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Safety and Efficacy Study of Albiglutide in Type 2 Diabetes

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: NCT00849017
Recruitment Status : Completed
First Posted : February 23, 2009
Results First Posted : June 5, 2014
Last Update Posted : January 9, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Diabetes Mellitus, Type 2
Interventions Biological: albiglutide
Biological: albiglutide uptitration
Biological: placebo
Enrollment 309
Recruitment Details  
Pre-assignment Details Participants (par.) who met eligibility criteria and completed a 4 week Run-in/Stabilization Period were then randomized to a 156-week Treatment Period, followed by 8 weeks of post-treatment follow-up. A total of 479 par. were screened; 309 par. were randomized, and 301 par. received >=1 treatment dose.
Arm/Group Title Placebo Albiglutide 30 mg Albiglutide 50 mg
Hide Arm/Group Description Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period. Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period. Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
Period Title: Treatment Period (156 Weeks)
Started 101 101 99
Completed 58 68 57
Not Completed 43 33 42
Reason Not Completed
Adverse Event             5             6             15
Noncompliance             3             3             4
Lost to Follow-up             10             7             8
Withdrawal by Subject             18             14             11
Physician Decision             0             2             1
Termination of Study/ Site by GSK             3             1             1
Increased Calcitonin             1             0             0
Physician Discontinued-Thrombocytopenia             1             0             0
Participant Moved to Africa             1             0             0
Pregnancy             1             0             1
Participant Decided to Move Out of State             0             0             1
Period Title: Follow-up Period (8 Weeks)
Started 101 [1] 101 [1] 99 [1]
Completed 76 83 74
Not Completed 25 18 25
Reason Not Completed
Adverse Event             1             0             0
Noncompliance             2             1             0
Lost to Follow-up             13             12             16
Did Not Enter Follow-up Period             1             1             4
Withdrawal by Subject             4             2             3
Physician Decision             0             1             1
Termination of Study/ Site by GSK             3             1             1
Participant Relocating to Africa             1             0             0
[1]
Participants withdrawing from the Treatment Period entered the Follow-up Period.
Arm/Group Title Placebo Albiglutide 30 mg Albiglutide 50 mg Total
Hide Arm/Group Description Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period. Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period. Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period. Total of all reporting groups
Overall Number of Baseline Participants 101 101 99 301
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 101 participants 101 participants 99 participants 301 participants
53.1  (11.68) 53.6  (10.89) 52.0  (11.75) 52.9  (11.43)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants 101 participants 99 participants 301 participants
Female
43
  42.6%
43
  42.6%
49
  49.5%
135
  44.9%
Male
58
  57.4%
58
  57.4%
50
  50.5%
166
  55.1%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 101 participants 101 participants 99 participants 301 participants
African American/African Heritage 14 10 14 38
American Indian or Alaskan Native 3 1 1 5
Asian - Central/South Asian Heritage 0 1 1 2
Asian - East Asian Heritage 2 0 0 2
Asian - Japanese Heritage 1 0 0 1
Asian - South East Asian Heritage 2 0 0 2
Native Hawaiian or Other Pacific Islander 2 2 2 6
White - Arabic/North African Heritage 0 2 3 5
White - White/Caucasian/European Heritage 77 85 78 240
1.Primary Outcome
Title Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52
Hide Description Glycated hemoglobin (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 BL HbA1c is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 52 minus the value at BL. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, history of prior myocardial infarction (yes versus no), and age category (<65 years versus ≥65 years) as factors and Baseline HbA1c as a continuous covariate. The last observation carried forward (LOCF) method was used to impute missing post-BL HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population with LOCF: all randomized par. who received >=1 dose of study medication and who had a BL assessment and >=1 post-BL assessment of HbA1c. Only par. with a value at BL and at the specified visit were analyzed. Values were carried forward for par. who were rescued or discontinued from active treatment before Week 52.
Arm/Group Title Placebo Albiglutide 30 mg Albiglutide 50 mg
Hide Arm/Group Description:
Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
Overall Number of Participants Analyzed 98 100 97
Least Squares Mean (Standard Error)
Unit of Measure: Percentage of HbA1c in the blood
0.15  (0.097) -0.70  (0.096) -0.89  (0.097)
Show Statistical Analysis 1 Hide Statistical Analysis 1
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 <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.84
Confidence Interval (2-Sided) 95%
-1.11 to -0.58
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Albiglutide 50 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.04
Confidence Interval (2-Sided) 95%
-1.31 to -0.77
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in HbA1c at Weeks 104 and 156
Hide Description HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed HbA1c values, excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.
Time Frame Baseline and Weeks 104 and 156
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
Arm/Group Title Placebo Albiglutide 30 mg Albiglutide 50 mg
Hide Arm/Group Description:
Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
Overall Number of Participants Analyzed 99 100 97
Mean (Standard Deviation)
Unit of Measure: Percentage of HbA1c in the blood
Week 104, n=21, 39, 42 -0.40  (0.676) -0.93  (1.027) -1.18  (0.909)
Week 156, n=14, 30, 32 -0.61  (0.644) -0.96  (0.968) -1.07  (0.887)
3.Secondary Outcome
Title Time to Hyperglycemia Rescue
Hide Description Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: FPG >=280 milligrams/deciliter (mg/dL) between >=Week 2 and <Week 4; FPG >=250 mg/dL between >=Week 4 and <Week 12; HbA1c >=8.5% and a <=0.5% reduction from Baseline between >=Week 12 and <Week 24; HbA1c >=8.5% between >=Week 24 and <Week 48; HbA1c >=8.0% between >= Week 48 and <Week 156. Participants could have been rescued at any time on or after Week 2. Time to hyperglycemia rescue is defined as the time between the date of the first dose of study medication and the date of hyperglycemia rescue plus 1 day, or the time between the date of the first dose of study medication and the date of the last visit during the active treatment period plus 1 day for participants not requiring rescue. This time was divided by 7 to express the result in weeks.
Time Frame From the start of study medication until the end of the treatment (up to Week 156)
Hide Outcome Measure Data
Hide Analysis Population Description
IIT Population. Only those participants with a value at Baseline and at the specified visit were analyzed.
Arm/Group Title Placebo Albiglutide 30 mg Albiglutide 50 mg
Hide Arm/Group Description:
Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
Overall Number of Participants Analyzed 99 100 97
Median (95% Confidence Interval)
Unit of Measure: Weeks
49.71
(32.14 to 67.29)
118.43 [1] 
(79.43 to NA)
NA [2] 
(NA to NA)
[1]
The 95% CI upper bound is not a available because it is beyond study duration.
[2]
There were too few events of hyperglycemia rescue (<50% of participants with events) to calculate the median and confidence interval.
4.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52
Hide Description The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. FPG values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on ANCOVA: change = treatment + Baseline weight + prior myocardial infarction history + age category + region + current antidiabetic therapy.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.
Arm/Group Title Placebo Albiglutide 30 mg Albiglutide 50 mg
Hide Arm/Group Description:
Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
Overall Number of Participants Analyzed 99 100 97
Least Squares Mean (Standard Error)
Unit of Measure: Millimoles per liter (mmol/L)
1.00  (0.239) -0.88  (0.237) -1.38  (0.241)
5.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (FPG) at Week 156
Hide Description The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline FPG minus the Baseline FPG.
Time Frame Baseline and Week 156
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed. This analysis used observed FPG values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.
Arm/Group Title Placebo Albiglutide 30 mg Albiglutide 50 mg
Hide Arm/Group Description:
Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
Overall Number of Participants Analyzed 14 29 32
Mean (Standard Deviation)
Unit of Measure: Millimoles per liter (mmol/L)
-0.23  (0.794) -1.31  (1.761) -1.83  (2.012)
6.Secondary Outcome
Title Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 52
Hide Description The number of participants who acheieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 52) were assessed.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.
Arm/Group Title Placebo Albiglutide 30 mg Albiglutide 50 mg
Hide Arm/Group Description:
Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
Overall Number of Participants Analyzed 98 100 97
Measure Type: Number
Unit of Measure: Participants
Week 52, HbA1c <6.5% 10 25 24
Week 52, HbA1c <7.0% 21 49 39
Week 52, HbA1c <7.5% 34 59 62
7.Secondary Outcome
Title Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156
Hide Description The number of participants who acheieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 156) were assessed.
Time Frame Week 156
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed. This analysis used observed HbA1c values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.
Arm/Group Title Placebo Albiglutide 30 mg Albiglutide 50 mg
Hide Arm/Group Description:
Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
Overall Number of Participants Analyzed 14 30 32
Measure Type: Number
Unit of Measure: Participants
Week 156, HbA1c <6.5% 6 10 11
Week 156, HbA1c <7.0% 8 18 19
Week 156, HbA1c <7.5% 13 24 29
8.Secondary Outcome
Title Change From Baseline in Body Weight at Week 52
Hide Description The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with prerescue values. Based on ANCOVA: change = treatment + Baseline weight + prior myocardial infarction history + age category + region + current antidiabetic therapy.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.
Arm/Group Title Placebo Albiglutide 30 mg Albiglutide 50 mg
Hide Arm/Group Description:
Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
Overall Number of Participants Analyzed 99 100 97
Least Squares Mean (Standard Error)
Unit of Measure: Kilograms
-0.66  (0.428) -0.39  (0.424) -0.86  (0.432)
9.Secondary Outcome
Title Change From Baseline in Body Weight at Week 156
Hide Description The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight.
Time Frame Baseline and Week 156
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population with observed values. Only those participants who were available at the indicated time points were analyzed. This analysis used observed body weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.
Arm/Group Title Placebo Albiglutide 30 mg Albiglutide 50 mg
Hide Arm/Group Description:
Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
Overall Number of Participants Analyzed 14 30 31
Mean (Standard Deviation)
Unit of Measure: Kilograms
-2.91  (5.213) -1.32  (5.123) -2.24  (5.589)
10.Secondary Outcome
Title Change From Baseline in Postprandial Blood Glucose Profile Parameter-4 Hour C-peptide AUC
Hide Description Changes from Baseline at Week 52 in postprandial parameters after a mixed-meal (MM) tolerance test were analyzed. Post prandial blood glucose parameter analyzed was 4 hour c-peptide AUC. The AUC was determined using the trapezoidal method using measurements until 4 hours following the meal. The standardized AUC is the total AUC divided by elapsed time. Those parameters were analyzed analogous to the primary endpoint using an ANCOVA model with treatment group as a factor, and corresponding Baseline postprandial profile as a continuous covariate. This analysis used observed values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
MM Population: all participants who participated in the MM tolerance test substudy and who had valid Baseline assessments and Week 52 assessments for at least 1 of the MM lab parameter of C-peptide.
Arm/Group Title Placebo Albiglutide 30 mg Weekly Albiglutide 50 mg Weekly
Hide Arm/Group Description:
Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
Overall Number of Participants Analyzed 8 16 20
Least Squares Mean (Standard Error)
Unit of Measure: Nanomoles/Liter (nmol/L)
0.05  (0.165) 0.03  (0.122) 0.08  (0.108)
11.Secondary Outcome
Title Change From Baseline in Postprandial Blood Glucose Profile Parameter- 4 Hour Blood Glucose AUC
Hide Description Changes from Baseline at Week 52 in postprandial parameters after a mixed-meal (MM) tolerance test were analyzed. Post prandial blood glucose parameter analyzed was: 4 hour blood glucose area under urve AUC The AUC was determined using the trapezoidal method using measurements until 4 hours following the meal. The standardized AUC is the total AUC divided by elapsed time. Those parameters were analyzed analogous to the primary endpoint using an ANCOVA model with treatment group as a factor, and corresponding Baseline postprandial profile as a continuous covariate. This analysis used observed values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
MM Population: all participants who participated in the MM tolerance test substudy and who had valid baseline assessments and Week 52 assessments for at least 1 of the MM lab parameter of glucose. The MM tolerance test was performed only in those participants who additionally consented to participate in.
Arm/Group Title Placebo Albiglutide 30 mg Albiglutide 50 mg
Hide Arm/Group Description:
Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
Overall Number of Participants Analyzed 8 18 19
Least Squares Mean (Standard Error)
Unit of Measure: Nanomoles/Liter (nmol/L)
-0.51  (0.630) -1.74  (0.414) -2.05  (0.407)
12.Secondary Outcome
Title Change From Baseline in Postprandial Blood Glucose Profile Parameters-4 Hour Insulin AUC and 4 Hour Proinsulin AUC
Hide Description Changes from Baseline at Week 52 in postprandial parameters after a mixed-meal (MM) tolerance test were analyzed. Post prandial blood glucose parameters analyzed were: 4-hour insulin AUC (4 hr Ins AUC), and 4-hour proinsulin AUC (4 hr pro-Ins AUC). The AUC was determined using the trapezoidal method using measurements until 4 hours following the meal. The standardized AUC is the total AUC divided by elapsed time. Those parameters were analyzed analogous to the primary endpoint using an ANCOVA model with treatment group as a factor, and corresponding Baseline postprandial profile as a continuous covariate. This analysis used observed values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
MM Population: all participant who participated in the MM tolerance test substudy and who had valid baseline assessments and Week 52 assessments for at least 1 of the MM lab parameters of insulin, proinsulin. The MM tolerance test was performed only in those participants who additionally consented to participate in.
Arm/Group Title Placebo Albiglutide 30 mg Albiglutide 50 mg
Hide Arm/Group Description:
Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
Overall Number of Participants Analyzed 8 16 20
Least Squares Mean (Standard Error)
Unit of Measure: picomoles/Liter (pmol/L)
4hr Ins AUC 49.2  (50.12) 2.9  (36.44) 39.9  (32.62)
4hr Pro-Ins AUC 1.0  (17.57) 1.9  (13.25) -10.7  (11.62)
13.Secondary Outcome
Title Albiglutide Plasma Concentration at Weeks 8 and 24
Hide Description Albiglutide plasma concentration data was analyzed at Week 8 pre-dose, Week 8 post dose, Week 24 pre-dose and Week 24 post-dose. All participants who received albiglutide were initiated on a 30mg weekly dosing regimen; however, beginning at Week 12, participants in the albiglutide 50 mg treatment group were uptitrated to receive albiglutide 50 mg for the remainder of the study.
Time Frame Weeks 8 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Only those participants with a PK sample available for analysis at the indicated time points were analyzed.
Arm/Group Title Albiglutide 30 mg Albiglutide 50 mg
Hide Arm/Group Description:
Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
Overall Number of Participants Analyzed 87 85
Mean (Standard Deviation)
Unit of Measure: nanograms/milliliter (ng/mL)
Week 8 Pre-dose, n=85, 85 1582  (735) 1433  (736)
Week 8 Post-dose, n=87, 80 1900  (1093) 1759  (861)
Week 24 Pre-dose, n=79, 74 1912  (966) 3060  (1610)
Week 24 Post-dose, n=81, 72 2289  (1255) 3484  (2301)
Time Frame On-treatment serious adverse events (SAEs) and non-serious AEs, defined as those events that had a start date on or after the first day of study medication and within 56 days after the end of study medication (up to Week 156), are reported.
Adverse Event Reporting Description SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
 
Arm/Group Title Placebo Albiglutide 30 mg Albiglutide 50 mg
Hide Arm/Group Description Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period. Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period. Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
All-Cause Mortality
Placebo Albiglutide 30 mg Albiglutide 50 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Albiglutide 30 mg Albiglutide 50 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   16/101 (15.84%)   15/101 (14.85%)   14/99 (14.14%) 
Cardiac disorders       
Cardiac failure congestive  1  2/101 (1.98%)  1/101 (0.99%)  0/99 (0.00%) 
Coronary artery disease  1  2/101 (1.98%)  1/101 (0.99%)  0/99 (0.00%) 
Acute myocardial infarction  1  2/101 (1.98%)  0/101 (0.00%)  0/99 (0.00%) 
Angina unstable  1  1/101 (0.99%)  0/101 (0.00%)  0/99 (0.00%) 
Atrial fibrillation  1  0/101 (0.00%)  1/101 (0.99%)  0/99 (0.00%) 
Cardiomyopathy  1  0/101 (0.00%)  1/101 (0.99%)  0/99 (0.00%) 
Congestive cardiomyopathy  1  0/101 (0.00%)  1/101 (0.99%)  0/99 (0.00%) 
Left ventricular dysfunction  1  1/101 (0.99%)  0/101 (0.00%)  0/99 (0.00%) 
Mitral valve incompetence  1  1/101 (0.99%)  0/101 (0.00%)  0/99 (0.00%) 
Pericardial effusion  1  0/101 (0.00%)  0/101 (0.00%)  1/99 (1.01%) 
Gastrointestinal disorders       
Colitis ischaemic  1  0/101 (0.00%)  1/101 (0.99%)  0/99 (0.00%) 
Peritoneal haemorrhage  1  1/101 (0.99%)  0/101 (0.00%)  0/99 (0.00%) 
Volvulus  1  1/101 (0.99%)  0/101 (0.00%)  0/99 (0.00%) 
Vomiting  1  0/101 (0.00%)  0/101 (0.00%)  1/99 (1.01%) 
General disorders       
Chest pain  1  0/101 (0.00%)  2/101 (1.98%)  0/99 (0.00%) 
Non-cardiac chest pain  1  0/101 (0.00%)  1/101 (0.99%)  1/99 (1.01%) 
Drowning  1  0/101 (0.00%)  0/101 (0.00%)  1/99 (1.01%) 
Infections and infestations       
Cellulitis  1  0/101 (0.00%)  0/101 (0.00%)  1/99 (1.01%) 
Cellulitis staphylococcal  1  0/101 (0.00%)  0/101 (0.00%)  1/99 (1.01%) 
Diabetic foot infection  1  0/101 (0.00%)  0/101 (0.00%)  1/99 (1.01%) 
Lobar pneumonia  1  0/101 (0.00%)  0/101 (0.00%)  1/99 (1.01%) 
Pneumonia  1  0/101 (0.00%)  0/101 (0.00%)  1/99 (1.01%) 
Pyelonephritis acute  1  1/101 (0.99%)  0/101 (0.00%)  0/99 (0.00%) 
Viral pericarditis  1  0/101 (0.00%)  0/101 (0.00%)  1/99 (1.01%) 
Injury, poisoning and procedural complications       
Concussion  1  0/101 (0.00%)  0/101 (0.00%)  1/99 (1.01%) 
Post procedural haemorrhage  1  0/101 (0.00%)  1/101 (0.99%)  0/99 (0.00%) 
Rib fracture  1  0/101 (0.00%)  1/101 (0.99%)  0/99 (0.00%) 
Musculoskeletal and connective tissue disorders       
Intervertebral disc degeneration  1  0/101 (0.00%)  1/101 (0.99%)  0/99 (0.00%) 
Musculoskeletal chest pain  1  0/101 (0.00%)  0/101 (0.00%)  1/99 (1.01%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Breast cancer  1  1/101 (0.99%)  0/101 (0.00%)  1/99 (1.01%) 
B-cell lymphoma  1  0/101 (0.00%)  0/101 (0.00%)  1/99 (1.01%) 
Bladder cancer  1  1/101 (0.99%)  0/101 (0.00%)  0/99 (0.00%) 
Colon cancer  1  1/101 (0.99%)  0/101 (0.00%)  0/99 (0.00%) 
Endometrial cancer stage I  1  0/101 (0.00%)  1/101 (0.99%)  0/99 (0.00%) 
Hodgkin's disease  1  0/101 (0.00%)  0/101 (0.00%)  1/99 (1.01%) 
Lung adenocarcinoma metastatic  1  0/101 (0.00%)  0/101 (0.00%)  1/99 (1.01%) 
Malignant melanoma in situ  1  1/101 (0.99%)  0/101 (0.00%)  0/99 (0.00%) 
Neuroendocrine tumour  1  0/101 (0.00%)  0/101 (0.00%)  1/99 (1.01%) 
Pancreatic carcinoma metastatic  1  0/101 (0.00%)  0/101 (0.00%)  1/99 (1.01%) 
Prostate cancer  1  1/101 (0.99%)  0/101 (0.00%)  0/99 (0.00%) 
Nervous system disorders       
Transient ischaemic attack  1  2/101 (1.98%)  2/101 (1.98%)  0/99 (0.00%) 
Carpal tunnel syndrome  1  0/101 (0.00%)  1/101 (0.99%)  0/99 (0.00%) 
Cerebral infarction  1  0/101 (0.00%)  1/101 (0.99%)  0/99 (0.00%) 
Convulsion  1  0/101 (0.00%)  1/101 (0.99%)  0/99 (0.00%) 
Ischemic stroke  1  1/101 (0.99%)  0/101 (0.00%)  0/99 (0.00%) 
Syncope  1  0/101 (0.00%)  1/101 (0.99%)  0/99 (0.00%) 
Psychiatric disorders       
Suicidal ideation  1  0/101 (0.00%)  1/101 (0.99%)  0/99 (0.00%) 
Renal and urinary disorders       
Calculus ureteric  1  1/101 (0.99%)  0/101 (0.00%)  1/99 (1.01%) 
Reproductive system and breast disorders       
Benign prostatic hyperplasia  1  1/101 (0.99%)  0/101 (0.00%)  0/99 (0.00%) 
Ovarian cyst  1  0/101 (0.00%)  1/101 (0.99%)  0/99 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Acute respiratory failure  1  0/101 (0.00%)  0/101 (0.00%)  1/99 (1.01%) 
Bronchial hyperreactivity  1  1/101 (0.99%)  0/101 (0.00%)  0/99 (0.00%) 
Respiratory failure  1  1/101 (0.99%)  0/101 (0.00%)  0/99 (0.00%) 
Vascular disorders       
Aortic aneurysm  1  0/101 (0.00%)  1/101 (0.99%)  0/99 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Placebo Albiglutide 30 mg Albiglutide 50 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   78/101 (77.23%)   84/101 (83.17%)   83/99 (83.84%) 
Blood and lymphatic system disorders       
Anaemia  1  1/101 (0.99%)  3/101 (2.97%)  3/99 (3.03%) 
Cardiac disorders       
Angina pectoris  1  5/101 (4.95%)  1/101 (0.99%)  0/99 (0.00%) 
Coronary artery disease  1  3/101 (2.97%)  1/101 (0.99%)  2/99 (2.02%) 
Ear and labyrinth disorders       
Vertigo  1  2/101 (1.98%)  2/101 (1.98%)  4/99 (4.04%) 
Eye disorders       
Diabetic retinopathy  1  1/101 (0.99%)  4/101 (3.96%)  1/99 (1.01%) 
Cataract  1  2/101 (1.98%)  2/101 (1.98%)  3/99 (3.03%) 
Vision blurred  1  0/101 (0.00%)  1/101 (0.99%)  4/99 (4.04%) 
Gastrointestinal disorders       
Nausea  1  10/101 (9.90%)  14/101 (13.86%)  11/99 (11.11%) 
Diarrhoea  1  15/101 (14.85%)  13/101 (12.87%)  16/99 (16.16%) 
Abdominal pain  1  8/101 (7.92%)  5/101 (4.95%)  2/99 (2.02%) 
Gastrooesophageal reflux disease  1  3/101 (2.97%)  5/101 (4.95%)  6/99 (6.06%) 
Dyspepsia  1  6/101 (5.94%)  5/101 (4.95%)  1/99 (1.01%) 
Vomiting  1  1/101 (0.99%)  4/101 (3.96%)  4/99 (4.04%) 
Constipation  1  4/101 (3.96%)  3/101 (2.97%)  6/99 (6.06%) 
Haemorrhoids  1  4/101 (3.96%)  2/101 (1.98%)  1/99 (1.01%) 
Umbilical hernia  1  1/101 (0.99%)  1/101 (0.99%)  2/99 (2.02%) 
Toothache  1  0/101 (0.00%)  0/101 (0.00%)  5/99 (5.05%) 
General disorders       
Injection site reaction  1  2/101 (1.98%)  10/101 (9.90%)  18/99 (18.18%) 
Fatigue  1  5/101 (4.95%)  7/101 (6.93%)  5/99 (5.05%) 
Oedema peripheral  1  3/101 (2.97%)  6/101 (5.94%)  4/99 (4.04%) 
Injection site rash  1  0/101 (0.00%)  5/101 (4.95%)  3/99 (3.03%) 
Injection site erythema  1  1/101 (0.99%)  4/101 (3.96%)  3/99 (3.03%) 
Chest pain  1  2/101 (1.98%)  3/101 (2.97%)  1/99 (1.01%) 
Injection site haematoma  1  5/101 (4.95%)  2/101 (1.98%)  2/99 (2.02%) 
Injection site pruritus  1  2/101 (1.98%)  2/101 (1.98%)  3/99 (3.03%) 
Asthenia  1  2/101 (1.98%)  1/101 (0.99%)  2/99 (2.02%) 
Irritability  1  0/101 (0.00%)  0/101 (0.00%)  3/99 (3.03%) 
Hepatobiliary disorders       
Hepatic steatosis  1  3/101 (2.97%)  1/101 (0.99%)  1/99 (1.01%) 
Immune system disorders       
Seasonal allergy  1  3/101 (2.97%)  1/101 (0.99%)  1/99 (1.01%) 
Infections and infestations       
Upper Respiratory tract infection  1  17/101 (16.83%)  11/101 (10.89%)  17/99 (17.17%) 
Bronchitis  1  10/101 (9.90%)  8/101 (7.92%)  7/99 (7.07%) 
Nasopharyngitis  1  6/101 (5.94%)  8/101 (7.92%)  7/99 (7.07%) 
Influenza  1  3/101 (2.97%)  8/101 (7.92%)  6/99 (6.06%) 
Cellulitis  1  2/101 (1.98%)  8/101 (7.92%)  2/99 (2.02%) 
Sinusitis  1  8/101 (7.92%)  6/101 (5.94%)  7/99 (7.07%) 
Urinary tract Infection  1  8/101 (7.92%)  5/101 (4.95%)  7/99 (7.07%) 
Gastroenteritis viral  1  1/101 (0.99%)  4/101 (3.96%)  1/99 (1.01%) 
Pharyngitis  1  7/101 (6.93%)  3/101 (2.97%)  4/99 (4.04%) 
Tinea pedis  1  1/101 (0.99%)  3/101 (2.97%)  1/99 (1.01%) 
Ear infection  1  3/101 (2.97%)  2/101 (1.98%)  0/99 (0.00%) 
Tooth abscess  1  1/101 (0.99%)  2/101 (1.98%)  2/99 (2.02%) 
Vulvovaginal candidiasis  1  0/101 (0.00%)  1/101 (0.99%)  2/99 (2.02%) 
Vulvovaginal mycotic infection  1  0/101 (0.00%)  1/101 (0.99%)  2/99 (2.02%) 
Acute sinusitis  1  0/101 (0.00%)  0/101 (0.00%)  2/99 (2.02%) 
Labyrinthitis  1  0/101 (0.00%)  0/101 (0.00%)  2/99 (2.02%) 
Viral infection  1  0/101 (0.00%)  0/101 (0.00%)  2/99 (2.02%) 
Injury, poisoning and procedural complications       
Muscle Strain  1  4/101 (3.96%)  4/101 (3.96%)  2/99 (2.02%) 
Arthropod Bite  1  4/101 (3.96%)  2/101 (1.98%)  0/99 (0.00%) 
Procedural pain  1  3/101 (2.97%)  2/101 (1.98%)  1/99 (1.01%) 
Excoriation  1  2/101 (1.98%)  1/101 (0.99%)  3/99 (3.03%) 
Laceration  1  1/101 (0.99%)  1/101 (0.99%)  4/99 (4.04%) 
Investigations       
Gamma-glutamyltransferase increased  1  0/101 (0.00%)  3/101 (2.97%)  0/99 (0.00%) 
Blood uric acid increased  1  0/101 (0.00%)  2/101 (1.98%)  2/99 (2.02%) 
Glycosylated haemoglobin increased  1  3/101 (2.97%)  1/101 (0.99%)  0/99 (0.00%) 
Metabolism and nutrition disorders       
Hypoglycaemia  1  8/101 (7.92%)  6/101 (5.94%)  9/99 (9.09%) 
Hyperlipidaemia  1  0/101 (0.00%)  4/101 (3.96%)  2/99 (2.02%) 
Vitamin D deficiency  1  2/101 (1.98%)  3/101 (2.97%)  2/99 (2.02%) 
Dyslipidaemia  1  3/101 (2.97%)  3/101 (2.97%)  0/99 (0.00%) 
Gout  1  1/101 (0.99%)  3/101 (2.97%)  0/99 (0.00%) 
Hyperuricaemia  1  4/101 (3.96%)  1/101 (0.99%)  0/99 (0.00%) 
Hypokalaemia  1  2/101 (1.98%)  1/101 (0.99%)  2/99 (2.02%) 
Hypercholesterolaemia  1  2/101 (1.98%)  0/101 (0.00%)  2/99 (2.02%) 
Hypertriglyceridaemia  1  2/101 (1.98%)  0/101 (0.00%)  2/99 (2.02%) 
Dehydration  1  1/101 (0.99%)  0/101 (0.00%)  2/99 (2.02%) 
Musculoskeletal and connective tissue disorders       
Back pain  1  6/101 (5.94%)  11/101 (10.89%)  5/99 (5.05%) 
Arthralgia  1  7/101 (6.93%)  6/101 (5.94%)  6/99 (6.06%) 
Pain in extremity  1  6/101 (5.94%)  6/101 (5.94%)  7/99 (7.07%) 
Osteoarthritis  1  2/101 (1.98%)  6/101 (5.94%)  1/99 (1.01%) 
Musculoskeletal pain  1  4/101 (3.96%)  4/101 (3.96%)  4/99 (4.04%) 
Musculoskeletal chest pain  1  2/101 (1.98%)  4/101 (3.96%)  0/99 (0.00%) 
Exostosis  1  2/101 (1.98%)  3/101 (2.97%)  0/99 (0.00%) 
Myalgia  1  3/101 (2.97%)  2/101 (1.98%)  2/99 (2.02%) 
Muscle spasms  1  3/101 (2.97%)  2/101 (1.98%)  1/99 (1.01%) 
Neck Pain  1  3/101 (2.97%)  2/101 (1.98%)  0/99 (0.00%) 
Tendonitis  1  0/101 (0.00%)  2/101 (1.98%)  3/99 (3.03%) 
Rotator cuff syndrome  1  2/101 (1.98%)  1/101 (0.99%)  2/99 (2.02%) 
Temporomandibular Joint Syndrome  1  0/101 (0.00%)  1/101 (0.99%)  2/99 (2.02%) 
Nervous system disorders       
Headache  1  19/101 (18.81%)  15/101 (14.85%)  11/99 (11.11%) 
Dizziness  1  7/101 (6.93%)  5/101 (4.95%)  2/99 (2.02%) 
Paraesthesia  1  1/101 (0.99%)  3/101 (2.97%)  2/99 (2.02%) 
Carpal tunnel syndrome  1  0/101 (0.00%)  3/101 (2.97%)  2/99 (2.02%) 
Hypoaesthesia  1  1/101 (0.99%)  1/101 (0.99%)  2/99 (2.02%) 
Sensory Loss  1  3/101 (2.97%)  1/101 (0.99%)  0/99 (0.00%) 
Migraine  1  3/101 (2.97%)  0/101 (0.00%)  2/99 (2.02%) 
Diabetic neuropathy  1  3/101 (2.97%)  0/101 (0.00%)  1/99 (1.01%) 
Psychiatric disorders       
Depression  1  5/101 (4.95%)  4/101 (3.96%)  5/99 (5.05%) 
Anxiety  1  1/101 (0.99%)  2/101 (1.98%)  3/99 (3.03%) 
Renal and urinary disorders       
Haematuria  1  4/101 (3.96%)  1/101 (0.99%)  0/99 (0.00%) 
Reproductive system and breast disorders       
Erectile dysfunction  1  0/101 (0.00%)  0/101 (0.00%)  3/99 (3.03%) 
Respiratory, thoracic and mediastinal disorders       
Sinus congestion  1  1/101 (0.99%)  6/101 (5.94%)  0/99 (0.00%) 
Cough  1  8/101 (7.92%)  5/101 (4.95%)  6/99 (6.06%) 
Rhinitis allergic  1  1/101 (0.99%)  5/101 (4.95%)  1/99 (1.01%) 
Oropharyngeal pain  1  2/101 (1.98%)  4/101 (3.96%)  2/99 (2.02%) 
Dyspnoea  1  1/101 (0.99%)  4/101 (3.96%)  0/99 (0.00%) 
Asthma  1  2/101 (1.98%)  1/101 (0.99%)  2/99 (2.02%) 
Nasal congestion  1  3/101 (2.97%)  0/101 (0.00%)  1/99 (1.01%) 
Pleural effusion  1  1/101 (0.99%)  0/101 (0.00%)  2/99 (2.02%) 
Skin and subcutaneous tissue disorders       
Dermatitis contact  1  5/101 (4.95%)  3/101 (2.97%)  3/99 (3.03%) 
Rash  1  4/101 (3.96%)  1/101 (0.99%)  3/99 (3.03%) 
Alopecia  1  1/101 (0.99%)  0/101 (0.00%)  2/99 (2.02%) 
Eczema  1  3/101 (2.97%)  0/101 (0.00%)  0/99 (0.00%) 
Hyperhidrosis  1  0/101 (0.00%)  0/101 (0.00%)  2/99 (2.02%) 
Vascular disorders       
Hypertension  1  12/101 (11.88%)  11/101 (10.89%)  12/99 (12.12%) 
Hot Flush  1  0/101 (0.00%)  3/101 (2.97%)  2/99 (2.02%) 
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
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00849017     History of Changes
Other Study ID Numbers: 112756
First Submitted: February 19, 2009
First Posted: February 23, 2009
Results First Submitted: April 24, 2014
Results First Posted: June 5, 2014
Last Update Posted: January 9, 2017