A Randomized, Open-label, Parallel-group, Multicenter Study to Determine the Efficacy and Long-term Safety of Albiglutide Compared With Insulin in Subjects With Type 2 Diabetes Mellitus.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 779
- 试验地点
- 1
- 主要终点
- Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52
研究概览
简要总结
A study to determine the safety and efficacy of albiglutide in subjects with type 2 diabetes.
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
- •type 2 diabetes
- •BMI 20-45kg/m2 inclusive
排除标准
- •females who are pregnant, lactating or within <6 weeks post-partum
- •current symptomatic heart failure (NYHA Class III-IV)
研究组 & 干预措施
albiglutide weekly injection
albiglutide weekly subcutaneous injection
干预措施: albiglutide (Biological)
insulin glargine
insulin glargine daily injection
干预措施: insulin glargine (Drug)
结局指标
主要结局
Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52
时间窗: Baseline and Week 52
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The BL HbA1c value is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 52 minus the value at BL. Based on analysis of covariance (ANCOVA): change = treatment + BL HbA1c + prior myocardial infarction history + age category + region + current antidiabetic therapy. Difference of least squares means (albiglutide - insulin glargine) is from the ANCOVA model. The last observation carried forward (LOCF) method was used to impute missing post-Baseline HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values.
次要结局
- Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156(Week 156)
- Time to Hyperglycemia Rescue(From the start of study medication until the end of the treatment (up to Week 156))
- Change From Baseline in HbA1c at Week 156(Baseline and Week 156)
- Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52(Baseline and Week 52)
- Change From Baseline in Fasting Plasma Glucose (FPG) at Week 156(Baseline and Week 156)
- Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 52(Week 52)
- Change From Baseline in Body Weight at Week 52(Baseline and Week 52)
- Change From Baseline in Body Weight at Week 156(Baseline and Week 156)
- Change From Baseline in Glucose Profile Measured by 24-hour Area Under Curve (AUC) at Week 52(Baseline and Week 52)
- Albiglutide Plasma Concentrations at Week 8 and Week 24(Weeks 8 and 24)