A Randomized, Open-Label, Long-Term, Parallel-Group, Comparator-Controlled, Multicenter Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly Suspension to Exenatide Twice Daily in Subjects With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 377
- 试验地点
- 1
- 主要终点
- Change in HbA1c (Glycosylated Hemoglobin) From Baseline to Week 28
研究概览
简要总结
To compare the effect on glycemic control (HbA1c) of exenatide suspension administered once weekly to that achieved by exenatide administered twice daily for 28 weeks in subjects with type 2 diabetes mellitus.
To examine the long-term (52 weeks of treatment) safety and effect on glucose control of exenatide suspension administered once weekly in subjects with type 2 diabetes mellitus.
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
- •At least 18 years old
- •Diagnosed with type 2 diabetes mellitus
- •HbA1c 7.1 to 11%, inclusive, at screening
- •Fasting plasma glucose <280 mg/dL (15.5 mmol/L)
- •Body mass index (BMI) <=45 kg/m2, inclusive, at screening
- •Treated with diet and exercise or a stable regimen of metformin, sulfonylurea, pioglitazone or any 2 of these agents
排除标准
- •History of pancreatitis or triglycerides >=500 mg/dL
- •Medullary carcinoma or multiple endocrine neoplasia (MEN2) or a family history of either
- •Active cardiovascular disease
- •Presence of congestive heart failure
- •Liver disease
- •History of severe gastrointestinal diseases
- •Repeated severe hypoglycemia within the last 6 months
- •Any previous use of exenatide or other glucagon-like peptide-1 (GLP-1 ) analog
- •Dipeptidyl peptidase-4 (DPP-4) inhibitor use in the last 3 months
研究组 & 干预措施
Exenatide once weekly suspension
Exenatide suspension 2 mg weekly subcutaneous injection
干预措施: Exenatide once weekly suspension (Drug)
Exenatide twice daily (BID)
Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks
干预措施: Exenatide twice daily (Drug)
结局指标
主要结局
Change in HbA1c (Glycosylated Hemoglobin) From Baseline to Week 28
时间窗: Baseline to Week 28
The primary objective of this study was to compare the effect on glycemic control (HbA1c) of exenatide suspension administered once weekly to that achieved by exenatide administered twice daily for 28 weeks in subjects with type 2 diabetes mellitus.
次要结局
- Percentage of Subjects Achieving HbA1c <7% at Week 28(Baseline to Week 28)
- Change in Fasting Plasma Glucose Concentrations From Baseline to Week 28(Baseline to Week 28)
- Change in Body Weight (kg) From Baseline to Week 28(Baseline to Week 28)
- Change in 2-hour Postprandial Glucose Concentrations From Baseline to Week 16(Baseline to Week 16)