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临床试验/NCT00839527
NCT00839527已完成3 期

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

GlaxoSmithKline1 个研究点 分布在 1 个国家目标入组 685 人开始时间: 2009年2月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

Metformin + glimepiride + pioglitazone + matching albiglutide placebo

干预措施: placebo to match albiglutide (Drug)

metformin + glimepiride + pioglitazone + albiglutide placebo

Active Comparator

Metformin + glimepiride + pioglitazone + matching albiglutide placebo

干预措施: metformin (Drug)

metformin + glimepiride + pioglitazone + albiglutide placebo

Active Comparator

Metformin + glimepiride + pioglitazone + matching albiglutide placebo

干预措施: glimepiride (Drug)

metformin + glimepiride + pioglitazone + albiglutide placebo

Active Comparator

Metformin + glimepiride + pioglitazone + matching albiglutide placebo

干预措施: pioglitazone (Drug)

metformin + glimepiride + pioglitazone placebo + albiglutide

Experimental

Metformin + open-label glimepiride + pioglitazone matching placebo + albiglutide

干预措施: albiglutide (Biological)

metformin + glimepiride + pioglitazone placebo + albiglutide

Experimental

Metformin + open-label glimepiride + pioglitazone matching placebo + albiglutide

干预措施: metformin (Drug)

metformin + glimepiride + pioglitazone placebo + albiglutide

Experimental

Metformin + open-label glimepiride + pioglitazone matching placebo + albiglutide

干预措施: glimepiride (Drug)

metformin + glimepiride + pioglitazone placebo + albiglutide

Experimental

Metformin + open-label glimepiride + pioglitazone matching placebo + albiglutide

干预措施: placebo to match pioglitazone (Drug)

met + glimepiride + pioglitazone placebo + albiglutide placebo

Active Comparator

metformin + open-label glimepiride + pioglitazone placebo + albiglutide placebo

干预措施: placebo to match albiglutide (Drug)

met + glimepiride + pioglitazone placebo + albiglutide placebo

Active Comparator

metformin + open-label glimepiride + pioglitazone placebo + albiglutide placebo

干预措施: metformin (Drug)

met + glimepiride + pioglitazone placebo + albiglutide placebo

Active Comparator

metformin + open-label glimepiride + pioglitazone placebo + albiglutide placebo

干预措施: glimepiride (Drug)

met + glimepiride + pioglitazone placebo + albiglutide placebo

Active Comparator

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)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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