BIOLOGICAL
albiglutide
albiglutide weekly subcutaneous injection
Status
Completed
Phase
Phase 3
Enrollment
841
Locations
173
Results
Posted
Publications
1
Study summary
This open-label study examines the efficacy and safety of albiglutide as compared with liraglutide in subjects with type 2 diabetes.
This randomized, open-label, multicenter, 2 parallel-group study evaluates the efficacy and safety of a weekly subcutaneously injected dose of albiglutide as compared with liraglutide. Subjects with a historical diagnosis of type 2 diabetes mellitus and whose glycemia is inadequately controlled on their current regimen of metformin, thiazolidinedione, sulfonylurea, or any combination of these oral antidiabetics will be recruited into the study.
Interventions
BIOLOGICAL
albiglutide weekly subcutaneous injection
DRUG
liraglutide daily subcutaneous injection, starting at 0.6mg, then up-titrating to 1.2mg then 1.8mg in accordance with prescribing information.
Timeline
First posted
May 24, 2010
Study start
May 2010
Primary completion
Sep 2011
Study completion
Sep 2011
Results posted
May 20, 2014
Registry updated
Feb 23, 2017
Outcomes
Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 32
Time frame · Baseline and Week 32
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 Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the value at Week 32 minus the value at Baseline. 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 data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.
Mean Change From Baseline in HbA1c at Weeks 4, 6, 12, 18 and 26
Time frame · Baseline, Weeks 4, 6, 12, 18 and 26
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 Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were considered in the treatment week if they had received at least one dose in that treatment week.
Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 32
Time frame · Baseline and Week 32
The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, Baseline HbA1c category, history of prior myocardial infarction (yes versus no), and age category (\<65 years versus ≥65 years) as factors and Baseline FPG as a continuous covariate. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were considered in the treatment week if they had received at least one dose in that treatment week.
Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 6, 12, 18 and 26
Time frame · Baseline, Weeks 1, 2, 3, 4, 6, 12, 18 and 26
The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were considered in the treatment week if they had received at least one dose in that treatment week.
Number of Participants Who Achieved HbA1c Response Level of <6.5% and <7.0% at Week 32
Time frame · Week 32
Number of participants who achieved HbA1c response levels of \<6.5% and \<7.0% at Week 32 were assessed. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.
Time to Hyperglycemia Rescue at Week 32
Time frame · Week 32
Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: fasting plasma glucose (FPG) \>=280 milligram/decilitre (mg/dL) \>= Week 2 and \< Week 4, FPG \>=250 mg/dL \>= Week 4 and \<Week 12, HbA1c ≥8.5% and ≤0.5% reduction from Baseline- \>= Week 12 and \<Week 26, or HbA1c ≥8.5% \>= Week 26. Time to hyperglycemia rescue is defined as the time between the date of the first dose of study medication and the date of hyperglycemia rescue plus one day, or the time between the date of the first dose of study medication and the date of the last visit during the active treatment period plus one day for participants not requiring rescue. This time was divided by 7 to express the result in weeks. All times extending beyond Week 32 relevant to hyperglycemia rescue were censored at Week 32.
Mean Change From Baseline in Body Weight at Week 32
Time frame · Baseline and Week 32
The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the value at Week 32 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, Baseline HbA1c category, history of prior myocardial infarction (yes versus no), and age category (\<65 years versus ≥65 years) as factors and Baseline weight as a continuous covariate. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values.
Eligibility
Inclusion Criteria: * Diagnosis of type 2 diabetes mellitus and experiencing inadequate glycemic control on their current regimen of metformin, TZD, SU, or any combination of these oral antidiabetic medications * BMI \>/=20kg/m2 and \</=45 kg/m2 * Fasting C-peptide \>/=0.8 ng/mL (\>/=0.26 nmol/L) * HbA1c between 7.0% and 10.0%, inclusive * Female subjects of childbearing potential must be practicing adequate contraception. Exclusion Criteria: * History of cancer * History of treated diabetic gastroparesis * Current biliary disease or history of pancreatitis * History of significant GI surgery * Recent clinically significant cardiovascular and/or cerebrovascular disease * Hypertension * History of human immunodeficiency virus infection * History of or current liver disease or acute symptomatic infection with hepatitis B or hepatitis C * History of alcohol or substance abuse * Female subject is pregnant, lactating, or \<6 weeks postpartum * Known allergy to any GLP 1 analogue, liraglutide, other study medications' excipients, excipients of albiglutide, or Baker's yeast * History of type 1 diabetes mellitus * Contraindications (as per the prescribing information) for the use of either background or potential randomized study medications (e.g., liraglutide) * Receipt of any investigational drug or liraglutide within the 30 days or 5 half lives, whichever is longer, before Screening or a history of receipt of an investigational antidiabetic drug within the 3 months before randomization or receipt of albiglutide in previous studies * History or family history of thyroid disease
Study locations
Australia · Israel · Peru · Philippines · South Korea · Spain · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.
GSK Investigational Site
Birmingham, Alabama, United States
GSK Investigational Site
Chandler, Arizona, United States
GSK Investigational Site
Gilbert, Arizona, United States
GSK Investigational Site
Phoenix, Arizona, United States
GSK Investigational Site
Tucson, Arizona, United States
GSK Investigational Site
Searcy, Arkansas, United States
GSK Investigational Site
Chula Vista, California, United States
GSK Investigational Site
Escondido, California, United States
GSK Investigational Site
Fresno, California, United States
GSK Investigational Site
Huntington Beach, California, United States
GSK Investigational Site
Indio, California, United States
GSK Investigational Site
Irvine, California, United States
GSK Investigational Site
Los Angeles, California, United States
GSK Investigational Site
Los Angeles, California, United States
GSK Investigational Site
Mission Viejo, California, United States
GSK Investigational Site
Orange, California, United States
GSK Investigational Site
Palm Desert, California, United States
GSK Investigational Site
Riverside, California, United States
GSK Investigational Site
San Diego, California, United States
GSK Investigational Site
San Diego, California, United States
GSK Investigational Site
Satna Monica, California, United States
GSK Investigational Site
Spring Valley, California, United States
GSK Investigational Site
Tarzana, California, United States
GSK Investigational Site
Tustin, California, United States
Related trials
Brigham and Women's Hospital · Cardiovascular Events · Type2 Diabetes
Not applicable
Active, not recruiting
781,430
2026-05
Ohio State University · Cardiovascular Kidney Metabolic Syndrome
Not applicable
Active, not recruiting
23,280,000
2025-09
Janssen · Diabetes Mellitus, Type 2 · Cardiovascular Diseases
Not applicable
Completed
714,582
2025-06
Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders · Type2diabetes
Phase 4
Unknown
938
2024-07
Sanofi · Type 2 Diabetes Mellitus
Phase 3
Completed
514
2022-03
GlaxoSmithKline · Diabetes Mellitus, Type 2
Phase 3
Completed
814
2020-11
University of California, San Francisco · Type 2 Diabetes Mellitus
Not applicable
Completed
22
2020-11
GlaxoSmithKline · Diabetes Mellitus, Type 2
Phase 4
Terminated
4
2020-10
Related PeptideStat pages
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.