Trial Outcomes & Findings for A Monotherapy Study to Evaluate the Efficacy and Safety of 2 Dose Levels of Albiglutide in Japanese Subjects With Type 2 Diabetes Mellitus (T2DM) (NCT NCT01733758)
NCT ID: NCT01733758
Last Updated: 2016-09-22
Results Overview
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.
COMPLETED
PHASE3
494 participants
Baseline and Week 24
2016-09-22
Participant Flow
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.
Participant milestones
| Measure |
Placebo
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.
|
Albiglutide 30 mg Weekly
Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
|
Albiglutide 50 mg Weekly
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.
|
Open Label Liraglutide 0.9 mg Daily
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 Study
STARTED
|
77
|
160
|
150
|
103
|
|
Overall Study
COMPLETED
|
62
|
148
|
135
|
95
|
|
Overall Study
NOT COMPLETED
|
15
|
12
|
15
|
8
|
Reasons for withdrawal
| Measure |
Placebo
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.
|
Albiglutide 30 mg Weekly
Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
|
Albiglutide 50 mg Weekly
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.
|
Open Label Liraglutide 0.9 mg Daily
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 Study
Adverse Event
|
5
|
7
|
8
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
5
|
3
|
|
Overall Study
Persistent Hyperglycemia
|
3
|
2
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
2
|
2
|
|
Overall Study
Non-compliance
|
1
|
0
|
0
|
0
|
|
Overall Study
Intro of New Anti-Diabetic Medication
|
4
|
0
|
0
|
1
|
|
Overall Study
Inv Decision, HbA1c not controlled
|
1
|
1
|
0
|
1
|
Baseline Characteristics
A Monotherapy Study to Evaluate the Efficacy and Safety of 2 Dose Levels of Albiglutide in Japanese Subjects With Type 2 Diabetes Mellitus (T2DM)
Baseline characteristics by cohort
| Measure |
Placebo
n=77 Participants
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.
|
Albiglutide 30 mg Weekly
n=160 Participants
Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
|
Albiglutide 50 mg Weekly
n=150 Participants
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.
|
Open Label Liraglutide 0.9 mg Daily
n=103 Participants
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
n=490 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
57.3 Years
STANDARD_DEVIATION 11.27 • n=5 Participants
|
59.6 Years
STANDARD_DEVIATION 9.00 • n=7 Participants
|
57.7 Years
STANDARD_DEVIATION 9.51 • n=5 Participants
|
58.4 Years
STANDARD_DEVIATION 9.72 • n=4 Participants
|
58.4 Years
STANDARD_DEVIATION 9.70 • n=21 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
118 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
81 Participants
n=4 Participants
|
372 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian - Japanese Heritage
|
77 Participants
n=5 Participants
|
160 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
103 Participants
n=4 Participants
|
490 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=77 Participants
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.
|
Albiglutide 30 mg Weekly
n=159 Participants
Participants received double blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
|
Albiglutide 50 mg Weekly
n=150 Participants
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.
|
Open-Label Liraglutide 0.9 mg Daily
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.
|
|---|---|---|---|---|
|
Model-adjusted Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24
|
0.25 Percentage of HbA1c in the blood
Standard Error 0.068
|
-1.10 Percentage of HbA1c in the blood
Standard Error 0.047
|
-1.30 Percentage of HbA1c in the blood
Standard Error 0.049
|
—
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=77 Participants
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.
|
Albiglutide 30 mg Weekly
n=159 Participants
Participants received double blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
|
Albiglutide 50 mg Weekly
n=150 Participants
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.
|
Open-Label Liraglutide 0.9 mg Daily
n=103 Participants
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.
|
|---|---|---|---|---|
|
Mean HbA1c at Baseline, Week 24, and Change From Baseline at Week 24
Baseline
|
8.16 Percentage of HbA1c in the blood
Standard Deviation 0.877
|
8.06 Percentage of HbA1c in the blood
Standard Deviation 0.783
|
8.15 Percentage of HbA1c in the blood
Standard Deviation 0.825
|
8.07 Percentage of HbA1c in the blood
Standard Deviation 0.787
|
|
Mean HbA1c at Baseline, Week 24, and Change From Baseline at Week 24
Week 24
|
8.39 Percentage of HbA1c in the blood
Standard Deviation 1.066
|
6.98 Percentage of HbA1c in the blood
Standard Deviation 0.735
|
6.83 Percentage of HbA1c in the blood
Standard Deviation 0.659
|
6.87 Percentage of HbA1c in the blood
Standard Deviation 0.642
|
|
Mean HbA1c at Baseline, Week 24, and Change From Baseline at Week 24
Change from Baseline
|
0.24 Percentage of HbA1c in the blood
Standard Deviation 0.715
|
-1.08 Percentage of HbA1c in the blood
Standard Deviation 0.619
|
-1.32 Percentage of HbA1c in the blood
Standard Deviation 0.702
|
-1.19 Percentage of HbA1c in the blood
Standard Deviation 0.636
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=62 Participants
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.
|
Albiglutide 30 mg Weekly
n=148 Participants
Participants received double blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
|
Albiglutide 50 mg Weekly
n=135 Participants
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.
|
Open-Label Liraglutide 0.9 mg Daily
n=95 Participants
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.
|
|---|---|---|---|---|
|
Change From Baseline in HbA1c at Week 52
|
-1.07 Percentage of HbA1c in the blood
Standard Deviation 0.695
|
-1.07 Percentage of HbA1c in the blood
Standard Deviation 0.790
|
-1.34 Percentage of HbA1c in the blood
Standard Deviation 0.753
|
-1.17 Percentage of HbA1c in the blood
Standard Deviation 0.776
|
SECONDARY outcome
Timeframe: Week 24Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=77 Participants
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.
|
Albiglutide 30 mg Weekly
n=159 Participants
Participants received double blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
|
Albiglutide 50 mg Weekly
n=150 Participants
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.
|
Open-Label Liraglutide 0.9 mg Daily
n=103 Participants
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.
|
|---|---|---|---|---|
|
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
HbA1c <6.5% at Week 24
|
1 Percentage of participants
|
31 Percentage of participants
|
47 Percentage of participants
|
29 Percentage of participants
|
|
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
HbA1c <7.0% at Week 24
|
4 Percentage of participants
|
92 Percentage of participants
|
100 Percentage of participants
|
66 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 52Population: 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.
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%.
Outcome measures
| Measure |
Placebo
n=62 Participants
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.
|
Albiglutide 30 mg Weekly
n=148 Participants
Participants received double blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
|
Albiglutide 50 mg Weekly
n=135 Participants
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.
|
Open-Label Liraglutide 0.9 mg Daily
n=95 Participants
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.
|
|---|---|---|---|---|
|
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
HbA1c <6.5% at Week 52
|
14 Percentage of participants
|
44 Percentage of participants
|
53 Percentage of participants
|
27 Percentage of participants
|
|
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
HbA1c <7.0% at Week 52
|
33 Percentage of participants
|
82 Percentage of participants
|
85 Percentage of participants
|
57 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=77 Participants
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.
|
Albiglutide 30 mg Weekly
n=159 Participants
Participants received double blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
|
Albiglutide 50 mg Weekly
n=150 Participants
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.
|
Open-Label Liraglutide 0.9 mg Daily
n=103 Participants
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.
|
|---|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Baseline
|
159.3 Milligrams per deciliter (mg/dL)
Standard Deviation 37.07
|
157.1 Milligrams per deciliter (mg/dL)
Standard Deviation 33.81
|
158.7 Milligrams per deciliter (mg/dL)
Standard Deviation 32.82
|
157.2 Milligrams per deciliter (mg/dL)
Standard Deviation 31.22
|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Week 24
|
167.0 Milligrams per deciliter (mg/dL)
Standard Deviation 37.51
|
132.2 Milligrams per deciliter (mg/dL)
Standard Deviation 26.09
|
128.8 Milligrams per deciliter (mg/dL)
Standard Deviation 24.03
|
128.1 Milligrams per deciliter (mg/dL)
Standard Deviation 23.68
|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Change from Baseline at Week 24
|
7.7 Milligrams per deciliter (mg/dL)
Standard Deviation 31.77
|
-24.9 Milligrams per deciliter (mg/dL)
Standard Deviation 27.58
|
-30.0 Milligrams per deciliter (mg/dL)
Standard Deviation 27.83
|
-29.1 Milligrams per deciliter (mg/dL)
Standard Deviation 29.00
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=62 Participants
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.
|
Albiglutide 30 mg Weekly
n=147 Participants
Participants received double blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
|
Albiglutide 50 mg Weekly
n=135 Participants
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.
|
Open-Label Liraglutide 0.9 mg Daily
n=95 Participants
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.
|
|---|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52
Baseline
|
154.5 Milligrams per deciliter (mg/dL)
Standard Deviation 35.65
|
154.7 Milligrams per deciliter (mg/dL)
Standard Deviation 29.36
|
159.8 Milligrams per deciliter (mg/dL)
Standard Deviation 33.52
|
157.4 Milligrams per deciliter (mg/dL)
Standard Deviation 30.27
|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52
Week 52
|
131.7 Milligrams per deciliter (mg/dL)
Standard Deviation 23.13
|
131.9 Milligrams per deciliter (mg/dL)
Standard Deviation 24.14
|
126.3 Milligrams per deciliter (mg/dL)
Standard Deviation 24.47
|
127.0 Milligrams per deciliter (mg/dL)
Standard Deviation 20.78
|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52
Change from Baseline at Week 52
|
-22.7 Milligrams per deciliter (mg/dL)
Standard Deviation 27.38
|
-22.8 Milligrams per deciliter (mg/dL)
Standard Deviation 26.03
|
-33.5 Milligrams per deciliter (mg/dL)
Standard Deviation 31.10
|
-30.4 Milligrams per deciliter (mg/dL)
Standard Deviation 28.06
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=77 Participants
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.
|
Albiglutide 30 mg Weekly
n=159 Participants
Participants received double blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
|
Albiglutide 50 mg Weekly
n=150 Participants
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.
|
Open-Label Liraglutide 0.9 mg Daily
n=103 Participants
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.
|
|---|---|---|---|---|
|
Change From Baseline in Body Weight at Week 24
Baseline
|
68.65 Kilograms (kg)
Standard Deviation 12.088
|
69.46 Kilograms (kg)
Standard Deviation 13.453
|
71.54 Kilograms (kg)
Standard Deviation 12.907
|
72.65 Kilograms (kg)
Standard Deviation 13.758
|
|
Change From Baseline in Body Weight at Week 24
Week 24
|
68.15 Kilograms (kg)
Standard Deviation 12.139
|
69.78 Kilograms (kg)
Standard Deviation 13.793
|
71.50 Kilograms (kg)
Standard Deviation 13.023
|
72.30 Kilograms (kg)
Standard Deviation 13.459
|
|
Change From Baseline in Body Weight at Week 24
Change from Baseline at Week 24
|
-0.50 Kilograms (kg)
Standard Deviation 1.700
|
0.32 Kilograms (kg)
Standard Deviation 1.795
|
-0.04 Kilograms (kg)
Standard Deviation 1.976
|
-0.34 Kilograms (kg)
Standard Deviation 2.587
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=62 Participants
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.
|
Albiglutide 30 mg Weekly
n=148 Participants
Participants received double blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
|
Albiglutide 50 mg Weekly
n=135 Participants
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.
|
Open-Label Liraglutide 0.9 mg Daily
n=95 Participants
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.
|
|---|---|---|---|---|
|
Change From Baseline in Body Weight at Week 52
Baseline
|
68.07 Kilograms (kg)
Standard Deviation 11.978
|
70.07 Kilograms (kg)
Standard Deviation 13.242
|
71.27 Kilograms (kg)
Standard Deviation 12.801
|
72.43 Kilograms (kg)
Standard Deviation 12.895
|
|
Change From Baseline in Body Weight at Week 52
Week 52
|
68.00 Kilograms (kg)
Standard Deviation 12.150
|
70.15 Kilograms (kg)
Standard Deviation 13.536
|
70.96 Kilograms (kg)
Standard Deviation 12.431
|
71.93 Kilograms (kg)
Standard Deviation 12.564
|
|
Change From Baseline in Body Weight at Week 52
Change from Baseline at Week 52
|
-0.07 Kilograms (kg)
Standard Deviation 2.179
|
0.08 Kilograms (kg)
Standard Deviation 2.078
|
-0.31 Kilograms (kg)
Standard Deviation 2.382
|
-0.50 Kilograms (kg)
Standard Deviation 2.690
|
SECONDARY outcome
Timeframe: Baseline through Week 52Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=77 Participants
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.
|
Albiglutide 30 mg Weekly
n=160 Participants
Participants received double blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
|
Albiglutide 50 mg Weekly
n=150 Participants
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.
|
Open-Label Liraglutide 0.9 mg Daily
n=103 Participants
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.
|
|---|---|---|---|---|
|
Time to Study Withdrawal Due to Hyperglycemia
|
NA Weeks
There were too few events of withdrawals due to hyperglycemia to calculate the median and confidence interval.
|
NA Weeks
There were too few events of withdrawals due to hyperglycemia to calculate the median and confidence interval.
|
NA Weeks
There were too few events of withdrawals due to hyperglycemia to calculate the median and confidence interval.
|
NA Weeks
There were too few events of withdrawals due to hyperglycemia to calculate the median and confidence interval.
|
SECONDARY outcome
Timeframe: Baseline through Week 52Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=77 Participants
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.
|
Albiglutide 30 mg Weekly
n=160 Participants
Participants received double blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
|
Albiglutide 50 mg Weekly
n=150 Participants
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.
|
Open-Label Liraglutide 0.9 mg Daily
n=103 Participants
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.
|
|---|---|---|---|---|
|
Time to Study Withdrawal for Any Reason
|
NA Weeks
There were too few events of withdrawals for any reason to calculate the median and confidence interval.
|
NA Weeks
There were too few events of withdrawals for any reason to calculate the median and confidence interval.
|
NA Weeks
There were too few events of withdrawals for any reason to calculate the median and confidence interval.
|
NA Weeks
There were too few events of withdrawals for any reason to calculate the median and confidence interval.
|
Adverse Events
Placebo - Before Switch
Placebo - After Switch
Albiglutide 30 mg Weekly
Albiglutide 50 mg Weekly
Open Label Liraglutide 0.9 mg Daily
Serious adverse events
| Measure |
Placebo - Before Switch
n=77 participants at risk
(Before Switch to 30 mg albiglutide) Participants received double blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24.
|
Placebo - After Switch
n=65 participants at risk
(After Switch to 30 mg algiblutide) After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
|
Albiglutide 30 mg Weekly
n=160 participants at risk
Participants received double blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
|
Albiglutide 50 mg Weekly
n=150 participants at risk
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.
|
Open Label Liraglutide 0.9 mg Daily
n=103 participants at risk
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.
|
|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/77 • 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.
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.
|
0.00%
0/65 • 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.
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.
|
0.00%
0/160 • 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.
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.
|
0.67%
1/150 • 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.
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.
|
0.00%
0/103 • 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.
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/77 • 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.
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.
|
0.00%
0/65 • 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.
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.
|
0.00%
0/160 • 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.
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.
|
0.67%
1/150 • 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.
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.
|
0.00%
0/103 • 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.
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/77 • 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.
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.
|
0.00%
0/65 • 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.
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.
|
0.00%
0/160 • 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.
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.
|
0.67%
1/150 • 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.
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.
|
0.00%
0/103 • 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.
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/77 • 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.
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.
|
0.00%
0/65 • 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.
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.
|
0.62%
1/160 • 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.
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.
|
0.00%
0/150 • 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.
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.
|
0.00%
0/103 • 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.
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.00%
0/77 • 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.
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.
|
0.00%
0/65 • 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.
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.
|
0.00%
0/160 • 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.
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.
|
0.67%
1/150 • 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.
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.
|
0.00%
0/103 • 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.
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Cancer
|
0.00%
0/77 • 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.
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.
|
0.00%
0/65 • 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.
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.
|
0.62%
1/160 • 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.
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.
|
0.00%
0/150 • 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.
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.
|
0.00%
0/103 • 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.
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.
|
|
Congenital, familial and genetic disorders
Rathke's cleft cyst
|
0.00%
0/77 • 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.
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.
|
0.00%
0/65 • 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.
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.
|
0.00%
0/160 • 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.
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.
|
0.67%
1/150 • 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.
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.
|
0.00%
0/103 • 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.
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.
|
|
Eye disorders
Macular oedema
|
0.00%
0/77 • 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.
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.
|
0.00%
0/65 • 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.
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.
|
0.62%
1/160 • 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.
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.
|
0.00%
0/150 • 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.
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.
|
0.00%
0/103 • 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.
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.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/77 • 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.
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.
|
0.00%
0/65 • 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.
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.
|
0.62%
1/160 • 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.
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.
|
0.00%
0/150 • 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.
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.
|
0.00%
0/103 • 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.
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.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/77 • 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.
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.
|
0.00%
0/65 • 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.
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.
|
0.62%
1/160 • 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.
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.
|
0.00%
0/150 • 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.
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.
|
0.00%
0/103 • 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.
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.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/77 • 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.
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.
|
0.00%
0/65 • 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.
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.
|
0.00%
0/160 • 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.
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.
|
0.67%
1/150 • 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.
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.
|
0.00%
0/103 • 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.
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.
|
|
Nervous system disorders
Cerebellar haemorrhage
|
0.00%
0/77 • 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.
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.
|
0.00%
0/65 • 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.
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.
|
0.62%
1/160 • 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.
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.
|
0.00%
0/150 • 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.
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.
|
0.00%
0/103 • 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.
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.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/77 • 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.
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.
|
0.00%
0/65 • 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.
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.
|
0.00%
0/160 • 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.
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.
|
0.67%
1/150 • 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.
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.
|
0.00%
0/103 • 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.
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.
|
Other adverse events
| Measure |
Placebo - Before Switch
n=77 participants at risk
(Before Switch to 30 mg albiglutide) Participants received double blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24.
|
Placebo - After Switch
n=65 participants at risk
(After Switch to 30 mg algiblutide) After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
|
Albiglutide 30 mg Weekly
n=160 participants at risk
Participants received double blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
|
Albiglutide 50 mg Weekly
n=150 participants at risk
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.
|
Open Label Liraglutide 0.9 mg Daily
n=103 participants at risk
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.
|
|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
23.4%
18/77 • 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.
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.
|
15.4%
10/65 • 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.
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.
|
28.1%
45/160 • 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.
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.
|
22.7%
34/150 • 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.
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.
|
24.3%
25/103 • 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.
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.
|
|
Gastrointestinal disorders
Constipation
|
3.9%
3/77 • 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.
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.
|
4.6%
3/65 • 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.
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.
|
8.8%
14/160 • 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.
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.
|
11.3%
17/150 • 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.
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.
|
6.8%
7/103 • 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.
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.
|
|
Gastrointestinal disorders
Nausea
|
5.2%
4/77 • 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.
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.
|
4.6%
3/65 • 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.
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.
|
1.2%
2/160 • 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.
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.
|
6.7%
10/150 • 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.
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.
|
3.9%
4/103 • 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.
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.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.6%
2/77 • 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.
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.
|
4.6%
3/65 • 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.
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.
|
5.0%
8/160 • 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.
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.
|
4.0%
6/150 • 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.
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.
|
2.9%
3/103 • 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.
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.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.2%
4/77 • 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.
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.
|
0.00%
0/65 • 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.
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.
|
1.2%
2/160 • 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.
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.
|
5.3%
8/150 • 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.
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.
|
4.9%
5/103 • 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.
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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.3%
1/77 • 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.
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.
|
3.1%
2/65 • 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.
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.
|
5.0%
8/160 • 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.
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.
|
2.7%
4/150 • 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.
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.
|
2.9%
3/103 • 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.
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.
|
|
Infections and infestations
Bronchitis
|
2.6%
2/77 • 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.
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.
|
3.1%
2/65 • 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.
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.
|
2.5%
4/160 • 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.
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.
|
5.3%
8/150 • 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.
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.
|
1.9%
2/103 • 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.
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.
|
|
Infections and infestations
Pharyngitis
|
1.3%
1/77 • 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.
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.
|
0.00%
0/65 • 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.
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.
|
8.1%
13/160 • 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.
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.
|
0.67%
1/150 • 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.
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.
|
1.9%
2/103 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
3.9%
3/77 • 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.
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.
|
0.00%
0/65 • 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.
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.
|
5.0%
8/160 • 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.
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.
|
1.3%
2/150 • 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.
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.
|
2.9%
3/103 • 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.
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.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
5.2%
4/77 • 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.
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.
|
3.1%
2/65 • 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.
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.
|
1.2%
2/160 • 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.
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.
|
2.7%
4/150 • 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.
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.
|
1.9%
2/103 • 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.
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.
|
|
General disorders
Injection site erythema
|
0.00%
0/77 • 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.
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.
|
1.5%
1/65 • 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.
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.
|
1.9%
3/160 • 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.
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.
|
6.0%
9/150 • 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.
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.
|
0.00%
0/103 • 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.
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.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER