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Trial · Interventional

CompletedPhase 3Results postedRegistry data

A Study to Determine the Efficacy and Safety of Albiglutide as Compared With Liraglutide.

Overview

Status
Completed
Phase
Phase 3
Enrollment
841 participants (actual)
Sponsor
GlaxoSmithKline · Industry
Design
Randomized · Open label (no masking)
Countries
8 countries

United States, Australia, Israel, Peru, Philippines, South Korea, Spain, United Kingdom

Start
May 2010
Primary completion
Sept 2011
Completion
Sept 2011
First posted
24 May 2010 (estimated)
Last update posted
23 Feb 2017
Conditions
Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201020112012
  1. Ph 3

    A Study to Determine the Efficacy and Safety of Albiglutide as Compared With Liraglutide.

    NCT01128894

    May 2010 to Sept 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This open-label study examines the efficacy and safety of albiglutide as compared with liraglutide in subjects with type 2 diabetes.

Interventions

  • albiglutideBiological
  • liraglutideDrug

Arms2

  • 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 32

    Time frame · Baseline and Week 32

    Registry description

    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.

Secondary outcomes(6)
  1. Mean Change From Baseline in HbA1c at Weeks 4, 6, 12, 18 and 26

    Time frame · Baseline, Weeks 4, 6, 12, 18 and 26

    Registry description

    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.

  2. Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 32

    Time frame · Baseline and Week 32

    Registry description

    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.

  3. 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

    Registry description

    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.

  4. Number of Participants Who Achieved HbA1c Response Level of <6.5% and <7.0% at Week 32

    Time frame · Week 32

    Registry description

    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.

  5. Time to Hyperglycemia Rescue at Week 32

    Time frame · Week 32

    Registry description

    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.

  6. Mean Change From Baseline in Body Weight at Week 32

    Time frame · Baseline and Week 32

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· Baseline and Week 32

Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 32

GroupValue (Percentage of HbA1c in the blood)Spread
Albiglutide 50 mg-0.780.047
Liraglutide 1.8 mg-0.990.046
Secondary and other outcome results(6)
Secondary outcomeMean· Baseline, Weeks 4, 6, 12, 18 and 26

Mean Change From Baseline in HbA1c at Weeks 4, 6, 12, 18 and 26

GroupValue (Percentage of HbA1c in the blood)Spread
Albiglutide 50 mg-0.520.481
Liraglutide 1.8 mg-0.730.447
Secondary outcomeLeast squares mean· Baseline and Week 32

Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 32

GroupValue (Millimoles per liter (mmol/L))Spread
Albiglutide 50 mg-1.220.115
Liraglutide 1.8 mg-1.680.115
Secondary outcomeMean· Baseline, Weeks 1, 2, 3, 4, 6, 12, 18 and 26

Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 6, 12, 18 and 26

GroupValue (Millimoles per liter (mmol/L))Spread
Albiglutide 50 mg-0.981.939
Liraglutide 1.8 mg-1.622.116
Secondary outcomeNumber· Week 32

Number of Participants Who Achieved HbA1c Response Level of <6.5% and <7.0% at Week 32

GroupValue (Participants)
Albiglutide 50 mg78
Liraglutide 1.8 mg113
Secondary outcomeMedian· Week 32

Time to Hyperglycemia Rescue at Week 32

GroupValue (Weeks)
Albiglutide 50 mgNA
Liraglutide 1.8 mgNA
Secondary outcomeMean· Baseline and Week 32

Mean Change From Baseline in Body Weight at Week 32

GroupValue (Kilograms)Spread
Albiglutide 50 mg-0.623.118
Liraglutide 1.8 mg-2.214.147

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Albiglutide 50 mgParticipants received albiglutide 30 milligrams (mg) once weekly subcutaneously (SC) from Baseline until Week 6 with up-titration to 50 mg weekly at Week 6.–20 / 404266 / 404
Liraglutide 1.8 mgParticipants received liraglutide 0.6 mg once daily (OD) SC from Baseline until Week 1. From Week 1 to Week 2 the dose was increased to 1.2 mg. At Week 2, the dose was increased to 1.8 mg.–23 / 408289 / 408

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

Indexing hint: Randomized controlled trial · 2014

Corrected

Once-weekly albiglutide versus once-daily liraglutide in patients with type 2 diabetes inadequately controlled on oral drugs (HARMONY 7): a randomised, open-label, multicentre, non-inferiority phase 3 study.

Pratley et al. 2014The lancet. Diabetes & endocrinologycited by 253

PMID 24703047DOI 10.1016/s2213-8587(13)70214-6PUB-24703047

Rights unknown

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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