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A Multi-center, Placebo-controlled Study to Evaluate the Safety of GSK716155 and Its Effects on Myocardial Metabolism, Myocardial Function, and Exercise Capacity in Patients With NYHA Class II/III Congestive Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01357850
Recruitment Status : Completed
First Posted : May 23, 2011
Results First Posted : October 1, 2014
Last Update Posted : August 17, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Basic Science
Condition Heart Failure, Congestive
Interventions Drug: GSK716155
Drug: Placebo
Enrollment 82
Recruitment Details  
Pre-assignment Details Participants (par.) who met eligibility criteria and completed a 30 day Screening were then randomized to a 13-week Treatment Period, followed by a Follow-up visit 28 days post-treatment. The duration of the study was approximately 20 weeks from Screening to Follow-up. A total of 100 par. were planned, and 82 par. were randomized.
Arm/Group Title Placebo Albiglutide 3.75 mg Albiglutide 15 mg Albiglutide 30 mg
Hide Arm/Group Description Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. Participants received albiglutide 3.75 milligrams (mg) weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Period Title: Overall Study
Started 30 12 13 27
Completed 29 12 13 27
Not Completed 1 0 0 0
Reason Not Completed
Lost to Follow-up             1             0             0             0
Arm/Group Title Placebo Albiglutide 3.75 mg Albiglutide 15 mg Albiglutide 30 mg Total
Hide Arm/Group Description Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. Total of all reporting groups
Overall Number of Baseline Participants 30 12 13 27 82
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 12 participants 13 participants 27 participants 82 participants
55.6  (9.60) 51.3  (12.44) 57.2  (11.02) 58.2  (10.23) 56.1  (10.53)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 12 participants 13 participants 27 participants 82 participants
Female
9
  30.0%
3
  25.0%
2
  15.4%
7
  25.9%
21
  25.6%
Male
21
  70.0%
9
  75.0%
11
  84.6%
20
  74.1%
61
  74.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants 12 participants 13 participants 27 participants 82 participants
African American/African Heritage 3 4 5 4 16
Native Hawaiian Or Other Pacific Islander 1 0 0 0 1
Asian - Central/South Asian Heritage 0 0 0 1 1
White - White/Caucasian/European Heritage 26 7 8 22 63
White - Arabic/North African Heritage 0 1 0 0 1
1.Primary Outcome
Title Change From Baseline in Myocardial Glucose Utilization as Assessed by [18F]Fluoro-2-deoxy-glucose Positron Emission Tomography (FDG-PET) Imaging
Hide Description FDG-PET imaging was performed at Baseline and Week 13 to assess myocardial glucose uptake. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on analysis using a mixed effects analysis of variance (ANOVA) model, fitting terms for treatment, visit and interaction of treatment and visit, with participants as random effects.
Time Frame Baseline and Week 13
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: all randomized participants who received >= 1 dose of study medication and had >= 1 on treatment assessment. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo Albiglutide 3.75 mg Albiglutide 15 mg Albiglutide 30 mg
Hide Arm/Group Description:
Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Overall Number of Participants Analyzed 10 4 4 11
Least Squares Mean (95% Confidence Interval)
Unit of Measure: micromoles per gram per minute
0.0185
(-0.0158 to 0.0528)
0.0103
(-0.0440 to 0.0646)
0.0369
(0.0042 to 0.0695)
0.0059
(-0.0268 to 0.0386)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Albiglutide 3.75 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7873
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.0119
Confidence Interval (2-Sided) 95%
-0.0768 to 0.1005
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Albiglutide 15 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0499
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.0678
Confidence Interval (2-Sided) 95%
0.0000 to 0.1356
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Albiglutide 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1666
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.0467
Confidence Interval (2-Sided) 95%
-0.0204 to 0.1137
Estimation Comments [Not Specified]
2.Primary Outcome
Title Change From Baseline in Myocardial Efficiency (Work Performed/Myocardial Oxygen Consumption [MVO2]) Assessed at Rest
Hide Description MVO2 was estimated by measuring the rate of myocardial clearance of 11C-activity which represents overall myocardial oxidative flux through the TCA cycle. Cardiac work was measured by echocardiography and cardiac efficiency index was calculated as work (by echocardiography) divided by MVO2. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on analysis using a mixed effects ANOVA model, fitting terms for treatment, visit and interaction of treatment and visit, with participants as random effects.
Time Frame Baseline and Week 13
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo Albiglutide 3.75 mg Albiglutide 15 mg Albiglutide 30 mg
Hide Arm/Group Description:
Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Overall Number of Participants Analyzed 10 5 11 11
Least Squares Mean (95% Confidence Interval)
Unit of Measure: millimeters of mercury/liter/minute2
-1051.90
(-3136.43 to 1032.63)
-1070.09
(-3846.14 to 1705.95)
-348.58
(-2278.39 to 1581.23)
-870.64
(-2771.39 to 1030.11)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Albiglutide 3.75 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9343
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 134.89
Confidence Interval (2-Sided) 95%
-3172.05 to 3441.83
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Albiglutide 15 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3375
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1278.77
Confidence Interval (2-Sided) 95%
-1398.13 to 3955.68
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Albiglutide 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5582
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 772.70
Confidence Interval (2-Sided) 95%
-1887.77 to 3433.17
Estimation Comments [Not Specified]
3.Primary Outcome
Title Change From Baseline in Peak Oxygen Uptake (Peak VO2) as Assessed by Bicycle Cardiopulmonary Exercise Testing
Hide Description Peak VO2 was measured at Baseline and Week 13. Participants performed a maximal exercise test limited by dyspnea or fatigue on a cycle ergometer. After a rest period, the workloads were increased in a step fashion by 25 watts every 3 minutes. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on analysis using a mixed effects ANOVA model, fitting terms for treatment, visit and interaction of treatment and visit, with participants as random effects.
Time Frame Baseline and Week 13
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo Albiglutide 3.75 mg Albiglutide 15 mg Albiglutide 30 mg
Hide Arm/Group Description:
Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Overall Number of Participants Analyzed 29 12 13 26
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Milliliters per kilogram per minute
-0.63
(-1.53 to 0.27)
0.05
(-1.35 to 1.45)
0.51
(-0.84 to 1.85)
0.88
(-0.07 to 1.83)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Albiglutide 3.75 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2256
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -2.06
Confidence Interval (2-Sided) 95%
-5.43 to 1.30
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Albiglutide 15 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5647
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.95
Confidence Interval (2-Sided) 95%
-4.22 to 2.32
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Albiglutide 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8942
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.18
Confidence Interval (2-Sided) 95%
-2.44 to 2.79
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Left Ventricular Ejection Fraction (LVEF) as Assessed by Echocardiogram
Hide Description Echocardiography was performed at Baseline and Week 13 using pulse-wave, continuous-wave, and tissue Doppler. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time Frame Baseline and Week 13
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo Albiglutide 3.75 mg Albiglutide 15 mg Albiglutide 30 mg
Hide Arm/Group Description:
Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Overall Number of Participants Analyzed 28 11 13 27
Geometric Mean (Standard Error)
Unit of Measure: Percentage
1.12  (1.06) 0.99  (2.21) 1.03  (1.64) 1.08  (1.08)
5.Secondary Outcome
Title Change From Baseline in Left Ventricular (LV) Volumes in Systole and Diastole as Assessed by Echocardiogram
Hide Description Echocardiography was performed at Baseline and Week 13 using pulse-wave, continuous-wave and tissue Doppler. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time Frame Baseline and Week 13
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo Albiglutide 3.75 mg Albiglutide 15 mg Albiglutide 30 mg
Hide Arm/Group Description:
Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Overall Number of Participants Analyzed 28 11 13 27
Geometric Mean (Standard Error)
Unit of Measure: Milliliters
LV end-diastolic volume 0.9  (4.92) 1.0  (3.05) 1.0  (4.37) 1.0  (5.54)
LV end-systolic volume 0.9  (4.05) 1.0  (3.80) 1.0  (5.08) 0.9  (5.11)
6.Secondary Outcome
Title Change From Baseline in LV and RV Function Assessed by Cardiac Magnetic Resonance (CMR) (LVEF), Myocardial Strain Assessed by Myocardial Tagging Indices
Hide Description Non-contrast CMR to assess left ventricular (LV) and right ventricular (RV) ejection fraction, volume, mass, and strain was performed following a period of rest after exercise testing at Baseline and after the Week 13 treatment phase. A 3Tesla magnetic resonance imagine (MRI) examination was performed including sequences for evaluation of LV structure and function. Only those participants available at the specified time points were analyzed. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time Frame Baseline and Week 13
Hide Outcome Measure Data
Hide Analysis Population Description
CMR Substudy Population: all randomized participants who participated in the CMR substudy and had valid Baseline and/or Week 13 assessments for >= 1 one of the imaging parameters of LV and RV function assessed by CMR (LVEF, LV and RV volumes in systole and diastole, LV mass), myocardial strain assessed by myocardial tagging indices.
Arm/Group Title Placebo Albiglutide 3.75 mg Albiglutide 15 mg Albiglutide 30 mg
Hide Arm/Group Description:
Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Overall Number of Participants Analyzed 5 1 2 7
Geometric Mean (Standard Error)
Unit of Measure: Percentage
1.17  (1.64) 1.14 [1]   (NA) 1.09  (4.0) 1.09  (1.90)
[1]
Only one participant was analyzed in this treatment arm at this time point; therefore the mean and standard error cannot be calculated.
7.Secondary Outcome
Title Change From Baseline in LV and RV Function Assessed by CMR (LV and RV Volumes in Systole and Diastole), Myocardial Strain Assessed by Myocardial Tagging Indices
Hide Description Non-contrast CMR to assess LV and RV ejection fraction, volume, mass, and strain was performed following a period of rest after exercise testing at Baseline and after the Week 13 treatment phase. A 3Tesla magnetic resonance imagine (MRI) examination was performed including sequences for evaluation of LV structure and function. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time Frame Baseline and Week 13
Hide Outcome Measure Data
Hide Analysis Population Description
CMR Substudy Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo Albiglutide 3.75 mg Albiglutide 15 mg Albiglutide 30 mg
Hide Arm/Group Description:
Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Overall Number of Participants Analyzed 5 1 2 7
Geometric Mean (Standard Error)
Unit of Measure: Milliliters
LV end-diastolic volume 0.99  (11.08) 1.02 [1]   (NA) 0.96  (12.50) 0.95  (11.79)
LV end-systolic volume 0.90  (7.80) 0.89 [1]   (NA) 0.94  (3.00) 0.89  (9.42)
[1]
Only one participant was analyzed in this treatment arm at this time point; therefore the mean and standard error cannot be calculated.
8.Secondary Outcome
Title Change From Baseline in LV and RV Function Assessed by CMR (LV Mass), Myocardial Strain Assessed by Myocardial Tagging Indices
Hide Description Non-contrast CMR to assess left/right ventricular ejection fraction, volume, mass, and strain was performed following a period of rest after exercise testing at Baseline and after the Week 13 treatment phase. A 3Tesla magnetic resonance imagine (MRI) examination was performed including sequences for evaluation of LV structure and function. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time Frame Baseline and Week 13
Hide Outcome Measure Data
Hide Analysis Population Description
CMR Substudy Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo Albiglutide 3.75 mg Albiglutide 15 mg Albiglutide 30 mg
Hide Arm/Group Description:
Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Overall Number of Participants Analyzed 5 1 2 7
Geometric Mean (Standard Error)
Unit of Measure: Grams
0.96  (7.99) 1.04 [1]   (NA) 1.08  (1.50) 0.97  (10.65)
[1]
Only one participant was analyzed in this treatment arm at this time point; therefore the mean and standard error cannot be calculated.
9.Secondary Outcome
Title Change From Baseline in Cardiac Energetics (PCr/ATP) Measured by 31P Magnetic Resonance Spectroscopy (MRS)
Hide Description Participants underwent a CMR scan performed on a 3 Tesla MR system at Baseline and Week 13 to assess cardiac mass, volumes (global function and dilatation), strain and torsion, cardiac and liver lipid content and cardiac energy metabolism. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time Frame Baseline and Week 13
Hide Outcome Measure Data
Hide Analysis Population Description
Magnetic Resonance Substudy Population (MRS): all randomized participants who participated in the MRS substudy and had valid Baseline and/or Week 13 assessments for either PCr/ATP via 31P MRS. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo Albiglutide 30 mg
Hide Arm/Group Description:
Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Overall Number of Participants Analyzed 5 6
Least Squares Mean (95% Confidence Interval)
Unit of Measure: ratio
0.33
(-0.29 to 0.94)
0.11
(-0.45 to 0.67)
10.Secondary Outcome
Title Change From Baseline in Cardiac and Liver Fat by Proton Spectroscopy (1H MRS)
Hide Description Change in Baseline in cardiac and liver fat by proton spectroscopy was planned at Baseline and Week 13. The protocol allowed for sites to perform all or only efficacy assessments, depending on site designation, capability and feasibility. No sites that enrolled participants into this study were able to perform this outcome measure.
Time Frame Baseline and Week 13
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Albiglutide 3.75 mg Albiglutide 15 mg Albiglutide 30 mg
Hide Arm/Group Description:
Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Change From Baseline in Exercise Capacity Assessed by 6-minute Walk Test
Hide Description The six minute walk test was performed at Baseline and Week 13. All participantss were given standardized instructions and the distance walked was measured. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time Frame Baseline and Week 13
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo Albiglutide 3.75 mg Albiglutide 15 mg Albiglutide 30 mg
Hide Arm/Group Description:
Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Overall Number of Participants Analyzed 28 12 13 27
Geometric Mean (95% Confidence Interval)
Unit of Measure: Meters
1.03
(0.98 to 1.07)
1.10
(0.96 to 1.25)
1.14
(1.00 to 1.30)
1.05
(1.00 to 1.10)
12.Secondary Outcome
Title Change From Baseline in Serum N-terminal Fragment Brain Natriuretic Peptide (NT-BNP) Level
Hide Description Baseline is defined as the last available assessment on or prior to the first dose of study medication. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time Frame Change from Baseline at Week 13
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo Albiglutide 3.75 mg Albiglutide 15 mg Albiglutide 30 mg
Hide Arm/Group Description:
Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Overall Number of Participants Analyzed 28 12 12 25
Geometric Mean (Standard Error)
Unit of Measure: Nanogram per liter
0.90  (10.43) 0.90  (34.20) 0.70  (31.50) 0.90  (25.73)
13.Secondary Outcome
Title Change From Baseline in Plasma Levels of Glucose, and Free Fatty Acids (FFA)
Hide Description Blood samples for biomarker analysis of fasting levels of glucose and FFA were collected at Weeks 1, 7 and 13; glucose was also collected at Weeks 2, 4, 6, 8, 10, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time Frame Baseline and Week 13
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed for different parameters at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.
Arm/Group Title Placebo Albiglutide 3.75 mg Albiglutide 15 mg Albiglutide 30 mg
Hide Arm/Group Description:
Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Overall Number of Participants Analyzed 30 12 13 27
Geometric Mean (Standard Error)
Unit of Measure: Millimole per liter (mmol/L)
FFA (n=24, 10, 12, 22) 0.81  (0.03) 0.90  (0.05) 0.74  (0.04) 0.87  (0.05)
Glucose (n=29, 12, 13, 27) 1.01  (0.14) 0.91  (0.27) 1.00  (0.16) 1.00  (0.17)
14.Secondary Outcome
Title Change From Baseline in Plasma Levels of Insulin
Hide Description Blood samples for biomarker analysis of fasting levels of insulin were collected at Weeks 1, 7 and 13. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time Frame Baseline and Week 13
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo Albiglutide 3.75 mg Albiglutide 15 mg Albiglutide 30 mg
Hide Arm/Group Description:
Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Overall Number of Participants Analyzed 28 12 13 26
Geometric Mean (Standard Error)
Unit of Measure: picomole per liter (pmol/L)
0.9  (18.08) 0.7  (30.49) 1.0  (15.41) 1.2  (15.56)
15.Secondary Outcome
Title Change From Baseline in Quality of Life as Assessed by the Minnesota Living With Heart Failure Questionnaire
Hide Description Minnesota living with heart failure questionnaire (MLHFQ) is a validated instrument to measure participant-reported quality of life at Baseline and Week 13. For each of 21 items, participants rated the effects of heart failure and its treatment on physical, socioeconomic and psychological aspects of their life. To measure the effects of symptoms, functional limitations, psychological distress on an individual's quality of life, the MLHF questionnaire asks each participant to indicate their response using a 6-point scale (ranging from 0 to 5, 0=no, 1=very little, and 5=very much). The min and max scores can range from 0 to 105. The likert scale measures the effect of heart failure and treatments for heart failure on an individual's ability to live as they want. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time Frame Baseline and Week 13
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo Albiglutide 3.75 mg Albiglutide 15 mg Albiglutide 30 mg
Hide Arm/Group Description:
Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Overall Number of Participants Analyzed 29 12 13 27
Geometric Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
0.8
(0.6 to 1.0)
0.7
(0.4 to 1.2)
0.7
(0.5 to 1.0)
0.7
(0.5 to 0.9)
16.Secondary Outcome
Title Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Please refer to the AE/SAE section for further details.
Time Frame Baseline and Week 13
Hide Outcome Measure Data
Hide Analysis Population Description
All Subject Population: all randomized participants who received >= 1 dose of study medication. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo Albiglutide 3.75 mg Albiglutide 15 mg Albiglutide 30 mg
Hide Arm/Group Description:
Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Overall Number of Participants Analyzed 30 12 13 27
Measure Type: Number
Unit of Measure: Participants
Any AE 25 12 12 20
Any SAEs 4 2 2 0
17.Secondary Outcome
Title Number of Participants With Adverse Events by the Indicated Severity
Hide Description An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Severity categories: Mild: an event that was easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities;Moderate: an event that was sufficiently discomforting to interfere with normal everyday activities; Severe: an event that prevents normal everyday activities.
Time Frame Baseline and Week 13
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo Albiglutide 3.75 mg Albiglutide 15 mg Albiglutide 30 mg
Hide Arm/Group Description:
Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Overall Number of Participants Analyzed 30 12 13 27
Measure Type: Number
Unit of Measure: Participants
Mild 10 6 4 12
Moderate 13 4 6 6
Severe 2 2 2 2
Time Frame Serious adverse events (SAEs) and non-serious AEs collected from the start of study medication and within 30 days after the end of study medication (Week 13) are reported.
Adverse Event Reporting Description AEs and non-serious AEs are reported for members of the All subjects Population, comprised of all participants randomized to treatment, who have taken at least one dose of study medication.
 
Arm/Group Title Placebo Albiglutide 3.75 mg Albiglutide 15 mg Albiglutide 30 mg
Hide Arm/Group Description Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
All-Cause Mortality
Placebo Albiglutide 3.75 mg Albiglutide 15 mg Albiglutide 30 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Placebo Albiglutide 3.75 mg Albiglutide 15 mg Albiglutide 30 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/30 (13.33%)   2/12 (16.67%)   2/13 (15.38%)   0/27 (0.00%) 
Cardiac disorders         
Atrial Fibrillation  1  1/30 (3.33%)  0/12 (0.00%)  0/13 (0.00%)  0/27 (0.00%) 
Cardiac Failure Congestive  1  1/30 (3.33%)  0/12 (0.00%)  0/13 (0.00%)  0/27 (0.00%) 
Ventricular Tachycardia  1  1/30 (3.33%)  0/12 (0.00%)  0/13 (0.00%)  0/27 (0.00%) 
Gastrointestinal disorders         
Small Intestinal Obstruction  1  0/30 (0.00%)  1/12 (8.33%)  0/13 (0.00%)  0/27 (0.00%) 
General disorders         
Device Malfunction  1  0/30 (0.00%)  1/12 (8.33%)  0/13 (0.00%)  0/27 (0.00%) 
Infections and infestations         
Urinary Tract Infection  1  0/30 (0.00%)  0/12 (0.00%)  1/13 (7.69%)  0/27 (0.00%) 
Injury, poisoning and procedural complications         
Procedural Vomiting  1  1/30 (3.33%)  0/12 (0.00%)  0/13 (0.00%)  0/27 (0.00%) 
Metabolism and nutrition disorders         
Dehydration  1  0/30 (0.00%)  0/12 (0.00%)  1/13 (7.69%)  0/27 (0.00%) 
Vascular disorders         
Hypotension  1  0/30 (0.00%)  1/12 (8.33%)  1/13 (7.69%)  0/27 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Albiglutide 3.75 mg Albiglutide 15 mg Albiglutide 30 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   22/30 (73.33%)   11/12 (91.67%)   11/13 (84.62%)   19/27 (70.37%) 
Blood and lymphatic system disorders         
Anaemia  1  0/30 (0.00%)  0/12 (0.00%)  1/13 (7.69%)  0/27 (0.00%) 
Eosinophilia  1  0/30 (0.00%)  0/12 (0.00%)  1/13 (7.69%)  0/27 (0.00%) 
Thrombocytopenia  1  0/30 (0.00%)  1/12 (8.33%)  0/13 (0.00%)  0/27 (0.00%) 
Cardiac disorders         
Palpitations  1  1/30 (3.33%)  1/12 (8.33%)  0/13 (0.00%)  1/27 (3.70%) 
Cardiac failure  1  2/30 (6.67%)  2/12 (16.67%)  2/13 (15.38%)  0/27 (0.00%) 
Angina pectoris  1  0/30 (0.00%)  0/12 (0.00%)  2/13 (15.38%)  0/27 (0.00%) 
Atrial fibrillation  1  0/30 (0.00%)  2/12 (16.67%)  0/13 (0.00%)  0/27 (0.00%) 
Ventricular tachycardia  1  1/30 (3.33%)  1/12 (8.33%)  0/13 (0.00%)  0/27 (0.00%) 
Ventricular extrasystoles  1  0/30 (0.00%)  0/12 (0.00%)  1/13 (7.69%)  0/27 (0.00%) 
Eye disorders         
Dry eye  1  0/30 (0.00%)  1/12 (8.33%)  0/13 (0.00%)  0/27 (0.00%) 
Vision blurred  1  0/30 (0.00%)  0/12 (0.00%)  1/13 (7.69%)  0/27 (0.00%) 
Gastrointestinal disorders         
Diarrhoea  1  5/30 (16.67%)  2/12 (16.67%)  3/13 (23.08%)  4/27 (14.81%) 
Vomiting  1  3/30 (10.00%)  0/12 (0.00%)  1/13 (7.69%)  2/27 (7.41%) 
Constipation  1  1/30 (3.33%)  0/12 (0.00%)  1/13 (7.69%)  2/27 (7.41%) 
Abdominal discomfort  1  0/30 (0.00%)  0/12 (0.00%)  0/13 (0.00%)  2/27 (7.41%) 
Abdominal pain  1  0/30 (0.00%)  0/12 (0.00%)  1/13 (7.69%)  1/27 (3.70%) 
Nausea  1  3/30 (10.00%)  0/12 (0.00%)  1/13 (7.69%)  0/27 (0.00%) 
Abdominal pain upper  1  0/30 (0.00%)  1/12 (8.33%)  0/13 (0.00%)  0/27 (0.00%) 
General disorders         
Fatigue  1  1/30 (3.33%)  2/12 (16.67%)  0/13 (0.00%)  2/27 (7.41%) 
Injection site pruritus  1  1/30 (3.33%)  1/12 (8.33%)  0/13 (0.00%)  1/27 (3.70%) 
Injection site haematoma  1  1/30 (3.33%)  2/12 (16.67%)  2/13 (15.38%)  0/27 (0.00%) 
Injection site pain  1  2/30 (6.67%)  0/12 (0.00%)  0/13 (0.00%)  0/27 (0.00%) 
Implant site pain  1  0/30 (0.00%)  0/12 (0.00%)  1/13 (7.69%)  0/27 (0.00%) 
Immune system disorders         
Seasonal allergy  1  0/30 (0.00%)  0/12 (0.00%)  1/13 (7.69%)  0/27 (0.00%) 
Infections and infestations         
Upper respiratory tract infection  1  4/30 (13.33%)  2/12 (16.67%)  1/13 (7.69%)  2/27 (7.41%) 
Nasopharyngitis  1  3/30 (10.00%)  1/12 (8.33%)  0/13 (0.00%)  1/27 (3.70%) 
Ear infection  1  0/30 (0.00%)  2/12 (16.67%)  0/13 (0.00%)  0/27 (0.00%) 
Eye infection  1  0/30 (0.00%)  1/12 (8.33%)  0/13 (0.00%)  0/27 (0.00%) 
Respiratory tract infection  1  0/30 (0.00%)  1/12 (8.33%)  0/13 (0.00%)  0/27 (0.00%) 
Subcutaneous abscess  1  0/30 (0.00%)  1/12 (8.33%)  0/13 (0.00%)  0/27 (0.00%) 
Urinary tract infection  1  0/30 (0.00%)  1/12 (8.33%)  0/13 (0.00%)  0/27 (0.00%) 
Vulvovaginal mycotic infection  1  0/30 (0.00%)  0/12 (0.00%)  1/13 (7.69%)  0/27 (0.00%) 
Injury, poisoning and procedural complications         
Contusion  1  0/30 (0.00%)  0/12 (0.00%)  0/13 (0.00%)  3/27 (11.11%) 
Excoriation  1  0/30 (0.00%)  0/12 (0.00%)  1/13 (7.69%)  0/27 (0.00%) 
Investigations         
Blood creatinine increased  1  1/30 (3.33%)  0/12 (0.00%)  0/13 (0.00%)  3/27 (11.11%) 
Lipase increased  1  0/30 (0.00%)  0/12 (0.00%)  0/13 (0.00%)  3/27 (11.11%) 
Blood urea increased  1  1/30 (3.33%)  1/12 (8.33%)  0/13 (0.00%)  2/27 (7.41%) 
International normalised ratio increased  1  1/30 (3.33%)  1/12 (8.33%)  0/13 (0.00%)  0/27 (0.00%) 
Brain natriuretic peptide increased  1  0/30 (0.00%)  0/12 (0.00%)  1/13 (7.69%)  0/27 (0.00%) 
Metabolism and nutrition disorders         
Impaired fasting glucose  1  0/30 (0.00%)  0/12 (0.00%)  1/13 (7.69%)  2/27 (7.41%) 
Gout  1  1/30 (3.33%)  1/12 (8.33%)  1/13 (7.69%)  0/27 (0.00%) 
Increased appetite  1  2/30 (6.67%)  0/12 (0.00%)  1/13 (7.69%)  0/27 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  0/30 (0.00%)  2/12 (16.67%)  0/13 (0.00%)  2/27 (7.41%) 
Musculoskeletal pain  1  2/30 (6.67%)  0/12 (0.00%)  1/13 (7.69%)  1/27 (3.70%) 
Muscle spasms  1  1/30 (3.33%)  0/12 (0.00%)  1/13 (7.69%)  1/27 (3.70%) 
Back pain  1  1/30 (3.33%)  1/12 (8.33%)  2/13 (15.38%)  0/27 (0.00%) 
Musculoskeletal discomfort  1  2/30 (6.67%)  0/12 (0.00%)  0/13 (0.00%)  0/27 (0.00%) 
Musculoskeletal chest pain  1  0/30 (0.00%)  0/12 (0.00%)  1/13 (7.69%)  0/27 (0.00%) 
Osteopenia  1  0/30 (0.00%)  1/12 (8.33%)  0/13 (0.00%)  0/27 (0.00%) 
Nervous system disorders         
Dizziness  1  2/30 (6.67%)  2/12 (16.67%)  1/13 (7.69%)  2/27 (7.41%) 
Headache  1  2/30 (6.67%)  0/12 (0.00%)  1/13 (7.69%)  0/27 (0.00%) 
Presyncope  1  2/30 (6.67%)  0/12 (0.00%)  0/13 (0.00%)  0/27 (0.00%) 
Paraesthesia  1  0/30 (0.00%)  1/12 (8.33%)  0/13 (0.00%)  0/27 (0.00%) 
Transient ischaemic attack  1  0/30 (0.00%)  0/12 (0.00%)  1/13 (7.69%)  0/27 (0.00%) 
Psychiatric disorders         
Anxiety  1  1/30 (3.33%)  1/12 (8.33%)  1/13 (7.69%)  0/27 (0.00%) 
Insomnia  1  2/30 (6.67%)  1/12 (8.33%)  0/13 (0.00%)  0/27 (0.00%) 
Renal and urinary disorders         
Renal failure acute  1  0/30 (0.00%)  1/12 (8.33%)  1/13 (7.69%)  0/27 (0.00%) 
Reproductive system and breast disorders         
Breast tenderness  1  1/30 (3.33%)  0/12 (0.00%)  1/13 (7.69%)  0/27 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Epistaxis  1  0/30 (0.00%)  0/12 (0.00%)  0/13 (0.00%)  2/27 (7.41%) 
Oropharyngeal pain  1  0/30 (0.00%)  0/12 (0.00%)  0/13 (0.00%)  2/27 (7.41%) 
Dyspnoea  1  2/30 (6.67%)  0/12 (0.00%)  2/13 (15.38%)  1/27 (3.70%) 
Dyspnoea paroxysmal nocturnal  1  0/30 (0.00%)  1/12 (8.33%)  0/13 (0.00%)  0/27 (0.00%) 
Hypoventilation  1  0/30 (0.00%)  0/12 (0.00%)  1/13 (7.69%)  0/27 (0.00%) 
Rales  1  0/30 (0.00%)  0/12 (0.00%)  1/13 (7.69%)  0/27 (0.00%) 
Rhinitis allergic  1  0/30 (0.00%)  1/12 (8.33%)  0/13 (0.00%)  0/27 (0.00%) 
Sinus congestion  1  0/30 (0.00%)  0/12 (0.00%)  1/13 (7.69%)  0/27 (0.00%) 
Wheezing  1  0/30 (0.00%)  1/12 (8.33%)  0/13 (0.00%)  0/27 (0.00%) 
Skin and subcutaneous tissue disorders         
Acne  1  0/30 (0.00%)  1/12 (8.33%)  0/13 (0.00%)  0/27 (0.00%) 
Acne cystic  1  0/30 (0.00%)  1/12 (8.33%)  0/13 (0.00%)  0/27 (0.00%) 
Actinic keratosis  1  0/30 (0.00%)  0/12 (0.00%)  1/13 (7.69%)  0/27 (0.00%) 
Hyperhidrosis  1  0/30 (0.00%)  1/12 (8.33%)  0/13 (0.00%)  0/27 (0.00%) 
Pruritus  1  0/30 (0.00%)  0/12 (0.00%)  1/13 (7.69%)  0/27 (0.00%) 
Rash papular  1  0/30 (0.00%)  1/12 (8.33%)  0/13 (0.00%)  0/27 (0.00%) 
Seborrhoeic dermatitis  1  0/30 (0.00%)  1/12 (8.33%)  0/13 (0.00%)  0/27 (0.00%) 
Vascular disorders         
Hypotension  1  2/30 (6.67%)  1/12 (8.33%)  0/13 (0.00%)  0/27 (0.00%) 
Hot flush  1  0/30 (0.00%)  1/12 (8.33%)  0/13 (0.00%)  0/27 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01357850    
Other Study ID Numbers: 112670
First Submitted: November 11, 2010
First Posted: May 23, 2011
Results First Submitted: April 17, 2014
Results First Posted: October 1, 2014
Last Update Posted: August 17, 2017