A Randomized, Long-Term, Open-Label, 3-Arm, Multicenter Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly Suspension to Sitagliptin and Placebo 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
- 365
- 试验地点
- 2
- 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 sitagliptin or placebo administered once daily for 28 weeks 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 of 7.1% to 11.0%, inclusive, at screening
- •Has stable body weight, i.e., not varying by >3% for at least 3 months prior to screening
- •Fasting plasma glucose concentration <280 mg/dL (15.5 mmol/L) at screening
- •Body mass index of <45 kg/m2 at screening
- •Has been treated with a stable regimen of ≥1500 mg/day metformin for a minimum of 2 months prior to Visit 1 (Screening)
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
- •History of renal transplantation, or is currently receiving renal dialysis, or has an estimated creatinine clearance <50 mL/min
- •Active cardiovascular disease
- •Presence or history of severe congestive heart failure
- •Central nervous system disease, including epilepsy
- •Liver disease
- •History of severe gastrointestinal diseases
- •Clinically significant malignant disease
- •Repeated severe hypoglycemia within the last 6 months
- •Any exposure to exenatide (BYETTA® or BYDUREON™) or any GLP-1 analog
- •Any DPP-4 inhibitor within 3 months prior screening
研究组 & 干预措施
Exenatide once weekly suspension
Exenatide once weekly suspension 2mg subcutaneous injection
干预措施: Exenatide once weekly suspension (Drug)
Sitagliptin 100mg
Overencapsulated Sitagliptin 100mg oral tablet once daily
干预措施: Sitagliptin (Drug)
Placebo
Placebo oral capsule once daily
干预措施: Placebo (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
Absolute change in HbA1c from baseline (Day 1, Visit 3) to Week 28/Study Termination (Visit 11). Hypothesis testing on the primary endpoint followed a serial gated procedure with all tests carried out at a 2-sided significance level of 0.05 to protect the family-wise error rate. These tests were conducted sequentially, and are presented in the statistical analysis section below in the order in which they were performed; each test was the gatekeeper of later tests.
次要结局
- 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)
- Percentage of Subjects Achieving HbA1c <7% at Week 28(Baseline to Week 28)
- Change in 2-hour Postprandial Glucose Concentrations From Baseline to Week 16 (Visit 8)(Baseline to Week 16)