP-1 analog
- •Are currently enrolled in, or discontinued within the last 3 months or longer if required by local guidelines, from a clinical trial involving use of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
- •Have previously been screen-failed from this study for any reason
- •If a subject discontinues metformin, sulfonylurea, or pioglitazone prior to screening, the subject can be included if they discontinued the medication (whether alone or as component of combined medication) according to a specific schedule.
研究组 & 干预措施
1
Experimental
干预措施: exenatide once weekly (Drug)
2
Active Comparator
干预措施: liraglutide (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 the treatment endpoint at Week 26.
次要结局
- Change in Systolic Blood Pressure (SBP) From Baseline to Week 26(Baseline, Week 26)
- Change in Diastolic Blood Pressure (DBP) From Baseline to Week 26(Baseline, Week 26)
- Change in Total Cholesterol From Baseline to Week 26(Baseline, Week 26)
- Assessment of Event Rate of Treatment-emergent Hypoglycemic Events(Baseline to Week 26)
- Percentage of Patients Achieving HbA1c <7.0% at Week 26(Baseline, Week 26)
- Change in Body Weight From Baseline to Week 26(Baseline, Week 26)
- Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26(Baseline, Week 26)
- Change in Fasting Serum Glucose 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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