A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide When Used in Combination With Pioglitazone With or Without Metformin in Subjects With Type 2 Diabetes Mellitus
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 310
- Locations
- 1
- 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 the safety, tolerability and efficacy of albiglutide in the treatment of 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
Exclusion Criteria
- •NYHA Class II to IV heart failure
- •females who are pregnant, lactating, or less than 6 weeks post-partum
Arms & Interventions
placebo + pioglitazone (with or without metformin)
Placebo albiglutide weekly injection + pioglitazone (with or without metformin)
Intervention: placebo (Drug)
albiglutide + pioglitazone (with or without metformin)
albiglutide weekly injection + pioglitazone (with or without meformin)
Intervention: albiglutide (Biological)
Outcomes
Primary Outcomes
Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52
Time Frame: 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. 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. One Intent-to-Treat (ITT) participant (par.) had all post-BL HbA1c measurements occur after hyperglycemic rescue. This par. is included in the ITT Population counts but did not contribute to this analysis.
Secondary Outcomes
- Change From Baseline in Body Weight at Week 52(Baseline and 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 Fasting Plasma Glucose (FPG) at Week 52(Baseline and 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 156(Baseline and Week 156)
- Change From Baseline in HbA1c at Weeks 104 and 156(Baseline and Weeks 104 and 156)
- 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)