A Randomized, Double-Blind, Placebo and Active-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide When Used in Combination With Metformin Compared With Metformin Plus Sitagliptin, Metformin Plus Glimepiride, and Metformin Plus Placebo in Subjects With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,049
- 试验地点
- 1
- 主要终点
- Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 104
研究概览
简要总结
The purpose of this study is to determine if albiglutide is safe and effective in the treatment of 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
- Double (Participant, Investigator)
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 <6 weeks post-partum
- •current symptomatic heart failure (NYHA Class III or IV)
研究组 & 干预措施
sitagliptin + metformin
Sitagliptin + metformin + placebo albiglutide + placebo glimepiride
干预措施: metformin (Drug)
albiglutide + metformin
Albiglutide + metformin + placebo sitagliptin + placebo glimepiride
干预措施: albiglutide (Biological)
albiglutide + metformin
Albiglutide + metformin + placebo sitagliptin + placebo glimepiride
干预措施: metformin (Drug)
albiglutide + metformin
Albiglutide + metformin + placebo sitagliptin + placebo glimepiride
干预措施: placebo sitagliptin (Drug)
albiglutide + metformin
Albiglutide + metformin + placebo sitagliptin + placebo glimepiride
干预措施: placebo glimepiride (Drug)
sitagliptin + metformin
Sitagliptin + metformin + placebo albiglutide + placebo glimepiride
干预措施: sitagliptin (Drug)
sitagliptin + metformin
Sitagliptin + metformin + placebo albiglutide + placebo glimepiride
干预措施: placebo albiglutide (Biological)
sitagliptin + metformin
Sitagliptin + metformin + placebo albiglutide + placebo glimepiride
干预措施: placebo glimepiride (Drug)
glimepiride + metformin
Glimepiride + metformin + placebo albiglutide + placebo sitagliptin
干预措施: glimepiride (Drug)
glimepiride + metformin
Glimepiride + metformin + placebo albiglutide + placebo sitagliptin
干预措施: metformin (Drug)
glimepiride + metformin
Glimepiride + metformin + placebo albiglutide + placebo sitagliptin
干预措施: placebo albiglutide (Biological)
glimepiride + metformin
Glimepiride + metformin + placebo albiglutide + placebo sitagliptin
干预措施: placebo sitagliptin (Drug)
metformin + placebo
Metformin + placebo albiglutide + placebo sitagliptin + placebo glimepiride
干预措施: metformin (Drug)
metformin + placebo
Metformin + placebo albiglutide + placebo sitagliptin + placebo glimepiride
干预措施: placebo albiglutide (Biological)
metformin + placebo
Metformin + placebo albiglutide + placebo sitagliptin + placebo glimepiride
干预措施: placebo sitagliptin (Drug)
metformin + placebo
Metformin + placebo albiglutide + placebo sitagliptin + placebo glimepiride
干预措施: placebo glimepiride (Drug)
结局指标
主要结局
Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 104
时间窗: Baseline and Week 104
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 104 minus the value at BL. Based on analysis of covariance (ANCOVA): change = treatment + BL HbA1c + prior myocardial infarction history + age category + region. Difference of least squares means (albiglutide - placebo, albiglutide - sitagliptin, albiglutide - glimepiride) 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
- Change From Baseline in HbA1c at Week 156(Baseline and Week 156)
- Change From Baseline in Body Weight at Week 104(Baseline and Week 104)
- Change From Baseline in 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 104(Week 104)
- 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 Body Weight at Week 156(Baseline and Week 156)
- Change From Baseline in Fasting Plasma Glucose (FPG) at Week 104(Baseline and Week 104)