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Safety and Efficacy 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: NCT00849056
Recruitment Status : Completed
First Posted : February 23, 2009
Results First Posted : July 1, 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
Drug: placebo
Enrollment 310
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 450 par. were screened; 310 par. were randomized, and 301 par. received >=1 treatment dose.
Arm/Group Title Placebo + Pioglitazone With or Without Metformin Albiglutide 30 mg + Pioglitazone With or Without Metformin
Hide Arm/Group Description Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. 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 and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
Period Title: Treatment Period (TP) (156 Weeks)
Started 151 150
Completed 88 100
Not Completed 63 50
Reason Not Completed
Adverse Event             13             11
Protocol Violation             3             6
Noncompliance             3             3
Lost to Follow-up             7             5
Withdrawal by Subject             31             18
Physician Decision             3             3
Termination of Study/Site by GSK             1             4
Calcitonin Out of Range             1             0
Pregnancy             1             0
Period Title: Follow-up Period (FUP) (8 Weeks)
Started 149 [1] 149 [2]
Completed 122 124
Not Completed 27 25
Reason Not Completed
Adverse Event             1             3
Noncompliance             0             1
Lost to Follow-up             14             9
Withdrawal by Subject             9             7
Physician Decision             1             1
Termination of Study/Site by GSK             1             4
Early Termination             1             0
[1]
Par. withdrawing from the TP could enter the FUP. Two par. did not participate in the FUP.
[2]
Par. withdrawing from the TP could enter the FUP. One par. did not participate in the FUP.
Arm/Group Title Placebo + Pioglitazone With or Without Metformin Albiglutide 30 mg + Pioglitazone With or Without Metformin Total
Hide Arm/Group Description Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. 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 and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period. Total of all reporting groups
Overall Number of Baseline Participants 151 150 301
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 151 participants 150 participants 301 participants
54.9  (9.40) 55.2  (9.98) 55.0  (9.67)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 151 participants 150 participants 301 participants
Female
63
  41.7%
58
  38.7%
121
  40.2%
Male
88
  58.3%
92
  61.3%
180
  59.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 151 participants 150 participants 301 participants
African American/African Heritage 20 19 39
American Indian or Alaskan Native 15 18 33
Asian - Central/South Asian Heritage 1 2 3
Asian - East Asian Heritage 2 3 5
Asian - Japanese Heritage 1 1 2
Asian - South East Asian Heritage 2 0 2
Native Hawaiian or other Pacific Islander 2 1 3
White - Arabic/North African Heritage 2 2 4
White - White/Caucasian/European Heritage 106 104 210
1.Primary Outcome
Title Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52
Hide Description HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The BL HbA1c value 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. Based on analysis of covariance (ANCOVA): change = treatment + BL HbA1c + prior myocardial infarction history + age category + region + current antidiabetic therapy. 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. One Intent-to-Treat (ITT) participant (par.) had all post-BL HbA1c measurements occur after hyperglycemic rescue. This par. is included in the ITT Population counts but did not contribute to this analysis.
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 + Pioglitazone With or Without Metformin Albiglutide 30 mg + Pioglitazone With or Without Metformin
Hide Arm/Group Description:
Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. 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 and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
Overall Number of Participants Analyzed 149 149
Least Squares Mean (Standard Error)
Unit of Measure: Percentage of HbA1c in the blood
-0.05  (0.071) -0.81  (0.071)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + Pioglitazone With or Without Metformin, Albiglutide 30 mg + Pioglitazone With or Without Metformin
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 -0.75
Confidence Interval (2-Sided) 95%
-0.95 to -0.56
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).
Arm/Group Title Placebo + Pioglitazone With or Without Metformin Albiglutide 30 mg + Pioglitazone With or Without Metformin
Hide Arm/Group Description:
Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. 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 and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
Overall Number of Participants Analyzed 29 72
Mean (Standard Deviation)
Unit of Measure: Percentage of HbA1c in the blood
Week 104, n= 29, 72 -0.72  (0.845) -0.92  (1.038)
Week 156, n=26, 54 -0.50  (0.805) -0.87  (0.926)
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
ITT Population. Only those participants with a value at Baseline and at the specified visit were analyzed.
Arm/Group Title Placebo + Pioglitazone With or Without Metformin Albiglutide 30 mg + Pioglitazone With or Without Metformin
Hide Arm/Group Description:
Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. 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 and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
Overall Number of Participants Analyzed 149 150
Median (95% Confidence Interval)
Unit of Measure: Weeks
52.86
(48.86 to 79.43)
NA [1] 
(NA to NA)
[1]
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 + Pioglitazone With or Without Metformin Albiglutide 30 mg + Pioglitazone With or Without Metformin
Hide Arm/Group Description:
Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. 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 and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
Overall Number of Participants Analyzed 149 149
Least Squares Mean (Standard Error)
Unit of Measure: Millimoles per liter (mmol/L)
0.35  (0.197) -1.28  (0.197)
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 + Pioglitazone With or Without Metformin Albiglutide 30 mg + Pioglitazone With or Without Metformin
Hide Arm/Group Description:
Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. 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 and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
Overall Number of Participants Analyzed 25 54
Mean (Standard Deviation)
Unit of Measure: Millimoles per liter (mmol/L)
0.03  (1.950) -1.26  (1.476)
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 achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <6.5%, and <7.0% 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 + Pioglitazone With or Without Metformin Albiglutide 30 mg + Pioglitazone With or Without Metformin
Hide Arm/Group Description:
Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. 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 and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
Overall Number of Participants Analyzed 149 149
Measure Type: Number
Unit of Measure: Participants
HbA1c <6.5% 8 37
HbA1c <7% 22 66
HbA1c <7.5% 44 96
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 achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <6.5%, and <7.0% 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 + Pioglitazone With or Without Metformin Albiglutide 30 mg + Pioglitazone With or Without Metformin
Hide Arm/Group Description:
Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. 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 and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
Overall Number of Participants Analyzed 26 54
Measure Type: Number
Unit of Measure: Participants
HbA1c <6.5% 7 20
HbA1c <7% 12 32
HbA1c <7.5% 17 44
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 + Pioglitazone With or Without Metformin Albiglutide 30 mg + Pioglitazone With or Without Metformin
Hide Arm/Group Description:
Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. 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 and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
Overall Number of Participants Analyzed 149 149
Least Squares Mean (Standard Error)
Unit of Measure: Kilograms
0.45  (0.348) 0.28  (0.348)
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 + Pioglitazone With or Without Metformin Albiglutide 30 mg + Pioglitazone With or Without Metformin
Hide Arm/Group Description:
Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. 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 and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
Overall Number of Participants Analyzed 26 55
Mean (Standard Deviation)
Unit of Measure: Kilograms
1.50  (6.939) -0.16  (6.284)
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 + Pioglitazone With or Without Metformin Albiglutide 30 mg + Pioglitazone With or Without Metformin
Hide Arm/Group Description Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. 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 and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
All-Cause Mortality
Placebo + Pioglitazone With or Without Metformin Albiglutide 30 mg + Pioglitazone With or Without Metformin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo + Pioglitazone With or Without Metformin Albiglutide 30 mg + Pioglitazone With or Without Metformin
Affected / at Risk (%) Affected / at Risk (%)
Total   28/151 (18.54%)   15/150 (10.00%) 
Cardiac disorders     
Coronary artery disease  1  2/151 (1.32%)  2/150 (1.33%) 
Acute myocardial infarction  1  0/151 (0.00%)  2/150 (1.33%) 
Angina unstable  1  0/151 (0.00%)  1/150 (0.67%) 
Aortic valve incompetence  1  1/151 (0.66%)  0/150 (0.00%) 
Atrial fibrillation  1  0/151 (0.00%)  1/150 (0.67%) 
Cardiac failure  1  1/151 (0.66%)  0/150 (0.00%) 
Cardiomyopathy  1  1/151 (0.66%)  0/150 (0.00%) 
Coronary artery stenosis  1  1/151 (0.66%)  0/150 (0.00%) 
Myocardial infarction  1  1/151 (0.66%)  0/150 (0.00%) 
Sick sinus syndrome  1  1/151 (0.66%)  0/150 (0.00%) 
Gastrointestinal disorders     
Colonic fistula  1  0/151 (0.00%)  1/150 (0.67%) 
Diabetic gastroparesis  1  1/151 (0.66%)  0/150 (0.00%) 
Gastric ulcer  1  1/151 (0.66%)  0/150 (0.00%) 
Gastrooesophageal reflux disease  1  0/151 (0.00%)  1/150 (0.67%) 
Small intestinal obstruction  1  1/151 (0.66%)  0/150 (0.00%) 
General disorders     
Chest pain  1  3/151 (1.99%)  0/150 (0.00%) 
Hepatobiliary disorders     
Cholecystitis acute  1  2/151 (1.32%)  0/150 (0.00%) 
Cholecystitis  1  0/151 (0.00%)  1/150 (0.67%) 
Infections and infestations     
Cellulitis  1  2/151 (1.32%)  1/150 (0.67%) 
Abscess limb  1  1/151 (0.66%)  1/150 (0.67%) 
Pneumonia  1  0/151 (0.00%)  2/150 (1.33%) 
Appendicitis perforated  1  0/151 (0.00%)  1/150 (0.67%) 
Diverticulitis  1  1/151 (0.66%)  0/150 (0.00%) 
Sinusitis  1  1/151 (0.66%)  0/150 (0.00%) 
Viral infection  1  0/151 (0.00%)  1/150 (0.67%) 
Vulval abscess  1  1/151 (0.66%)  0/150 (0.00%) 
Injury, poisoning and procedural complications     
Face injury  1  1/151 (0.66%)  0/150 (0.00%) 
Metabolism and nutrition disorders     
Obesity  1  1/151 (0.66%)  0/150 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  2/151 (1.32%)  0/150 (0.00%) 
Osteoarthritis  1  1/151 (0.66%)  1/150 (0.67%) 
Bursitis  1  0/151 (0.00%)  1/150 (0.67%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer stage I  1  1/151 (0.66%)  0/150 (0.00%) 
Lung cancer metastatic  1  0/151 (0.00%)  1/150 (0.67%) 
Metastases to liver  1  1/151 (0.66%)  0/150 (0.00%) 
Non-small cell lung cancer  1  1/151 (0.66%)  0/150 (0.00%) 
Prostate cancer metastatic  1  0/151 (0.00%)  1/150 (0.67%) 
Nervous system disorders     
Dizziness  1  0/151 (0.00%)  1/150 (0.67%) 
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous  1  1/151 (0.66%)  0/150 (0.00%) 
Psychiatric disorders     
Major depression  1  1/151 (0.66%)  0/150 (0.00%) 
Renal and urinary disorders     
Nephrolithiasis  1  0/151 (0.00%)  1/150 (0.67%) 
Renal colic  1  0/151 (0.00%)  1/150 (0.67%) 
Renal impairment  1  1/151 (0.66%)  0/150 (0.00%) 
Vascular disorders     
Deep vein thrombosis  1  2/151 (1.32%)  0/150 (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 + Pioglitazone With or Without Metformin Albiglutide 30 mg + Pioglitazone With or Without Metformin
Affected / at Risk (%) Affected / at Risk (%)
Total   117/151 (77.48%)   126/150 (84.00%) 
Blood and lymphatic system disorders     
Anaemia  1  9/151 (5.96%)  6/150 (4.00%) 
Cardiac disorders     
Palpitations  1  0/151 (0.00%)  4/150 (2.67%) 
Angina pectoris  1  4/151 (2.65%)  0/150 (0.00%) 
Ear and labyrinth disorders     
Vertigo  1  2/151 (1.32%)  5/150 (3.33%) 
Ear pain  1  4/151 (2.65%)  1/150 (0.67%) 
Eye disorders     
Cataract  1  3/151 (1.99%)  7/150 (4.67%) 
Diabetic retinopathy  1  2/151 (1.32%)  7/150 (4.67%) 
Presbyopia  1  4/151 (2.65%)  2/150 (1.33%) 
Refraction disorder  1  4/151 (2.65%)  1/150 (0.67%) 
Gastrointestinal disorders     
Diarrhoea  1  16/151 (10.60%)  22/150 (14.67%) 
Nausea  1  18/151 (11.92%)  18/150 (12.00%) 
Gastrooesophageal reflux disease  1  1/151 (0.66%)  9/150 (6.00%) 
Vomiting  1  6/151 (3.97%)  8/150 (5.33%) 
Toothache  1  4/151 (2.65%)  8/150 (5.33%) 
Abdominal pain upper  1  6/151 (3.97%)  6/150 (4.00%) 
Constipation  1  2/151 (1.32%)  5/150 (3.33%) 
Dyspepsia  1  5/151 (3.31%)  4/150 (2.67%) 
Gastritis  1  3/151 (1.99%)  4/150 (2.67%) 
Abdominal pain  1  8/151 (5.30%)  2/150 (1.33%) 
General disorders     
Oedema peripheral  1  16/151 (10.60%)  15/150 (10.00%) 
Fatigue  1  7/151 (4.64%)  10/150 (6.67%) 
Injection site reaction  1  5/151 (3.31%)  8/150 (5.33%) 
Injection site haemorrhage  1  1/151 (0.66%)  7/150 (4.67%) 
Injection site haematoma  1  4/151 (2.65%)  6/150 (4.00%) 
Pyrexia  1  4/151 (2.65%)  3/150 (2.00%) 
Injection stie pruritis  1  5/151 (3.31%)  0/150 (0.00%) 
Immune system disorders     
Seasonal allergy  1  5/151 (3.31%)  5/150 (3.33%) 
Infections and infestations     
Upper respiratory tract infection  1  24/151 (15.89%)  24/150 (16.00%) 
Urinary tract infection  1  9/151 (5.96%)  17/150 (11.33%) 
Sinusitis  1  9/151 (5.96%)  15/150 (10.00%) 
Nasopharyngitis  1  22/151 (14.57%)  12/150 (8.00%) 
Bronchitis  1  15/151 (9.93%)  10/150 (6.67%) 
Gastroenteritis  1  2/151 (1.32%)  7/150 (4.67%) 
Pharyngitis  1  7/151 (4.64%)  6/150 (4.00%) 
Influenza  1  2/151 (1.32%)  6/150 (4.00%) 
Cellulitis  1  4/151 (2.65%)  5/150 (3.33%) 
Injury, poisoning and procedural complications     
Contusion  1  9/151 (5.96%)  12/150 (8.00%) 
Laceration  1  2/151 (1.32%)  7/150 (4.67%) 
Meniscus lesion  1  2/151 (1.32%)  4/150 (2.67%) 
Ligament sprain  1  4/151 (2.65%)  3/150 (2.00%) 
Procedural pain  1  4/151 (2.65%)  3/150 (2.00%) 
Muscle strain  1  5/151 (3.31%)  2/150 (1.33%) 
Limb injury  1  4/151 (2.65%)  2/150 (1.33%) 
Metabolism and nutrition disorders     
Hypoglycaemia  1  13/151 (8.61%)  25/150 (16.67%) 
Decreased appetite  1  4/151 (2.65%)  3/150 (2.00%) 
Dyslipidaemia  1  8/151 (5.30%)  2/150 (1.33%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  13/151 (8.61%)  15/150 (10.00%) 
Back pain  1  10/151 (6.62%)  13/150 (8.67%) 
Musculoskeletal pain  1  10/151 (6.62%)  13/150 (8.67%) 
Osteoarthritis  1  6/151 (3.97%)  11/150 (7.33%) 
Pain in extremity  1  11/151 (7.28%)  7/150 (4.67%) 
Myalgia  1  3/151 (1.99%)  6/150 (4.00%) 
Neck pain  1  3/151 (1.99%)  5/150 (3.33%) 
Muscle spasms  1  7/151 (4.64%)  4/150 (2.67%) 
Bursitis  1  4/151 (2.65%)  1/150 (0.67%) 
Intervertebral disc protrusion  1  4/151 (2.65%)  0/150 (0.00%) 
Nervous system disorders     
Headache  1  18/151 (11.92%)  13/150 (8.67%) 
Dizziness  1  5/151 (3.31%)  10/150 (6.67%) 
Hypoaesthesia  1  2/151 (1.32%)  4/150 (2.67%) 
Neuropathy peripheral  1  6/151 (3.97%)  2/150 (1.33%) 
Carpal tunnel syndrome  1  6/151 (3.97%)  1/150 (0.67%) 
Psychiatric disorders     
Anxiety  1  6/151 (3.97%)  7/150 (4.67%) 
Depression  1  5/151 (3.31%)  4/150 (2.67%) 
Insomnia  1  4/151 (2.65%)  4/150 (2.67%) 
Renal and urinary disorders     
Nephrolithiasis  1  2/151 (1.32%)  5/150 (3.33%) 
Renal cyst  1  4/151 (2.65%)  0/150 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  8/151 (5.30%)  10/150 (6.67%) 
Sinus congestion  1  4/151 (2.65%)  8/150 (5.33%) 
Oropharyngeal pain  1  4/151 (2.65%)  4/150 (2.67%) 
Skin and subcutaneous tissue disorders     
Pruritis  1  1/151 (0.66%)  5/150 (3.33%) 
Rash  1  3/151 (1.99%)  4/150 (2.67%) 
Dry skin  1  1/151 (0.66%)  4/150 (2.67%) 
Vascular disorders     
Hypertension  1  15/151 (9.93%)  17/150 (11.33%) 
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
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00849056     History of Changes
Other Study ID Numbers: 112755
First Submitted: February 19, 2009
First Posted: February 23, 2009
Results First Submitted: April 24, 2014
Results First Posted: July 1, 2014
Last Update Posted: January 9, 2017