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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01128894
Registration number
NCT01128894
Ethics application status
Date submitted
29/04/2010
Date registered
24/05/2010
Date last updated
23/02/2017
Titles & IDs
Public title
A Study to Determine the Efficacy and Safety of Albiglutide as Compared With Liraglutide.
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Scientific title
A Randomized, Open-Label, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide as Compared With Liraglutide in Subjects With Type 2 Diabetes Mellitus
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Secondary ID [1]
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114179
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2
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Condition category
Condition code
Metabolic and Endocrine
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - albiglutide
Treatment: Drugs - liraglutide
Experimental: albiglutide - weekly albiglutide subcutaneous injection
Active Comparator: liraglutide - liraglutide daily subcutaneous injection, starting at 0.6mg, then up-titrating to 1.2mg then 1.8mg in accordance with prescribing information.
Other interventions: albiglutide
albiglutide weekly subcutaneous injection
Treatment: Drugs: liraglutide
liraglutide daily subcutaneous injection, starting at 0.6mg, then up-titrating to 1.2mg then 1.8mg in accordance with prescribing information.
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 32
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline and Week 32
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Secondary outcome [1]
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Mean Change From Baseline in HbA1c at Weeks 4, 6, 12, 18 and 26
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline, Weeks 4, 6, 12, 18 and 26
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Secondary outcome [2]
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Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 32
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline and Week 32
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Secondary outcome [3]
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Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 6, 12, 18 and 26
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline, Weeks 1, 2, 3, 4, 6, 12, 18 and 26
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Secondary outcome [4]
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Number of Participants Who Achieved HbA1c Response Level of <6.5% and <7.0% at Week 32
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Assessment method [4]
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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.
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Timepoint [4]
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Week 32
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Secondary outcome [5]
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Time to Hyperglycemia Rescue at Week 32
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Assessment method [5]
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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.
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Timepoint [5]
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Week 32
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Secondary outcome [6]
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Mean Change From Baseline in Body Weight at Week 32
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Assessment method [6]
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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.
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Timepoint [6]
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Baseline and Week 32
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/09/2011
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Sample size
Target
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Accrual to date
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Final
841
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC,WA
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Recruitment hospital [1]
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GSK Investigational Site - Garran
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GSK Investigational Site - Camperdown
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GSK Investigational Site - St Leonards
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GSK Investigational Site - Herston
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GSK Investigational Site - Box Hill
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GSK Investigational Site - Geelong
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GSK Investigational Site - Heidelberg
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GSK Investigational Site - Ringwood East
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Recruitment hospital [9]
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GSK Investigational Site - Fremantle
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Recruitment postcode(s) [1]
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2606 - Garran
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Recruitment postcode(s) [2]
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2050 - Camperdown
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Recruitment postcode(s) [3]
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2065 - St Leonards
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Recruitment postcode(s) [4]
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4029 - Herston
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Recruitment postcode(s) [5]
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3128 - Box Hill
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Recruitment postcode(s) [6]
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3220 - Geelong
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Recruitment postcode(s) [7]
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3081 - Heidelberg
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Recruitment postcode(s) [8]
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3135 - Ringwood East
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Recruitment postcode(s) [9]
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6160 - Fremantle
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Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
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Name
GlaxoSmithKline
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This open-label study examines the efficacy and safety of albiglutide as compared with
liraglutide in subjects with type 2 diabetes.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01128894
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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GSK Clinical Trials
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GlaxoSmithKline
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01128894
Download to PDF