Safety and Efficacy of Albiglutide in Type 2 Diabetes | NCT00849056

Label	Type	Description	Intervention Names
placebo + pioglitazone (with or without metformin)	Placebo Comparator	Placebo albiglutide weekly injection + pioglitazone (with or without metformin)	Drug: placebo
albiglutide + pioglitazone (with or without metformin)	Experimental	albiglutide weekly injection + pioglitazone (with or without meformin)	Biological: albiglutide

Name	Type	Description	Arm Group Labels	Other Names
albiglutide	Biological	albiglutide weekly subcutaneous injection	albiglutide + pioglitazone (with or without metformin)

Measure	Description	Time Frame
Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52	HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The BL HbA1c value is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 52 minus the value at BL. Based on analysis of covariance (ANCOVA): change = treatment + BL HbA1c + prior myocardial infarction history + age category + region + current antidiabetic therapy. The last observation carried forward (LOCF) method was used to impute missing post-BL HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values. One Intent-to-Treat (ITT) participant (par.) had all post-BL HbA1c measurements occur after hyperglycemic rescue. This par. is included in the ITT Population counts but did not contribute to this analysis.	Baseline and Week 52

Measure	Description	Time Frame
Change From Baseline in HbA1c at Weeks 104 and 156	HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed HbA1c values, excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Alabaster	Alabama	35007	United States
GSK Investigational Site

PubMed Identifier	Type	Citation	Retractions
28683300	Derived	Home PD, Ahren B, Reusch JEB, Rendell M, Weissman PN, Cirkel DT, Miller D, Ambery P, Carr MC, Nauck MA. Three-year data from 5 HARMONY phase 3 clinical trials of albiglutide in type 2 diabetes mellitus: Long-term efficacy with or without rescue therapy. Diabetes Res Clin Pract. 2017 Sep;131:49-60. doi: 10.1016/j.diabres.2017.06.013. Epub 2017 Jun 15.

Label	URL
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.	View source

ID	Type	URL	Comment
112755	Individual Participant Data Set	View IPD

ID	Title	Description
FG000	Placebo + Pioglitazone With or Without Metformin	Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.

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

Secondary

Change From Baseline in HbA1c at Weeks 104 and 156

HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed HbA1c values, excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.

ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed (represented by n=X, X in the category titles).

Posted

Mean

Standard Deviation

Percentage of HbA1c in the blood

Baseline and Weeks 104 and 156

ID	Title	Description
OG000	Placebo + Pioglitazone With or Without Metformin	Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
OG001	Albiglutide 30 mg + Pioglitazone With or Without Metformin	Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.

Units	Counts
Participants	OG00029 OG00172

Title

Denominators

Categories

Week 104, n= 29, 72

Title	Measurements
	OG000-0.72± 0.845 OG001-0.92± 1.038

Week 156, n=26, 54

Title	Measurements
	OG000

Primary

Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52

HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The BL HbA1c value is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 52 minus the value at BL. Based on analysis of covariance (ANCOVA): change = treatment + BL HbA1c + prior myocardial infarction history + age category + region + current antidiabetic therapy. The last observation carried forward (LOCF) method was used to impute missing post-BL HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values. One Intent-to-Treat (ITT) participant (par.) had all post-BL HbA1c measurements occur after hyperglycemic rescue. This par. is included in the ITT Population counts but did not contribute to this analysis.

Intent-to-Treat (ITT) Population with LOCF: all randomized par. who received >=1 dose of study medication and who had a BL assessment and >=1 post-BL assessment of HbA1c. Only par. with a value at BL and at the specified visit were analyzed. Values were carried forward for par. who were rescued or discontinued from active treatment before Week 52.

Posted

Least Squares Mean

Standard Error

Percentage of HbA1c in the blood

Baseline and Week 52

ID	Title	Description
OG000	Placebo + Pioglitazone With or Without Metformin	Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.

Secondary

Time to Hyperglycemia Rescue

Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: FPG >=280 milligrams/deciliter (mg/dL) between >=Week 2 and <Week 4; FPG >=250 mg/dL between >=Week 4 and <Week 12; HbA1c >=8.5% and a <=0.5% reduction from Baseline between >=Week 12 and <Week 24; HbA1c >=8.5% between >=Week 24 and <Week 48; HbA1c >=8.0% between >= Week 48 and \

ITT Population. Only those participants with a value at Baseline and at the specified visit were analyzed.

Posted

Median

95% Confidence Interval

Weeks

From the start of study medication until the end of the treatment (up to Week 156)

ID	Title	Description
OG000	Placebo + Pioglitazone With or Without Metformin	Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.

Secondary

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52

The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. FPG values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on ANCOVA: change = treatment + Baseline weight + prior myocardial infarction history + age category + region + current antidiabetic therapy.

Intent-to-Treat (ITT) Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.

Posted

Least Squares Mean

Standard Error

Millimoles per liter (mmol/L)

Baseline and Week 52

ID	Title	Description
OG000	Placebo + Pioglitazone With or Without Metformin	Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
OG001	Albiglutide 30 mg + Pioglitazone With or Without Metformin

Secondary

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 156

The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline FPG minus the Baseline FPG.

ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed. This analysis used observed FPG values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.

Posted

Mean

Standard Deviation

Millimoles per liter (mmol/L)

Baseline and Week 156

ID	Title	Description
OG000	Placebo + Pioglitazone With or Without Metformin	Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
OG001	Albiglutide 30 mg + Pioglitazone With or Without Metformin	Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.

Secondary

Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 52

The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <6.5%, and <7.0% at Week 52) were assessed.

ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.

Posted

Number

Participants

Week 52

ID	Title	Description
OG000	Placebo + Pioglitazone With or Without Metformin	Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
OG001	Albiglutide 30 mg + Pioglitazone With or Without Metformin	Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.

Secondary

Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156

The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <6.5%, and <7.0% at Week 156) were assessed.

ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed. This analysis used observed HbA1c values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.

Posted

Number

Participants

Week 156

ID	Title	Description
OG000	Placebo + Pioglitazone With or Without Metformin	Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
OG001	Albiglutide 30 mg + Pioglitazone With or Without Metformin	Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.

Secondary

Change From Baseline in Body Weight at Week 52

The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with prerescue values. Based on ANCOVA: change = treatment + Baseline weight + prior myocardial infarction history + age category + region + current antidiabetic therapy.

Posted

Least Squares Mean

Standard Error

Kilograms

Baseline and Week 52

ID	Title	Description
OG000	Placebo + Pioglitazone With or Without Metformin	Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
OG001	Albiglutide 30 mg + Pioglitazone With or Without Metformin	Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.

Secondary

Change From Baseline in Body Weight at Week 156

The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight.

ITT Population with observed values. Only those participants who were available at the indicated time points were analyzed. This analysis used observed body weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.

Posted

Mean

Standard Deviation

Kilograms

Baseline and Week 156

ID	Title	Description
OG000	Placebo + Pioglitazone With or Without Metformin	Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
OG001	Albiglutide 30 mg + Pioglitazone With or Without Metformin	Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Coronary artery disease	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 affected151 at risk EG0012 affected150 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected151 at risk EG0012 affected150 at risk
Angina unstable	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected151 at risk EG0011 affected150 at risk
Aortic valve incompetence	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected151 at risk EG0010 affected150 at risk
Atrial fibrillation	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected151 at risk EG0011 affected150 at risk
Cardiac failure	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected151 at risk EG0010 affected150 at risk
Cardiomyopathy	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected151 at risk EG0010 affected150 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected151 at risk EG0010 affected150 at risk
Myocardial infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected151 at risk EG0010 affected150 at risk
Sick sinus syndrome	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected151 at risk EG0010 affected150 at risk
Cellulitis	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected151 at risk EG0011 affected150 at risk
Abscess limb	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected151 at risk EG0011 affected150 at risk
Pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected151 at risk EG0012 affected150 at risk
Appendicitis perforated	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected151 at risk EG0011 affected150 at risk
Diverticulitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected151 at risk EG0010 affected150 at risk
Sinusitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected151 at risk EG0010 affected150 at risk
Viral infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected151 at risk EG0011 affected150 at risk
Vulval abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected151 at risk EG0010 affected150 at risk
Colonic fistula	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected151 at risk EG0011 affected150 at risk
Diabetic gastroparesis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected151 at risk EG0010 affected150 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected151 at risk EG0010 affected150 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected151 at risk EG0011 affected150 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected151 at risk EG0010 affected150 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 affected151 at risk EG0010 affected150 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected151 at risk EG0011 affected150 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected151 at risk EG0011 affected150 at risk
Breast cancer stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected151 at risk EG0010 affected150 at risk
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected151 at risk EG0011 affected150 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected151 at risk EG0010 affected150 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected151 at risk EG0010 affected150 at risk
Prostate cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected151 at risk EG0011 affected150 at risk
Chest pain	General disorders	MedDRA	Systematic Assessment	EG0003 affected151 at risk EG0010 affected150 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0002 affected151 at risk EG0010 affected150 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected151 at risk EG0011 affected150 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected151 at risk EG0011 affected150 at risk
Renal colic	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected151 at risk EG0011 affected150 at risk
Renal impairment	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected151 at risk EG0010 affected150 at risk
Deep vein thrombosis	Vascular disorders	MedDRA	Systematic Assessment	EG0002 affected151 at risk EG0010 affected150 at risk
Face injury	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected151 at risk EG0010 affected150 at risk
Obesity	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected151 at risk EG0010 affected150 at risk
Dizziness	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected151 at risk EG0011 affected150 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA	Systematic Assessment	EG0001 affected151 at risk EG0010 affected150 at risk
Major depression	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected151 at risk EG0010 affected150 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Upper respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG00024 affected151 at risk EG00124 affected150 at risk
Urinary tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0009 affected151 at risk EG00117 affected150 at risk
Sinusitis	Infections and infestations	MedDRA	Systematic Assessment	EG0009 affected151 at risk EG00115 affected150 at risk
Nasopharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG00022 affected151 at risk EG00112 affected150 at risk
Bronchitis	Infections and infestations	MedDRA	Systematic Assessment	EG00015 affected151 at risk EG00110 affected150 at risk
Gastroenteritis	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected151 at risk EG0017 affected150 at risk
Pharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG0007 affected151 at risk EG0016 affected150 at risk
Influenza	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected151 at risk EG0016 affected150 at risk
Cellulitis	Infections and infestations	MedDRA	Systematic Assessment	EG0004 affected151 at risk EG0015 affected150 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00013 affected151 at risk EG00115 affected150 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00010 affected151 at risk EG00113 affected150 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00010 affected151 at risk EG00113 affected150 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0006 affected151 at risk EG00111 affected150 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00011 affected151 at risk EG0017 affected150 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0003 affected151 at risk EG0016 affected150 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0003 affected151 at risk EG0015 affected150 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0007 affected151 at risk EG0014 affected150 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0004 affected151 at risk EG0011 affected150 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0004 affected151 at risk EG0010 affected150 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00016 affected151 at risk EG00122 affected150 at risk
Nausea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00018 affected151 at risk EG00118 affected150 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected151 at risk EG0019 affected150 at risk
Vomiting	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0006 affected151 at risk EG0018 affected150 at risk
Toothache	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0004 affected151 at risk EG0018 affected150 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0006 affected151 at risk EG0016 affected150 at risk
Constipation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected151 at risk EG0015 affected150 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0005 affected151 at risk EG0014 affected150 at risk
Gastritis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0003 affected151 at risk EG0014 affected150 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0008 affected151 at risk EG0012 affected150 at risk
Oedema peripheral	General disorders	MedDRA	Systematic Assessment	EG00016 affected151 at risk EG00115 affected150 at risk
Fatigue	General disorders	MedDRA	Systematic Assessment	EG0007 affected151 at risk EG00110 affected150 at risk
Injection site reaction	General disorders	MedDRA	Systematic Assessment	EG0005 affected151 at risk EG0018 affected150 at risk
Injection site haemorrhage	General disorders	MedDRA	Systematic Assessment	EG0001 affected151 at risk EG0017 affected150 at risk
Injection site haematoma	General disorders	MedDRA	Systematic Assessment	EG0004 affected151 at risk EG0016 affected150 at risk
Pyrexia	General disorders	MedDRA	Systematic Assessment	EG0004 affected151 at risk EG0013 affected150 at risk
Injection stie pruritis	General disorders	MedDRA	Systematic Assessment	EG0005 affected151 at risk EG0010 affected150 at risk
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG00018 affected151 at risk EG00113 affected150 at risk
Dizziness	Nervous system disorders	MedDRA	Systematic Assessment	EG0005 affected151 at risk EG00110 affected150 at risk
Hypoaesthesia	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 affected151 at risk EG0014 affected150 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA	Systematic Assessment	EG0006 affected151 at risk EG0012 affected150 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA	Systematic Assessment	EG0006 affected151 at risk EG0011 affected150 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00013 affected151 at risk EG00125 affected150 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0004 affected151 at risk EG0013 affected150 at risk
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0008 affected151 at risk EG0012 affected150 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0009 affected151 at risk EG00112 affected150 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 affected151 at risk EG0017 affected150 at risk
Meniscus lesion	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 affected151 at risk EG0014 affected150 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0004 affected151 at risk EG0013 affected150 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0004 affected151 at risk EG0013 affected150 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0005 affected151 at risk EG0012 affected150 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0004 affected151 at risk EG0012 affected150 at risk
Hypertension	Vascular disorders	MedDRA	Systematic Assessment	EG00015 affected151 at risk EG00117 affected150 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0008 affected151 at risk EG00110 affected150 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0004 affected151 at risk EG0018 affected150 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0004 affected151 at risk EG0014 affected150 at risk
Anxiety	Psychiatric disorders	MedDRA	Systematic Assessment	EG0006 affected151 at risk EG0017 affected150 at risk
Depression	Psychiatric disorders	MedDRA	Systematic Assessment	EG0005 affected151 at risk EG0014 affected150 at risk
Insomnia	Psychiatric disorders	MedDRA	Systematic Assessment	EG0004 affected151 at risk EG0014 affected150 at risk
Cataract	Eye disorders	MedDRA	Systematic Assessment	EG0003 affected151 at risk EG0017 affected150 at risk
Diabetic retinopathy	Eye disorders	MedDRA	Systematic Assessment	EG0002 affected151 at risk EG0017 affected150 at risk
Presbyopia	Eye disorders	MedDRA	Systematic Assessment	EG0004 affected151 at risk EG0012 affected150 at risk
Refraction disorder	Eye disorders	MedDRA	Systematic Assessment	EG0004 affected151 at risk EG0011 affected150 at risk
Pruritis	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected151 at risk EG0015 affected150 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0003 affected151 at risk EG0014 affected150 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected151 at risk EG0014 affected150 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0009 affected151 at risk EG0016 affected150 at risk
Vertigo	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0002 affected151 at risk EG0015 affected150 at risk
Ear pain	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0004 affected151 at risk EG0011 affected150 at risk
Seasonal allergy	Immune system disorders	MedDRA	Systematic Assessment	EG0005 affected151 at risk EG0015 affected150 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0002 affected151 at risk EG0015 affected150 at risk
Renal cyst	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0004 affected151 at risk EG0010 affected150 at risk
Palpitations	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected151 at risk EG0014 affected150 at risk
Angina pectoris	Cardiac disorders	MedDRA	Systematic Assessment	EG0004 affected151 at risk EG0010 affected150 at risk

ID	Term
D003924	Diabetes Mellitus, Type 2
D003920	Diabetes Mellitus

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

ID	Title	Description
BG000	Placebo + Pioglitazone With or Without Metformin	Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
BG001	Albiglutide 30 mg + Pioglitazone With or Without Metformin	Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up 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	Placebo + Pioglitazone With or Without Metformin	Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.			28	151	117	151
EG001	Albiglutide 30 mg + Pioglitazone With or Without Metformin	Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.			15	150	126	150