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Efficacy and Safety of Albiglutide in Treatment of Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT00838903
Recruitment Status : Completed
First Posted : February 9, 2009
Results First Posted : May 16, 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: sitagliptin
Drug: glimepiride
Drug: metformin
Biological: placebo albiglutide
Drug: placebo sitagliptin
Drug: placebo glimepiride
Enrollment 1049

Recruitment Details  
Pre-assignment Details Eligible participants (par.) entered a 2-week Screening Period, a 4-week Run-in/Stabilization Period, a 156-week Treatment Period, and a 8-week post-treatment Follow-up Period. A total of 1525 par. were screened, 1049 were randomized and 1012 par. received at least 1 dose of study treatment.
Arm/Group Title Placebo Plus Metformin Sitagliptin 100 mg Plus Metformin Glimepiride 2 mg Plus Metformin Albiglutide 30 mg Plus Metformin
Hide Arm/Group Description Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period. Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period. Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period. Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Period Title: Treatment Period (156 Weeks)
Started 101 302 307 302
Missing Active Treatment Status 1 0 0 0
Completed 55 190 191 192
Not Completed 46 112 116 110
Reason Not Completed
Adverse Event             5             13             17             25
Protocol Violation             1             6             6             5
Noncompliance             9             13             12             6
Severe or Repeated Hypoglycaemia             0             0             1             0
Lost to Follow-up             4             16             15             13
Withdrawal by Subject             20             55             56             53
Physician Decision             1             2             1             2
Termination of Study/Site by GSK             3             5             5             4
Patient and PI Decision to Discontinue             0             1             0             0
Poor Glycemic Control             0             0             0             1
Poor Therapeutic Response             1             0             0             0
Pregnancy             0             0             1             0
PI Decided for Safety Purpose             0             0             1             0
Site closed             0             0             1             0
Site Closed and Subject Withdrew Consent             1             0             0             0
Subject Migrated to Other Country             0             1             0             1
Missing Active Treatment Status             1             0             0             0
Period Title: Follow-up Period (8 Weeks)
Started 101 [1] 302 [1] 307 [1] 302 [1]
Completed 75 237 243 244
Not Completed 26 65 64 58
Reason Not Completed
Adverse Event             0             0             3             1
Noncompliance             2             8             5             5
Lost to Follow-up             6             28             22             24
Did Not Enter Follow-up Period             5             7             12             7
Subject Withdrawn from Follow-up             8             13             14             14
Physician Decision             1             1             1             1
Termination of Study/Site by GSK             3             4             6             4
ICF Withdrawn             0             1             0             0
Investigator Stopped Study at Site             0             1             0             0
Subject Moved out of Town             0             0             0             1
Missing             1             2             1             1
[1]
Participants withdrawing from the Treatment Period entered the Follow-up Period.
Arm/Group Title Placebo Plus Metformin Sitagliptin 100 mg Plus Metformin Glimepiride 2 mg Plus Metformin Albiglutide 30 mg Plus Metformin Total
Hide Arm/Group Description Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period. Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period. Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period. Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period. Total of all reporting groups
Overall Number of Baseline Participants 101 302 307 302 1012
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 101 participants 302 participants 307 participants 302 participants 1012 participants
56.1  (10.01) 54.3  (9.81) 54.4  (9.97) 54.3  (10.12) 54.5  (9.97)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants 302 participants 307 participants 302 participants 1012 participants
Female
51
  50.5%
163
  54.0%
149
  48.5%
167
  55.3%
530
  52.4%
Male
50
  49.5%
139
  46.0%
158
  51.5%
135
  44.7%
482
  47.6%
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 101 participants 302 participants 307 participants 302 participants 1012 participants
African American/African Heritage 23 35 39 53 150
American Indian or Alaskan Native 9 22 25 17 73
Asian - Central/South Asian Heritage 1 7 3 2 13
Asian - East Asian Heritage 0 2 3 5 10
Asian - Japanese Heritage 1 0 1 0 2
Asian - South East Asian Heritage 3 11 9 11 34
Native Hawaiian or Other Pacific Islander 1 0 0 1 2
White - Arabic/North African Heritage 0 1 9 3 13
White - White/Caucasian/European Heritage 64 225 220 214 723
[1]
Measure Description: A participant may have been counted in more than one category.
1.Primary Outcome
Title Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 104
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 104 minus the value at BL. Based on analysis of covariance (ANCOVA): change = treatment + BL HbA1c + prior myocardial infarction history + age category + region. Difference of least squares means (albiglutide – placebo, albiglutide – sitagliptin, albiglutide - glimepiride) is from the ANCOVA model. The last observation carried forward (LOCF) method was used to impute missing post-Baseline 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 104
Show Outcome Measure DataHide 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 104.
Arm/Group Title Placebo Plus Metformin Sitagliptin 100 mg Plus Metformin Glimepiride 2 mg Plus Metformin Albiglutide 30 mg Plus Metformin
Hide Arm/Group Description:
Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Overall Number of Participants Analyzed 97 297 299 293
Least Squares Mean (Standard Error)
Unit of Measure: Percentage of HbA1c in the blood
0.27  (0.113) -0.28  (0.065) -0.36  (0.064) -0.63  (0.065)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Plus Metformin, Albiglutide 30 mg Plus Metformin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.91
Confidence Interval (2-Sided) 95%
-1.16 to -0.65
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sitagliptin 100 mg Plus Metformin, Albiglutide 30 mg Plus Metformin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.35
Confidence Interval (2-Sided) 95%
-0.53 to -0.17
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Glimepiride 2 mg Plus Metformin, Albiglutide 30 mg Plus Metformin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.27
Confidence Interval (2-Sided) 95%
-0.45 to -0.09
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo Plus Metformin, Albiglutide 30 mg Plus Metformin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The p-value is for superiority testing of albiglutide over placebo at 0.05 level.
Method t-test, 2 sided
Comments The p-value is from a two-sided t-test to test whether the difference of least square means (albiglutide – placebo) is equal to zero
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Sitagliptin 100 mg Plus Metformin, Albiglutide 30 mg Plus Metformin
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments To test whether the difference of least square means (albiglutide - sitagliptin) is equal to the pre-specified non-inferiority margin of 0.3%.
Statistical Test of Hypothesis P-Value <0.0001
Comments The p-value is for non-inferiority testing of albiglutide versus sitagliptin at 0.0125 level.
Method t-test, 1 sided
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Glimepiride 2 mg Plus Metformin, Albiglutide 30 mg Plus Metformin
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments To test whether the difference of least square means (albiglutide - glimepiride) is equal to the pre-specified non-inferiority margin of 0.3%.
Statistical Test of Hypothesis P-Value <0.0001
Comments The p-value is for non-inferiority testing of albiglutide versus glimepiride at 0.0125 level.
Method t-test, 1 sided
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Sitagliptin 100 mg Plus Metformin, Albiglutide 30 mg Plus Metformin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments The p-value is for superiority testing of albiglutide versus sitagliptin at 0.025 level.
Method t-test, 2 sided
Comments The p-value is from a two-sided t-test to test whether the difference of least square means (albiglutide – sitagliptin) is equal to zero.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Glimepiride 2 mg Plus Metformin, Albiglutide 30 mg Plus Metformin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0033
Comments The p-value is for superiority testing of albiglutide versus glimepiride at 0.025 level.
Method t-test, 2 sided
Comments The p-value is from a two-sided t-test to test whether the difference of least square means (albiglutide - glimepiride) is equal to zero.
2.Secondary Outcome
Title Change From Baseline in HbA1c at Week 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 Week 156
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population with observed values. Only those par. with a value at Baseline and at the specified visit were analyzed.
Arm/Group Title Placebo Plus Metformin Sitagliptin 100 mg Plus Metformin Glimepiride 2 mg Plus Metformin Albiglutide 30 mg Plus Metformin
Hide Arm/Group Description:
Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Overall Number of Participants Analyzed 16 88 102 115
Mean (Standard Deviation)
Unit of Measure: Percentage of HbA1c in the blood
-0.46  (0.820) -0.56  (1.160) -0.59  (0.999) -0.88  (0.959)
3.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (FPG) at Week 104
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 FPG + Baseline HbA1c category + prior myocardial infarction history + age category + region.
Time Frame Baseline and Week 104
Show Outcome Measure DataHide 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 104.
Arm/Group Title Placebo Plus Metformin Sitagliptin 100 mg Plus Metformin Glimepiride 2 mg Plus Metformin Albiglutide 30 mg Plus Metformin
Hide Arm/Group Description:
Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Overall Number of Participants Analyzed 100 299 302 296
Least Squares Mean (Standard Error)
Unit of Measure: Millimoles per liter (mmol/L)
0.55  (0.277) -0.12  (0.160) -0.41  (0.159) -0.98  (0.161)
4.Secondary Outcome
Title Change From Baseline in FPG at Week 156
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. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed FPG values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.
Time Frame Baseline and Week 156
Show Outcome Measure DataHide 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.
Arm/Group Title Placebo Plus Metformin Sitagliptin 100 mg Plus Metformin Glimepiride 2 mg Plus Metformin Albiglutide 30 mg Plus Metformin
Hide Arm/Group Description:
Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Overall Number of Participants Analyzed 16 88 98 112
Mean (Standard Deviation)
Unit of Measure: Millimoles per liter (mmol/L)
-0.11  (1.498) -0.50  (2.519) -0.71  (2.684) -1.30  (2.602)
5.Secondary Outcome
Title Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 104
Hide Description The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 52) were assessed.
Time Frame Week 104
Show Outcome Measure DataHide 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 104.
Arm/Group Title Placebo Plus Metformin Sitagliptin 100 mg Plus Metformin Glimepiride 2 mg Plus Metformin Albiglutide 30 mg Plus Metformin
Hide Arm/Group Description:
Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Overall Number of Participants Analyzed 97 297 299 293
Measure Type: Number
Unit of Measure: Participants
HbA1c <6.5% 7 45 40 50
HbA1c <7.0% 15 94 94 113
HbA1c <7.5% 27 132 147 172
6.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%, <7%, and <7.5% at Week 156) were assessed.
Time Frame Week 156
Show Outcome Measure DataHide 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.
Arm/Group Title Placebo Plus Metformin Sitagliptin 100 mg Plus Metformin Glimepiride 2 mg Plus Metformin Albiglutide 30 mg Plus Metformin
Hide Arm/Group Description:
Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Overall Number of Participants Analyzed 16 88 102 115
Measure Type: Number
Unit of Measure: Participants
HbA1c <6.5% 4 23 15 31
HbA1c <7.0% 7 44 44 69
HbA1c <7.5% 13 69 69 90
7.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 hyperglycemic 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 week
Time Frame From the start of study medication until the end of the treatment (up to Week 156)
Show Outcome Measure DataHide 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 Plus Metformin Sitagliptin 100 mg Plus Metformin Glimepiride 2 mg Plus Metformin Albiglutide 30 mg Plus Metformin
Hide Arm/Group Description:
Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Overall Number of Participants Analyzed 100 300 302 297
Median (95% Confidence Interval)
Unit of Measure: Weeks
67.71
(53.14 to 122.14)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
There were few events of hyperglycemia rescue (<50% of participants with events) to calculate the median and confidence interval.
8.Secondary Outcome
Title Change From Baseline in Body Weight at Week 104
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 + Baseline HbA1c category + prior myocardial infarction history + age category + region.
Time Frame Baseline and Week 104
Show Outcome Measure DataHide 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 104.
Arm/Group Title Placebo Plus Metformin Sitagliptin 100 mg Plus Metformin Glimepiride 2 mg Plus Metformin Albiglutide 30 mg Plus Metformin
Hide Arm/Group Description:
Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Overall Number of Participants Analyzed 100 300 302 296
Least Squares Mean (Standard Error)
Unit of Measure: Kilograms
-1.00  (0.411) -0.86  (0.237) 1.17  (0.237) -1.21  (0.239)
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. This analysis used observed body weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.
Time Frame Baseline and Week 156
Show Outcome Measure DataHide 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.
Arm/Group Title Placebo Plus Metformin Sitagliptin 100 mg Plus Metformin Glimepiride 2 mg Plus Metformin Albiglutide 30 mg Plus Metformin
Hide Arm/Group Description:
Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Overall Number of Participants Analyzed 16 89 102 116
Mean (Standard Deviation)
Unit of Measure: Kilograms
-3.61  (3.460) -2.05  (4.109) 0.98  (4.760) -2.31  (5.093)
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 Plus Metformin Sitagliptin 100 mg Plus Metformin Glimepiride 2 mg Plus Metformin Albiglutide 30 mg Plus Metformin
Hide Arm/Group Description Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period. Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period. Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period. Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
All-Cause Mortality
Placebo Plus Metformin Sitagliptin 100 mg Plus Metformin Glimepiride 2 mg Plus Metformin Albiglutide 30 mg Plus Metformin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Plus Metformin Sitagliptin 100 mg Plus Metformin Glimepiride 2 mg Plus Metformin Albiglutide 30 mg Plus Metformin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   15/101 (14.85%)   32/302 (10.60%)   36/307 (11.73%)   44/302 (14.57%) 
Cardiac disorders         
Acute myocardial infarction  1  1/101 (0.99%)  2/302 (0.66%)  1/307 (0.33%)  2/302 (0.66%) 
Coronary artery disease  1  2/101 (1.98%)  1/302 (0.33%)  2/307 (0.65%)  1/302 (0.33%) 
Myocardial infarction  1  1/101 (0.99%)  0/302 (0.00%)  1/307 (0.33%)  3/302 (0.99%) 
Cardiac failure congestive  1  0/101 (0.00%)  1/302 (0.33%)  1/307 (0.33%)  2/302 (0.66%) 
Angina pectoris  1  0/101 (0.00%)  0/302 (0.00%)  0/307 (0.00%)  2/302 (0.66%) 
Angina unstable  1  1/101 (0.99%)  0/302 (0.00%)  0/307 (0.00%)  1/302 (0.33%) 
Cardio-respiratory arrest  1  1/101 (0.99%)  0/302 (0.00%)  0/307 (0.00%)  1/302 (0.33%) 
Arrhythmia  1  0/101 (0.00%)  1/302 (0.33%)  0/307 (0.00%)  0/302 (0.00%) 
Arteriospasm coronary  1  0/101 (0.00%)  0/302 (0.00%)  0/307 (0.00%)  1/302 (0.33%) 
Cardiac failure  1  0/101 (0.00%)  0/302 (0.00%)  0/307 (0.00%)  1/302 (0.33%) 
Coronary artery stenosis  1  0/101 (0.00%)  0/302 (0.00%)  1/307 (0.33%)  0/302 (0.00%) 
Eye disorders         
Retinal detachment  1  0/101 (0.00%)  1/302 (0.33%)  1/307 (0.33%)  0/302 (0.00%) 
Dacryostenosis acquired  1  0/101 (0.00%)  1/302 (0.33%)  0/307 (0.00%)  0/302 (0.00%) 
Gastrointestinal disorders         
Gastritis  1  0/101 (0.00%)  0/302 (0.00%)  0/307 (0.00%)  2/302 (0.66%) 
Intestinal obstruction  1  0/101 (0.00%)  1/302 (0.33%)  1/307 (0.33%)  0/302 (0.00%) 
Pancreatitis acute  1  0/101 (0.00%)  0/302 (0.00%)  1/307 (0.33%)  1/302 (0.33%) 
Rectal haemorrhage  1  1/101 (0.99%)  0/302 (0.00%)  1/307 (0.33%)  0/302 (0.00%) 
Abdominal pain  1  0/101 (0.00%)  0/302 (0.00%)  1/307 (0.33%)  0/302 (0.00%) 
Colitis ischaemic  1  0/101 (0.00%)  0/302 (0.00%)  0/307 (0.00%)  1/302 (0.33%) 
Gastrointestinal haemorrhage  1  1/101 (0.99%)  0/302 (0.00%)  0/307 (0.00%)  0/302 (0.00%) 
Gastrooesophageal reflux disease  1  0/101 (0.00%)  0/302 (0.00%)  0/307 (0.00%)  1/302 (0.33%) 
Lower gastrointestinal haemorrhage  1  0/101 (0.00%)  0/302 (0.00%)  0/307 (0.00%)  1/302 (0.33%) 
Oesophageal spasm  1  0/101 (0.00%)  0/302 (0.00%)  1/307 (0.33%)  0/302 (0.00%) 
Small intestinal obstruction  1  0/101 (0.00%)  0/302 (0.00%)  0/307 (0.00%)  1/302 (0.33%) 
General disorders         
Chest pain  1  0/101 (0.00%)  1/302 (0.33%)  2/307 (0.65%)  4/302 (1.32%) 
Non-cardiac chest pain  1  0/101 (0.00%)  1/302 (0.33%)  1/307 (0.33%)  0/302 (0.00%) 
Death  1  0/101 (0.00%)  0/302 (0.00%)  0/307 (0.00%)  1/302 (0.33%) 
Device malfunction  1  0/101 (0.00%)  0/302 (0.00%)  0/307 (0.00%)  1/302 (0.33%) 
Hepatobiliary disorders         
Cholecystitis acute  1  0/101 (0.00%)  1/302 (0.33%)  0/307 (0.00%)  1/302 (0.33%) 
Cholelithiasis  1  1/101 (0.99%)  0/302 (0.00%)  1/307 (0.33%)  0/302 (0.00%) 
Bile duct stone  1  0/101 (0.00%)  1/302 (0.33%)  0/307 (0.00%)  0/302 (0.00%) 
Cholecystitis  1  0/101 (0.00%)  0/302 (0.00%)  0/307 (0.00%)  1/302 (0.33%) 
Immune system disorders         
Hypersensitivity  1  0/101 (0.00%)  1/302 (0.33%)  0/307 (0.00%)  0/302 (0.00%) 
Infections and infestations         
Pneumonia  1  1/101 (0.99%)  2/302 (0.66%)  1/307 (0.33%)  2/302 (0.66%) 
Gastroenteritis  1  0/101 (0.00%)  1/302 (0.33%)  2/307 (0.65%)  1/302 (0.33%) 
Appendicitis  1  0/101 (0.00%)  0/302 (0.00%)  0/307 (0.00%)  3/302 (0.99%) 
Pyelonephritis acute  1  1/101 (0.99%)  1/302 (0.33%)  0/307 (0.00%)  1/302 (0.33%) 
Cellulitis  1  0/101 (0.00%)  0/302 (0.00%)  2/307 (0.65%)  0/302 (0.00%) 
Pyelonephritis  1  0/101 (0.00%)  1/302 (0.33%)  0/307 (0.00%)  1/302 (0.33%) 
Abscess limb  1  0/101 (0.00%)  0/302 (0.00%)  1/307 (0.33%)  0/302 (0.00%) 
Arthritis bacterial  1  0/101 (0.00%)  1/302 (0.33%)  0/307 (0.00%)  0/302 (0.00%) 
Helicobacter infection  1  0/101 (0.00%)  1/302 (0.33%)  0/307 (0.00%)  0/302 (0.00%) 
Osteomyelitis  1  1/101 (0.99%)  0/302 (0.00%)  0/307 (0.00%)  0/302 (0.00%) 
Pelvic abscess  1  0/101 (0.00%)  1/302 (0.33%)  0/307 (0.00%)  0/302 (0.00%) 
Post procedural cellulitis  1  0/101 (0.00%)  0/302 (0.00%)  1/307 (0.33%)  0/302 (0.00%) 
Subcutaneous abscess  1  0/101 (0.00%)  0/302 (0.00%)  0/307 (0.00%)  1/302 (0.33%) 
Upper respiratory tract infection  1  0/101 (0.00%)  1/302 (0.33%)  0/307 (0.00%)  0/302 (0.00%) 
Urinary tract infection  1  0/101 (0.00%)  0/302 (0.00%)  0/307 (0.00%)  1/302 (0.33%) 
Viral infection  1  0/101 (0.00%)  0/302 (0.00%)  0/307 (0.00%)  1/302 (0.33%) 
Injury, poisoning and procedural complications         
Coronary artery restenosis  1  0/101 (0.00%)  0/302 (0.00%)  1/307 (0.33%)  0/302 (0.00%) 
Femur fracture  1  0/101 (0.00%)  1/302 (0.33%)  0/307 (0.00%)  0/302 (0.00%) 
Fibula fracture  1  0/101 (0.00%)  0/302 (0.00%)  1/307 (0.33%)  0/302 (0.00%) 
Head injury  1  1/101 (0.99%)  0/302 (0.00%)  0/307 (0.00%)  0/302 (0.00%) 
Intentional overdose  1  0/101 (0.00%)  0/302 (0.00%)  0/307 (0.00%)  1/302 (0.33%) 
Joint dislocation  1  0/101 (0.00%)  0/302 (0.00%)  0/307 (0.00%)  1/302 (0.33%) 
Ligament sprain  1  0/101 (0.00%)  0/302 (0.00%)  1/307 (0.33%)  0/302 (0.00%) 
Spinal fracture  1  0/101 (0.00%)  1/302 (0.33%)  0/307 (0.00%)  0/302 (0.00%) 
Tibia fracture  1  0/101 (0.00%)  0/302 (0.00%)  1/307 (0.33%)  0/302 (0.00%) 
Metabolism and nutrition disorders         
Hyperglycaemia  1  0/101 (0.00%)  0/302 (0.00%)  0/307 (0.00%)  3/302 (0.99%) 
Diabetes mellitus inadequate control  1  0/101 (0.00%)  1/302 (0.33%)  0/307 (0.00%)  0/302 (0.00%) 
Hypoglycaemia  1  0/101 (0.00%)  1/302 (0.33%)  0/307 (0.00%)  0/302 (0.00%) 
Hyponatraemia  1  0/101 (0.00%)  0/302 (0.00%)  0/307 (0.00%)  1/302 (0.33%) 
Musculoskeletal and connective tissue disorders         
Osteoarthritis  1  1/101 (0.99%)  0/302 (0.00%)  2/307 (0.65%)  1/302 (0.33%) 
Back pain  1  0/101 (0.00%)  0/302 (0.00%)  2/307 (0.65%)  0/302 (0.00%) 
Spinal osteoarthritis  1  1/101 (0.99%)  0/302 (0.00%)  0/307 (0.00%)  1/302 (0.33%) 
Arthralgia  1  0/101 (0.00%)  0/302 (0.00%)  0/307 (0.00%)  1/302 (0.33%) 
Arthritis  1  0/101 (0.00%)  1/302 (0.33%)  0/307 (0.00%)  0/302 (0.00%) 
Costochondritis  1  0/101 (0.00%)  0/302 (0.00%)  0/307 (0.00%)  1/302 (0.33%) 
Intervertebral disc protrusion  1  1/101 (0.99%)  0/302 (0.00%)  0/307 (0.00%)  0/302 (0.00%) 
Musculoskeletal chest pain  1  0/101 (0.00%)  0/302 (0.00%)  0/307 (0.00%)  1/302 (0.33%) 
Myopathy  1  0/101 (0.00%)  0/302 (0.00%)  0/307 (0.00%)  1/302 (0.33%) 
Osteoporosis  1  0/101 (0.00%)  1/302 (0.33%)  0/307 (0.00%)  0/302 (0.00%) 
Scoliosis  1  0/101 (0.00%)  0/302 (0.00%)  1/307 (0.33%)  0/302 (0.00%) 
Spondylolisthesis  1  1/101 (0.99%)  0/302 (0.00%)  0/307 (0.00%)  0/302 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Thyroid cancer  1  0/101 (0.00%)  2/302 (0.66%)  0/307 (0.00%)  1/302 (0.33%) 
B-cell lymphoma  1  0/101 (0.00%)  0/302 (0.00%)  2/307 (0.65%)  0/302 (0.00%) 
Breast cancer  1  1/101 (0.99%)  1/302 (0.33%)  0/307 (0.00%)  0/302 (0.00%) 
Lung cancer metastatic  1  0/101 (0.00%)  0/302 (0.00%)  2/307 (0.65%)  0/302 (0.00%) 
Uterine cancer  1  0/101 (0.00%)  0/302 (0.00%)  1/307 (0.33%)  1/302 (0.33%) 
Bladder cancer  1  0/101 (0.00%)  0/302 (0.00%)  0/307 (0.00%)  1/302 (0.33%) 
Breast cancer stage III  1  0/101 (0.00%)  1/302 (0.33%)  0/307 (0.00%)  0/302 (0.00%) 
Gastrointestinal cancer metastatic  1  0/101 (0.00%)  1/302 (0.33%)  0/307 (0.00%)  0/302 (0.00%) 
Hepatic cancer metastatic  1  0/101 (0.00%)  0/302 (0.00%)  1/307 (0.33%)  0/302 (0.00%) 
Lung squamous cell carcinoma stage II  1  0/101 (0.00%)  1/302 (0.33%)  0/307 (0.00%)  0/302 (0.00%) 
Malignant melanoma  1  0/101 (0.00%)  1/302 (0.33%)  0/307 (0.00%)  0/302 (0.00%) 
Prostate cancer  1  0/101 (0.00%)  1/302 (0.33%)  0/307 (0.00%)  0/302 (0.00%) 
Prostate cancer metastatic  1  1/101 (0.99%)  0/302 (0.00%)  0/307 (0.00%)  0/302 (0.00%) 
Rectal cancer  1  0/101 (0.00%)  1/302 (0.33%)  0/307 (0.00%)  0/302 (0.00%) 
Renal cancer  1  0/101 (0.00%)  1/302 (0.33%)  0/307 (0.00%)  0/302 (0.00%) 
Squamous cell carcinoma  1  0/101 (0.00%)  0/302 (0.00%)  1/307 (0.33%)  0/302 (0.00%) 
Uterine leiomyoma  1  0/101 (0.00%)  0/302 (0.00%)  0/307 (0.00%)  1/302 (0.33%) 
Nervous system disorders         
Cerebrovascular accident  1  1/101 (0.99%)  0/302 (0.00%)  0/307 (0.00%)  2/302 (0.66%) 
Carotid artery stenosis  1  0/101 (0.00%)  0/302 (0.00%)  1/307 (0.33%)  0/302 (0.00%) 
Complicated migraine  1  0/101 (0.00%)  0/302 (0.00%)  1/307 (0.33%)  0/302 (0.00%) 
Convulsion  1  0/101 (0.00%)  0/302 (0.00%)  0/307 (0.00%)  1/302 (0.33%) 
Polyneuropathy  1  0/101 (0.00%)  0/302 (0.00%)  0/307 (0.00%)  1/302 (0.33%) 
Presyncope  1  0/101 (0.00%)  0/302 (0.00%)  0/307 (0.00%)  1/302 (0.33%) 
Subarachnoid haemorrhage  1  1/101 (0.99%)  0/302 (0.00%)  0/307 (0.00%)  0/302 (0.00%) 
Syncope  1  0/101 (0.00%)  1/302 (0.33%)  0/307 (0.00%)  0/302 (0.00%) 
Transient ischaemic attack  1  0/101 (0.00%)  0/302 (0.00%)  0/307 (0.00%)  1/302 (0.33%) 
Viith nerve paralysis  1  1/101 (0.99%)  0/302 (0.00%)  0/307 (0.00%)  0/302 (0.00%) 
Pregnancy, puerperium and perinatal conditions         
Abortion Spontaneous  1  0/101 (0.00%)  0/302 (0.00%)  1/307 (0.33%)  0/302 (0.00%) 
Psychiatric disorders         
Mental status changes  1  0/101 (0.00%)  0/302 (0.00%)  1/307 (0.33%)  0/302 (0.00%) 
Suicidal ideation  1  0/101 (0.00%)  0/302 (0.00%)  0/307 (0.00%)  1/302 (0.33%) 
Renal and urinary disorders         
Nephrolithiasis  1  0/101 (0.00%)  0/302 (0.00%)  1/307 (0.33%)  1/302 (0.33%) 
Azotaemia  1  0/101 (0.00%)  0/302 (0.00%)  0/307 (0.00%)  1/302 (0.33%) 
Calculus ureteric  1  1/101 (0.99%)  0/302 (0.00%)  0/307 (0.00%)  0/302 (0.00%) 
Reproductive system and breast disorders         
Cervical Polyp  1  0/101 (0.00%)  0/302 (0.00%)  0/307 (0.00%)  1/302 (0.33%) 
Respiratory, thoracic and mediastinal disorders         
Pleural effusion  1  0/101 (0.00%)  0/302 (0.00%)  1/307 (0.33%)  1/302 (0.33%) 
Pulmonary embolism  1  0/101 (0.00%)  0/302 (0.00%)  0/307 (0.00%)  2/302 (0.66%) 
Atelectasis  1  0/101 (0.00%)  0/302 (0.00%)  0/307 (0.00%)  1/302 (0.33%) 
Chronic obstructive pulmonary disease  1  0/101 (0.00%)  0/302 (0.00%)  0/307 (0.00%)  1/302 (0.33%) 
Epistaxis  1  0/101 (0.00%)  1/302 (0.33%)  0/307 (0.00%)  0/302 (0.00%) 
Skin and subcutaneous tissue disorders         
Angioedema  1  1/101 (0.99%)  0/302 (0.00%)  2/307 (0.65%)  0/302 (0.00%) 
Vascular disorders         
Peripheral vascular disorder  1  1/101 (0.99%)  1/302 (0.33%)  1/307 (0.33%)  0/302 (0.00%) 
Deep vein thrombosis  1  0/101 (0.00%)  0/302 (0.00%)  0/307 (0.00%)  2/302 (0.66%) 
Hypertension  1  1/101 (0.99%)  0/302 (0.00%)  0/307 (0.00%)  1/302 (0.33%) 
Hypertensive crisis  1  1/101 (0.99%)  0/302 (0.00%)  0/307 (0.00%)  0/302 (0.00%) 
Ischaemia  1  0/101 (0.00%)  1/302 (0.33%)  0/307 (0.00%)  0/302 (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 Plus Metformin Sitagliptin 100 mg Plus Metformin Glimepiride 2 mg Plus Metformin Albiglutide 30 mg Plus Metformin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   75/101 (74.26%)   229/302 (75.83%)   258/307 (84.04%)   242/302 (80.13%) 
Blood and lymphatic system disorders         
Anaemia  1  8/101 (7.92%)  14/302 (4.64%)  12/307 (3.91%)  14/302 (4.64%) 
Ear and labyrinth disorders         
Vertigo  1  3/101 (2.97%)  3/302 (0.99%)  1/307 (0.33%)  8/302 (2.65%) 
Eye disorders         
Diabetic retinopathy  1  2/101 (1.98%)  7/302 (2.32%)  14/307 (4.56%)  14/302 (4.64%) 
Cataract  1  6/101 (5.94%)  12/302 (3.97%)  20/307 (6.51%)  13/302 (4.30%) 
Conjunctivitis  1  0/101 (0.00%)  4/302 (1.32%)  7/307 (2.28%)  4/302 (1.32%) 
Gastrointestinal disorders         
Diarrhoea  1  11/101 (10.89%)  28/302 (9.27%)  31/307 (10.10%)  46/302 (15.23%) 
Nausea  1  13/101 (12.87%)  22/302 (7.28%)  25/307 (8.14%)  37/302 (12.25%) 
Vomiting  1  1/101 (0.99%)  14/302 (4.64%)  13/307 (4.23%)  22/302 (7.28%) 
Constipation  1  14/101 (13.86%)  8/302 (2.65%)  13/307 (4.23%)  19/302 (6.29%) 
Dyspepsia  1  2/101 (1.98%)  5/302 (1.66%)  8/307 (2.61%)  13/302 (4.30%) 
Abdominal pain  1  0/101 (0.00%)  12/302 (3.97%)  8/307 (2.61%)  12/302 (3.97%) 
Gastritis  1  4/101 (3.96%)  7/302 (2.32%)  7/307 (2.28%)  10/302 (3.31%) 
Gastrooesophageal reflux disease  1  4/101 (3.96%)  10/302 (3.31%)  10/307 (3.26%)  7/302 (2.32%) 
Abdominal pain upper  1  3/101 (2.97%)  6/302 (1.99%)  3/307 (0.98%)  4/302 (1.32%) 
Flatulence  1  3/101 (2.97%)  1/302 (0.33%)  1/307 (0.33%)  4/302 (1.32%) 
Dental caries  1  3/101 (2.97%)  7/302 (2.32%)  8/307 (2.61%)  2/302 (0.66%) 
Abdominal discomfort  1  0/101 (0.00%)  7/302 (2.32%)  2/307 (0.65%)  1/302 (0.33%) 
General disorders         
Injection site reaction  1  2/101 (1.98%)  5/302 (1.66%)  9/307 (2.93%)  33/302 (10.93%) 
Oedema peripheral  1  2/101 (1.98%)  10/302 (3.31%)  25/307 (8.14%)  13/302 (4.30%) 
Injection site haematoma  1  2/101 (1.98%)  11/302 (3.64%)  11/307 (3.58%)  9/302 (2.98%) 
Fatigue  1  4/101 (3.96%)  8/302 (2.65%)  6/307 (1.95%)  8/302 (2.65%) 
Chest pain  1  3/101 (2.97%)  6/302 (1.99%)  5/307 (1.63%)  8/302 (2.65%) 
Injection site erythema  1  1/101 (0.99%)  2/302 (0.66%)  3/307 (0.98%)  7/302 (2.32%) 
Immune system disorders         
Seasonal allergy  1  1/101 (0.99%)  3/302 (0.99%)  5/307 (1.63%)  8/302 (2.65%) 
Infections and infestations         
Upper respiratory tract infection  1  10/101 (9.90%)  33/302 (10.93%)  32/307 (10.42%)  58/302 (19.21%) 
Urinary tract infection  1  11/101 (10.89%)  37/302 (12.25%)  35/307 (11.40%)  27/302 (8.94%) 
Nasopharyngitis  1  9/101 (8.91%)  31/302 (10.26%)  30/307 (9.77%)  24/302 (7.95%) 
Bronchitis  1  10/101 (9.90%)  26/302 (8.61%)  23/307 (7.49%)  24/302 (7.95%) 
Influenza  1  7/101 (6.93%)  17/302 (5.63%)  25/307 (8.14%)  21/302 (6.95%) 
Gastroenteritis  1  4/101 (3.96%)  16/302 (5.30%)  9/307 (2.93%)  19/302 (6.29%) 
Pharyngitis  1  10/101 (9.90%)  22/302 (7.28%)  17/307 (5.54%)  17/302 (5.63%) 
Sinusitis  1  5/101 (4.95%)  22/302 (7.28%)  22/307 (7.17%)  17/302 (5.63%) 
Herpes zoster  1  1/101 (0.99%)  2/302 (0.66%)  5/307 (1.63%)  8/302 (2.65%) 
Cellulitis  1  1/101 (0.99%)  7/302 (2.32%)  6/307 (1.95%)  7/302 (2.32%) 
Pneumonia  1  1/101 (0.99%)  2/302 (0.66%)  7/307 (2.28%)  6/302 (1.99%) 
Tooth abscess  1  6/101 (5.94%)  10/302 (3.31%)  7/307 (2.28%)  4/302 (1.32%) 
Otitis media  1  1/101 (0.99%)  7/302 (2.32%)  2/307 (0.65%)  4/302 (1.32%) 
Ear infection  1  3/101 (2.97%)  5/302 (1.66%)  6/307 (1.95%)  3/302 (0.99%) 
Viral infection  1  1/101 (0.99%)  7/302 (2.32%)  4/307 (1.30%)  3/302 (0.99%) 
Lower respiratory tract infection  1  4/101 (3.96%)  6/302 (1.99%)  1/307 (0.33%)  3/302 (0.99%) 
Gastroenteritis viral  1  1/101 (0.99%)  7/302 (2.32%)  5/307 (1.63%)  1/302 (0.33%) 
Injury, poisoning and procedural complications         
Contusion  1  1/101 (0.99%)  3/302 (0.99%)  7/307 (2.28%)  8/302 (2.65%) 
Excoriation  1  2/101 (1.98%)  2/302 (0.66%)  5/307 (1.63%)  7/302 (2.32%) 
Muscle strain  1  4/101 (3.96%)  4/302 (1.32%)  9/307 (2.93%)  6/302 (1.99%) 
Fall  1  1/101 (0.99%)  7/302 (2.32%)  0/307 (0.00%)  6/302 (1.99%) 
Ligament sprain  1  2/101 (1.98%)  8/302 (2.65%)  9/307 (2.93%)  5/302 (1.66%) 
Investigations         
Weight Increased  1  1/101 (0.99%)  2/302 (0.66%)  7/307 (2.28%)  5/302 (1.66%) 
Metabolism and nutrition disorders         
Dyslipidaemia  1  4/101 (3.96%)  11/302 (3.64%)  5/307 (1.63%)  9/302 (2.98%) 
Hypertriglyceridaemia  1  3/101 (2.97%)  8/302 (2.65%)  12/307 (3.91%)  8/302 (2.65%) 
Hypercholesterolaemia  1  1/101 (0.99%)  4/302 (1.32%)  6/307 (1.95%)  7/302 (2.32%) 
Gout  1  2/101 (1.98%)  3/302 (0.99%)  3/307 (0.98%)  7/302 (2.32%) 
Hyperuricaemia  1  2/101 (1.98%)  4/302 (1.32%)  7/307 (2.28%)  3/302 (0.99%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  8/101 (7.92%)  31/302 (10.26%)  28/307 (9.12%)  24/302 (7.95%) 
Musculoskeletal pain  1  2/101 (1.98%)  11/302 (3.64%)  6/307 (1.95%)  20/302 (6.62%) 
Back pain  1  9/101 (8.91%)  22/302 (7.28%)  19/307 (6.19%)  19/302 (6.29%) 
Pain in extremity  1  6/101 (5.94%)  15/302 (4.97%)  21/307 (6.84%)  17/302 (5.63%) 
Osteoarthritis  1  6/101 (5.94%)  11/302 (3.64%)  9/307 (2.93%)  10/302 (3.31%) 
Muscle spasms  1  5/101 (4.95%)  8/302 (2.65%)  9/307 (2.93%)  10/302 (3.31%) 
Arthritis  1  3/101 (2.97%)  5/302 (1.66%)  3/307 (0.98%)  7/302 (2.32%) 
Myalgia  1  2/101 (1.98%)  7/302 (2.32%)  5/307 (1.63%)  6/302 (1.99%) 
Tendonitis  1  2/101 (1.98%)  0/302 (0.00%)  7/307 (2.28%)  4/302 (1.32%) 
Hypoglycaemia  1  18/101 (17.82%)  24/302 (7.95%)  102/307 (33.22%)  35/302 (11.59%) 
Nervous system disorders         
Headache  1  5/101 (4.95%)  26/302 (8.61%)  34/307 (11.07%)  22/302 (7.28%) 
Dizziness  1  5/101 (4.95%)  13/302 (4.30%)  14/307 (4.56%)  10/302 (3.31%) 
Neuropathy peripheral  1  1/101 (0.99%)  5/302 (1.66%)  7/307 (2.28%)  8/302 (2.65%) 
Diabetic neuropathy  1  2/101 (1.98%)  5/302 (1.66%)  7/307 (2.28%)  5/302 (1.66%) 
Paraesthesia  1  3/101 (2.97%)  3/302 (0.99%)  5/307 (1.63%)  4/302 (1.32%) 
Sciatica  1  3/101 (2.97%)  1/302 (0.33%)  1/307 (0.33%)  2/302 (0.66%) 
Amnesia  1  3/101 (2.97%)  0/302 (0.00%)  1/307 (0.33%)  1/302 (0.33%) 
Psychiatric disorders         
Depression  1  5/101 (4.95%)  9/302 (2.98%)  10/307 (3.26%)  15/302 (4.97%) 
Insomnia  1  2/101 (1.98%)  6/302 (1.99%)  10/307 (3.26%)  12/302 (3.97%) 
Anxiety  1  6/101 (5.94%)  6/302 (1.99%)  9/307 (2.93%)  8/302 (2.65%) 
Reproductive system and breast disorders         
Erectile Dysfunction  1  3/101 (2.97%)  4/302 (1.32%)  4/307 (1.30%)  6/302 (1.99%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  9/101 (8.91%)  24/302 (7.95%)  28/307 (9.12%)  26/302 (8.61%) 
Oropharyngeal pain  1  1/101 (0.99%)  7/302 (2.32%)  16/307 (5.21%)  9/302 (2.98%) 
Nasal congestion  1  1/101 (0.99%)  4/302 (1.32%)  10/307 (3.26%)  5/302 (1.66%) 
Rhinitis allergic  1  2/101 (1.98%)  5/302 (1.66%)  9/307 (2.93%)  4/302 (1.32%) 
Skin and subcutaneous tissue disorders         
Rash  1  0/101 (0.00%)  8/302 (2.65%)  5/307 (1.63%)  10/302 (3.31%) 
Hyperkeratosis  1  3/101 (2.97%)  0/302 (0.00%)  2/307 (0.65%)  0/302 (0.00%) 
Vascular disorders         
Hypertension  1  6/101 (5.94%)  28/302 (9.27%)  32/307 (10.42%)  32/302 (10.60%) 
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: NCT00838903     History of Changes
Other Study ID Numbers: 112753
First Submitted: February 5, 2009
First Posted: February 9, 2009
Results First Submitted: April 17, 2014
Results First Posted: May 16, 2014
Last Update Posted: January 9, 2017