Out-Patient Study in Patients With Type 2 Diabetes Mellitus Who Are Taking no Diabetes Medication or Metformin Only

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A 16-Week, Parallel-Group, Double-Blind, Randomized, Placebo-Controlled, Multicenter, Dose-Ranging Study to Evaluate the Efficacy, Safety, and Tolerability of Multiple Doses and Multiple Treatment Regimens of GSK716155, With Byetta as an Open Label Active Reference, in Subjects With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00518115
• Other study ID #: GLP110125
• Status: Completed
• Phase: Phase 2
• First received: August 17, 2007
• Last updated: June 19, 2014
• Start date: April 2007
• Est. completion date: May 2008

Study information

• Verified date: May 2014
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is a placebo-controlled study in patients with Type 2 Diabetes Mellitus who are either taking no diabetes medication or who are taking metformin only. This study will investigate the safety, tolerability, and efficacy of Albiglutide (GSK716155) and will measure the levels of Albiglutide (GSK716155) in the bloodstream when it is given for 16 weeks. As a comparison, some subjects will receive exenatide instead of Albiglutide (GSK716155). The study will involve weekly visits for 17 weeks,and less frequent follow-up visits for an additional 10 weeks. Assessments include repeat blood sampling and monitoring of any side effects.

Description:

A 16-week, parallel-group, double-blind, randomized, placebo-controlled, multicenter, dose-ranging study to evaluate the efficacy, safety and tolerability of multiple doses and multiple treatment regimens of Albiglutide (GSK716155) with Byetta as an open-label active reference, in subjects with Type 2 Diabetes Mellitus.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 361
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Has type 2 diabetes mellitus as defined by the criteria of the American Diabetes Association and recognized by World Health Organization Expert Committee on the Diagnosis and Classification of Diabetes Mellitus [American Diabetes Association, 2004a] at least three months preceding screening

• Has concurrent type 2 diabetes mellitus therapy: Must be diet and exercise treated; must not have taken antidiabetic medication for at least three months prior to prescreening or Monotherapy with metformin, with a history of a stable dose for at least three months before prescreening (not taking more than one oral antidiabetic agent)

• Has HbA1c level at screening =7 and =10%

• Is male or female 18 to 75 years of age, inclusive, at screening

• Has body mass index =20 and =40 kg/m²

• If subject is a smoker, must be able to abstain while in clinic at each visit

• If female, is eligible to enter and participate throughout the study, including the follow-up period: 1) If of nonchildbearing potential (i.e. physiologically incapable of becoming pregnant {tubal ligation}, including any female who is postmenopausal [>1 year without menstrual period]); or, 2) If of childbearing potential, has negative pregnancy tests at screening (serum) and at baseline (urine) and: 3) Has a male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject, or 4) Uses double-barrier methods of contraception; condoms (with spermicide) and intrauterine devices are acceptable, or 5) Uses hormonal contraceptives (oral, depots, patches, etc) with double-barrier methods of contraception as outlined above, or, 6) Abstains from sexual intercourse, or 7) Is with a same-sex partner and does not participate in bisexual activities where there is any risk of pregnancy

• Signs and dates informed consent before any study-related procedures are performed

Exclusion Criteria:

• Has metabolic disease including but not limited to: 1) Diagnosis of type 1 diabetes mellitus, 2) Uncorrected thyroid dysfunction (NOTE: subjects with hypothyroidism on a stable dose of thyroid replacement therapy for at least three months prior to screening, and who have a screening thyroid-stimulating hormone within the limits of normal may participate)

• Has qualitative changes in lifestyle that, in the opinion of the investigator, would affect the subject's weight or disease status

• Had previous use of insulin within one month prior to screening, or more than seven total days of insulin treatment within three months prior to screening

• Has clinically significant cardiovascular and/or cerebrovascular disease including, but not limited to: 1) Previous history of stroke or transient ischemic attack, 2) Active, unstable coronary heart disease within the past six months, 3) Documented myocardial infarction within a year prior to screening 4) Any cardiac surgery including percutaneous transluminal coronary angioplasty or coronary artery bypass graft surgery within a year prior to screening 5) Unstable angina 6) Clinically significant arrhythmia or valvular heart disease within the past year 7) Congestive heart failure with New York Heart Association Class II to Class IV symptoms. Class I is acceptable. 8) Untreated hypertension, with systolic pressure greater than 160mm Hg and/or diastolic pressure greater than 95mm Hg. 9) ECG exclusion criteria: Heart rate is <40 and >110 beats per minute, PR Interval is <120 and >210msec, QRS duration is <70 and >120msec, QTc interval (Bazett) is >450msec or >480msec with bundle branch block

• Has fasting serum triglycerides =800mg/dL or 9mmol/L at screening (Visit 2). Subjects receiving lipid-lowering therapy must have been on the same dose of therapy for the past three months. Fasting is defined as no food/drink for at least eight hours prior to sampling

• If female, is currently lactating, pregnant, or actively trying to become pregnant

• Has significant renal disease as manifested by one or more of the following: 1) Creatinine clearance <60mL/min. (estimated from serum creatinine and demographic data using the modification of diet in renal disease calculation; refer to the SPM/ISFM), 2) Urine albumin excretion =500 µg/mL on a urine spot check, 3) Known loss of a kidney either by surgical ablation, injury, or disease

• Has history of significant comorbid diseases active within the last six months (e.g., gastrointestinal disease)

• Has history of pancreatitis within five years prior to randomization

• Has a documented history of chronic or advanced hepatobiliary disease including a history of, or positive laboratory results for, hepatitis at screening (Visit 2), and/or clinically significant hepatic enzyme elevation including: 1) Any two of the following enzymes greater than 1.5 times the upper limit of normal (ULN) value: - alanine aminotransferase (ALT), - aspartate aminotransferase (AST), - alkaline phosphatase (ALP), 2) Any one of the above enzymes two times greater than the ULN value AND total or direct bilirubin >1.5 times the ULN

• Has a history of alcohol or substance abuse within the past year, as determined by the investigator or a positive urine drug screen at screening (Visit 2) or during treatment: 1) Unwilling to refrain from the use of excessive alcohol or illicit drugs and adhere to other protocol-stated restrictions while participating in the study, 2) History of alcohol abuse defined as an average weekly intake of greater than 21 units or an average daily intake of greater than three units (males) or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than two units (females). One unit is equivalent to a half-pint of beer or one measure of spirits or one glass of wine, 2) The investigator should exercise their medical judgment to determine if a urine drug screen is indicated

• Is currently taking prohibited concomitant medications listed in Section 6.6.2

• Has clinically significant anemia (i.e., hemoglobin <12.0g/dL or <120.0g/L for males and <11.0g/dL or <110.0g/L for females) or any other abnormal hematological profile that is considered by the investigator to be clinically significant

• Has known allergy to any formulation excipients, or history of drug or other allergy, which, in the opinion of the responsible study physician, contradicts participation

• Received treatment with an investigational drug or participated in any other clinical trial during the previous 30 days

• Has prior use of investigational agents with long half-lives of greater than seven days within the three months prior to screening

• Has any prior use of a GLP-1 analog, including GSK716155

• In the opinion of the investigator, has a risk of noncompliance with study procedures, or cannot read, understand, or complete study-related materials, particularly the informed consent

• Has any concurrent condition or any clinically significant abnormality identified on the screening physical examination, laboratory tests, ECG, including pulmonary, neurological, or inflammatory diseases, which, in the opinion of the investigator, may affect the interpretation of efficacy and safety data, or which otherwise, contraindicates participation in a clinical trial with a new chemical entity

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Albiglutide (GSK716155) or exenatide
Albiglutide weekly subcutaneous injection or exenatide twice daily injection

Locations

Country	Name	City	State
Chile	GSK Investigational Site	Buin	Región Metro De Santiago
Chile	GSK Investigational Site	Concepcion	Región Del Biobio
Chile	GSK Investigational Site	Santiago	Región Metro De Santiago
Chile	GSK Investigational Site	Santiago	Región Metro De Santiago
Dominican Republic	GSK Investigational Site	Santo Domingo
United States	GSK Investigational Site	Ames	Iowa
United States	GSK Investigational Site	Anderson	Indiana
United States	GSK Investigational Site	Anniston	Alabama
United States	GSK Investigational Site	Asheville	North Carolina
United States	GSK Investigational Site	Athens	Georgia
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Augusta	Georgia
United States	GSK Investigational Site	Aurora	Illinois
United States	GSK Investigational Site	Bend	Oregon
United States	GSK Investigational Site	Bensalem	Pennsylvania
United States	GSK Investigational Site	Billings	Montana
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Bismarck	North Dakota
United States	GSK Investigational Site	Bismarck	North Dakota
United States	GSK Investigational Site	Bradenton	Florida
United States	GSK Investigational Site	Bristol	Tennessee
United States	GSK Investigational Site	Buffalo	New York
United States	GSK Investigational Site	Bull Shoals	Arizona
United States	GSK Investigational Site	Caro	Michigan
United States	GSK Investigational Site	Castro Valley	California
United States	GSK Investigational Site	Chadbourn	North Carolina
United States	GSK Investigational Site	Charlotte	North Carolina
United States	GSK Investigational Site	Charlotte	North Carolina
United States	GSK Investigational Site	Chester	Virginia
United States	GSK Investigational Site	Clarksville	Tennessee
United States	GSK Investigational Site	Clearwater	Florida
United States	GSK Investigational Site	Cleburne	Texas
United States	GSK Investigational Site	Cleveland	Ohio
United States	GSK Investigational Site	Columbus	Ohio
United States	GSK Investigational Site	Columbus	Georgia
United States	GSK Investigational Site	Covington	Louisiana
United States	GSK Investigational Site	Culver City	California
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Dearborn	Michigan
United States	GSK Investigational Site	Decatur	Georgia
United States	GSK Investigational Site	Denver	Colorado
United States	GSK Investigational Site	Dubuque	Iowa
United States	GSK Investigational Site	Euless	Texas
United States	GSK Investigational Site	Evergreen Park	Illinois
United States	GSK Investigational Site	Fargo	North Dakota
United States	GSK Investigational Site	Fargo	North Dakota
United States	GSK Investigational Site	Ft. Lauderdale	Florida
United States	GSK Investigational Site	Fullerton	California
United States	GSK Investigational Site	Gainesville	Florida
United States	GSK Investigational Site	Garden Grove	California
United States	GSK Investigational Site	Glendale	Arizona
United States	GSK Investigational Site	Glens Falls	New York
United States	GSK Investigational Site	Grand Forks	North Dakota
United States	GSK Investigational Site	Greensboro	North Carolina
United States	GSK Investigational Site	Harrisburg	Pennsylvania
United States	GSK Investigational Site	Harrisburg	Arkansas
United States	GSK Investigational Site	Haverhill	Massachusetts
United States	GSK Investigational Site	Honolulu	Hawaii
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Huntington Beach	California
United States	GSK Investigational Site	Huntington Beach	California
United States	GSK Investigational Site	Huntington Park	California
United States	GSK Investigational Site	Indianapolis	Indiana
United States	GSK Investigational Site	Jacksonville	Florida
United States	GSK Investigational Site	Jefferson City	Missouri
United States	GSK Investigational Site	Johnson City	Tennessee
United States	GSK Investigational Site	Jonesboro	Arkansas
United States	GSK Investigational Site	Jonesboro	Arizona
United States	GSK Investigational Site	Kalamazoo	Michigan
United States	GSK Investigational Site	Kansas City	Kansas
United States	GSK Investigational Site	Knoxville	Tennessee
United States	GSK Investigational Site	La Grange	Illinois
United States	GSK Investigational Site	Lacombe	Louisiana
United States	GSK Investigational Site	Lake Forest	California
United States	GSK Investigational Site	LaPorte	Texas
United States	GSK Investigational Site	Las Vegas	Nevada
United States	GSK Investigational Site	Las Vegas	Nevada
United States	GSK Investigational Site	Lewisville	Texas
United States	GSK Investigational Site	Lexington	Kentucky
United States	GSK Investigational Site	Libertyville	Illinois
United States	GSK Investigational Site	Lincoln	Nebraska
United States	GSK Investigational Site	Little Rock	Arkansas
United States	GSK Investigational Site	Little Rock	Arkansas
United States	GSK Investigational Site	Loma Linda	California
United States	GSK Investigational Site	Longview	Texas
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Madison	Washington
United States	GSK Investigational Site	Manassas	Virginia
United States	GSK Investigational Site	Marianna	Florida
United States	GSK Investigational Site	Memphis	Tennessee
United States	GSK Investigational Site	Meridian	Idaho
United States	GSK Investigational Site	Metairie	Louisiana
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Midland	Texas
United States	GSK Investigational Site	Milan	Tennessee
United States	GSK Investigational Site	Mint Hill	North Carolina
United States	GSK Investigational Site	Missouri City	Texas
United States	GSK Investigational Site	Mobile	Alabama
United States	GSK Investigational Site	Morrisville	Pennsylvania
United States	GSK Investigational Site	Nashville	Tennessee
United States	GSK Investigational Site	North Platte	Nebraska
United States	GSK Investigational Site	Oak Brook	Illinois
United States	GSK Investigational Site	Oklahoma City	Oklahoma
United States	GSK Investigational Site	Omaha	Nebraska
United States	GSK Investigational Site	Orange	California
United States	GSK Investigational Site	Oviedo	Florida
United States	GSK Investigational Site	Palm Harbor	Florida
United States	GSK Investigational Site	Pasadena	Texas
United States	GSK Investigational Site	Pearland	Texas
United States	GSK Investigational Site	Perry	Georgia
United States	GSK Investigational Site	Pharr	Texas
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Picayune	Mississippi
United States	GSK Investigational Site	Plantation	Florida
United States	GSK Investigational Site	Raleigh	North Carolina
United States	GSK Investigational Site	Redwood City	California
United States	GSK Investigational Site	Reedley	California
United States	GSK Investigational Site	Riverside	California
United States	GSK Investigational Site	Rochester	New York
United States	GSK Investigational Site	Rolling Fork	Mississippi
United States	GSK Investigational Site	Round Rock	Texas
United States	GSK Investigational Site	Sacramento	California
United States	GSK Investigational Site	Salem	Virginia
United States	GSK Investigational Site	Salt Lake City	Utah
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	San Marcos	Texas
United States	GSK Investigational Site	Searcy	Arkansas
United States	GSK Investigational Site	South Bend	Indiana
United States	GSK Investigational Site	South Bend	Indiana
United States	GSK Investigational Site	South Burlington	Vermont
United States	GSK Investigational Site	Spokane	Washington
United States	GSK Investigational Site	Spring	Texas
United States	GSK Investigational Site	Springfield	Missouri
United States	GSK Investigational Site	St. Peters	Missouri
United States	GSK Investigational Site	Sugar Land	Texas
United States	GSK Investigational Site	Suwanee	Georgia
United States	GSK Investigational Site	Syracuse	New York
United States	GSK Investigational Site	Tallahassee	Florida
United States	GSK Investigational Site	Tampa	Florida
United States	GSK Investigational Site	The Woodlands	Texas
United States	GSK Investigational Site	Toledo	Ohio
United States	GSK Investigational Site	Tomball	Texas
United States	GSK Investigational Site	Topeka	Kansas
United States	GSK Investigational Site	Torrance	California
United States	GSK Investigational Site	Trumbull	Connecticut
United States	GSK Investigational Site	Tucker	Georgia
United States	GSK Investigational Site	Uniontown	Pennsylvania
United States	GSK Investigational Site	Van Buys	California
United States	GSK Investigational Site	Ventura	California
United States	GSK Investigational Site	Victorville	California
United States	GSK Investigational Site	Watertown	South Dakota
United States	GSK Investigational Site	Watseka	Illinois
United States	GSK Investigational Site	Williamsville	New York
United States	GSK Investigational Site	Wilmington	North Carolina
United States	GSK Investigational Site	Winston-Salem	North Carolina
United States	GSK Investigational Site	Winter Haven	Florida
United States	GSK Investigational Site	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Chile,  Dominican Republic, 

References & Publications (1)

Rosenstock J, Reusch J, Bush M, Yang F, Stewart M; Albiglutide Study Group. Potential of albiglutide, a long-acting GLP-1 receptor agonist, in type 2 diabetes: a randomized controlled trial exploring weekly, biweekly, and monthly dosing. Diabetes Care. 2009 Oct;32(10):1880-6. doi: 10.2337/dc09-0366. Epub 2009 Jul 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 16	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 Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the value at Week 16 minus the value at Baseline. Based on ANCOVA: Change = treatment + Baseline HbA1c + prior therapy + gender + region. The last observation carried forward (LOCF) method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.	Baseline and Week 16	No
Secondary	Change From Baseline in HbA1c at Weeks 4, 5, 7, 8, 9, 12, 15, and 16	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 Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the post-Baseline value minus the value at Baseline. The last observation carried forward (LOCF) method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.	Baseline and Weeks 4, 5, 7, 8, 9, 12, 15, and 16	No
Secondary	Number of Participants Who Achieved Target Values for HbA1c <6.5% and >=6.5% to <7% at Weeks 4, 5, 7, 8, 9, 12, 15, and 16	The number of participants who achieved target values for HbA1c (i.e., HbA1c <6.5% and >=6.5% to <7%) were assessed. The last observation carried forward (LOCF) method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.	Weeks (W) 4, 5, 7, 8, 9, 12, 15, and 16	No
Secondary	Change From Baseline in Waist Circumference at Week 16	The Baseline value is the last non-missing value before the start of treatment. Change from Baseline in waist circumference was calculated as the value at Week 16 minus the value at Baseline. The last observation carried forward (LOCF) method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.	Baseline and Week 16	No
Secondary	Change From Baseline in Body Weight at Week 16	The Baseline value is the last non-missing value before the start of treatment. Change from Baseline in body weight was calculated as the value at Week 16 minus the value at Baseline. The last observation carried forward (LOCF) method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.	Baseline and Week 16	No
Secondary	Percent Change From Baseline in Body Weight at Week 16	The Baseline value is the last non-missing value before the start of treatment. Change from Baseline in body weight was calculated as the value at Week 16 minus the value at Baseline. Percent change from Baseline was calculated as the ([value at Week 16 minus the Baseline value] divided by the Baseline value) multiplied by 100. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.	Baseline and Week 16	No
Secondary	Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 4, 5, 7, 8, 9, 12, 15, and 16	The FPG test measures blood sugar levels after the participant has not eaten (fasted) for at least eight hours prior to the sampling. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline in FPG was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.	Baseline and Weeks 4, 5, 7, 8, 9, 12, 15, and 16	No
Secondary	Change From Baseline in Fasting Fructosamine at Weeks 5, 8, 12, and 16	Fasting fructosamine levels were measured after the participant had not eaten (fasted) for at least eight hours prior to the sampling. The Baseline fructosamine value is the last non-missing value before the start of treatment. Change from Baseline in fructosamine was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.	Baseline and Weeks 5, 8, 12, and 16	No
Secondary	Change From Baseline in Fasting C-peptide at Weeks 5, 8, 12, and 16	Fasting C-peptide levels were measured after the participant had not eaten (fasted) for at least eight hours prior to the sampling. The Baseline C-peptide value is the last non-missing value before the start of treatment. Change from Baseline in C-peptide was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.	Baseline and Weeks 5, 8, 12, and 16	No
Secondary	Change From Baseline in Fasting Glucagon at Weeks 5, 8, 12, and 16	Fasting glucagon levels were measured after the participant had not eaten (fasted) for at least eight hours prior to the sampling. The Baseline glucagon value is the last non-missing value before the start of treatment. Change from Baseline in glucagon was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.	Baseline and Weeks 5, 8, 12, and 16	No
Secondary	Change From Baseline in Fasting Insulin at Weeks 5, 8, 12, and 16	Fasting insulin levels were measured after the participant had not eaten (fasted) for at least eight hours prior to the sampling. The Baseline insulin value is the last non-missing value before the start of treatment. Change from Baseline in insulin was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.	Baseline and Weeks 5, 8, 12, and 16	No
Secondary	Change From Baseline in Triglycerides, Free Fatty Acids, Total Cholesterol, Low-density Lipoprotein Cholesterol, and High-density Lipoprotein Cholesterol at Weeks 5, 8, 12, and 16	Serum lipid components, including triglycerides (TG), free fatty acids (FFA), total cholesterol (CL), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C), were measured at Baseline and Weeks 5, 8, 12, and 16. The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.	Baseline and Weeks 5, 8, 12, and 16	No
Secondary	Change From Baseline in Functional Living Index - Emesis (FLIE) Scores at Week 16	The FLIE questionnaire is used to record the participant's feelings/opinions concerning the effects of nausea/vomiting on their quality of life during the past five days. Participants completed the questionnaire by responding to 18 questions. The first set of 9 questions refer to nausea, and the second set of 9 questions refer to vomiting. Each question is scored on a seven-point visual analog scale (1 to 7). On this scale, a score of 1 corresponds to 0 millimeters (mm), and a score of 7 correspond to 100 mm. Anything in between is marked at the appropriate point on the scale and is measured in mm. Data are reported in mm in this table. In FLIE questions (FLIEQ) 1, 2, 4, 5, 7, 8, 9, 10, 12, 13, 14, 16, and 17, a score of 1 indicates no effect on the quality of life, and a score of 7 indicates a great effect on the quality of life. In FLIEQ 3, 6, 11, 15, and 18, a score of 1 indicates a great effect on the quality of life, and a score of 7 indicates no effect on the quality of life.	Baseline and Week 16	No
Secondary	Number of Participants With the Indicated Response to Questions on the Hunger, Craving, and Fullness Questionnaire (HCFQ) at Week 16	The HCFQ questionnaire is used to record how often participants have felt hungry or craved food, and how full participants felt after finishing meals, on average, in the past week. Participants answered the following seven questions with the response that best described their feelings of hunger, craving, and fullness: Q1, "In the past week I was hungry"; Q2, "In the past week I thought about food"; Q3, "In the past week I wanted to eat"; Q4, "In the past week I ate more than I should have"; Q5, "In the past week, I craved specific food"; Q6, "In the past week when finished meals I felt full"; Q7, "In the past week when finished meals I felt satisfied."	Week 16	No
Secondary	Mean Clearance of Albiglutide	Clearance is defined as the volume of plasma cleared of albiglutide per unit time. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 4, 5, 7, 8, 9, 12, 15) and on the day of the clinic visit at Weeks 16, 17, 18, 20, 23, and 27. The Week 5, 8, and 12 post-dose pharmacokinetic (PK) sampling was performed within 6 days of drug administration.	Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27	No
Secondary	Mean Volume of Distribution of Albiglutide	Volume of distribution is defined as the apparent volume in which albiglutide is distributed. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 4, 5, 7, 8, 9, 12, 15) and on the day of the clinic visit at Weeks 16, 17, 18, 20, 23, and 27. The Week 5, 8, and 12 post-dose (PK sampling was performed within 6 days of drug administration.	Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27	No
Secondary	Mean Absorption Rate of Albiglutide	Absorption rate is defined as the rate at which albiglutide enters the blood circulation. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 4, 5, 7, 8, 9, 12, 15) and on the day of the clinic visit at Weeks 16, 17, 18, 20, 23, and 27. The Week 5, 8, and 12 post-dose (PK sampling was performed within 6 days of drug administration.	Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27	No
Secondary	Mean Half-maximal Effective Concentration (EC50) of Albiglutide for HbA1c and FPG	EC50 is defined as the concentration of albiglutide that give a half-maximal HbA1c and FPG response. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 4, 5, 7, 8, 9, 12, 15) and on the day of the clinic visit at Weeks 16, 17, 18, 20, 23, and 27. The Week 5, 8, and 12 post-dose (PK sampling was performed within 6 days of drug administration. EC50 estimates used PK data as well as HbA1c and FPG efficacy data. EC50 was estimated from an inhibitory Emax (maximal possible effect of albiglutide) model.	Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27	No