Safety and Efficacy of Albiglutide + Insulin Glargine Ver... | NCT02229227

ID	Type	Description	Link
2014-001821-34	EudraCT Number

Name	Class
PPD Development, LP	INDUSTRY

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Albiglutide + Insulin Glargine Arm	Experimental	During standardization period, subjects will transit from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. During treatment period, subject will receive Albiglutide 30 milligrams (mg) weekly subcutaneous (SC) injection and insulin lispro dose will be downtitrated to half that used in the standardization period. At Week 4, Albiglutide will be uptitrated to 50 mg weekly SC injection and insulin lispro will be stopped for the remainder of the treatment Period. Insulin lispro may be re-introduced after Week 8 according to pre-defined hyperglycemia thresholds. Insulin will be adjusted according to protocol-defined insulin titration algorithms	Drug: Albiglutide
Insulin Glargine + Insulin Lispro Arm	Experimental	During standardization period, subjects will transit from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. During treatment period, subject will continue with the same doses as at the end of the standardization period and doses will be adjusted according to protocol-defined insulin titration algorithms	Drug: Insulin Glargine and Insulin Lispro

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Albiglutide	Drug	Albiglutide is intended for self-administration as a SC injection. It is provided as a fixed dose of 30 mg of albiglutide or 50 mg of albiglutide in a 0.5 mL injection volume, fully disposable pen injector

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26	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.	Baseline (Day -1) and Week 26

Secondary Outcomes

Measure	Description	Time Frame
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	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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female, 18 years of age or older (inclusive at the time of Screening) with T2DM
HbA1c >= 7.0% and <= 9.0% at Screening.
Currently treated with a basal-bolus insulin regimen (with or without metformin) for at least 3 months before Screening. The subject must be taking the following:
Basal insulin (1 or 2 daily injections of neutral protamine Hagedorn insulin, insulin glargine, insulin detemir, or insulin degludec) AND
Bolus insulin (at least 2 injections of regular insulin, insulin glulisine, insulin aspart, or insulin lispro) with a total daily dose of bolus insulin <= 70 units
In addition, the total daily dose of insulin must be <= 140 units
If taking metformin, a stable dose for at least 8 weeks before Screening Note: Subject should not have received any other antidiabetic medication within 30 days before screening (e.g., glucagon-like peptide-1 receptor (GLP-1R) agonist, dipeptidyl peptidase-IV inhibitor, SU, or thiazolidinedione). Subjects receiving commercially available premixed basal and prandial insulin are not eligible for this study.
Fasting C-peptide >= 0.8 nanogram (ng) per milliliter (mL) [>= 0.26 nanomoles per litre (nmol/L)]
Body mass index <= 40 kilogram per square meter( kg/m^2)
Thyroid-stimulating hormone (TSH) level is normal or clinically euthyroid as demonstrated by further thyroid tests (e.g., free T4)
Female subjects of childbearing potential (i.e., not surgically sterile and/or not postmenopausal) must be practicing adequate contraception (as defined in the protocol) for the duration of participation in the study including the 4-week post treatment Follow-up Period..
Willing and able to comply with all study procedures including performance of frequent self-monitored blood glucose (SMBG) profiles according to the protocol
Able and willing to provide written informed consent

Exclusion Criteria:

Type 1 diabetes mellitus
History of cancer that has not been in full remission for at least 3 years before Screening. (A history of squamous cell or basal cell carcinoma of the skin or treated cervical intra-epithelial neoplasia I or II is allowed)
Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
Current symptomatic biliary disease or history of acute or chronic pancreatitis
Severe gastroparesis, i.e., requiring regular therapy within 6 months before Screening
History of significant GI surgery that in the opinion of the investigator is likely to significantly affect upper GI or pancreatic function [e.g., gastric bypass and banding, antrectomy, Roux-en-Y bypass, gastric vagotomy, small bowel resection, or surgeries thought to significantly affect upper GI function]
History of severe hypoglycemia unawareness
Diabetic complications (e.g., active proliferative retinopathy or severe diabetic neuropathy) or any other clinically significant abnormality (including a psychiatric disorder) that, in the opinion of the investigator, may pose additional risk in administering the investigational product
Clinically significant CV and/or cerebrovascular disease within 3 months before Screening including, but not limited to, the following:
Stroke or transient ischemic attack
Acute coronary syndrome (myocardial infarction [MI] or unstable angina not responsive to nitroglycerin)
Cardiac surgery or percutaneous coronary procedure
Current or history of heart failure (New York Heart Association class III or IV)
Alanine aminotransferase (ALT) >2.5 × upper limit of normal (ULN) or bilirubin >1.5 × ULN (isolated bilirubin >1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). (Chronic stable hepatitis B and C are acceptable if subject otherwise meets entry criteria and is not on active antiviral treatment [e.g., presence of hepatitis B surface antigen or positive hepatitis C test result within 3 months of Screening])
Hemoglobin <11 gram (g) per (dL) [<110 g/L] for male subjects and <10 g/dL (<100 g/L) for female subjects at Screening
Estimated glomerular filtration rate (eGFR) <= 30 millilitre per minute per 1.73 square meters (mL/min/1.73 m^2) (calculated using the Modification of Diet in Renal Disease [MDRD] formula) at Screening Note: As the use of metformin in subjects with varying degrees of renal function may differ from country to country, use of metformin should be in accordance with the metformin product label within the participating country.
Fasting triglyceride level >750 mg/dL at Screening
Hemoglobinopathy that may affect proper interpretation of HbA1c
Known allergy to albiglutide or any product components (including yeast and human albumin), any other GLP-1 analogue, insulin, or other study medication's excipients OR other contraindications (per the prescribing information) for the use of potential study medications (e.g., insulin glargine, insulin lispro)
Use of oral or systemically injected glucocorticoids within the 3 months before randomization or high likelihood of a requirement for prolonged treatment (>1 week) in the 6 months following randomization. However, short courses of oral steroids (single dose or multiple doses for up to 7 days) may be permitted provided these cases are discussed with the medical monitor. Inhaled, intra-articular, epidural, and topical corticosteroids are allowed
Female subject is pregnant (confirmed by laboratory testing) or lactating
Receipt of any investigational drug within the 30 days or 5 half-lives, whichever is longer, before Screening, a history of receipt of an investigational antidiabetic drug within the 3 months before randomization, or receipt of albiglutide in previous studies

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Searcy	Arkansas	72143	United States
GSK Investigational Site

PubMed Identifier	Type	Citation	Retractions
32694215	Background	Rosenstock J, Nino A, Soffer J, Erskine L, Acusta A, Dole J, Carr MC, Mallory J, Home P. Impact of a Weekly Glucagon-Like Peptide 1 Receptor Agonist, Albiglutide, on Glycemic Control and on Reducing Prandial Insulin Use in Type 2 Diabetes Inadequately Controlled on Multiple Insulin Therapy: A Randomized Trial. Diabetes Care. 2020 Oct;43(10):2509-2518. doi: 10.2337/dc19-2316. Epub 2020 Jul 21.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 24, 2015	Mar 6, 2018

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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

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.

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

Posted

Least Squares Mean

Standard Error

Percentage of glycosylated hemoglobin

Baseline (Day -1) and Week 26

ID	Title	Description
OG000	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 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.
OG001	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.

Units	Counts
Participants	OG000345 OG001350

Title

Denominators

Categories

Title	Measurements
	OG000-1.04± 0.041 OG001-1.10± 0.040

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		t-test, 2 sided		<0.0001	Non-inferiority p-value. P-value from testing the null hypothesis that the difference in change from baseline least squares means (albiglutide-insulin lispro) is greater than 0.30% based on one-sided t-test with 0.025 level of significance.	Mean Difference (Net)	0.06			2-Sided	95	-0.05	0.17			Least Square mean of albiglutide + insulin glargine from insulin lispro + insulin glargine has been presented.		Non-Inferiority	If the upper bound of the confidence interval is less than or equal to 0.3%, non-inferiority will be concluded.

Secondary

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

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.

FA Population.

Posted

Number

Participants

Up to Week 26

ID	Title	Description
OG000	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 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.

Units	Counts
Participants

Secondary

Percentage of Participants With Severe or Documented Symptomatic Hypoglycemia Through Week 26

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]).

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

Posted

Number

Percentage of participants

Up to Week 26

ID	Title	Description
OG000	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 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.
OG001	Insulin Lispro + Insulin Glargine

Secondary

Change From Baseline in Body Weight at Week 26

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

Posted

Least Squares Mean

Standard Error

Kilograms

Baseline (Day -1) and Week 26

ID	Title	Description
OG000	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 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.
OG001	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.

Secondary

Change From Baseline to Week 26 in Body Weight

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.

FA Population.

Posted

Least Squares Mean

Standard Error

Kilograms

Baseline (Day -1) to Week 26

ID	Title	Description
OG000	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 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.
OG001	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.

Secondary

Total Daily Insulin Dose at Week 26

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.

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

Posted

Least Squares Mean

Standard Error

International Units

Week 26

ID	Title	Description
OG000	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 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.
OG001	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.

Secondary

Change From Baseline to Week 26 in HbA1c

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.

FA Population.

Posted

Least Squares Mean

Standard Error

Percentage of glycosylated hemoglobin

Baseline to Week 26

ID	Title	Description
OG000	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 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.
OG001	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.

Secondary

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

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.

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

Posted

Least Squares Mean

Standard Error

Millimoles per Liter

Baseline and Week 26

ID	Title	Description
OG000	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 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.
OG001	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.

Secondary

Change From Baseline to Week 26 in FPG

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.

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

Posted

Least Squares Mean

Standard Error

Millimoles per Liter

Baseline to Week 26

ID	Title	Description
OG000	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 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.
OG001	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.

Secondary

Number of Participants Achieving HbA1c <7.0% at Week 26

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

FA Population.

Posted

Number

Participants

Week 26

ID	Title	Description
OG000	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 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.
OG001	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.

Secondary

Number of Participants Achieving HbA1c <7.0% up to Week 26

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

FA Population.

Posted

Number

Participants

Up to Week 26

ID	Title	Description
OG000	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 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.
OG001	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.

Secondary

Number of Participants Achieving a HbA1c <6.5% at Week 26

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

FA Population.

Posted

Number

Participants

Week 26

ID	Title	Description
OG000	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 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.
OG001	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.

Secondary

Number of Participants Achieving a HbA1c <6.5% up to Week 26

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

FA Population.

Posted

Number

Participants

Up to Week 26

ID	Title	Description
OG000	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 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.
OG001	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.

Secondary

Number of Participants Who Met Prespecified Criteria for Severe, Persistent Hyperglycemia at Week 26

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.

FA Population.

Posted

Number

Participants

Week 26

ID	Title	Description
OG000	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 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.
OG001	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.

Secondary

Number of Participants Meeting Prespecified Criteria for Severe, Persistent Hyperglycemia up to Week 26

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.

FA Population.

Posted

Number

Participants

Up to Week 26

ID	Title	Description
OG000	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 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.
OG001	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.

Secondary

Total Daily Insulin Dose at Week 4, Week 10 and Week 18

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.

FA Population.

Posted

Least Squares Mean

Standard Error

International Units

Weeks 4, 10, and 18

ID	Title	Description
OG000	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 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.
OG001	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.

Secondary

Total Daily Basal Insulin (Insulin Glargine) at Week 4, 10, 18, and 26 Visits

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.

FA Population.

Posted

Least Squares Mean

Standard Error

International Units

Weeks 4, 10, 18, and 26

ID	Title	Description
OG000	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 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.
OG001	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.

Secondary

Total Daily Bolus Insulin (Insulin Lispro) at Week 4, 10, 18, and 26 Visits

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.

FA Population.

Posted

Least Squares Mean

Standard Error

International Units

Weeks 4, 10, 18, and 26

ID	Title	Description
OG000	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 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.
OG001	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.

Secondary

Total Number of Weekly Insulin Injections to Achieve Glycemic Control at Baseline/Randomization and Week 4, 10, 18, and 26

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.

FA Population.

Posted

Mean

Standard Deviation

Insulin Injections

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

ID	Title	Description
OG000	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 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.
OG001	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.

Secondary

Percentage of Participants Achieving HbA1c <7.0% Without Weight Gain at Week 26

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

FA Population.

Posted

Number

Percentage of participants

Week 26

ID	Title	Description
OG000	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 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.
OG001	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.

Secondary

Percentage of Participants Achieving HbA1c <7.0% Without Severe or Documented Symptomatic Hypoglycemia at Week 26

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

FA Population.

Posted

Number

Percentage of participants

Week 26

ID	Title	Description
OG000	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 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.
OG001	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.

Secondary

Percentage of Participants Achieving HbA1c <7.0% Without Weight Gain and Without Severe or Documented Hypoglycemia at Week 26

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

FA Population.

Posted

Number

Percentage of participants

Week 26

ID	Title	Description
OG000	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 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.
OG001	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.

Secondary

Number of Participants With On-therapy Adverse Events (AE) and Serious AE (SAE), and AE Leading to Discontinuation of Randomized Study Medication

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.

Safety Population.

Posted

Number

Participants

Up to Week 26

ID	Title	Description
OG000	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 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.

Secondary

Number of Participants With Other AE of Special Interest

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.

Safety Population.

Posted

Number

Participants

Up to Week 26

ID	Title	Description
OG000	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 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.
OG001	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.

Secondary

Percentage of Participants With Events of Hypoglycemia With Confirmed Home Blood Glucose Monitoring and/or Third-party Intervention Through Week 26

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.

Safety Population.

Posted

Number

Percentage of participants

Up to Week 26

ID	Title	Description
OG000	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 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.
OG001	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.

Secondary

Number of Participants With Hypoglycemic Events (in Total and by Each Category as Defined by the American Diabetes Association Criteria)

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.

Safety Population.

Posted

Number

Participants

Up to Week 26

ID	Title	Description
OG000	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 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.
OG001	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.

Secondary

Number of Participants With Daytime and Nocturnal Hypoglycemia

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.

Safety Population.

Posted

Number

Participants

Up to Week 26

ID	Title	Description
OG000	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 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.
OG001	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.

Secondary

Number of Participants With Hypoglycemia With Blood Glucose <56 Milligrams Per Deciliter (mg/dL) (<3.1 Millimoles Per Liter [mmol/L]), Regardless of Symptoms

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

Safety Population.

Posted

Number

Participants

Up to Week 26

ID	Title	Description
OG000	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 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.
OG001	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.

Secondary

Number of Participants With Hematology Values of Clinical Concern

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.

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

Posted

Number

Participants

Up to 30 weeks

ID	Title	Description
OG000	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 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.
OG001

Secondary

Number of Participants With Clinical Chemistry Values of Clinical Concern

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.

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

Posted

Number

Participants

Up to 30 weeks

ID	Title	Description
OG000	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 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.

Secondary

Mean Urine Albumin/Creatinine Ratio at Week 0 and Week 26

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.

Safety Population.

Posted

Mean

Standard Deviation

Grams per mole

Week 0 and Week 26

ID	Title	Description
OG000	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 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.
OG001	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.

Secondary

Mean Albumin at Week 0 and Week 26

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.

Safety Population.

Posted

Mean

Standard Deviation

Milligrams per Liter

Week 0 and Week 26

ID	Title	Description
OG000	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 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.
OG001	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.

Secondary

Mean Creatinine at Week 0 and Week 26

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.

Safety Population.

Posted

Mean

Standard Deviation

Micromoles per Liter

Week 0 and Week 26

ID	Title	Description
OG000	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 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.
OG001	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.

Secondary

Mean Specific Gravity at Week 0 and Week 26

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.

Safety Population.

Posted

Mean

Standard Deviation

Ratio

Week 0 and Week 26

ID	Title	Description
OG000	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 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.
OG001	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.

Secondary

Number of Participants With Different Values of Potential of Hydrogen (pH) at Week 0 and Week 26

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.

Safety Population.

Posted

Number

Participants

Week 0 and Week 26

ID	Title	Description
OG000	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 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.
OG001	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.

Secondary

Number of Participants With Different Number of Erythrocytes in Urine at Week 0 and Week 26

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.

Safety Population.

Posted

Number

Participants

Week 0 and Week 26

ID	Title	Description
OG000	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 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.
OG001	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.

Secondary

Number of Participants With Different Number of Leukocytes in Urine at Week 0 and Week 26

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.

Safety Population.

Posted

Number

Participants

Week 0 and Week 26

ID	Title	Description
OG000	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 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.
OG001	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.

Secondary

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

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.

Safety Population.

Posted

Mean

Standard Deviation

Millimoles per Liters

Baseline, Week 10 and Week 26

ID	Title	Description
OG000	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 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.

Secondary

Number of Participants With Vital Signs of Clinical Concern

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.

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

Posted

Number

Participants

Up to 30 weeks

ID	Title	Description
OG000	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 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.
OG001	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.

Secondary

Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Parameters

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.

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

Posted

Number

Participants

Up to 30 weeks

ID	Title	Description
OG000	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 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.
OG001	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.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute myocardial infarction	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected400 at risk EG0012 events2 affected413 at risk
Angina unstable	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0002 events1 affected400 at risk EG0011 events1 affected413 at risk
Angina pectoris	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected413 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected400 at risk EG0012 events1 affected413 at risk
Atrial flutter	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0002 events1 affected400 at risk EG0010 events0 affected413 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected400 at risk EG0010 events0 affected413 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected413 at risk
Syncope	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected400 at risk EG0011 events1 affected413 at risk
Brain stem infarction	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected413 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected413 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected413 at risk
Facial paralysis	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected400 at risk EG0010 events0 affected413 at risk
Hyperaesthesia	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected400 at risk EG0010 events0 affected413 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected413 at risk
Sciatica	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected400 at risk EG0010 events0 affected413 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected413 at risk
Pneumonia	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected400 at risk EG0012 events2 affected413 at risk
Osteomyelitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected400 at risk EG0012 events2 affected413 at risk
Appendicitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected400 at risk EG0010 events0 affected413 at risk
Gastroenteritis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected400 at risk EG0010 events0 affected413 at risk
Influenza	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected400 at risk EG0010 events0 affected413 at risk
Pyelonephritis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected400 at risk EG0010 events0 affected413 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected400 at risk EG0016 events6 affected413 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected413 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected400 at risk EG0011 events1 affected413 at risk
Hypertensive crisis	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected413 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected400 at risk EG0010 events0 affected413 at risk
Peripheral artery stenosis	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected413 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected400 at risk EG0010 events0 affected413 at risk
Colitis	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected413 at risk
Mesenteric artery stenosis	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected400 at risk EG0010 events0 affected413 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected400 at risk EG0010 events0 affected413 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected413 at risk
Ligament injury	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected413 at risk
Multiple injuries	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected400 at risk EG0010 events0 affected413 at risk
Perineal injury	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected413 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected400 at risk EG0010 events0 affected413 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected413 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected413 at risk
Teratoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected400 at risk EG0010 events0 affected413 at risk
Conductive deafness	Ear and labyrinth disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected400 at risk EG0010 events0 affected413 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected400 at risk EG0010 events0 affected413 at risk
Chest pain	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected400 at risk EG0010 events0 affected413 at risk
Non-cardiac chest pain	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected413 at risk
Metrorrhagia	Reproductive system and breast disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected413 at risk
Uterine polyp	Reproductive system and breast disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected400 at risk EG0010 events0 affected413 at risk
Angle closure glaucoma	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected400 at risk EG0010 events0 affected413 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected400 at risk EG0011 events1 affected413 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected400 at risk EG0010 events0 affected413 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected400 at risk EG0010 events0 affected413 at risk

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D049528	Insulin, Long-Acting
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D061266	Insulin, Short-Acting

ID	Title	Description
BG000	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 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.
BG001	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.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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 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.	0	400	23	400	114	400
EG001	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.	1	413	31	413	101	413

ID	Term
C534611	rGLP-1 protein
D000069036	Insulin Glargine
D061268	Insulin Lispro