| Outcome Measures: |
Primary: Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26, Blood samples will be collected from participants at specific time points to evaluate HbA1c to monitor for potential hyperglycemia. The last measurement collected prior to the first dose of randomized study treatment was considered as Baseline value. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The analysis was performed using a mixed-effect model with repeated measures (MMRM) method. The primary analysis will include all HbA1c values collected at scheduled visits from Week 4 up to Week 26. This will include values after hyperglycemia rescue and discontinuation from investigational product. Imputation under the non-inferiority null hypothesis for missing data will be incorporated., Baseline and Week 26 | Secondary: Number of Participants With On-therapy Adverse Events (AEs) and Serious AEs (SAEs), An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth effect, other situations and is associated with liver injury or impaired liver function., Up to Week 26|Number of Participants With Clinical Chemistry Parameters of Potential Clinical Concern (PCC), Chemistry parameters for which PCC values were identified were alanine aminotransferase (ALT) (if value \>3 \* upper limit of normal \[ULN\]), albumin (if value \>5 gram/liter \[g/L\] above ULN or below lower limit of normal \[LLN\]), alkaline phosphatase (alk.phosph.) (if value \>3\*ULN), aspartate aminotransferase (AST) (if value \>3\*ULN), total bilirubin (if value \>1.5 ULN), calcium (if value \<1.8 or \>3.0 millimoles per liter \[mmol/L\]), carbon di oxide (CO2) (if value \<16 or \>40 mmol/L), creatinine (if value \>159 micromoles per liter \[µmol/L\]), direct bilirubin (if value \>1.35\*ULN), gamma glutamyl transferase (GGT) (if value \>3\*ULN), potassium (if value \>0.5 mmol/L below LLN and \>1.0 mmol/L above ULN), protein (if value \>15 g/L above ULN or below LLN), sodium (\>5 mmol/L below LLN or above ULN), urate (if value \>654 µmol/L) and urea (if value \>2\*ULN). Number of participants with chemistry parameters of PCC at 'any visit post-Baseline' are presented., Up to Week 26|Number of Participants With Hematology Parameters of PCC, Hematology parameters for which PCC values were identified were hematocrit (if value \>0.05 below LLN or \>0.04 above ULN), Hemoglobin (Hb) (if value \>20 g/L below LLN or \>10 g/L above ULN), lymphocytes (if value \<0.5\*LLN), neutrophils (if value \<1 giga unit per liter \[GI/L\]) and platelets (if value \<80 GI/L or \>500 GI/L). Number of participants with hematology parameters of PCC at 'any visit post-Baseline' are presented., Up to Week 26|Number of Participants With Vital Signs of PCC, Vital signs including systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate were measured in a seated position after at least 5 minutes of rest. SBP values \<100 millimeters of mercury (mmHg) and \>170 mmHg, DBP values \<50 mmHg and \>110 mmHg, pulse rate values \<50 beats per minute (bpm) and \>120 bpm were considered as PCC values. Number of participants with PCC values of vital signs for 'any visit post-Baseline' are presented., Up to Week 34|Number of Participants With Electrocardiogram (ECG) Parameters of PCC, Single measurements of 12-lead ECG were obtained in semi recumbent position using an ECG machine that automatically calculates the heart rate and measures PR and QT interval corrected for heart rate according to Fridericia's formula (QTcF). Number of participants with ECG values of PCC at 'any visit post-Baseline' are presented. ECG mean heart rate values \<50 or \>120, PR interval \>300 milliseconds (msec), QRS interval \>200 msec, QTcF interval \>=500 msec were considered as PCC values. Number of participants with PCC values of ECG parameters for 'any visit post-Baseline' are presented., Up to Week 26|Number of Participants With Positive Result for Anti-albiglutide Antibody, Blood samples were obtained from participants at specific time points before administration of study treatment. The presence of anti-albiglutide antibodies was assessed using a validated enzyme linked immunosorbent assay (ELISA). The assay involves screening, confirmation, and titration steps (tiered-testing approach). Number of participants with positive anti- albiglutide antibody results at 'any visit post-Baseline' are presented., Up to Week 34|Number of Participants With Injection Site Reactions (ISR), Number of participants with ISR incidences were evaluated at specific time points. Each week included those participants with the onset of an ISR during that particular week as well as those participants with ISR from previous weeks that have not resolved., Up to Week 34|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26, Blood samples were collected from participants at specific time points to evaluate FPG to monitor for potential hyperglycemia. The last measurement collected prior to the first dose of randomized study treatment was considered as Baseline value. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The analysis was performed using a MMRM model., Baseline and Week 26|Change From Baseline in HbA1c Over Time, Blood samples were collected from participants at specific time points to evaluate HbA1c to monitor for potential hyperglycemia. The last measurement collected prior to the first dose of randomized study treatment was considered as Baseline value. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The analysis was performed using a MMRM model and model-adjusted least square mean (LS mean) and standard error have been presented. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)., Baseline and up to Week 26|Change From Baseline in FPG Over Time, Blood samples were collected from participants at specific time points to evaluate FPG to monitor for potential hyperglycemia. The last measurement collected prior to the first dose of randomized study treatment was considered as Baseline value. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The analysis was performed using a MMRM model. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)., Baseline and up to Week 26|Trough Plasma Concentration of Albiglutide Over Time, Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of albiglutide. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)., Pre-dose at Week 12 and Week 26
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| Locations: |
GSK Investigational Site, Birmingham, Alabama, 35216, United States|GSK Investigational Site, Birmingham, Alabama, 35235, United States|GSK Investigational Site, Chandler, Arizona, 85224, United States|GSK Investigational Site, Glendale, Arizona, 85306, United States|GSK Investigational Site, Phoenix, Arizona, 85018, United States|GSK Investigational Site, Anaheim, California, 92801, United States|GSK Investigational Site, Canyon Country, California, 91351, United States|GSK Investigational Site, Chula Vista, California, 91911, United States|GSK Investigational Site, Fresno, California, 93720, United States|GSK Investigational Site, Lomita, California, 90717, United States|GSK Investigational Site, Oceanside, California, 92056, United States|GSK Investigational Site, Sacramento, California, 95821, United States|GSK Investigational Site, San Diego, California, 92120, United States|GSK Investigational Site, Spring Valley, California, 91978, United States|GSK Investigational Site, Tustin, California, 92780, United States|GSK Investigational Site, Van Nuys, California, 91405, United States|GSK Investigational Site, Walnut Creek, California, 94598, United States|GSK Investigational Site, Littleton, Colorado, 80128, United States|GSK Investigational Site, Bradenton, Florida, 34208, United States|GSK Investigational Site, Brooksville, Florida, 34601, United States|GSK Investigational Site, Clearwater, Florida, 33765-2616, United States|GSK Investigational Site, Fleming Island, Florida, 32003, United States|GSK Investigational Site, Hallandale Beach, Florida, 33009, United States|GSK Investigational Site, Hialeah, Florida, 33016, United States|GSK Investigational Site, Miami, Florida, 33156, United States|GSK Investigational Site, Miami, Florida, 33176, United States|GSK Investigational Site, New Port Richey, Florida, 34652, United States|GSK Investigational Site, Orlando, Florida, 32825, United States|GSK Investigational Site, Saint Petersburg, Florida, 33709, United States|GSK Investigational Site, Conyers, Georgia, 30094, United States|GSK Investigational Site, Snellville, Georgia, 30078, United States|GSK Investigational Site, Meridian, Idaho, 83642, United States|GSK Investigational Site, Chicago, Illinois, 60612, United States|GSK Investigational Site, Elgin, Illinois, 60124, United States|GSK Investigational Site, Evansville, Indiana, 47714, United States|GSK Investigational Site, Topeka, Kansas, 66606, United States|GSK Investigational Site, Lexington, Kentucky, 40503, United States|GSK Investigational Site, Lake Charles, Louisiana, 70601, United States|GSK Investigational Site, New Orleans, Louisiana, 70119, United States|GSK Investigational Site, Kalamazoo, Michigan, 49009, United States|GSK Investigational Site, Troy, Michigan, 48098, United States|GSK Investigational Site, Chesterfield, Missouri, 63017, United States|GSK Investigational Site, Saint Louis, Missouri, 63141, United States|GSK Investigational Site, Las Vegas, Nevada, 89123, United States|GSK Investigational Site, Albuquerque, New Mexico, 87102, United States|GSK Investigational Site, New Hyde Park, New York, 11042, United States|GSK Investigational Site, Greensboro, North Carolina, 27405, United States|GSK Investigational Site, Shelby, North Carolina, 28150, United States|GSK Investigational Site, Columbus, Ohio, 43201, United States|GSK Investigational Site, Maumee, Ohio, 43537-9402, United States|GSK Investigational Site, Norwood, Ohio, 45212, United States|GSK Investigational Site, Perrysburg, Ohio, 43551, United States|GSK Investigational Site, Altoona, Pennsylvania, 16602, United States|GSK Investigational Site, Anderson, South Carolina, 29621, United States|GSK Investigational Site, Columbia, South Carolina, 29204, United States|GSK Investigational Site, Arlington, Texas, 76012, United States|GSK Investigational Site, Dallas, Texas, 75230, United States|GSK Investigational Site, Houston, Texas, 77051, United States|GSK Investigational Site, Houston, Texas, 77058, United States|GSK Investigational Site, Houston, Texas, 77074, United States|GSK Investigational Site, Katy, Texas, 77079, United States|GSK Investigational Site, Pharr, Texas, 78577, United States|GSK Investigational Site, San Antonio, Texas, 78229, United States|GSK Investigational Site, San Antonio, Texas, 78231, United States|GSK Investigational Site, Schertz, Texas, 78154, United States|GSK Investigational Site, Spring, Texas, 77379, United States|GSK Investigational Site, Murray, Utah, 84123, United States|GSK Investigational Site, Federal Way, Washington, 98003, United States|GSK Investigational Site, Spokane, Washington, 99208, United States|GSK Investigational Site, Tacoma, Washington, 98405, United States
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