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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01128894
Enrollment
841
Registered
2010-05-24
Start date
2010-05-31
Completion date
2011-09-30
Last updated
2017-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

GSK716155, liraglutide, albiglutide, open-label

Brief summary

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

Detailed description

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

BIOLOGICALalbiglutide

albiglutide weekly subcutaneous injection

DRUGliraglutide

liraglutide daily subcutaneous injection, starting at 0.6mg, then up-titrating to 1.2mg then 1.8mg in accordance with prescribing information.

Sponsors

GlaxoSmithKline
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

MeasureTime frameDescription
Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 32Baseline and Week 32The 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 26Baseline, Weeks 1, 2, 3, 4, 6, 12, 18 and 26The 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.
Mean Change From Baseline in HbA1c at Weeks 4, 6, 12, 18 and 26Baseline, Weeks 4, 6, 12, 18 and 26HbA1c 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.
Time to Hyperglycemia Rescue at Week 32Week 32Participants 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 32Baseline and Week 32The 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.
Number of Participants Who Achieved HbA1c Response Level of <6.5% and <7.0% at Week 32Week 32Number 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.

Countries

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

Participant flow

Pre-assignment details

Eligible participants entered into 2 weeks of Prescreening and Screening; 4 weeks of Run-in/stabilization; a 32-week Treatment Period for evaluation of efficacy and safety and 8 weeks of post treatment Follow-up. A total of 1764 participants were screened, 841 were randomized and 812 received at least one dose of study treatment.

Participants by arm

ArmCount
Albiglutide 50 mg
Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously (SC) from Baseline until Week 6 with up-titration to 50 mg weekly at Week 6.
404
Liraglutide 1.8 mg
Participants 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.
408
Total812

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyAdverse Event3141
Overall StudyConflicting HbA1c Results at Screening10
Overall StudyLost to Follow-up88
Overall StudyNoncompliance45
Overall StudyPhysician Decision21
Overall StudyProtocol Violation21
Overall StudyWithdrawal by Subject1012

Baseline characteristics

CharacteristicAlbiglutide 50 mgLiraglutide 1.8 mgTotal
Age, Continuous55.4 Years
STANDARD_DEVIATION 10.11
55.8 Years
STANDARD_DEVIATION 9.95
55.6 Years
STANDARD_DEVIATION 10.03
Gender
Female
213 Participants190 Participants403 Participants
Gender
Male
191 Participants218 Participants409 Participants
Race/Ethnicity, Customized
African American/African Heritage
47 Participants29 Participants76 Participants
Race/Ethnicity, Customized
American Indian or Alaskan Native
30 Participants37 Participants67 Participants
Race/Ethnicity, Customized
Asian - Central/South Asian Heritage
3 Participants9 Participants12 Participants
Race/Ethnicity, Customized
Asian - East Asian Heritage
26 Participants18 Participants44 Participants
Race/Ethnicity, Customized
Asian - Japanese Heritage
0 Participants3 Participants3 Participants
Race/Ethnicity, Customized
Asian - South East Asian Heritage
17 Participants19 Participants36 Participants
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
0 Participants2 Participants2 Participants
Race/Ethnicity, Customized
White - Arabic/North African Heritage
5 Participants6 Participants11 Participants
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
276 Participants285 Participants561 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
266 / 404289 / 408
serious
Total, serious adverse events
20 / 40423 / 408

Outcome results

Primary

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

Time frame: Baseline and Week 32

Population: Intent-to-Treat (ITT) Population: all participants who received at least one dose of study medication and who had at least one post-Baseline assessment of the primary endpoint, HbA1c. Only those participants available at the indicated time point were assessed.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Albiglutide 50 mgMean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 32-0.78 Percentage of HbA1c in the bloodStandard Error 0.047
Liraglutide 1.8 mgMean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 32-0.99 Percentage of HbA1c in the bloodStandard Error 0.046
p-value: 0.084695% CI: [0.08, 0.34]ANCOVA
Secondary

Mean Change From Baseline in Body Weight at 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.

Time frame: Baseline and Week 32

Population: ITT Population. Only those participants available at the indicated time point were assessed.

ArmMeasureValue (MEAN)Dispersion
Albiglutide 50 mgMean Change From Baseline in Body Weight at Week 32-0.62 KilogramsStandard Deviation 3.118
Liraglutide 1.8 mgMean Change From Baseline in Body Weight at Week 32-2.21 KilogramsStandard Deviation 4.147
Secondary

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

Time frame: Baseline and Week 32

Population: ITT Population. Only those participants available at the indicated time point were assessed.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Albiglutide 50 mgMean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 32-1.22 Millimoles per liter (mmol/L)Standard Error 0.115
Liraglutide 1.8 mgMean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 32-1.68 Millimoles per liter (mmol/L)Standard Error 0.115
Secondary

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

Time frame: Baseline, Weeks 1, 2, 3, 4, 6, 12, 18 and 26

Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.

ArmMeasureGroupValue (MEAN)Dispersion
Albiglutide 50 mgMean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 6, 12, 18 and 26Week 6, n= 400, 402-1.25 Millimoles per liter (mmol/L)Standard Deviation 2.317
Albiglutide 50 mgMean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 6, 12, 18 and 26Week 1, n=386, 381-0.98 Millimoles per liter (mmol/L)Standard Deviation 1.939
Albiglutide 50 mgMean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 6, 12, 18 and 26Week 12, n= 400, 402-1.73 Millimoles per liter (mmol/L)Standard Deviation 2.526
Albiglutide 50 mgMean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 6, 12, 18 and 26Week 2, n= 399, 398-1.33 Millimoles per liter (mmol/L)Standard Deviation 2.194
Albiglutide 50 mgMean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 6, 12, 18 and 26Week 18, n= 400, 402-1.44 Millimoles per liter (mmol/L)Standard Deviation 2.362
Albiglutide 50 mgMean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 6, 12, 18 and 26Week 3, n= 400, 402-1.61 Millimoles per liter (mmol/L)Standard Deviation 2.067
Albiglutide 50 mgMean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 6, 12, 18 and 26Week 26, n= 400, 402-1.14 Millimoles per liter (mmol/L)Standard Deviation 2.694
Albiglutide 50 mgMean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 6, 12, 18 and 26Week 4, n= 400, 402-1.52 Millimoles per liter (mmol/L)Standard Deviation 2.148
Liraglutide 1.8 mgMean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 6, 12, 18 and 26Week 26, n= 400, 402-1.64 Millimoles per liter (mmol/L)Standard Deviation 2.717
Liraglutide 1.8 mgMean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 6, 12, 18 and 26Week 2, n= 399, 398-2.25 Millimoles per liter (mmol/L)Standard Deviation 2.296
Liraglutide 1.8 mgMean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 6, 12, 18 and 26Week 3, n= 400, 402-2.43 Millimoles per liter (mmol/L)Standard Deviation 2.47
Liraglutide 1.8 mgMean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 6, 12, 18 and 26Week 4, n= 400, 402-2.45 Millimoles per liter (mmol/L)Standard Deviation 2.381
Liraglutide 1.8 mgMean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 6, 12, 18 and 26Week 6, n= 400, 402-2.11 Millimoles per liter (mmol/L)Standard Deviation 2.451
Liraglutide 1.8 mgMean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 6, 12, 18 and 26Week 12, n= 400, 402-2.10 Millimoles per liter (mmol/L)Standard Deviation 2.59
Liraglutide 1.8 mgMean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 6, 12, 18 and 26Week 18, n= 400, 402-1.74 Millimoles per liter (mmol/L)Standard Deviation 2.704
Liraglutide 1.8 mgMean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 6, 12, 18 and 26Week 1, n=386, 381-1.62 Millimoles per liter (mmol/L)Standard Deviation 2.116
Secondary

Mean Change From Baseline in HbA1c at 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.

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

Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.

ArmMeasureGroupValue (MEAN)Dispersion
Albiglutide 50 mgMean Change From Baseline in HbA1c at Weeks 4, 6, 12, 18 and 26Week 12, n=398, 402-0.88 Percentage of HbA1c in the bloodStandard Deviation 0.824
Albiglutide 50 mgMean Change From Baseline in HbA1c at Weeks 4, 6, 12, 18 and 26Week 6, n=398, 401-0.66 Percentage of HbA1c in the bloodStandard Deviation 0.566
Albiglutide 50 mgMean Change From Baseline in HbA1c at Weeks 4, 6, 12, 18 and 26Week 18, n=398, 402-0.87 Percentage of HbA1c in the bloodStandard Deviation 0.921
Albiglutide 50 mgMean Change From Baseline in HbA1c at Weeks 4, 6, 12, 18 and 26Week 4, n=387, 392-0.52 Percentage of HbA1c in the bloodStandard Deviation 0.481
Albiglutide 50 mgMean Change From Baseline in HbA1c at Weeks 4, 6, 12, 18 and 26Week 26, n=398, 402-0.79 Percentage of HbA1c in the bloodStandard Deviation 0.968
Liraglutide 1.8 mgMean Change From Baseline in HbA1c at Weeks 4, 6, 12, 18 and 26Week 26, n=398, 402-1.00 Percentage of HbA1c in the bloodStandard Deviation 0.969
Liraglutide 1.8 mgMean Change From Baseline in HbA1c at Weeks 4, 6, 12, 18 and 26Week 6, n=398, 401-0.94 Percentage of HbA1c in the bloodStandard Deviation 0.569
Liraglutide 1.8 mgMean Change From Baseline in HbA1c at Weeks 4, 6, 12, 18 and 26Week 12, n=398, 402-1.18 Percentage of HbA1c in the bloodStandard Deviation 0.798
Liraglutide 1.8 mgMean Change From Baseline in HbA1c at Weeks 4, 6, 12, 18 and 26Week 18, n=398, 402-1.13 Percentage of HbA1c in the bloodStandard Deviation 0.904
Liraglutide 1.8 mgMean Change From Baseline in HbA1c at Weeks 4, 6, 12, 18 and 26Week 4, n=387, 392-0.73 Percentage of HbA1c in the bloodStandard Deviation 0.447
Secondary

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

Population: ITT Population. Only those participants available at the indicated time point were assessed.

ArmMeasureGroupValue (NUMBER)
Albiglutide 50 mgNumber of Participants Who Achieved HbA1c Response Level of <6.5% and <7.0% at Week 32HbA1c <7.0%168 Participants
Albiglutide 50 mgNumber of Participants Who Achieved HbA1c Response Level of <6.5% and <7.0% at Week 32HbA1c <6.5%78 Participants
Liraglutide 1.8 mgNumber of Participants Who Achieved HbA1c Response Level of <6.5% and <7.0% at Week 32HbA1c <7.0%208 Participants
Liraglutide 1.8 mgNumber of Participants Who Achieved HbA1c Response Level of <6.5% and <7.0% at Week 32HbA1c <6.5%113 Participants
Secondary

Time to Hyperglycemia Rescue at 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.

Time frame: Week 32

Population: ITT Population

ArmMeasureValue (MEDIAN)
Albiglutide 50 mgTime to Hyperglycemia Rescue at Week 32NA Weeks
Liraglutide 1.8 mgTime to Hyperglycemia Rescue at Week 32NA Weeks

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026