Trial Outcomes & Findings for Safety and Efficacy of Albiglutide + Insulin Glargine Versus Insulin Lispro + Insulin Glargine Subjects With Type 2 Diabetes Mellitus (NCT NCT02229227)

NCT ID: NCT02229227

Last Updated: 2020-11-27

Results Overview

HbA1c is glycosylated hemoglobin. It was measured at Baseline and at Week 26. The analysis was conducted using mixed-effect model with repeated measures (MMRM). The model included HbA1c change from Baseline as the dependent variable; treatment, region, age category, current metformin use, visit week, treatment-by-week interaction, and Baseline HbA1c-by-week interaction as fixed effects; Baseline HbA1c as a continuous covariate; and participant as a random effect. The Baseline value was the last available non-missing value prior to the first dose of the randomized treatment, thus Baseline was Day -1. Change from Baseline is defined as the post-Baseline value minus the Baseline value.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 814 participants
• Primary outcome timeframe: Baseline (Day -1) and Week 26
• Results posted on: 2020-11-27

Participant Flow

This study was conducted from 21-Nov-2014 to 24-Jul-2017 at 186 centers in 14 countries: Canada, United States of America, Mexico, Brazil, Hungary, Poland, France, Germany, Italy, Spain, United Kingdom, Korea, Philippines and South Africa.

A total of 2004 participants were screened, of which 973 participants were screen failures and 160 participants were re-screened. A total of 1031 participants then entered the standardization period, of which 217 participants were standardization failures. A total of 814 participants were randomized in the study.

Participant milestones

Measure	Albiglutide + Insulin Glargine During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 milligrams (mg) weekly subcutaneous (SC) injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	Insulin Lispro + Insulin Glargine During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Overall Study STARTED	402	412
Overall Study COMPLETED	351	350
Overall Study NOT COMPLETED	51	62

Reasons for withdrawal

Measure	Albiglutide + Insulin Glargine During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 milligrams (mg) weekly subcutaneous (SC) injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	Insulin Lispro + Insulin Glargine During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Overall Study Adverse Event	14	9
Overall Study Lack of Efficacy	3	3
Overall Study Protocol Violation	6	8
Overall Study Protocol defined stopping criteria	1	3
Overall Study Lost to Follow-up	3	3
Overall Study Study terminated by sponsor	11	11
Overall Study Withdrawal by Subject	8	12
Overall Study Other	0	1
Overall Study Physician Decision	5	12

Baseline Characteristics

Safety and Efficacy of Albiglutide + Insulin Glargine Versus Insulin Lispro + Insulin Glargine Subjects With Type 2 Diabetes Mellitus

Baseline characteristics by cohort

Measure	Albiglutide + Insulin Glargine n=402 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	Insulin Lispro + Insulin Glargine n=412 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.	Total n=814 Participants Total of all reporting groups
Age, Continuous	58.0 Years STANDARD_DEVIATION 9.40 • n=5 Participants	58.1 Years STANDARD_DEVIATION 9.49 • n=7 Participants	58.1 Years STANDARD_DEVIATION 9.44 • n=5 Participants
Sex: Female, Male Female	228 Participants n=5 Participants	214 Participants n=7 Participants	442 Participants n=5 Participants
Sex: Female, Male Male	174 Participants n=5 Participants	198 Participants n=7 Participants	372 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	43 Participants n=5 Participants	28 Participants n=7 Participants	71 Participants n=5 Participants
Race/Ethnicity, Customized Asian-Central/South Asian (A) Heritage (H)	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants
Race/Ethnicity, Customized Asian-Japanese H/East AH/South East AH	25 Participants n=5 Participants	24 Participants n=7 Participants	49 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	37 Participants n=5 Participants	32 Participants n=7 Participants	69 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized White	284 Participants n=5 Participants	312 Participants n=7 Participants	596 Participants n=5 Participants
Race/Ethnicity, Customized Multiple-Black or African American and White	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Day -1) and Week 26

Population: FA Population. Only those participants available at the specified time points were analyzed.

HbA1c is glycosylated hemoglobin. It was measured at Baseline and at Week 26. The analysis was conducted using mixed-effect model with repeated measures (MMRM). The model included HbA1c change from Baseline as the dependent variable; treatment, region, age category, current metformin use, visit week, treatment-by-week interaction, and Baseline HbA1c-by-week interaction as fixed effects; Baseline HbA1c as a continuous covariate; and participant as a random effect. The Baseline value was the last available non-missing value prior to the first dose of the randomized treatment, thus Baseline was Day -1. Change from Baseline is defined as the post-Baseline value minus the Baseline value.

Outcome measures

Measure	Albiglutide + Insulin Glargine n=345 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	Insulin Lispro + Insulin Glargine n=350 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26	-1.04 Percentage of glycosylated hemoglobin Standard Error 0.041	-1.10 Percentage of glycosylated hemoglobin Standard Error 0.040

SECONDARY outcome

Timeframe: Up to Week 26

Population: FA Population.

Participants who did not meet prespecified criteria for severe, persistent hyperglycemia through Week 26 were those participants treated with once-weekly albiglutide that were able to replace prandial insulin without lispro re-introduction through Week 26. Number of participants treated with once-weekly albiglutide that were able to discontinue insulin lispro at Week 4 and did not meet prespecified criteria for severe, persistent hyperglycemia through Week 26 have been presented.

Outcome measures

Measure	Albiglutide + Insulin Glargine n=402 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	Insulin Lispro + Insulin Glargine During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Number of Participants Treated With Once-weekly Albiglutide That Were Able to Discontinue Insulin Lispro at Week 4 and Did Not Meet Prespecified Criteria for Severe, Persistent Hyperglycemia Through Week 26	218 Participants	—

SECONDARY outcome

Timeframe: Up to Week 26

Population: FA Population. Only those participants available at the specified time points were analyzed.

Severe hypoglycemia was considered as an event requiring assistance of another person to actively administer carbohydrates, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal was considered sufficient evidence that the event was induced by a low plasma glucose concentration. Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia are accompanied by a measured plasma glucose concentration <=70 milligrams per deciliters (mg/dL) (<=3.9 millimoles per liters [mmol/L]).

Outcome measures

Measure	Albiglutide + Insulin Glargine n=402 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	Insulin Lispro + Insulin Glargine n=412 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Percentage of Participants With Severe or Documented Symptomatic Hypoglycemia Through Week 26	57.2 Percentage of participants	75.0 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day -1) and Week 26

Population: FA Population. Only those participants available at the specified time points were analyzed.

Body weight was measured to the nearest 0.1 kilogram on a standard calibrated scale. Participants dressed in light indoor clothes (no coat, jacket, etc.) without shoes and with a voided bladder. The same equipment was used wherever possible. The Baseline value was the last available non-missing value prior to the first dose of the randomized treatment, thus Baseline was Day -1. Change from Baseline is defined as the post-Baseline value minus the Baseline value.

Outcome measures

Measure	Albiglutide + Insulin Glargine n=349 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	Insulin Lispro + Insulin Glargine n=352 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Change From Baseline in Body Weight at Week 26	-1.95 Kilograms Standard Error 0.207	2.43 Kilograms Standard Error 0.205

SECONDARY outcome

Timeframe: Baseline (Day -1) to Week 26

Population: FA Population.

Body weight was measured to the nearest 0.1 kilogram on a standard calibrated scale. Participants dressed in light indoor clothes (no coat, jacket, etc.) without shoes and with a voided bladder. The same equipment was used wherever possible. The Baseline value was the last available non-missing value prior to the first dose of the randomized treatment, thus Baseline was Day -1. Change from Baseline is defined as the post-Baseline value minus the Baseline value. Change from Baseline to Week 26 in body weight are presented. FA Population was analyzed. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles.

Outcome measures

Measure	Albiglutide + Insulin Glargine n=402 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	Insulin Lispro + Insulin Glargine n=412 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Change From Baseline to Week 26 in Body Weight Week 4, n=368,384	-0.55 Kilograms Standard Error 0.091	0.66 Kilograms Standard Error 0.091
Change From Baseline to Week 26 in Body Weight Week 5, n=382,393	-0.95 Kilograms Standard Error 0.102	0.85 Kilograms Standard Error 0.102
Change From Baseline to Week 26 in Body Weight Week 10, n=379,397	-1.71 Kilograms Standard Error 0.133	1.46 Kilograms Standard Error 0.131
Change From Baseline to Week 26 in Body Weight Week 18, n=365,372	-1.96 Kilograms Standard Error 0.177	2.06 Kilograms Standard Error 0.175
Change From Baseline to Week 26 in Body Weight Week 26, n=349,352	-1.95 Kilograms Standard Error 0.207	2.43 Kilograms Standard Error 0.205

SECONDARY outcome

Timeframe: Week 26

Population: FA Population. Only those participants available at the specified time points were analyzed.

Insulin dose at Week 26 was defined as the prescribed insulin dose at Week 25. Based on MMRM model, prescribed total daily basal insulin dose was equal to Baseline prescribed total daily basal insulin dose + treatment + Baseline HbA1c category + region + age category + current use of metformin + visit week + treatment-by-visit week interaction + Baseline prescribed total daily basal insulin dose-by-visit week interaction. Total daily insulin dose at Week 26 is presented. Only those participants available at the specified time points were analyzed.

Outcome measures

Measure	Albiglutide + Insulin Glargine n=342 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	Insulin Lispro + Insulin Glargine n=341 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Total Daily Insulin Dose at Week 26	70.36 International Units Standard Error 2.160	131.19 International Units Standard Error 2.149

SECONDARY outcome

Timeframe: Baseline to Week 26

Population: FA Population.

HbA1c is glycosylated hemoglobin and was measured up to Week 26. The Baseline value was the last available non-missing value prior to the first dose of the randomized treatment, thus Baseline was Day -1. Change from Baseline is defined as the post-Baseline value minus the Baseline value. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles.

Outcome measures

Measure	Albiglutide + Insulin Glargine n=402 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	Insulin Lispro + Insulin Glargine n=412 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Change From Baseline to Week 26 in HbA1c Week 4, n=358,375	-0.59 Percentage of glycosylated hemoglobin Standard Error 0.023	-0.47 Percentage of glycosylated hemoglobin Standard Error 0.023
Change From Baseline to Week 26 in HbA1c Week 5, n=374,392	-0.67 Percentage of glycosylated hemoglobin Standard Error 0.026	-0.58 Percentage of glycosylated hemoglobin Standard Error 0.025
Change From Baseline to Week 26 in HbA1c Week 10, n=376,390	-0.88 Percentage of glycosylated hemoglobin Standard Error 0.034	-0.96 Percentage of glycosylated hemoglobin Standard Error 0.033
Change From Baseline to Week 26 in HbA1c Week 18, n=360,365	-1.04 Percentage of glycosylated hemoglobin Standard Error 0.038	-1.14 Percentage of glycosylated hemoglobin Standard Error 0.038
Change From Baseline to Week 26 in HbA1c Week 26, n=345,350	-1.04 Percentage of glycosylated hemoglobin Standard Error 0.041	-1.1 Percentage of glycosylated hemoglobin Standard Error 0.040

SECONDARY outcome

Timeframe: Baseline and Week 26

Population: FA Population. Only those participants available at the specified time points were analyzed.

FPG was measured at Baseline (Day -1). FPG values for all participants at Week 26 were not collected due to an error in the protocol and were imputed with the fasting serum glucose (FSG) values at this time point. The imputation of the FPG at Week 26 from the FSG values was deemed acceptable from the results of the analysis of the correlation between FPG and FSG at the screening visit. The Baseline value was the last available non-missing value prior to the first dose of the randomized treatment, thus Baseline was Day -1. Change from Baseline is defined as the post-Baseline value minus the Baseline value.

Outcome measures

Measure	Albiglutide + Insulin Glargine n=345 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	Insulin Lispro + Insulin Glargine n=349 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26	-2.01 Millimoles per Liter Standard Error 0.120	-1.46 Millimoles per Liter Standard Error 0.121

SECONDARY outcome

Timeframe: Baseline to Week 26

Population: FA Population. Only those participants available at the specified time points were analyzed.

FPG was measured at Baseline (Day -1) up to Week 26. FPG values for all participants at Week 26 were not collected due to an error in the protocol and were imputed with the FSG values at this time point. The imputation of the FPG at Week 26 from the FSG values was deemed acceptable from the results of the analysis of the correlation between FPG and FSG at the screening visit. The Baseline value was the last available non-missing value prior to the first dose of the randomized treatment, thus Baseline was Day -1. Change from Baseline is defined as the post-Baseline value minus the Baseline value.

Outcome measures

Measure	Albiglutide + Insulin Glargine n=402 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	Insulin Lispro + Insulin Glargine n=412 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Change From Baseline to Week 26 in FPG Week 4, n=356,371	-1.30 Millimoles per Liter Standard Error 0.119	-0.76 Millimoles per Liter Standard Error 0.118
Change From Baseline to Week 26 in FPG Week 5, n=366,388	-1.07 Millimoles per Liter Standard Error 0.126	-0.88 Millimoles per Liter Standard Error 0.125
Change From Baseline to Week 26 in FPG Week 18, n=348,353	-1.76 Millimoles per Liter Standard Error 0.124	-1.23 Millimoles per Liter Standard Error 0.124
Change From Baseline to Week 26 in FPG Week 26, n=345,349	-2.01 Millimoles per Liter Standard Error 0.120	-1.46 Millimoles per Liter Standard Error 0.121

SECONDARY outcome

Timeframe: Week 26

Population: FA Population.

HbA1c is glycosylated hemoglobin. Number of participants achieving a HbA1c <7.0% at Week 26 are presented.

Outcome measures

Measure	Albiglutide + Insulin Glargine n=402 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	Insulin Lispro + Insulin Glargine n=412 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Number of Participants Achieving HbA1c <7.0% at Week 26	244 Participants	255 Participants

SECONDARY outcome

Timeframe: Up to Week 26

Population: FA Population.

HbA1c is glycosylated hemoglobin. Number of participants achieving a HbA1c <7.0% up to Week 26 are presented.

Outcome measures

Measure	Albiglutide + Insulin Glargine n=402 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	Insulin Lispro + Insulin Glargine n=412 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Number of Participants Achieving HbA1c <7.0% up to Week 26 Week 4	142 Participants	139 Participants
Number of Participants Achieving HbA1c <7.0% up to Week 26 Week 5	157 Participants	182 Participants
Number of Participants Achieving HbA1c <7.0% up to Week 26 Week 10	220 Participants	261 Participants
Number of Participants Achieving HbA1c <7.0% up to Week 26 Week 18	251 Participants	281 Participants
Number of Participants Achieving HbA1c <7.0% up to Week 26 Week 26	244 Participants	255 Participants

SECONDARY outcome

Timeframe: Week 26

Population: FA Population.

Number of participants achieving a HbA1c <6.5% at Week 26 are presented.

Outcome measures

Measure	Albiglutide + Insulin Glargine n=402 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	Insulin Lispro + Insulin Glargine n=412 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Number of Participants Achieving a HbA1c <6.5% at Week 26	147 Participants	169 Participants

SECONDARY outcome

Timeframe: Up to Week 26

Population: FA Population.

Number of participants achieving a HbA1c <6.5% up to Week 26 are presented.

Outcome measures

Measure	Albiglutide + Insulin Glargine n=402 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	Insulin Lispro + Insulin Glargine n=412 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Number of Participants Achieving a HbA1c <6.5% up to Week 26 Week 4	39 Participants	33 Participants
Number of Participants Achieving a HbA1c <6.5% up to Week 26 Week 5	63 Participants	62 Participants
Number of Participants Achieving a HbA1c <6.5% up to Week 26 Week 10	116 Participants	140 Participants
Number of Participants Achieving a HbA1c <6.5% up to Week 26 Week 18	150 Participants	178 Participants
Number of Participants Achieving a HbA1c <6.5% up to Week 26 Week 26	147 Participants	169 Participants

SECONDARY outcome

Timeframe: Week 26

Population: FA Population.

Meeting prespecified criteria for severe, persistent hyperglycemia was defined operationally as being withdrawn due to lack of efficacy as recorded on the Treatment Discontinuation and Study Conclusion electronic case report form pages. Number of participants who met prespecified criteria for severe, persistent hyperglycemia at Week 26 are presented.

Outcome measures

Measure	Albiglutide + Insulin Glargine n=402 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	Insulin Lispro + Insulin Glargine n=412 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Number of Participants Who Met Prespecified Criteria for Severe, Persistent Hyperglycemia at Week 26	3 Participants	3 Participants

SECONDARY outcome

Timeframe: Up to Week 26

Population: FA Population.

Meeting prespecified criteria for severe, persistent hyperglycemia was defined operationally as being withdrawn due to lack of efficacy as recorded on the Treatment Discontinuation and Study Conclusion electronic case report form pages. Number of participants meeting prespecified criteria for severe, persistent hyperglycemia up to Week 26 are presented.

Outcome measures

Measure	Albiglutide + Insulin Glargine n=402 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	Insulin Lispro + Insulin Glargine n=412 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Number of Participants Meeting Prespecified Criteria for Severe, Persistent Hyperglycemia up to Week 26 0 to <=4 Weeks	0 Participants	0 Participants
Number of Participants Meeting Prespecified Criteria for Severe, Persistent Hyperglycemia up to Week 26 >4 to <=5 Weeks	0 Participants	0 Participants
Number of Participants Meeting Prespecified Criteria for Severe, Persistent Hyperglycemia up to Week 26 >5 to <=10 Weeks	2 Participants	0 Participants
Number of Participants Meeting Prespecified Criteria for Severe, Persistent Hyperglycemia up to Week 26 >10 to <=18 Weeks	0 Participants	1 Participants
Number of Participants Meeting Prespecified Criteria for Severe, Persistent Hyperglycemia up to Week 26 >18 to <=26 Weeks	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Weeks 4, 10, and 18

Population: FA Population.

Based on MMRM model, prescribed total daily basal insulin dose was equal to Baseline prescribed total daily basal insulin dose + treatment + Baseline HbA1c category + region + age category + current use of metformin + visit week + treatment-by-visit week interaction + Baseline prescribed total daily basal insulin dose-by-visit week interaction. Total daily insulin dose at Week 4, Week 10 and Week 18 is presented. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles.

Outcome measures

Measure	Albiglutide + Insulin Glargine n=402 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	Insulin Lispro + Insulin Glargine n=412 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Total Daily Insulin Dose at Week 4, Week 10 and Week 18 Week 4, n=388,403	50.53 International Units Standard Error 1.183	106.91 International Units Standard Error 1.187
Total Daily Insulin Dose at Week 4, Week 10 and Week 18 Week 10, n=375,386	57.99 International Units Standard Error 1.597	121.69 International Units Standard Error 1.589
Total Daily Insulin Dose at Week 4, Week 10 and Week 18 Week 18, n=359,361	68.23 International Units Standard Error 2.010	130.22 International Units Standard Error 1.998

SECONDARY outcome

Timeframe: Weeks 4, 10, 18, and 26

Population: FA Population.

Based on MMRM model, prescribed total daily basal insulin dose was equal to Baseline prescribed total daily basal insulin dose + treatment + Baseline HbA1c category + region + age category + current use of metformin + visit week + treatment-by-visit week interaction + Baseline prescribed total daily basal insulin dose-by-visit week interaction. Total daily basal insulin (insulin glargine) at Week 4, 10, 18, and 26 visits is presented. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles.

Outcome measures

Measure	Albiglutide + Insulin Glargine n=402 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	Insulin Lispro + Insulin Glargine n=412 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Total Daily Basal Insulin (Insulin Glargine) at Week 4, 10, 18, and 26 Visits Week 4, n=388,403	49.97 International Units Standard Error 0.534	50.94 International Units Standard Error 0.536
Total Daily Basal Insulin (Insulin Glargine) at Week 4, 10, 18, and 26 Visits Week 10, n=375,386	56.14 International Units Standard Error 0.767	55.79 International Units Standard Error 0.761
Total Daily Basal Insulin (Insulin Glargine) at Week 4, 10, 18, and 26 Visits Week 18, n=359,361	59.42 International Units Standard Error 0.928	59.18 International Units Standard Error 0.920
Total Daily Basal Insulin (Insulin Glargine) at Week 4, 10, 18, and 26 Visits Week 26, n=342,341	59.83 International Units Standard Error 0.996	59.43 International Units Standard Error 0.988

SECONDARY outcome

Timeframe: Weeks 4, 10, 18, and 26

Population: FA Population.

Based on MMRM model, prescribed total daily basal insulin dose was equal to Baseline prescribed total daily basal insulin dose + treatment + Baseline HbA1c category + region + age category + current use of metformin + visit week + treatment-by-visit week interaction + Baseline prescribed total daily basal insulin dose-by-visit week interaction. Total daily bolus insulin (insulin lispro) at Week 4, 10, 18, and 26 visits is presented. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles.

Outcome measures

Measure	Albiglutide + Insulin Glargine n=402 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	Insulin Lispro + Insulin Glargine n=412 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Total Daily Bolus Insulin (Insulin Lispro) at Week 4, 10, 18, and 26 Visits Week 4, n=388,403	0.62 International Units Standard Error 0.887	56.67 International Units Standard Error 0.892
Total Daily Bolus Insulin (Insulin Lispro) at Week 4, 10, 18, and 26 Visits Week 10, n=375,386	1.90 International Units Standard Error 1.147	66.66 International Units Standard Error 1.144
Total Daily Bolus Insulin (Insulin Lispro) at Week 4, 10, 18, and 26 Visits Week 18, n=359,361	8.89 International Units Standard Error 1.436	71.81 International Units Standard Error 1.430
Total Daily Bolus Insulin (Insulin Lispro) at Week 4, 10, 18, and 26 Visits Week 26, n=342,341	10.64 International Units Standard Error 1.523	72.47 International Units Standard Error 1.517

SECONDARY outcome

Timeframe: Baseline (Day -1) and Weeks 4, 10, 18 and 26

Population: FA Population.

Total number of weekly insulin injections (7 days) to achieve glycemic control at Baseline/Randomization and Week 4, 10, 18, and 26 are presented. Only those participants available at the specified time points were analyzed represented by n=X,X in category titles.

Outcome measures

Measure	Albiglutide + Insulin Glargine n=402 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	Insulin Lispro + Insulin Glargine n=412 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Total Number of Weekly Insulin Injections to Achieve Glycemic Control at Baseline/Randomization and Week 4, 10, 18, and 26 Baseline, n=401,412	28.79 Insulin Injections Standard Deviation 1.470	28.00 Insulin Injections Standard Deviation 0.000
Total Number of Weekly Insulin Injections to Achieve Glycemic Control at Baseline/Randomization and Week 4, 10, 18, and 26 Week 4, n=388,403	8.11 Insulin Injections Standard Deviation 1.506	28.00 Insulin Injections Standard Deviation 0.000
Total Number of Weekly Insulin Injections to Achieve Glycemic Control at Baseline/Randomization and Week 4, 10, 18, and 26 Week 10, n=375,386	9.06 Insulin Injections Standard Deviation 3.121	28.00 Insulin Injections Standard Deviation 0.000
Total Number of Weekly Insulin Injections to Achieve Glycemic Control at Baseline/Randomization and Week 4, 10, 18, and 26 Week 18, n=359,361	12.62 Insulin Injections Standard Deviation 7.330	28.00 Insulin Injections Standard Deviation 0.000
Total Number of Weekly Insulin Injections to Achieve Glycemic Control at Baseline/Randomization and Week 4, 10, 18, and 26 Week 26, n=342,341	13.22 Insulin Injections Standard Deviation 7.758	28.00 Insulin Injections Standard Deviation 0.000

SECONDARY outcome

Timeframe: Week 26

Population: FA Population.

Percentage of participants achieving HbA1c <7.0% without weight gain are presented.

Outcome measures

Measure	Albiglutide + Insulin Glargine n=402 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	Insulin Lispro + Insulin Glargine n=412 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Percentage of Participants Achieving HbA1c <7.0% Without Weight Gain at Week 26	49.8 Percentage of participants	21.4 Percentage of participants

SECONDARY outcome

Timeframe: Week 26

Population: FA Population.

Percentage of participants achieving HbA1c <7.0% without severe or documented symptomatic hypoglycemia are presented.

Outcome measures

Measure	Albiglutide + Insulin Glargine n=402 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	Insulin Lispro + Insulin Glargine n=412 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Percentage of Participants Achieving HbA1c <7.0% Without Severe or Documented Symptomatic Hypoglycemia at Week 26	21.1 Percentage of participants	9.5 Percentage of participants

SECONDARY outcome

Timeframe: Week 26

Population: FA Population.

Percentage of participants achieving HbA1c <7.0% without weight gain and without severe or documented hypoglycemia are presented.

Outcome measures

Measure	Albiglutide + Insulin Glargine n=402 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	Insulin Lispro + Insulin Glargine n=412 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Percentage of Participants Achieving HbA1c <7.0% Without Weight Gain and Without Severe or Documented Hypoglycemia at Week 26	15.9 Percentage of participants	3.9 Percentage of participants

SECONDARY outcome

Timeframe: Up to Week 26

Population: Safety Population.

AE is any untoward medical occurrence in a participant, temporally associated with use of medicinal product (MP), whether or not considered related to MP. AE can be any unfavorable, unintended sign (also an abnormal laboratory finding), symptom, or disease (new/exacerbated) temporally associated with use of MP. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, or is a congenital anomaly/birth defect or is medically significant or all events of possible drug induced liver injury with hyperbilirubinemia. Safety Population: All participants who received at least 1 dose of randomized study medication. A participant randomized to Albiglutide + Insulin glargine by mistake received Insulin Lispro + Insulin Glargine instead. Since this participant received actual treatment as Insulin Lispro + Insulin Glargine, was summarized as such in Safety Population.

Outcome measures

Measure	Albiglutide + Insulin Glargine n=400 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	Insulin Lispro + Insulin Glargine n=413 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Number of Participants With On-therapy Adverse Events (AE) and Serious AE (SAE), and AE Leading to Discontinuation of Randomized Study Medication AE	261 Participants	254 Participants
Number of Participants With On-therapy Adverse Events (AE) and Serious AE (SAE), and AE Leading to Discontinuation of Randomized Study Medication SAE	23 Participants	31 Participants
Number of Participants With On-therapy Adverse Events (AE) and Serious AE (SAE), and AE Leading to Discontinuation of Randomized Study Medication AE leading to study medication discontinuation	12 Participants	6 Participants

SECONDARY outcome

Timeframe: Up to Week 26

Population: Safety Population.

AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with use of a MP, whether or not considered related to MP. AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with use of MP. AE of special interest included hypoglycemic events, cardiovascular events, gastrointestinal events, injection site reactions, potential systemic allergic reactions, pancreatitis, pancreatic cancer, malignant neoplasms following treatment with insulin, diabetic retinopathy events, appendicitis, liver events, pneumonia, and atrial fibrillation/flutter.

Outcome measures

Measure	Albiglutide + Insulin Glargine n=400 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	Insulin Lispro + Insulin Glargine n=413 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Number of Participants With Other AE of Special Interest Hypoglycemic Events	305 Participants	361 Participants
Number of Participants With Other AE of Special Interest Cardiovascular Events	7 Participants	9 Participants
Number of Participants With Other AE of Special Interest Gastrointestinal Events	102 Participants	53 Participants
Number of Participants With Other AE of Special Interest Injection Site Reactions	8 Participants	1 Participants
Number of Participants With Other AE of Special Interest Systemic Allergic Reactions	3 Participants	0 Participants
Number of Participants With Other AE of Special Interest Pancreatitis	1 Participants	0 Participants
Number of Participants With Other AE of Special Interest Pancreatic cancer	0 Participants	0 Participants
Number of Participants With Other AE of Special Interest Malignant Neoplasm	2 Participants	2 Participants
Number of Participants With Other AE of Special Interest Diabetic Retinopathy	4 Participants	17 Participants
Number of Participants With Other AE of Special Interest Appendicitis	1 Participants	0 Participants
Number of Participants With Other AE of Special Interest Liver Events	0 Participants	2 Participants
Number of Participants With Other AE of Special Interest Pneumonia	1 Participants	3 Participants
Number of Participants With Other AE of Special Interest Atrial Fibrillation/Flutter	4 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to Week 26

Population: Safety Population.

Hypoglycemic events with confirmed home plasma glucose monitoring <3.9 millimoles per Liter and/or requiring third party intervention were severe, documented symptomatic (DS) and asymptomatic hypoglycemic events. Participants with more than one hypoglycemic event are counted in all categories reported. Any severe, documented symptomatic, and asymptomatic hypoglycemic events in 3-month intervals (i.e., from Day 0 to Week 12, >Week 12 to Week 26) are presented.

Outcome measures

Measure	Albiglutide + Insulin Glargine n=400 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	Insulin Lispro + Insulin Glargine n=413 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Percentage of Participants With Events of Hypoglycemia With Confirmed Home Blood Glucose Monitoring and/or Third-party Intervention Through Week 26 Any event: Onset date falls under 0 to <= 12 weeks	55.3 Percentage of participants	79.2 Percentage of participants
Percentage of Participants With Events of Hypoglycemia With Confirmed Home Blood Glucose Monitoring and/or Third-party Intervention Through Week 26 Any event: Onset date falls > 12 to <= 26 Weeks	60.3 Percentage of participants	79.4 Percentage of participants
Percentage of Participants With Events of Hypoglycemia With Confirmed Home Blood Glucose Monitoring and/or Third-party Intervention Through Week 26 Severe: Onset date falls under 0 to <= 12 weeks	1.8 Percentage of participants	3.6 Percentage of participants
Percentage of Participants With Events of Hypoglycemia With Confirmed Home Blood Glucose Monitoring and/or Third-party Intervention Through Week 26 Severe: Onset date falls > 12 to <= 26 Weeks	0.8 Percentage of participants	1.9 Percentage of participants
Percentage of Participants With Events of Hypoglycemia With Confirmed Home Blood Glucose Monitoring and/or Third-party Intervention Through Week 26 DS: Onset date falls under 0 to <= 12 weeks	33.8 Percentage of participants	63.0 Percentage of participants
Percentage of Participants With Events of Hypoglycemia With Confirmed Home Blood Glucose Monitoring and/or Third-party Intervention Through Week 26 DS: Onset date falls > 12 to <= 26 Weeks	40.8 Percentage of participants	62.0 Percentage of participants
Percentage of Participants With Events of Hypoglycemia With Confirmed Home Blood Glucose Monitoring and/or Third-party Intervention Through Week 26 Asymptomatic: Onset date under 0 to <= 12 weeks	38.3 Percentage of participants	56.9 Percentage of participants
Percentage of Participants With Events of Hypoglycemia With Confirmed Home Blood Glucose Monitoring and/or Third-party Intervention Through Week 26 Asymptomatic: Onset date falls > 12 to <= 26 Weeks	44.3 Percentage of participants	54.7 Percentage of participants

SECONDARY outcome

Timeframe: Up to Week 26

Population: Safety Population.

The American Diabetes Association has categorized hypoglycemic events as follows: Severe, documented symptomatic, asymptomatic, probably symptomatic and pseudohypoglycemia. Number of participants with hypoglycemic events in total are also presented.

Outcome measures

Measure	Albiglutide + Insulin Glargine n=400 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	Insulin Lispro + Insulin Glargine n=413 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Number of Participants With Hypoglycemic Events (in Total and by Each Category as Defined by the American Diabetes Association Criteria) Pseudohypoglycemia	45 Participants	83 Participants
Number of Participants With Hypoglycemic Events (in Total and by Each Category as Defined by the American Diabetes Association Criteria) Severe	9 Participants	22 Participants
Number of Participants With Hypoglycemic Events (in Total and by Each Category as Defined by the American Diabetes Association Criteria) Documented Symptomatic	203 Participants	299 Participants
Number of Participants With Hypoglycemic Events (in Total and by Each Category as Defined by the American Diabetes Association Criteria) Asymptomatic	230 Participants	293 Participants
Number of Participants With Hypoglycemic Events (in Total and by Each Category as Defined by the American Diabetes Association Criteria) Probably Symptomatic	29 Participants	52 Participants
Number of Participants With Hypoglycemic Events (in Total and by Each Category as Defined by the American Diabetes Association Criteria) Missing	9 Participants	13 Participants
Number of Participants With Hypoglycemic Events (in Total and by Each Category as Defined by the American Diabetes Association Criteria) Total	305 Participants	361 Participants

SECONDARY outcome

Timeframe: Up to Week 26

Population: Safety Population.

Daytime hypoglycemia was defined as hypoglycemic events with an onset between 06:00 hours and 00:00 hours (inclusive), and nocturnal hypoglycemia (in total and by category), defined as hypoglycemic events with an onset between 00:01 hours and 05:59 hours (inclusive). Number of participants with daytime and nocturnal hypoglycemia (in total and by category) are presented.

Outcome measures

Measure	Albiglutide + Insulin Glargine n=400 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	Insulin Lispro + Insulin Glargine n=413 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Number of Participants With Daytime and Nocturnal Hypoglycemia Any (Total) Daytime Hypoglycemic Event	288 Participants	356 Participants
Number of Participants With Daytime and Nocturnal Hypoglycemia Any (Total) Nocturnal Hypoglycemic Event	155 Participants	225 Participants
Number of Participants With Daytime and Nocturnal Hypoglycemia Severe Daytime Hypoglycemic Event	6 Participants	14 Participants
Number of Participants With Daytime and Nocturnal Hypoglycemia Severe Nocturnal Hypoglycemic Event	4 Participants	6 Participants
Number of Participants With Daytime and Nocturnal Hypoglycemia Documented Symptomatic Daytime Hypoglycemic event	187 Participants	293 Participants
Number of Participants With Daytime and Nocturnal Hypoglycemia Documented Symptomatic Nocturnal Hypoglycemia	101 Participants	152 Participants
Number of Participants With Daytime and Nocturnal Hypoglycemia Asymptomatic Daytime Hypoglycemic event	217 Participants	281 Participants
Number of Participants With Daytime and Nocturnal Hypoglycemia Asymptomatic Nocturnal Hypoglycemic event	77 Participants	106 Participants
Number of Participants With Daytime and Nocturnal Hypoglycemia Probably Symptomatic Daytime Hypoglycemic event	22 Participants	44 Participants
Number of Participants With Daytime and Nocturnal Hypoglycemia Probably Symptomatic Nocturnal Hypoglycemic event	7 Participants	21 Participants
Number of Participants With Daytime and Nocturnal Hypoglycemia Pseudohypoglycemia Daytime Hypoglycemic event	36 Participants	70 Participants
Number of Participants With Daytime and Nocturnal Hypoglycemia Pseudohypoglycemia Nocturnal Hypoglycemic event	17 Participants	34 Participants
Number of Participants With Daytime and Nocturnal Hypoglycemia Missing Daytime Hypoglycemic Event	9 Participants	11 Participants
Number of Participants With Daytime and Nocturnal Hypoglycemia Mising Nocturnal Hypoglycemic Event	2 Participants	4 Participants

SECONDARY outcome

Timeframe: Up to Week 26

Population: Safety Population.

Number of participants with hypoglycemia with blood glucose <56 mg/dL (<3.1 mmol/L), regardless of symptoms are presented.

Outcome measures

Measure	Albiglutide + Insulin Glargine n=400 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	Insulin Lispro + Insulin Glargine n=413 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Number of Participants With Hypoglycemia With Blood Glucose <56 Milligrams Per Deciliter (mg/dL) (<3.1 Millimoles Per Liter [mmol/L]), Regardless of Symptoms	141 Participants	239 Participants

SECONDARY outcome

Timeframe: Up to 30 weeks

Population: Safety Population. Only those participants available at the specified time points were analyzed.

Hematology parameters included basophils, eosinophils, hematocrit, hemoglobin, lymphocytes, monocytes, neutrophils, neutrophil bands, platelets, red blood cell (RBC) count, segmented neutrophils and white blood cell (WBC) count. The potential clinical concern values were: Hematocrit >0.05 below lower limit of normal (LLN) and >0.04 above upper limit of normal (ULN), hemoglobin: >20 grams cells per Liter (g/L) below LLN and >10 g/L above ULN, lymphocytes: <0.5 x LLN, neutrophils: <1 giga cells per liter (GI/L), platelets: <80 GI/L and >500 GI/L, segmented neutrophils: <0.5 x LLN, RBC count: >1 GI/L below LLN and >5 GI/L above ULN and none for basophils, eosinophils, monocytes, neutrophil bands and RBC count. Only those parameters for which at least one value of potential clinical concern was reported are summarized.

Outcome measures

Measure	Albiglutide + Insulin Glargine n=394 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	Insulin Lispro + Insulin Glargine n=407 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Number of Participants With Hematology Values of Clinical Concern Hematocrit: >0.05 (fraction) below LLN	5 Participants	6 Participants
Number of Participants With Hematology Values of Clinical Concern Hematocrit: >0.04 (fraction) above ULN	9 Participants	12 Participants
Number of Participants With Hematology Values of Clinical Concern Hemoglobin: >20 g/L below LLN	9 Participants	9 Participants
Number of Participants With Hematology Values of Clinical Concern Hemoglobin: >10 g/L above ULN	2 Participants	3 Participants
Number of Participants With Hematology Values of Clinical Concern Leukocytes: >1 GI/L below LLN	1 Participants	1 Participants
Number of Participants With Hematology Values of Clinical Concern Leukocytes: >5 GI/L above ULN	4 Participants	1 Participants
Number of Participants With Hematology Values of Clinical Concern Neutrophils: <1 GI/L	2 Participants	3 Participants
Number of Participants With Hematology Values of Clinical Concern Neutrophils, Segmented: <0.5 x LLN	2 Participants	3 Participants
Number of Participants With Hematology Values of Clinical Concern Platelets: <80 GI/L	1 Participants	1 Participants
Number of Participants With Hematology Values of Clinical Concern Platelets: >500 GI/L	3 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to 30 weeks

Population: Safety Population. Only those participants available at the specified time points were analyzed.

Clinical chemistry parameters and their potential clinical concern values were: albumin (>5 g/L above ULN or below LLN), alkaline phosphatase(>3 x ULN), alanine aminotransferase (>3 x ULN), aspartate aminotransferase (>3 x ULN), carbon dioxide content (<16 millimoles per Liter [mmol/L] and > 40 mmol/L), blood urea nitrogen (>2 x ULN), calcium (<1.8 mmol/L and >3.0 mmol/L), chloride (none), creatinine (>159 micromoles/Liter), direct bilirubin (>1.35 x ULN), gamma glutamyl transferase (>3 x ULN), glucose (fasting) (<3 mmol/L and >22 mmol/L), magnesium (<0.411 mmol/L and >1.644 mmol/L), phosphate (>0.323 mmol/L above ULN or below LLN), potassium (>0.5 mmol/L below LLN and >1.0 mmol/L above ULN), sodium (>5 mmol/L above ULN or below LLN), triglycerides (> 9.04 mmol/L), total bilirubin (>1.5 x ULN), total protein (>15 g/L above ULN or below LLN) and uric acid (>654 umol/L). Only those parameters for which at least one value of potential clinical concern was reported are summarized.

Outcome measures

Measure	Albiglutide + Insulin Glargine n=400 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	Insulin Lispro + Insulin Glargine n=413 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Number of Participants With Clinical Chemistry Values of Clinical Concern Fasting Serum Glucose: <3 mmol/L, n= 394,405	12 Participants	16 Participants
Number of Participants With Clinical Chemistry Values of Clinical Concern Fasting Serum Glucose: >22 mmol/L, n= 394,405	0 Participants	1 Participants
Number of Participants With Clinical Chemistry Values of Clinical Concern Fasting Plasma Glucose: <3 mmol/L, n= 388,406	9 Participants	14 Participants
Number of Participants With Clinical Chemistry Values of Clinical Concern Fasting Plasma Glucose: >22 mmol/L, n= 388,406	1 Participants	0 Participants
Number of Participants With Clinical Chemistry Values of Clinical Concern Albumin: >5 g/L below LLN, n=394,407	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Values of Clinical Concern Albumin: >5 g/L above ULN, n=394,407	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Values of Clinical Concern Calcium: <1.8 mmol/L, n=394,407	1 Participants	1 Participants
Number of Participants With Clinical Chemistry Values of Clinical Concern Calcium: >3.0 mmol/L, n=394,407	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Values of Clinical Concern Carbon Dioxide: <16 mmol/L, n=394,407	5 Participants	8 Participants
Number of Participants With Clinical Chemistry Values of Clinical Concern Carbon Dioxide: >40 mmol/L, n=394,407	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Values of Clinical Concern Magnesium: <0.411 mmol/L, n=394,407	1 Participants	1 Participants
Number of Participants With Clinical Chemistry Values of Clinical Concern Magnesium: >1.644 mmol/L, n=394,407	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Values of Clinical Concern Phosphate: >0.323 mmol/L below LLN, n=394,407	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Values of Clinical Concern Phosphate: >0.323 mmol/L above ULN, n=394,407	2 Participants	4 Participants
Number of Participants With Clinical Chemistry Values of Clinical Concern Potassium: >0.5 mmol/L below LLN, n=394,407	1 Participants	0 Participants
Number of Participants With Clinical Chemistry Values of Clinical Concern Potassium: >1.0 mmol/L above ULN, n=394,407	0 Participants	1 Participants
Number of Participants With Clinical Chemistry Values of Clinical Concern Protein: >15 g/L below LLN, n=394,407	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Values of Clinical Concern Protein: >15 g/L above ULN, n=394,407	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Values of Clinical Concern Sodium: >5 mmol/L below LLN, n=394,407	1 Participants	0 Participants
Number of Participants With Clinical Chemistry Values of Clinical Concern Sodium: >5 mmol/L above ULN, n=394,407	1 Participants	0 Participants
Number of Participants With Clinical Chemistry Values of Clinical Concern Triglycerides: >9.04 mmol/L, n=393,405	7 Participants	1 Participants
Number of Participants With Clinical Chemistry Values of Clinical Concern Urate: >654 μmol/L, n=394,407	0 Participants	2 Participants
Number of Participants With Clinical Chemistry Values of Clinical Concern Urea: >2 x ULN, n=394,407	2 Participants	1 Participants
Number of Participants With Clinical Chemistry Values of Clinical Concern Alanine Aminotransferase: >3 x ULN, n=396,410	0 Participants	5 Participants
Number of Participants With Clinical Chemistry Values of Clinical Concern Alkaline Phosphatase: >3 x ULN, n=396,410	1 Participants	0 Participants
Number of Participants With Clinical Chemistry Values of Clinical Concern Aspartate Aminotransferase: >3 x ULN, n=396,410	0 Participants	2 Participants
Number of Participants With Clinical Chemistry Values of Clinical Concern Bilirubin: >1.5 x ULN, n=396,410	1 Participants	1 Participants
Number of Participants With Clinical Chemistry Values of Clinical Concern Creatinine: >159 μmol/L, n=396,410	20 Participants	16 Participants
Number of Participants With Clinical Chemistry Values of Clinical Concern Direct Bilirubin: >1.35 x ULN, n=396,410	0 Participants	1 Participants
Number of Participants With Clinical Chemistry Values of Clinical Concern Gamma Glutamyl Transferase: >3 x ULN, n=396,410	14 Participants	14 Participants

SECONDARY outcome

Timeframe: Week 0 and Week 26

Population: Safety Population.

Urine samples were collected for analysis of albumin/creatinine ratio. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles. Mean urine albumin/creatinine ratio at Week 0 and Week 26 are presented.

Outcome measures

Measure	Albiglutide + Insulin Glargine n=400 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	Insulin Lispro + Insulin Glargine n=413 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Mean Urine Albumin/Creatinine Ratio at Week 0 and Week 26 Week 0, n=369,376	14.40 Grams per mole Standard Deviation 49.884	11.57 Grams per mole Standard Deviation 31.089
Mean Urine Albumin/Creatinine Ratio at Week 0 and Week 26 Week 26, n=317,324	10.37 Grams per mole Standard Deviation 32.992	11.55 Grams per mole Standard Deviation 31.975

SECONDARY outcome

Timeframe: Week 0 and Week 26

Population: Safety Population.

Urine samples were collected for analysis of albumin. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles. Mean albumin at Week 0 and Week 26 are presented.

Outcome measures

Measure	Albiglutide + Insulin Glargine n=400 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	Insulin Lispro + Insulin Glargine n=413 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Mean Albumin at Week 0 and Week 26 Week 0, n=394,405	127.7 Milligrams per Liter Standard Deviation 428.46	108.2 Milligrams per Liter Standard Deviation 301.88
Mean Albumin at Week 0 and Week 26 Week 26, n=348,345	110.5 Milligrams per Liter Standard Deviation 375.41	146.3 Milligrams per Liter Standard Deviation 628.73

SECONDARY outcome

Timeframe: Week 0 and Week 26

Population: Safety Population.

Urine samples were collected for analysis of creatinine. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles. Mean creatinine at Week 0 and Week 26 are presented.

Outcome measures

Measure	Albiglutide + Insulin Glargine n=400 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	Insulin Lispro + Insulin Glargine n=413 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Mean Creatinine at Week 0 and Week 26 Week 0, n=395,406	10646.3 Micromoles per Liter Standard Deviation 5190.43	10663.8 Micromoles per Liter Standard Deviation 5639.54
Mean Creatinine at Week 0 and Week 26 Week 26, n=350,345	11364.6 Micromoles per Liter Standard Deviation 5998.72	11394.2 Micromoles per Liter Standard Deviation 5663.72

SECONDARY outcome

Timeframe: Week 0 and Week 26

Population: Safety Population.

Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. A urinary specific gravity measurement is a routine part of urinalysis. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles.

Outcome measures

Measure	Albiglutide + Insulin Glargine n=400 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	Insulin Lispro + Insulin Glargine n=413 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Mean Specific Gravity at Week 0 and Week 26 Week 0, n=388,402	1.0182 Ratio Standard Deviation 0.00599	1.0180 Ratio Standard Deviation 0.00588
Mean Specific Gravity at Week 0 and Week 26 Week 26, n=347,343	1.0180 Ratio Standard Deviation 0.00627	1.0186 Ratio Standard Deviation 0.00588

SECONDARY outcome

Timeframe: Week 0 and Week 26

Population: Safety Population.

Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Safety Population was analyzed. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles.

Outcome measures

Measure	Albiglutide + Insulin Glargine n=400 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	Insulin Lispro + Insulin Glargine n=413 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Number of Participants With Different Values of Potential of Hydrogen (pH) at Week 0 and Week 26 pH=5; Week 0, n=388,402	92 Participants	107 Participants
Number of Participants With Different Values of Potential of Hydrogen (pH) at Week 0 and Week 26 pH=5.5; Week 0, n=388,402	132 Participants	132 Participants
Number of Participants With Different Values of Potential of Hydrogen (pH) at Week 0 and Week 26 pH=6; Week 0, n=388,402	86 Participants	77 Participants
Number of Participants With Different Values of Potential of Hydrogen (pH) at Week 0 and Week 26 pH=6.5; Week 0, n=388,402	29 Participants	43 Participants
Number of Participants With Different Values of Potential of Hydrogen (pH) at Week 0 and Week 26 pH=7; Week 0, n=388,402	29 Participants	24 Participants
Number of Participants With Different Values of Potential of Hydrogen (pH) at Week 0 and Week 26 pH=7.5; Week 0, n=388,402	13 Participants	11 Participants
Number of Participants With Different Values of Potential of Hydrogen (pH) at Week 0 and Week 26 pH=8; Week 0, n=388,402	6 Participants	7 Participants
Number of Participants With Different Values of Potential of Hydrogen (pH) at Week 0 and Week 26 pH=8.5; Week 0, n=388,402	1 Participants	1 Participants
Number of Participants With Different Values of Potential of Hydrogen (pH) at Week 0 and Week 26 pH=5; Week 26, n=347,343	80 Participants	100 Participants
Number of Participants With Different Values of Potential of Hydrogen (pH) at Week 0 and Week 26 pH=5.5; Week 26, n=347,343	107 Participants	104 Participants
Number of Participants With Different Values of Potential of Hydrogen (pH) at Week 0 and Week 26 pH=6; Week 26, n=347,343	69 Participants	70 Participants
Number of Participants With Different Values of Potential of Hydrogen (pH) at Week 0 and Week 26 pH=6.5; Week 26, n=347,343	42 Participants	23 Participants
Number of Participants With Different Values of Potential of Hydrogen (pH) at Week 0 and Week 26 pH=7; Week 26, n=347,343	19 Participants	23 Participants
Number of Participants With Different Values of Potential of Hydrogen (pH) at Week 0 and Week 26 pH=7.5; Week 26, n=347,343	17 Participants	18 Participants
Number of Participants With Different Values of Potential of Hydrogen (pH) at Week 0 and Week 26 pH=8; Week 26, n=347,343	7 Participants	5 Participants
Number of Participants With Different Values of Potential of Hydrogen (pH) at Week 0 and Week 26 pH=8.5; Week 26, n=347,343	5 Participants	0 Participants
Number of Participants With Different Values of Potential of Hydrogen (pH) at Week 0 and Week 26 pH>9; Week 26, n=347,343	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 0 and Week 26

Population: Safety Population.

Urine samples were collected for analysis of erythrocyte count. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles. Number of participants with different number of erythrocytes in urine at Week 0 and Week 26 are presented.

Outcome measures

Measure	Albiglutide + Insulin Glargine n=400 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	Insulin Lispro + Insulin Glargine n=413 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Number of Participants With Different Number of Erythrocytes in Urine at Week 0 and Week 26 None Seen; Week 0, n=171,187	119 Participants	101 Participants
Number of Participants With Different Number of Erythrocytes in Urine at Week 0 and Week 26 0 to 1; Week 0, n=171,187	34 Participants	51 Participants
Number of Participants With Different Number of Erythrocytes in Urine at Week 0 and Week 26 1 to 3; Week 0, n=171,187	9 Participants	14 Participants
Number of Participants With Different Number of Erythrocytes in Urine at Week 0 and Week 26 3 to 5; Week 0, n=171,187	3 Participants	12 Participants
Number of Participants With Different Number of Erythrocytes in Urine at Week 0 and Week 26 5 to 10; Week 0, n=171,187	2 Participants	4 Participants
Number of Participants With Different Number of Erythrocytes in Urine at Week 0 and Week 26 10 to 15; Week 0, n=171,187	0 Participants	2 Participants
Number of Participants With Different Number of Erythrocytes in Urine at Week 0 and Week 26 15 to 25; Week 0, n=171,187	2 Participants	1 Participants
Number of Participants With Different Number of Erythrocytes in Urine at Week 0 and Week 26 50 to 100; Week 0, n=171,187	0 Participants	1 Participants
Number of Participants With Different Number of Erythrocytes in Urine at Week 0 and Week 26 >100; Week 0, n=171,187	2 Participants	1 Participants
Number of Participants With Different Number of Erythrocytes in Urine at Week 0 and Week 26 None Seen; Week 26, n=166,144	98 Participants	79 Participants
Number of Participants With Different Number of Erythrocytes in Urine at Week 0 and Week 26 0 to 1; Week 26, n=166,144	48 Participants	36 Participants
Number of Participants With Different Number of Erythrocytes in Urine at Week 0 and Week 26 1 to 3; Week 26, n=166,144	8 Participants	19 Participants
Number of Participants With Different Number of Erythrocytes in Urine at Week 0 and Week 26 3 to 5; Week 26, n=166,144	4 Participants	3 Participants
Number of Participants With Different Number of Erythrocytes in Urine at Week 0 and Week 26 5 to 10; Week 26, n=166,144	4 Participants	4 Participants
Number of Participants With Different Number of Erythrocytes in Urine at Week 0 and Week 26 25 to 50; Week 26, n=166,144	1 Participants	2 Participants
Number of Participants With Different Number of Erythrocytes in Urine at Week 0 and Week 26 50 to 100; Week 26, n=166,144	2 Participants	0 Participants
Number of Participants With Different Number of Erythrocytes in Urine at Week 0 and Week 26 >100; Week 26, n=166,144	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Week 0 and Week 26

Population: Safety Population.

Urine samples were collected for analysis of leukocyte count. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles. Number of participants with different number of leukocytes in urine at Week 0 and Week 26 are presented.

Outcome measures

Measure	Albiglutide + Insulin Glargine n=400 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	Insulin Lispro + Insulin Glargine n=413 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Number of Participants With Different Number of Leukocytes in Urine at Week 0 and Week 26 10 to 15; Week 26, n=166,144	8 Participants	5 Participants
Number of Participants With Different Number of Leukocytes in Urine at Week 0 and Week 26 15 to 25; Week 26, n=166,144	3 Participants	3 Participants
Number of Participants With Different Number of Leukocytes in Urine at Week 0 and Week 26 None Seen; Week 0, n=171,187	69 Participants	67 Participants
Number of Participants With Different Number of Leukocytes in Urine at Week 0 and Week 26 0 to 1; Week 0, n=171,187	27 Participants	31 Participants
Number of Participants With Different Number of Leukocytes in Urine at Week 0 and Week 26 1 to 3; Week 0, n=171,187	20 Participants	18 Participants
Number of Participants With Different Number of Leukocytes in Urine at Week 0 and Week 26 3 to 5; Week 0, n=171,187	16 Participants	13 Participants
Number of Participants With Different Number of Leukocytes in Urine at Week 0 and Week 26 5 to 10; Week 0, n=171,187	17 Participants	19 Participants
Number of Participants With Different Number of Leukocytes in Urine at Week 0 and Week 26 10 to 15; Week 0, n=171,187	7 Participants	6 Participants
Number of Participants With Different Number of Leukocytes in Urine at Week 0 and Week 26 15 to 25; Week 0, n=171,187	5 Participants	11 Participants
Number of Participants With Different Number of Leukocytes in Urine at Week 0 and Week 26 25 to 50; Week 0, n=171,187	5 Participants	11 Participants
Number of Participants With Different Number of Leukocytes in Urine at Week 0 and Week 26 50 to 100; Week 0, n=171,187	1 Participants	7 Participants
Number of Participants With Different Number of Leukocytes in Urine at Week 0 and Week 26 >100; Week 0, n=171,187	4 Participants	3 Participants
Number of Participants With Different Number of Leukocytes in Urine at Week 0 and Week 26 Innumerable; Week 0, n=171,187	0 Participants	1 Participants
Number of Participants With Different Number of Leukocytes in Urine at Week 0 and Week 26 None Seen; Week 26, n=166,144	65 Participants	44 Participants
Number of Participants With Different Number of Leukocytes in Urine at Week 0 and Week 26 0 to 1; Week 26, n=166,144	25 Participants	29 Participants
Number of Participants With Different Number of Leukocytes in Urine at Week 0 and Week 26 1 to 3; Week 26, n=166,144	22 Participants	20 Participants
Number of Participants With Different Number of Leukocytes in Urine at Week 0 and Week 26 3 to 5; Week 26, n=166,144	10 Participants	15 Participants
Number of Participants With Different Number of Leukocytes in Urine at Week 0 and Week 26 5 to 10; Week 26, n=166,144	22 Participants	14 Participants
Number of Participants With Different Number of Leukocytes in Urine at Week 0 and Week 26 20 to 50; Week 26, n=166,144	0 Participants	1 Participants
Number of Participants With Different Number of Leukocytes in Urine at Week 0 and Week 26 25 to 50; Week 26, n=166,144	5 Participants	6 Participants
Number of Participants With Different Number of Leukocytes in Urine at Week 0 and Week 26 50 to 100; Week 26, n=166,144	5 Participants	5 Participants
Number of Participants With Different Number of Leukocytes in Urine at Week 0 and Week 26 >100; Week 26, n=166,144	1 Participants	1 Participants
Number of Participants With Different Number of Leukocytes in Urine at Week 0 and Week 26 Innumerable; Week 26, n=166,144	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, Week 10 and Week 26

Population: Safety Population.

Lipid parameters included TC, LDL-c, HDL-c, TG and FFA. The Baseline value was the last available non-missing value prior to the first dose of the randomized treatment, thus Baseline was Day -1. Change from Baseline is defined as the post-Baseline value minus the Baseline value. LDL-c and FFA were collected as part of the lipid panel and results were reviewed by investigators for individual participants. Change from Baseline at Week 10 and Week 26 was not assessed for these parameters. Analysis of these parameters was not a specific study objective and would not have any impact on study conclusions. Only those parameters with data values have been presented. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles.

Outcome measures

Measure	Albiglutide + Insulin Glargine n=400 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	Insulin Lispro + Insulin Glargine n=413 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Change From Baseline in Total Cholesterol (TC), Low-density Lipoprotein Cholesterol (LDL-c), High Density Lipoprotein (HDL-c), Triglycerides (TG) and Free Fatty Acids (FFA) at Week 10 and Week 26 TC: Week 10, n=376,393	-0.244 Millimoles per Liters Standard Deviation 0.8047	0.041 Millimoles per Liters Standard Deviation 0.7425
Change From Baseline in Total Cholesterol (TC), Low-density Lipoprotein Cholesterol (LDL-c), High Density Lipoprotein (HDL-c), Triglycerides (TG) and Free Fatty Acids (FFA) at Week 10 and Week 26 TC: Week 26, n=348,351	-0.059 Millimoles per Liters Standard Deviation 0.8721	0.073 Millimoles per Liters Standard Deviation 0.8232
Change From Baseline in Total Cholesterol (TC), Low-density Lipoprotein Cholesterol (LDL-c), High Density Lipoprotein (HDL-c), Triglycerides (TG) and Free Fatty Acids (FFA) at Week 10 and Week 26 HDL-c: Week 10, n=376,393	-0.041 Millimoles per Liters Standard Deviation 0.1944	0.016 Millimoles per Liters Standard Deviation 0.1810
Change From Baseline in Total Cholesterol (TC), Low-density Lipoprotein Cholesterol (LDL-c), High Density Lipoprotein (HDL-c), Triglycerides (TG) and Free Fatty Acids (FFA) at Week 10 and Week 26 HDL-c: Week 26, n=348,351	-0.013 Millimoles per Liters Standard Deviation 0.2102	0.005 Millimoles per Liters Standard Deviation 0.2138
Change From Baseline in Total Cholesterol (TC), Low-density Lipoprotein Cholesterol (LDL-c), High Density Lipoprotein (HDL-c), Triglycerides (TG) and Free Fatty Acids (FFA) at Week 10 and Week 26 TG: Week 10, n=376,393	-0.039 Millimoles per Liters Standard Deviation 1.3563	-0.065 Millimoles per Liters Standard Deviation 0.8045
Change From Baseline in Total Cholesterol (TC), Low-density Lipoprotein Cholesterol (LDL-c), High Density Lipoprotein (HDL-c), Triglycerides (TG) and Free Fatty Acids (FFA) at Week 10 and Week 26 TG: Week 26, n=348,351	0.025 Millimoles per Liters Standard Deviation 1.1949	-0.028 Millimoles per Liters Standard Deviation 0.9342

SECONDARY outcome

Timeframe: Up to 30 weeks

Population: Safety Population. Only those participants available at the specified time points were analyzed.

Vital signs included systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate values. Assessment of vitals were performed with the participant in a semi recumbent or seated position having rested in this position for at least 5 minutes before each reading. The potential clinical concern values were: SBP: <100 millimeters of mercury (mmHg) and >170 mmHg, DBP: <50 mmHg and >110 mmHg and pulse rate: <50 beats per minute (bpm) and > 120 bpm. Number of participants with vital signs of clinical concern are presented.

Outcome measures

Measure	Albiglutide + Insulin Glargine n=397 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	Insulin Lispro + Insulin Glargine n=411 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Number of Participants With Vital Signs of Clinical Concern Pulse Rate: > 120 bpm	3 Participants	1 Participants
Number of Participants With Vital Signs of Clinical Concern SBP: < 100 mmHg	21 Participants	20 Participants
Number of Participants With Vital Signs of Clinical Concern SBP: > 170 mmHg	27 Participants	30 Participants
Number of Participants With Vital Signs of Clinical Concern DBP: < 50 mmHg	1 Participants	4 Participants
Number of Participants With Vital Signs of Clinical Concern DBP: > 110 mmHg	1 Participants	5 Participants
Number of Participants With Vital Signs of Clinical Concern Pulse Rate: < 50 bpm	4 Participants	9 Participants

SECONDARY outcome

Timeframe: Up to 30 weeks

Population: Safety Population. Only those participants available at the specified time points were analyzed.

A single 12-lead ECG recordings were performed in a participant in semi recumbent position for 10 to 15 minutes before obtaining the ECG. Any clinically significant favorable and unfavorable findings are reported.

Outcome measures

Measure	Albiglutide + Insulin Glargine n=384 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	Insulin Lispro + Insulin Glargine n=394 Participants During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Parameters Clinically Significant Change: Favorable	18 Participants	9 Participants
Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Parameters Clinically Significant Change: Unfavorable	4 Participants	5 Participants

Adverse Events

Albiglutide + Insulin Glargine

Serious events: 23 serious events

Other events: 114 other events

Deaths: 0 deaths

Insulin Lispro + Insulin Glargine

Serious events: 31 serious events

Other events: 101 other events

Deaths: 1 deaths

Serious adverse events

Measure	Albiglutide + Insulin Glargine n=400 participants at risk During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	Insulin Lispro + Insulin Glargine n=413 participants at risk During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Nervous system disorders Brain stem infarction	0.00% 0/400 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.	0.24% 1/413 • Number of events 1 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.
Nervous system disorders Carpal tunnel syndrome	0.00% 0/400 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.	0.24% 1/413 • Number of events 1 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.
Nervous system disorders Cerebrovascular accident	0.00% 0/400 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.	0.24% 1/413 • Number of events 1 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.
Nervous system disorders Facial paralysis	0.25% 1/400 • Number of events 1 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.	0.00% 0/413 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.
Nervous system disorders Hyperaesthesia	0.25% 1/400 • Number of events 1 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.	0.00% 0/413 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.
Nervous system disorders Ischaemic stroke	0.00% 0/400 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.	0.24% 1/413 • Number of events 1 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.
Nervous system disorders Sciatica	0.25% 1/400 • Number of events 1 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.	0.00% 0/413 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.
Nervous system disorders Transient ischaemic attack	0.00% 0/400 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.	0.24% 1/413 • Number of events 1 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.
Infections and infestations Pneumonia	0.25% 1/400 • Number of events 1 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.	0.48% 2/413 • Number of events 2 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.
Infections and infestations Osteomyelitis	0.00% 0/400 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.	0.48% 2/413 • Number of events 2 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.
Infections and infestations Appendicitis	0.25% 1/400 • Number of events 1 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.	0.00% 0/413 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.
Infections and infestations Gastroenteritis	0.25% 1/400 • Number of events 1 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.	0.00% 0/413 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.
Infections and infestations Influenza	0.25% 1/400 • Number of events 1 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.	0.00% 0/413 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.
Infections and infestations Pyelonephritis	0.25% 1/400 • Number of events 1 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.	0.00% 0/413 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/400 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.	1.5% 6/413 • Number of events 6 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/400 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.	0.24% 1/413 • Number of events 1 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.
Vascular disorders Peripheral ischaemia	0.25% 1/400 • Number of events 1 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.	0.24% 1/413 • Number of events 1 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.
Vascular disorders Hypertensive crisis	0.00% 0/400 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.	0.24% 1/413 • Number of events 1 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.
Vascular disorders Peripheral arterial occlusive disease	0.25% 1/400 • Number of events 1 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.	0.00% 0/413 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.
Vascular disorders Peripheral artery stenosis	0.00% 0/400 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.	0.24% 1/413 • Number of events 1 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.
Vascular disorders Peripheral vascular disorder	0.25% 1/400 • Number of events 1 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.	0.00% 0/413 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.
Gastrointestinal disorders Colitis	0.00% 0/400 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.	0.24% 1/413 • Number of events 1 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.
Gastrointestinal disorders Mesenteric artery stenosis	0.25% 1/400 • Number of events 1 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.	0.00% 0/413 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.
Gastrointestinal disorders Pancreatitis	0.25% 1/400 • Number of events 1 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.	0.00% 0/413 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/400 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.	0.24% 1/413 • Number of events 1 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.
Injury, poisoning and procedural complications Ligament injury	0.00% 0/400 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.	0.24% 1/413 • Number of events 1 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.
Injury, poisoning and procedural complications Multiple injuries	0.25% 1/400 • Number of events 1 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.	0.00% 0/413 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.
Injury, poisoning and procedural complications Perineal injury	0.00% 0/400 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.	0.24% 1/413 • Number of events 1 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.25% 1/400 • Number of events 1 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.	0.00% 0/413 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.00% 0/400 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.	0.24% 1/413 • Number of events 1 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/400 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.	0.24% 1/413 • Number of events 1 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Teratoma	0.25% 1/400 • Number of events 1 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.	0.00% 0/413 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.
Ear and labyrinth disorders Conductive deafness	0.25% 1/400 • Number of events 1 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.	0.00% 0/413 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.
Ear and labyrinth disorders Vertigo positional	0.25% 1/400 • Number of events 1 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.	0.00% 0/413 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.
General disorders Chest pain	0.25% 1/400 • Number of events 1 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.	0.00% 0/413 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.
General disorders Non-cardiac chest pain	0.00% 0/400 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.	0.24% 1/413 • Number of events 1 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.
Reproductive system and breast disorders Metrorrhagia	0.00% 0/400 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.	0.24% 1/413 • Number of events 1 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.
Reproductive system and breast disorders Uterine polyp	0.25% 1/400 • Number of events 1 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.	0.00% 0/413 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.
Eye disorders Angle closure glaucoma	0.25% 1/400 • Number of events 1 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.	0.00% 0/413 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/400 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.	0.24% 1/413 • Number of events 1 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.
Renal and urinary disorders Acute kidney injury	0.25% 1/400 • Number of events 1 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.	0.00% 0/413 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.25% 1/400 • Number of events 1 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.	0.00% 0/413 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.
Cardiac disorders Acute myocardial infarction	0.25% 1/400 • Number of events 1 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.	0.48% 2/413 • Number of events 2 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.
Cardiac disorders Angina unstable	0.25% 1/400 • Number of events 2 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.	0.24% 1/413 • Number of events 1 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.
Cardiac disorders Angina pectoris	0.00% 0/400 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.	0.24% 1/413 • Number of events 1 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.
Cardiac disorders Atrial fibrillation	0.00% 0/400 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.	0.24% 1/413 • Number of events 2 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.
Cardiac disorders Atrial flutter	0.25% 1/400 • Number of events 2 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.	0.00% 0/413 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.
Cardiac disorders Atrioventricular block complete	0.25% 1/400 • Number of events 1 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.	0.00% 0/413 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.
Cardiac disorders Cardiac failure congestive	0.00% 0/400 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.	0.24% 1/413 • Number of events 1 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.
Nervous system disorders Syncope	0.25% 1/400 • Number of events 1 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.	0.24% 1/413 • Number of events 1 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.

Other adverse events

Measure	Albiglutide + Insulin Glargine n=400 participants at risk During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.	Insulin Lispro + Insulin Glargine n=413 participants at risk During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Infections and infestations Urinary tract infection	5.5% 22/400 • Number of events 25 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.	5.6% 23/413 • Number of events 24 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.
Gastrointestinal disorders Nausea	9.2% 37/400 • Number of events 53 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.	1.7% 7/413 • Number of events 7 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.
Infections and infestations Influenza	6.0% 24/400 • Number of events 30 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.	8.7% 36/413 • Number of events 42 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.
Infections and infestations Viral upper respiratory tract infection	6.2% 25/400 • Number of events 33 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.	8.2% 34/413 • Number of events 39 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.
Gastrointestinal disorders Diarrhoea	7.8% 31/400 • Number of events 51 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.	4.4% 18/413 • Number of events 19 • Up to 26 weeks On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.

Additional Information

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• Principal investigator is a sponsor employee 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.
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