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A Monotherapy Study to Evaluate the Efficacy and Safety of 2 Dose Levels of Albiglutide in Japanese Subjects With Type 2 Diabetes Mellitus (T2DM)

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ClinicalTrials.gov Identifier: NCT01733758
Recruitment Status : Completed
First Posted : November 27, 2012
Results First Posted : May 18, 2015
Last Update Posted : September 22, 2016
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Diabetes Mellitus, Type 2
Interventions Drug: Albiglutide 30 mg weekly
Drug: Albiglutide 50 mg weekly
Drug: Placebo
Drug: Liraglutide 0.9 mg daily
Enrollment 494

Recruitment Details A total of 494 participants (par.) were randomized to one of the four treatment groups – placebo (switched to albiglutide 30 mg at Week 24), albiglutide 30 mg, albiglutide 50 mg, liraglutide (open label), 490 par. took at least one dose of study drug (Safety Population). All 490 par. were included in Intent-to-Treat Population.
Pre-assignment Details  
Arm/Group Title Placebo Albiglutide 30 mg Weekly Albiglutide 50 mg Weekly Open Label Liraglutide 0.9 mg Daily
Hide Arm/Group Description Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly to Week 52. Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52. Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52. Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
Period Title: Overall Study
Started 77 160 150 103
Completed 62 148 135 95
Not Completed 15 12 15 8
Reason Not Completed
Adverse Event             5             7             8             1
Withdrawal by Subject             1             1             5             3
Persistent Hyperglycemia             3             2             0             0
Protocol Violation             0             1             2             2
Non-compliance             1             0             0             0
Intro of New Anti-Diabetic Medication             4             0             0             1
Inv Decision, HbA1c not controlled             1             1             0             1
Arm/Group Title Placebo Albiglutide 30 mg Weekly Albiglutide 50 mg Weekly Open Label Liraglutide 0.9 mg Daily Total
Hide Arm/Group Description Participants received double blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52. Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52. Participants received double blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52. Participants received open label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52. Total of all reporting groups
Overall Number of Baseline Participants 77 160 150 103 490
Hide Baseline Analysis Population Description
Baseline characteristics are presented for the Safety Population.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 77 participants 160 participants 150 participants 103 participants 490 participants
57.3  (11.27) 59.6  (9.00) 57.7  (9.51) 58.4  (9.72) 58.4  (9.70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 77 participants 160 participants 150 participants 103 participants 490 participants
Female
25
  32.5%
35
  21.9%
36
  24.0%
22
  21.4%
118
  24.1%
Male
52
  67.5%
125
  78.1%
114
  76.0%
81
  78.6%
372
  75.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Asian - Japanese Heritage Number Analyzed 77 participants 160 participants 150 participants 103 participants 490 participants
77 160 150 103 490
1.Primary Outcome
Title Model-adjusted Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24
Hide 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 nonmissing value before the start of treatment. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. Based on analysis of covariance (ANCOVA): Change at Week 24 = treatment (placebo, albiglutide 30 mg, albiglutide 50 mg) + Baseline HbA1c + prior diabetes therapy + age category (<65 years versus ≥65 years). Participants who discontinued from study treatment before Week 24 had their last post-Baseline HbA1c carried forward for the analysis unless the value is past 14 days after the last dose of study drug. The open-label liraglutide group was a reference group and not included in the primary endpoint analysis model. Descriptive summary statistics are provided as a separate outcome measure.
Time Frame Baseline and Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population (Last Observation Carried Forward): all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment of HbA1c.
Arm/Group Title Placebo Albiglutide 30 mg Weekly Albiglutide 50 mg Weekly Open-Label Liraglutide 0.9 mg Daily
Hide Arm/Group Description:
Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
Participants received double blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
Overall Number of Participants Analyzed 77 159 150 0
Least Squares Mean (Standard Error)
Unit of Measure: Percentage of HbA1c in the blood
0.25  (0.068) -1.10  (0.047) -1.30  (0.049)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Albiglutide 50 mg Weekly
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.55
Confidence Interval (2-Sided) 95%
-1.72 to -1.39
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Albiglutide 30 mg Weekly
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.35
Confidence Interval (2-Sided) 95%
-1.51 to -1.18
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Albiglutide 50 mg Weekly
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The first test in a sequential testing procedure starting with albiglutide 50 mg versus placebo, and if significant at 0.05 level, followed by albiglutide 30 mg versus placebo.
Method t-test, 2 sided
Comments The p-value is from a 2-sided t-test to test whether the difference of least squares (LS) means (albiglutide 50 mg – placebo) is equal to zero.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Albiglutide 30 mg Weekly
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The second test in a sequential testing procedure starting with albiglutide 50 mg versus placebo, and if significant at 0.05 level, followed by albiglutide 30 mg versus placebo.
Method t-test, 2 sided
Comments The p-value is from a 2-sided t-test to test whether the difference of LS means (albiglutide 30 mg – placebo) is equal to zero.
2.Primary Outcome
Title Mean HbA1c at Baseline, Week 24, and Change From Baseline at Week 24
Hide 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 nonmissing value before the start of treatment. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. Participants who discontinued from study treatment before Week 24 had their last post-Baseline HbA1c value carried forward for the summary, unless the value was past 14 days after the last dose of study drug. The open-label liraglutide group was a reference group; descriptive statistics comparing albiglutide and liraglutide were exploratory endpoints.
Time Frame Baseline and Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population (Last Observation Carried Forward): all randomized participants who received at least 1 dose of study treatment and had a Baseline assessment and at least 1 post-Baseline assessment of HbA1c on or before Week 24 provided it was not past more than 14 days after the last dose of study drug intake.
Arm/Group Title Placebo Albiglutide 30 mg Weekly Albiglutide 50 mg Weekly Open-Label Liraglutide 0.9 mg Daily
Hide Arm/Group Description:
Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
Overall Number of Participants Analyzed 77 159 150 103
Mean (Standard Deviation)
Unit of Measure: Percentage of HbA1c in the blood
Baseline 8.16  (0.877) 8.06  (0.783) 8.15  (0.825) 8.07  (0.787)
Week 24 8.39  (1.066) 6.98  (0.735) 6.83  (0.659) 6.87  (0.642)
Change from Baseline 0.24  (0.715) -1.08  (0.619) -1.32  (0.702) -1.19  (0.636)
3.Secondary Outcome
Title Change From Baseline in HbA1c at Week 52
Hide 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 on or before the start of treatment. Change from Baseline was calculated as the value at Week 52 minus the value at Baseline.
Time Frame Baseline and Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (Observed Case) Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment. Participants who discontinued from study treatment before Week 52 were not included in the analysis. No missing data were imputed.
Arm/Group Title Placebo Albiglutide 30 mg Weekly Albiglutide 50 mg Weekly Open-Label Liraglutide 0.9 mg Daily
Hide Arm/Group Description:
Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
Overall Number of Participants Analyzed 62 148 135 95
Mean (Standard Deviation)
Unit of Measure: Percentage of HbA1c in the blood
-1.07  (0.695) -1.07  (0.790) -1.34  (0.753) -1.17  (0.776)
4.Secondary Outcome
Title Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of <6.5% and <7.0%) at Week 24
Hide 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. Clinically meaningful levels of response in HbA1c are defined as <6.5% and <7.0%. Participants who discontinued the study before Week 24 had their last post-Baseline HbA1c value carried forwrad for the summary unless the value was past 14 days after the last dose of study drug.
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (Last Observation Carried Forward) Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment.
Arm/Group Title Placebo Albiglutide 30 mg Weekly Albiglutide 50 mg Weekly Open-Label Liraglutide 0.9 mg Daily
Hide Arm/Group Description:
Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
Overall Number of Participants Analyzed 77 159 150 103
Measure Type: Number
Unit of Measure: Percentage of participants
HbA1c <6.5% at Week 24 1 31 47 29
HbA1c <7.0% at Week 24 4 92 100 66
5.Secondary Outcome
Title Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of <6.5% and <7.0%) at Week 52
Hide 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. Clinically meaningful levels of response in HbA1c are defined as <6.5% and <7.0%.
Time Frame Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (Observed Case) Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment. Participants who discontinued from study treatment before Week 52 were not included in the analysis. No missing data were imputed.
Arm/Group Title Placebo Albiglutide 30 mg Weekly Albiglutide 50 mg Weekly Open-Label Liraglutide 0.9 mg Daily
Hide Arm/Group Description:
Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
Overall Number of Participants Analyzed 62 148 135 95
Measure Type: Number
Unit of Measure: Percentage of participants
HbA1c <6.5% at Week 52 14 44 53 27
HbA1c <7.0% at Week 52 33 82 85 57
6.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Hide Description FPG is an indicator of efficacy. The Baseline FPG value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the FPG value at Week 24 minus the FPG value at Baseline. Participants who discontinued from study treatment before Week 24 had their last post-Baseline FPG observation carried forward for the summary unless the value was 14 days past the last dose of study drug.
Time Frame Baseline and Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (Last Observation Carried Forward) Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment.
Arm/Group Title Placebo Albiglutide 30 mg Weekly Albiglutide 50 mg Weekly Open-Label Liraglutide 0.9 mg Daily
Hide Arm/Group Description:
Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
Overall Number of Participants Analyzed 77 159 150 103
Mean (Standard Deviation)
Unit of Measure: Milligrams per deciliter (mg/dL)
Baseline 159.3  (37.07) 157.1  (33.81) 158.7  (32.82) 157.2  (31.22)
Week 24 167.0  (37.51) 132.2  (26.09) 128.8  (24.03) 128.1  (23.68)
Change from Baseline at Week 24 7.7  (31.77) -24.9  (27.58) -30.0  (27.83) -29.1  (29.00)
7.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52
Hide Description FPG is an indicator of efficacy. The Baseline FPG value is defined as the last non-missing value on or before the start of treatment. Change from Baseline was calculated as the FPG value at Week 52 minus the FPG value at Baseline.
Time Frame Baseline and Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (Observed Case) Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment. Participants who discontinued from study treatment before Week 52 were not included in this analysis. No missing data were imputed.
Arm/Group Title Placebo Albiglutide 30 mg Weekly Albiglutide 50 mg Weekly Open-Label Liraglutide 0.9 mg Daily
Hide Arm/Group Description:
Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
Overall Number of Participants Analyzed 62 147 135 95
Mean (Standard Deviation)
Unit of Measure: Milligrams per deciliter (mg/dL)
Baseline 154.5  (35.65) 154.7  (29.36) 159.8  (33.52) 157.4  (30.27)
Week 52 131.7  (23.13) 131.9  (24.14) 126.3  (24.47) 127.0  (20.78)
Change from Baseline at Week 52 -22.7  (27.38) -22.8  (26.03) -33.5  (31.10) -30.4  (28.06)
8.Secondary Outcome
Title Change From Baseline in Body Weight at Week 24
Hide Description The Baseline body weight value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the body weight value at Week 24 minus the value at Baseline. Participants who discontinued from the study treatment before Week 24 had their last non-missing weight carried forward for the summary, unless the value is past 14 days after the last dose of study drug.
Time Frame Baseline and Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (Last Observation Carried Forward) Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment.
Arm/Group Title Placebo Albiglutide 30 mg Weekly Albiglutide 50 mg Weekly Open-Label Liraglutide 0.9 mg Daily
Hide Arm/Group Description:
Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
Overall Number of Participants Analyzed 77 159 150 103
Mean (Standard Deviation)
Unit of Measure: Kilograms (kg)
Baseline 68.65  (12.088) 69.46  (13.453) 71.54  (12.907) 72.65  (13.758)
Week 24 68.15  (12.139) 69.78  (13.793) 71.50  (13.023) 72.30  (13.459)
Change from Baseline at Week 24 -0.50  (1.700) 0.32  (1.795) -0.04  (1.976) -0.34  (2.587)
9.Secondary Outcome
Title Change From Baseline in Body Weight at Week 52
Hide Description The Baseline body weight value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the body weight value at Week 52 minus the value at Baseline.
Time Frame Baseline and Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (Observed Case) Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment. Participants who discontinued before Week 52 from study treatment were not included in the analysis. No missing data were imputed.
Arm/Group Title Placebo Albiglutide 30 mg Weekly Albiglutide 50 mg Weekly Open-Label Liraglutide 0.9 mg Daily
Hide Arm/Group Description:
Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
Overall Number of Participants Analyzed 62 148 135 95
Mean (Standard Deviation)
Unit of Measure: Kilograms (kg)
Baseline 68.07  (11.978) 70.07  (13.242) 71.27  (12.801) 72.43  (12.895)
Week 52 68.00  (12.150) 70.15  (13.536) 70.96  (12.431) 71.93  (12.564)
Change from Baseline at Week 52 -0.07  (2.179) 0.08  (2.078) -0.31  (2.382) -0.50  (2.690)
10.Secondary Outcome
Title Time to Study Withdrawal Due to Hyperglycemia
Hide Description Participants who experienced persistent hyperglycemia after uptitration were to be withdrawn from the study. Hyperglycemia is defined as a fasting plasma glucose (FPG) ≥280 mg/dL (≥15.5 mmol/L) from ≥Week 2 to <Week 4, ≥250 mg/dL (≥13.9 mmol/L) from ≥Week 4 to <Week 12, or ≥230 mg/dL (≥12.8 mmol/L) from ≥Week 12 to <Week 52, confirmed a second evaluation within 7 days.
Time Frame Baseline through Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population: all randomized par. who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment. Par. who did not conform to the protocol-defined criteria of persistent hyperglycemia with respect to FPG values defined above were not included in this analysis.
Arm/Group Title Placebo Albiglutide 30 mg Weekly Albiglutide 50 mg Weekly Open-Label Liraglutide 0.9 mg Daily
Hide Arm/Group Description:
Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
Overall Number of Participants Analyzed 77 160 150 103
Median (95% Confidence Interval)
Unit of Measure: Weeks
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
There were too few events of withdrawals due to hyperglycemia to calculate the median and confidence interval.
11.Secondary Outcome
Title Time to Study Withdrawal for Any Reason
Hide Description Time to withdrawal was calculated as the number of days between the date of first dose and the date of withdrawal plus 1. Time to withdrawal was summarized by visit.
Time Frame Baseline through Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline assessment and at least one post-Baseline assessment (scheduled or unscheduled) of the primary endpoint, HbA1c.
Arm/Group Title Placebo Albiglutide 30 mg Weekly Albiglutide 50 mg Weekly Open-Label Liraglutide 0.9 mg Daily
Hide Arm/Group Description:
Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
Overall Number of Participants Analyzed 77 160 150 103
Median (95% Confidence Interval)
Unit of Measure: Weeks
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
There were too few events of withdrawals for any reason to calculate the median and confidence interval.
Time Frame On-therapy non-serious AEs and serious AEs (SAEs), events with an onset on or after the start date of study treatment and within 56 days after the date of the last dose of study treatment, are summarized through Week 52.
Adverse Event Reporting Description The nonserious AEs and SAEs are reported for the Safety Population, comprised of all participants who received >= 1 dose of study treatment. Randomized treatment allocation was by design imbalanced in a ratio of 3:6:6:4 for placebo, albiglutide 30 mg, albiglutide 50 mg, and liraglutide. Non-serious AEs excludes hypoglycemia events.
 
Arm/Group Title Placebo - Before Switch Placebo - After Switch Albiglutide 30 mg Weekly Albiglutide 50 mg Weekly Open Label Liraglutide 0.9 mg Daily
Hide Arm/Group Description (Before Switch to 30 mg albiglutide) Participants received double blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. (After Switch to 30 mg algiblutide) After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52. Participants received double blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52. Participants received double blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52. Participants received open label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
All-Cause Mortality
Placebo - Before Switch Placebo - After Switch Albiglutide 30 mg Weekly Albiglutide 50 mg Weekly Open Label Liraglutide 0.9 mg Daily
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo - Before Switch Placebo - After Switch Albiglutide 30 mg Weekly Albiglutide 50 mg Weekly Open Label Liraglutide 0.9 mg Daily
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/77 (0.00%)   0/65 (0.00%)   5/160 (3.13%)   6/150 (4.00%)   0/103 (0.00%) 
Congenital, familial and genetic disorders           
Rathke's cleft cyst  0/77 (0.00%)  0/65 (0.00%)  0/160 (0.00%)  1/150 (0.67%)  0/103 (0.00%) 
Eye disorders           
Macular oedema  0/77 (0.00%)  0/65 (0.00%)  1/160 (0.63%)  0/150 (0.00%)  0/103 (0.00%) 
Hepatobiliary disorders           
Cholecystitis  0/77 (0.00%)  0/65 (0.00%)  1/160 (0.63%)  0/150 (0.00%)  0/103 (0.00%) 
Infections and infestations           
Pulmonary tuberculosis  0/77 (0.00%)  0/65 (0.00%)  1/160 (0.63%)  0/150 (0.00%)  0/103 (0.00%) 
Injury, poisoning and procedural complications           
Spinal compression fracture  0/77 (0.00%)  0/65 (0.00%)  0/160 (0.00%)  1/150 (0.67%)  0/103 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Breast cancer  0/77 (0.00%)  0/65 (0.00%)  0/160 (0.00%)  1/150 (0.67%)  0/103 (0.00%) 
Gastric cancer  0/77 (0.00%)  0/65 (0.00%)  0/160 (0.00%)  1/150 (0.67%)  0/103 (0.00%) 
Lymphoma  0/77 (0.00%)  0/65 (0.00%)  0/160 (0.00%)  1/150 (0.67%)  0/103 (0.00%) 
Pancreatic carcinoma  0/77 (0.00%)  0/65 (0.00%)  1/160 (0.63%)  0/150 (0.00%)  0/103 (0.00%) 
Plasma cell myeloma  0/77 (0.00%)  0/65 (0.00%)  0/160 (0.00%)  1/150 (0.67%)  0/103 (0.00%) 
Rectal Cancer  0/77 (0.00%)  0/65 (0.00%)  1/160 (0.63%)  0/150 (0.00%)  0/103 (0.00%) 
Nervous system disorders           
Cerebellar haemorrhage  0/77 (0.00%)  0/65 (0.00%)  1/160 (0.63%)  0/150 (0.00%)  0/103 (0.00%) 
Renal and urinary disorders           
Renal failure acute  0/77 (0.00%)  0/65 (0.00%)  0/160 (0.00%)  1/150 (0.67%)  0/103 (0.00%) 
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo - Before Switch Placebo - After Switch Albiglutide 30 mg Weekly Albiglutide 50 mg Weekly Open Label Liraglutide 0.9 mg Daily
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   33/77 (42.86%)   24/65 (36.92%)   85/160 (53.13%)   76/150 (50.67%)   46/103 (44.66%) 
Gastrointestinal disorders           
Constipation  3/77 (3.90%)  3/65 (4.62%)  14/160 (8.75%)  17/150 (11.33%)  7/103 (6.80%) 
Nausea  4/77 (5.19%)  3/65 (4.62%)  2/160 (1.25%)  10/150 (6.67%)  4/103 (3.88%) 
Diarrhoea  4/77 (5.19%)  0/65 (0.00%)  2/160 (1.25%)  8/150 (5.33%)  5/103 (4.85%) 
General disorders           
Injection site erythema  0/77 (0.00%)  1/65 (1.54%)  3/160 (1.88%)  9/150 (6.00%)  0/103 (0.00%) 
Infections and infestations           
Nasopharyngitis  18/77 (23.38%)  10/65 (15.38%)  45/160 (28.13%)  34/150 (22.67%)  25/103 (24.27%) 
Bronchitis  2/77 (2.60%)  2/65 (3.08%)  4/160 (2.50%)  8/150 (5.33%)  2/103 (1.94%) 
Pharyngitis  1/77 (1.30%)  0/65 (0.00%)  13/160 (8.13%)  1/150 (0.67%)  2/103 (1.94%) 
Metabolism and nutrition disorders           
Hypoglycaemia  2/77 (2.60%)  3/65 (4.62%)  8/160 (5.00%)  6/150 (4.00%)  3/103 (2.91%) 
Musculoskeletal and connective tissue disorders           
Back pain  1/77 (1.30%)  2/65 (3.08%)  8/160 (5.00%)  4/150 (2.67%)  3/103 (2.91%) 
Respiratory, thoracic and mediastinal disorders           
Upper respiratory tract inflammation  3/77 (3.90%)  0/65 (0.00%)  8/160 (5.00%)  2/150 (1.33%)  3/103 (2.91%) 
Skin and subcutaneous tissue disorders           
Eczema  4/77 (5.19%)  2/65 (3.08%)  2/160 (1.25%)  4/150 (2.67%)  2/103 (1.94%) 
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01733758     History of Changes
Other Study ID Numbers: 113121
First Submitted: November 21, 2012
First Posted: November 27, 2012
Results First Submitted: April 2, 2015
Results First Posted: May 18, 2015
Last Update Posted: September 22, 2016