A Randomized, Double-blind, Placebo and Active-Controlled, Parallel-group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide Administered in Combination With Metformin and Glimepiride Compared With Metformin Plus Glimepiride and Placebo and With Metformin Plus Glimepiride and Pioglitazone in Subjects With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 685
- 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
The purpose of this study is 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
- 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 less than 6 weeks post-partum
- •current symptomatic heart failure (NYHA Class II-IV)
研究组 & 干预措施
metformin + glimepiride + pioglitazone + albiglutide placebo
Metformin + glimepiride + pioglitazone + matching albiglutide placebo
干预措施: placebo to match albiglutide (Drug)
metformin + glimepiride + pioglitazone + albiglutide placebo
Metformin + glimepiride + pioglitazone + matching albiglutide placebo
干预措施: metformin (Drug)
metformin + glimepiride + pioglitazone + albiglutide placebo
Metformin + glimepiride + pioglitazone + matching albiglutide placebo
干预措施: glimepiride (Drug)
metformin + glimepiride + pioglitazone + albiglutide placebo
Metformin + glimepiride + pioglitazone + matching albiglutide placebo
干预措施: pioglitazone (Drug)
metformin + glimepiride + pioglitazone placebo + albiglutide
Metformin + open-label glimepiride + pioglitazone matching placebo + albiglutide
干预措施: albiglutide (Biological)
metformin + glimepiride + pioglitazone placebo + albiglutide
Metformin + open-label glimepiride + pioglitazone matching placebo + albiglutide
干预措施: metformin (Drug)
metformin + glimepiride + pioglitazone placebo + albiglutide
Metformin + open-label glimepiride + pioglitazone matching placebo + albiglutide
干预措施: glimepiride (Drug)
metformin + glimepiride + pioglitazone placebo + albiglutide
Metformin + open-label glimepiride + pioglitazone matching placebo + albiglutide
干预措施: placebo to match pioglitazone (Drug)
met + glimepiride + pioglitazone placebo + albiglutide placebo
metformin + open-label glimepiride + pioglitazone placebo + albiglutide placebo
干预措施: placebo to match albiglutide (Drug)
met + glimepiride + pioglitazone placebo + albiglutide placebo
metformin + open-label glimepiride + pioglitazone placebo + albiglutide placebo
干预措施: metformin (Drug)
met + glimepiride + pioglitazone placebo + albiglutide placebo
metformin + open-label glimepiride + pioglitazone placebo + albiglutide placebo
干预措施: glimepiride (Drug)
met + glimepiride + pioglitazone placebo + albiglutide placebo
metformin + open-label glimepiride + pioglitazone placebo + albiglutide placebo
干预措施: placebo to match pioglitazone (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. The last observation carried forward (LOCF) method was used to impute missing post-BL 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. Nine par. with post-BL values obtained \>14 days after the last dose or after hyperglycemic rescue were included in the analysis population but were not analyzed for this endpoint.
次要结局
- Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52(Baseline and Week 52)
- Change From Baseline in FPG at Week 104 and Week 156(Baseline, Week 104, and Week 156)
- Change From Baseline in HbA1c at Week 104 and Week 156(Baseline, Week 104, and Week 156)
- Time to Hyperglycemia Rescue(From the start of study medication until the end of the treatment (up to Week 156))
- Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 52(Week 52)
- Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156(Week 156)
- Change From Baseline in Body Weight at Week 52(Baseline and Week 52)
- Change From Baseline in Body Weight at Week 104 and Week 156(Baseline, Week 104, and Week 156)
