Safety and Efficacy Study of Albiglutide Liquid Drug Product in Type 2 Diabetes Mellitus

Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26

Time frame · Baseline and 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.

Number of Participants With On-therapy Adverse Events (AEs) and Serious AEs (SAEs)

Time frame · Up to Week 26

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.

Number of Participants With Clinical Chemistry Parameters of Potential Clinical Concern (PCC)

Time frame · Up to Week 26

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.

Number of Participants With Hematology Parameters of PCC

Time frame · Up to Week 26

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.

Number of Participants With Vital Signs of PCC

Time frame · Up to Week 34

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.

Number of Participants With Electrocardiogram (ECG) Parameters of PCC

Time frame · Up to Week 26

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.

Number of Participants With Positive Result for Anti-albiglutide Antibody

Time frame · Up to Week 34

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.

Number of Participants With Injection Site Reactions (ISR)

Time frame · Up to Week 34

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.

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26

Time frame · Baseline and 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.

Change From Baseline in HbA1c Over Time

Time frame · Baseline and up to Week 26

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).

Change From Baseline in FPG Over Time

Time frame · Baseline and up to 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. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).