A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Two Dose Levels of Albiglutide Compared With Placebo in Subjects With Type 2 Diabetes Mellitus
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 309
- Locations
- 263
- Primary Endpoint
- Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52
Study Overview
Brief Summary
The purpose of this study is to determine whether albiglutide is effective in the treament of patients with type 2 diabetes.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •type 2 diabetes
- •BMI 20-45kg/m2 inclusive
Exclusion Criteria
- •females who are pregnant, lactating, or <6 weeks post-partum
- •CHF NYHA class III-IV
Outcomes
Primary Outcomes
Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52
Time Frame: Baseline and Week 52
Glycated hemoglobin (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 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. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, history of prior myocardial infarction (yes versus no), and age category (\<65 years versus ≥65 years) as factors and Baseline HbA1c as a continuous covariate. 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.
Secondary Outcomes
- Change From Baseline in Postprandial Blood Glucose Profile Parameters-4 Hour Insulin AUC and 4 Hour Proinsulin AUC(Baseline and Week 52)
- Change From Baseline in HbA1c at Weeks 104 and 156(Baseline and Weeks 104 and 156)
- Change From Baseline in Body Weight at Week 156(Baseline and Week 156)
- Change From Baseline in Postprandial Blood Glucose Profile Parameter- 4 Hour Blood Glucose AUC(Baseline and Week 52)
- 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)
- 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 52(Baseline and Week 52)
- Change From Baseline in Postprandial Blood Glucose Profile Parameter-4 Hour C-peptide AUC(Baseline and Week 52)
- Albiglutide Plasma Concentration at Weeks 8 and 24(Weeks 8 and 24)
- Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156(Week 156)