Out-Patient Study in Patients With Type 2 Diabetes Mellit... | NCT00518115 | Trialant
NCT00518115
Sponsor
GlaxoSmithKline
Status
Completed
Last Update Posted
Dec 16, 2016Estimated
Enrollment
361Actual
Phase
Phase 2
Conditions
Diabetes Mellitus, Type 2
Interventions
Albiglutide (GSK716155) or exenatide
Countries
United States
Chile
Dominican Republic
Protocol Section
Identification Module
NCT ID
NCT00518115
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
GLP110125
Secondary IDs
Not provided
Brief Title
Out-Patient Study in Patients With Type 2 Diabetes Mellitus Who Are Taking no Diabetes Medication or Metformin Only
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
Acronym
Not provided
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
Nov 2016
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 2007
Primary Completion Date
May 2008Actual
Completion Date
May 2008Actual
First Submitted Date
Aug 17, 2007
First Submission Date that Met QC Criteria
Aug 17, 2007
First Posted Date
Aug 20, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
May 1, 2014
Results First Submitted that Met QC Criteria
Jun 19, 2014
Results First Posted Date
Jun 23, 2014Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Jul 22, 2009
Certification/Extension First Submitted that Passed QC Review
Jul 22, 2009
Certification/Extension First Posted Date
Aug 10, 2009Estimated
Last Update Submitted Date
Nov 3, 2016
Last Update Posted Date
Dec 16, 2016Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
GlaxoSmithKlineINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief 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.
Detailed 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.
Conditions Module
Conditions
Diabetes Mellitus, Type 2
Keywords
GLP-1,
Type 2 Diabetes,
pharmacokinetics,
pharmacodynamics,
GSK716155,
metformin,
exenatide
Type 2 Diabetes Mellitus
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
361Actual
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Albiglutide (GSK716155) or exenatide
Drug
Albiglutide weekly subcutaneous injection or exenatide twice daily injection
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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
Secondary Outcomes
Measure
Description
Time Frame
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.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
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
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.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
A total of 361 participants were randomized into the study; however, only 356 of these participants received at least one dose of study drug.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo
Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
FG001
Exenatide BID
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Mexico
Peru
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Baseline and Weeks 4, 5, 7, 8, 9, 12, 15, and 16
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
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
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
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
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
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
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
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
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
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
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
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
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.
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.
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.
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.
For additional information about this study please refer to the GSK Clinical Study Register
Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
FG002
Albiglutide 4 mg Weekly
Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
FG003
Albiglutide 15 mg Weekly
Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
FG004
Albiglutide 30 mg Weekly
Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
FG005
Albiglutide 15 mg Bi-weekly
Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
FG006
Albiglutide 30 mg Bi-weekly
Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
FG007
Albiglutide 50 mg Bi-weekly
Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
FG008
Albiglutide 50 mg Every 4 Weeks
Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
FG009
Albiglutide 100 mg Every 4 Weeks
Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
FG00052 subjects
FG00135 subjects
FG00236 subjects
FG00335 subjects
FG00431 subjects
FG00534 subjects
FG00633 subjects
FG00735 subjects
FG00835 subjects
FG00935 subjects
Safety Population
FG00051 subjectsThese participants received at least one dose of study drug.
FG00135 subjectsThese participants received at least one dose of study drug.
FG00235 subjectsThese participants received at least one dose of study drug.
FG00335 subjectsThese participants received at least one dose of study drug.
FG00431 subjectsThese participants received at least one dose of study drug.
FG00533 subjectsThese participants received at least one dose of study drug.
FG00632 subjectsThese participants received at least one dose of study drug.
FG00735 subjectsThese participants received at least one dose of study drug.
FG00835 subjectsThese participants received at least one dose of study drug.
FG00934 subjectsThese participants received at least one dose of study drug.
COMPLETED
FG00040 subjects
FG00129 subjects
FG00219 subjects
FG00324 subjects
FG00421 subjects
FG00519 subjects
FG00625 subjects
FG00720 subjects
FG00830 subjects
FG00920 subjects
NOT COMPLETED
FG00012 subjects
FG0016 subjects
FG00217 subjects
FG00311 subjects
FG00410 subjects
FG00515 subjects
FG0068 subjects
FG00715 subjects
FG0085 subjects
FG00915 subjects
Type
Comment
Reasons
Adverse Event
FG0006 subjects
FG0011 subjects
FG0025 subjects
FG0036 subjects
FG0045 subjects
FG0055 subjects
FG0065 subjects
FG00710 subjects
FG0082 subjects
FG0099 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0033 subjects
FG004
Protocol Violation
FG0001 subjects
FG0013 subjects
FG0021 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0011 subjects
FG0025 subjects
FG0030 subjects
FG004
Lack of Efficacy
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Non-Compliance
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Treatment Eligibility Criteria Not Met
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Prescribed Antidiabetic Drug
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Different Monotherapy Diabetic Drug
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Wrong Monotherapy Administered
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Violation of Exclusion Criteria
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Family Emergency; Had to Go to England
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrew Consent
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Moved Out of State
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
BG001
Exenatide BID
Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
BG002
Albiglutide 4 mg Weekly
Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
BG003
Albiglutide 15 mg Weekly
Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
BG004
Albiglutide 30 mg Weekly
Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
BG005
Albiglutide 15 mg Bi-weekly
Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
BG006
Albiglutide 30 mg Bi-weekly
Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
BG007
Albiglutide 50 mg Bi-weekly
Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
BG008
Albiglutide 50 mg Every 4 Weeks
Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
BG009
Albiglutide 100 mg Every 4 Weeks
Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
BG010
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00051
BG00135
BG00235
BG00335
BG00431
BG00533
BG00632
BG00735
BG00835
BG00934
BG010356
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Baseline data are reported for participants in the Safety Population, comprised of all randomly assigned participants who received at least one dose of study drug.
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00054.0± 10.62
BG00153.7± 9.38
BG00250.4± 10.25
BG003
Gender
Baseline data are reported for participants in the Safety Population, comprised of all randomly assigned participants who received at least one dose of study drug.
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00023
BG00119
Race/Ethnicity, Customized
Baseline data are reported for participants in the Safety Population, comprised of all randomly assigned participants who received at least one dose of study drug.
Number
Participants
Title
Denominators
Categories
African American/African Heritage
Title
Measurements
BG0008
BG00110
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 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.
Intent-to-Treat (ITT) Population: all randomly assigned participants with at least one post-Baseline assessment of the primary endpoint. Participants from the exenatide arm were not included in the analysis. Only those participants with a value at Baseline and at the specified visit were analyzed.
Posted
Least Squares Mean
Standard Error
Percentage of HbA1c in the blood
Baseline and Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG001
Exenatide BID
Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
OG002
Albiglutide 4 mg Weekly
Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG003
Albiglutide 15 mg Weekly
Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG004
Albiglutide 30 mg Weekly
Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG005
Albiglutide 15 mg Bi-weekly
Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
Units
Counts
Participants
OG00050
OG0010
OG00234
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.46± 0.136
OG002-0.25± 0.159
OG003-0.71± 0.160
OG004
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
OG002
ANCOVA
0.2968
Mean Difference (Final Values)
0.20
2-Sided
95
-0.18
0.59
No
Superiority or Other
OG000
OG003
ANCOVA
0.1860
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.
ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
Posted
Mean
Standard Deviation
Percentage of HbA1c in the blood
Baseline and Weeks 4, 5, 7, 8, 9, 12, 15, and 16
ID
Title
Description
OG000
Placebo
Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG001
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.
ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
Posted
Number
Participants
Weeks (W) 4, 5, 7, 8, 9, 12, 15, and 16
ID
Title
Description
OG000
Placebo
Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG001
Exenatide BID
Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
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.
ITT Population. Only participants with a value at Baseline and at Week 16 were analyzed.
Posted
Mean
Standard Deviation
Centimeters
Baseline and Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG001
Exenatide BID
Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
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.
ITT Population. Only participants with a value at Baseline and at Week 16 were analyzed.
Posted
Mean
Standard Deviation
Kilograms (Kg)
Baseline and Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG001
Exenatide BID
Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
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.
ITT Population. Only participants with a value at Baseline and at Week 16 were analyzed.
Posted
Mean
Standard Deviation
Percent change
Baseline and Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG001
Exenatide BID
Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
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.
ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
Posted
Mean
Standard Deviation
Millimoles per liter (mmol/L)
Baseline and Weeks 4, 5, 7, 8, 9, 12, 15, and 16
ID
Title
Description
OG000
Placebo
Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG001
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.
ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
Posted
Mean
Standard Deviation
Micromoles per liter (µmol/L)
Baseline and Weeks 5, 8, 12, and 16
ID
Title
Description
OG000
Placebo
Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG001
Exenatide BID
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.
ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
Posted
Mean
Standard Deviation
Nanomoles per liter (nmol/L)
Baseline and Weeks 5, 8, 12, and 16
ID
Title
Description
OG000
Placebo
Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG001
Exenatide BID
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.
ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
Posted
Mean
Standard Deviation
Nanograms per liter (ng/L)
Baseline and Weeks 5, 8, 12, and 16
ID
Title
Description
OG000
Placebo
Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG001
Exenatide BID
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.
ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
Posted
Mean
Standard Deviation
Picomoles per liter (pmol/L)
Baseline and Weeks 5, 8, 12, and 16
ID
Title
Description
OG000
Placebo
Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG001
Exenatide BID
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.
ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
Posted
Mean
Standard Deviation
mmol/L
Baseline and Weeks 5, 8, 12, and 16
ID
Title
Description
OG000
Placebo
Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
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.
Safety Population: all randomly assigned participants who received at least one dose of study drug. Only those participants available at the specified time point were analyzed. Change from Baseline was calculated as the score at Week 16 minus the score at Baseline.
Posted
Mean
Standard Deviation
Score on a scale
Baseline and Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
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."
Safety Population. Only those participants available at the specified time point were analyzed.
Posted
Number
Participants
Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG001
Exenatide BID
Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
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.
PK Analysis Population: all participants for whom a PK sample was obtained and analyzed
All Participants Receiving Any Dose of Albiglutide
Participants received one of the following doses of albiglutide: 4 mg weekly, 15 mg weekly, 30 mg weekly (administered as a subcutaneous injection for 16 weeks) ; 15 mg bi-weekly, 30 mg bi-weekly, 50 mg bi-weekly (alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks); 50 mg every 4 weeks, 100 mg every 4 weeks (administered as a subcutaneous injection for 16 weeks). Participants received subcutaneous injections alternating between the left and right sides of the body.
Units
Counts
Participants
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.
All Participants Receiving Any Dose of Albiglutide
Participants received one of the following doses of albiglutide: 4 mg weekly, 15 mg weekly, 30 mg weekly (administered as a subcutaneous injection for 16 weeks) ; 15 mg bi-weekly, 30 mg bi-weekly, 50 mg bi-weekly (alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks); 50 mg every 4 weeks, 100 mg every 4 weeks (administered as a subcutaneous injection for 16 weeks). Participants received subcutaneous injections alternating between the left and right sides of the body.
Units
Counts
Participants
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.
All Participants Receiving Any Dose of Albiglutide
Participants received one of the following doses of albiglutide: 4 mg weekly, 15 mg weekly, 30 mg weekly (administered as a subcutaneous injection for 16 weeks) ; 15 mg bi-weekly, 30 mg bi-weekly, 50 mg bi-weekly (alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks); 50 mg every 4 weeks, 100 mg every 4 weeks (administered as a subcutaneous injection for 16 weeks). Participants received subcutaneous injections alternating between the left and right sides of the body.
Units
Counts
Participants
OG000
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.
PK/PD Analysis Population: all participants in the PK Analysis Population with sufficient dosing history for inclusion in the PK/PD analysis
All Participants Receiving Any Dose of Albiglutide
Participants received one of the following doses of albiglutide: 4 mg weekly, 15 mg weekly, 30 mg weekly (administered as a subcutaneous injection for 16 weeks) ; 15 mg bi-weekly, 30 mg bi-weekly, 50 mg bi-weekly (alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks); 50 mg every 4 weeks, 100 mg every 4 weeks (administered as a subcutaneous injection for 16 weeks). Participants received subcutaneous injections alternating between the left and right sides of the body.
Time Frame
On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
Description
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
All-Cause Mortality Comment
Not provided
Arm/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
Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
2
51
29
51
EG001
Exenatide BID
Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
1
35
22
35
EG002
Albiglutide 4 mg Weekly
Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
0
35
24
35
EG003
Albiglutide 15 mg Weekly
Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
3
35
20
35
EG004
Albiglutide 30 mg Weekly
Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
7
31
22
31
EG005
Albiglutide 15 mg Bi-weekly
Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
2
33
22
33
EG006
Albiglutide 30 mg Bi-weekly
Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
5
32
25
32
EG007
Albiglutide 50 mg Bi-weekly
Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
5
35
27
35
EG008
Albiglutide 50 mg Every 4 Weeks
Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
7
35
27
35
EG009
Albiglutide 100 mg Every 4 Weeks
Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
5
34
26
34
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Angina pectoris
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected35 at risk
EG0020 affected35 at risk
EG0030 affected35 at risk
EG0040 affected31 at risk
EG0050 affected33 at risk
EG0060 affected32 at risk
EG0070 affected35 at risk
EG0080 affected35 at risk
EG0091 affected34 at risk
Coronary artery disease
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected35 at risk
EG0020 affected35 at risk
EG003
Prinzmetal angina
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected35 at risk
EG0020 affected35 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected35 at risk
EG0020 affected35 at risk
EG003
Injection site erythema
General disorders
MedDRA
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected35 at risk
EG0020 affected35 at risk
EG003
Injection site hypersensitivity
General disorders
MedDRA
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected35 at risk
EG0020 affected35 at risk
EG003
Injection site pruritus
General disorders
MedDRA
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected35 at risk
EG0020 affected35 at risk
EG003
Injection site rash
General disorders
MedDRA
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected35 at risk
EG0020 affected35 at risk
EG003
Injection site reaction
General disorders
MedDRA
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected35 at risk
EG0020 affected35 at risk
EG003
Injection site urticaria
General disorders
MedDRA
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected35 at risk
EG0020 affected35 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected35 at risk
EG0020 affected35 at risk
EG003
Nerve compression
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected35 at risk
EG0020 affected35 at risk
EG003
Syncope
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected35 at risk
EG0020 affected35 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected35 at risk
EG0020 affected35 at risk
EG003
Postmenopausal haemorrhage
Reproductive system and breast disorders
MedDRA
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected35 at risk
EG0020 affected35 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected35 at risk
EG0020 affected35 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected35 at risk
EG0020 affected35 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected35 at risk
EG0020 affected35 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nausea
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0006 affected51 at risk
EG00114 affected35 at risk
EG0025 affected35 at risk
EG0037 affected35 at risk
EG0048 affected31 at risk
EG0059 affected33 at risk
EG0068 affected32 at risk
EG00719 affected35 at risk
EG00813 affected35 at risk
EG00918 affected34 at risk
Vomiting
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected51 at risk
EG0016 affected35 at risk
EG0020 affected35 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0002 affected51 at risk
EG0018 affected35 at risk
EG0025 affected35 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected35 at risk
EG0020 affected35 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0002 affected51 at risk
EG0010 affected35 at risk
EG0020 affected35 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected51 at risk
EG0012 affected35 at risk
EG0020 affected35 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0002 affected51 at risk
EG0010 affected35 at risk
EG0021 affected35 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected51 at risk
EG0012 affected35 at risk
EG0021 affected35 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected35 at risk
EG0020 affected35 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected35 at risk
EG0021 affected35 at risk
EG003
Stomach discomfort
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected35 at risk
EG0020 affected35 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected35 at risk
EG0022 affected35 at risk
EG003
Sinusitis
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected35 at risk
EG0023 affected35 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA
Systematic Assessment
EG0003 affected51 at risk
EG0012 affected35 at risk
EG0022 affected35 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA
Systematic Assessment
EG0003 affected51 at risk
EG0010 affected35 at risk
EG0022 affected35 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA
Systematic Assessment
EG0005 affected51 at risk
EG0014 affected35 at risk
EG0023 affected35 at risk
EG003
Influenza
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected35 at risk
EG0021 affected35 at risk
EG003
Bronchitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected51 at risk
EG0012 affected35 at risk
EG0020 affected35 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected35 at risk
EG0021 affected35 at risk
EG003
Headache
Nervous system disorders
MedDRA
Systematic Assessment
EG0003 affected51 at risk
EG0014 affected35 at risk
EG0026 affected35 at risk
EG003
Dizziness
Nervous system disorders
MedDRA
Systematic Assessment
EG0004 affected51 at risk
EG0013 affected35 at risk
EG0025 affected35 at risk
EG003
Sinus headache
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected35 at risk
EG0020 affected35 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0007 affected51 at risk
EG0010 affected35 at risk
EG0026 affected35 at risk
EG003
Anorexia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected35 at risk
EG0020 affected35 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected35 at risk
EG0020 affected35 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected35 at risk
EG0020 affected35 at risk
EG003
Increased appetite
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected35 at risk
EG0020 affected35 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected35 at risk
EG0022 affected35 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected35 at risk
EG0020 affected35 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0003 affected51 at risk
EG0010 affected35 at risk
EG0025 affected35 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected35 at risk
EG0020 affected35 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected35 at risk
EG0021 affected35 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected35 at risk
EG0020 affected35 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected35 at risk
EG0020 affected35 at risk
EG003
Fatigue
General disorders
MedDRA
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected35 at risk
EG0021 affected35 at risk
EG003
Injection site erythema
General disorders
MedDRA
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected35 at risk
EG0020 affected35 at risk
EG003
Asthenia
General disorders
MedDRA
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected35 at risk
EG0020 affected35 at risk
EG003
Injection site pruritus
General disorders
MedDRA
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected35 at risk
EG0020 affected35 at risk
EG003
Injection site pain
General disorders
MedDRA
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected35 at risk
EG0020 affected35 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected35 at risk
EG0021 affected35 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected35 at risk
EG0020 affected35 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected35 at risk
EG0020 affected35 at risk
EG003
Allergic sinusitis
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected35 at risk
EG0020 affected35 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected35 at risk
EG0020 affected35 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected35 at risk
EG0021 affected35 at risk
EG003
Hypotension
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected35 at risk
EG0020 affected35 at risk
EG003
Hypertension
Vascular disorders
MedDRA
Systematic Assessment
EG0002 affected51 at risk
EG0012 affected35 at risk
EG0023 affected35 at risk
EG003
Weight decreased
Investigations
MedDRA
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected35 at risk
EG0020 affected35 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected35 at risk
EG0020 affected35 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected35 at risk
EG0020 affected35 at risk
EG003
Ingrowing nail
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected35 at risk
EG0020 affected35 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected35 at risk
EG0021 affected35 at risk
EG003
Joint sprain
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected35 at risk
EG0020 affected35 at risk
EG003
Erectile dysfunction
Reproductive system and breast disorders
MedDRA
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected35 at risk
EG0020 affected35 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Point of Contact
Title
Organization
Phone
Extension
Email
GSK Response Center
GlaxoSmithKline
866-435-7343
ID
Term
D003924
Diabetes Mellitus, Type 2
Ancestor Terms
ID
Term
D003920
Diabetes Mellitus
D044882
Glucose Metabolism Disorders
D008659
Metabolic Diseases
D009750
Nutritional and Metabolic Diseases
D004700
Endocrine System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C534611
rGLP-1 protein
D000077270
Exenatide
Ancestor Terms
ID
Term
D010455
Peptides
D000602
Amino Acids, Peptides, and Proteins
D014688
Venoms
D045424
Complex Mixtures
D014118
Toxins, Biological
D001685
Biological Factors
Browse Leaves
Not provided
Browse Branches
Not provided
1 subjects
FG0053 subjects
FG0060 subjects
FG0071 subjects
FG0081 subjects
FG0091 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
2 subjects
FG0051 subjects
FG0060 subjects
FG0072 subjects
FG0081 subjects
FG0093 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
1 subjects
FG0051 subjects
FG0061 subjects
FG0071 subjects
FG0080 subjects
FG0091 subjects
0 subjects
FG0054 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
1 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
55.5
± 10.48
BG00454.2± 9.66
BG00552.5± 9.55
BG00655.5± 9.87
BG00751.1± 10.25
BG00854.1± 11.30
BG00954.4± 9.89
BG01053.5± 10.17
BG00220
BG00317
BG00423
BG00519
BG00616
BG00716
BG00818
BG00915
BG010186
Male
BG00028
BG00116
BG00215
BG00318
BG0048
BG00514
BG00616
BG00719
BG00817
BG00919
BG010170
BG0027
BG0034
BG0043
BG0053
BG0065
BG0074
BG0086
BG0095
BG01055
American Indian or Alaskan Native
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0041
BG0051
BG0061
BG0071
BG0081
BG0090
BG0105
Asian - Central/South Asian Heritage
Title
Measurements
BG0000
BG0011
BG0020
BG0031
BG0040
BG0050
BG0064
BG0071
BG0081
BG0091
BG0109
Asian - East Asian Heritage
Title
Measurements
BG0002
BG0010
BG0021
BG0030
BG0041
BG0051
BG0061
BG0071
BG0081
BG0090
BG0108
Asian - Japanese Heritage
Title
Measurements
BG0000
BG0011
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0101
Asian - South East Asian Heritage
Title
Measurements
BG0000
BG0010
BG0021
BG0030
BG0040
BG0051
BG0060
BG0072
BG0080
BG0091
BG0105
Native Hawaiian or Other Pacific Islander
Title
Measurements
BG0001
BG0011
BG0021
BG0030
BG0040
BG0050
BG0061
BG0070
BG0080
BG0091
BG0105
White- Arabic/North African Heritage
Title
Measurements
BG0004
BG0012
BG0022
BG0034
BG0042
BG0050
BG0060
BG0070
BG0083
BG0090
BG01017
White - White/Caucasian/European Heritage
Title
Measurements
BG00029
BG00120
BG00218
BG00319
BG00420
BG00521
BG00614
BG00719
BG00818
BG00920
BG010198
Hispanic
Title
Measurements
BG0003
BG0010
BG0024
BG0037
BG0042
BG0053
BG0065
BG0075
BG0084
BG0094
BG01037
Hispanic, Puerto Rican
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0081
BG0090
BG0101
Mestizo
Title
Measurements
BG0000
BG0010
BG0021
BG0030
BG0040
BG0051
BG0060
BG0071
BG0080
BG0090
BG0103
Mexican
Title
Measurements
BG0003
BG0010
BG0020
BG0030
BG0041
BG0052
BG0061
BG0071
BG0080
BG0090
BG0108
Mulatto
Title
Measurements
BG0001
BG0010
BG0020
BG0030
BG0041
BG0050
BG0060
BG0070
BG0080
BG0091
BG0103
Puerto Rican
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0091
BG0101
OG006
Albiglutide 30 mg Bi-weekly
Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG007
Albiglutide 50 mg Bi-weekly
Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG008
Albiglutide 50 mg Every 4 Weeks
Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG009
Albiglutide 100 mg Every 4 Weeks
Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
34
OG00429
OG00530
OG00632
OG00734
OG00835
OG00933
-1.08
± 0.175
OG005-0.68± 0.167
OG006-1.01± 0.162
OG007-1.03± 0.159
OG008-0.80± 0.157
OG009-1.06± 0.161
Mean Difference (Final Values)
-0.26
2-Sided
95
-0.64
0.12
No
Superiority or Other
OG000
OG004
ANCOVA
0.0027
Mean Difference (Final Values)
-0.62
2-Sided
95
-1.03
-0.22
No
Superiority or Other
OG000
OG005
ANCOVA
0.2766
Mean Difference (Final Values)
-0.22
2-Sided
95
-0.62
0.18
No
Superiority or Other
OG000
OG006
ANCOVA
0.0057
Mean Difference (Final Values)
-0.55
2-Sided
95
-0.94
-0.16
No
Superiority or Other
OG000
OG007
ANCOVA
0.0032
Mean Difference (Final Values)
-0.57
2-Sided
95
-0.96
-0.19
No
Superiority or Other
OG000
OG008
ANCOVA
0.0786
Mean Difference (Final Values)
-0.34
2-Sided
95
-0.72
0.04
No
Superiority or Other
OG000
OG009
ANCOVA
0.0022
Mean Difference (Final Values)
-0.60
2-Sided
95
-0.99
-0.22
No
Superiority or Other
Exenatide BID
Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
OG002
Albiglutide 4 mg Weekly
Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG003
Albiglutide 15 mg Weekly
Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG004
Albiglutide 30 mg Weekly
Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG005
Albiglutide 15 mg Bi-weekly
Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG006
Albiglutide 30 mg Bi-weekly
Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG007
Albiglutide 50 mg Bi-weekly
Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG008
Albiglutide 50 mg Every 4 Weeks
Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG009
Albiglutide 100 mg Every 4 Weeks
Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
Units
Counts
Participants
OG00050
OG00134
OG00234
OG00334
OG00429
OG00530
OG00632
OG00734
OG00835
OG00933
Title
Denominators
Categories
Week 4, n=47,34,33,34,28,29,31,34,34,30
Title
Measurements
OG000-0.14± 0.538
OG001-0.23± 0.485
OG002-0.12± 0.658
OG003-0.33± 0.442
OG004-0.56± 0.401
OG005-0.35± 0.470
OG006-0.34± 0.678
OG007-0.45± 0.547
OG008-0.41± 0.429
OG009-0.42± 0.523
Week 5, n=49,34,34,34,29,30,32,34,35,31
Title
Measurements
OG000-0.09± 0.570
OG001-0.32± 0.495
OG002-0.16± 0.758
OG003
Week 7, n=50,34,34,34,29,30,32,34,35,32
Title
Measurements
OG000-0.15± 0.749
OG001-0.36± 0.554
OG002-0.19± 0.855
OG003
Week 8, n=50,34,34,34,29,30,32,34,35,32
Title
Measurements
OG000-0.17± 0.793
OG001-0.45± 0.588
OG002-0.24± 0.897
OG003
Week 9, n=50,34,34,34,29,30,32,34,35,32
Title
Measurements
OG000-0.21± 0.842
OG001-0.51± 0.633
OG002-0.19± 0.947
OG003
Week 12, n=50,34,34,34,29,30,32,34,35,33
Title
Measurements
OG000-0.19± 0.892
OG001-0.56± 0.868
OG002-0.18± 1.025
OG003
Week 15, n=50,34,34,34,29,30,32,34,35,33
Title
Measurements
OG000-0.27± 0.948
OG001-0.53± 0.865
OG002-0.19± 0.989
OG003
Week 16, n=50,34,34,34,29,30,32,34,35,33
Title
Measurements
OG000-0.17± 1.006
OG001-0.54± 0.906
OG002-0.11± 1.156
OG003
OG002
Albiglutide 4 mg Weekly
Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG003
Albiglutide 15 mg Weekly
Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG004
Albiglutide 30 mg Weekly
Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG005
Albiglutide 15 mg Bi-weekly
Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG006
Albiglutide 30 mg Bi-weekly
Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG007
Albiglutide 50 mg Bi-weekly
Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG008
Albiglutide 50 mg Every 4 Weeks
Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG009
Albiglutide 100 mg Every 4 Weeks
Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
Units
Counts
Participants
OG00050
OG00134
OG00234
OG00334
OG00429
OG00530
OG00632
OG00734
OG00835
OG00933
Title
Denominators
Categories
W4: <6.5%, n=47,34,33,34,28,29,31,34,34,30
Title
Measurements
OG0001
OG0010
OG0020
OG0031
OG0044
OG0050
OG0060
OG0073
OG0081
OG0093
W4: >=6.5% to <7%, n=47,34,33,34,28,29,31,34,34,30
Title
Measurements
OG0008
OG0015
OG0025
OG003
W5: <6.5%, n=49,34,34,34,29,30,32,34,35,31
Title
Measurements
OG0002
OG0010
OG0021
OG003
W5: >=6.5% to <7%, n=49,34,34,34,29,30,32,34,35,31
Title
Measurements
OG0004
OG0017
OG0025
OG003
W7: <6.5%, n=50,34,34,34,29,30,32,34,35,32
Title
Measurements
OG0001
OG0011
OG0021
OG003
W7: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,32
Title
Measurements
OG0009
OG0019
OG0024
OG003
W8: <6.5%, n=50,34,34,34,29,30,32,34,35,32
Title
Measurements
OG0001
OG0012
OG0021
OG003
W8: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,32
Title
Measurements
OG00010
OG0017
OG0026
OG003
W9: <6.5%, n=50,34,34,34,29,30,32,34,35,32
Title
Measurements
OG0003
OG0012
OG0022
OG003
W9: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,32
Title
Measurements
OG0009
OG0019
OG0025
OG003
W12: <6.5%, n=50,34,34,34,29,30,32,34,35,33
Title
Measurements
OG0003
OG0013
OG0022
OG003
W12:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,33
Title
Measurements
OG0007
OG0018
OG0024
OG003
W15: <6.5%, n=50,34,34,34,29,30,32,34,35,33
Title
Measurements
OG0003
OG0014
OG0022
OG003
W15:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,33
Title
Measurements
OG0008
OG0016
OG0025
OG003
W16: <6.5%, n=50,34,34,34,29,30,32,34,35,33
Title
Measurements
OG0002
OG0014
OG0023
OG003
W16:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,33
Title
Measurements
OG0008
OG0018
OG0023
OG003
OG002
Albiglutide 4 mg Weekly
Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG003
Albiglutide 15 mg Weekly
Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG004
Albiglutide 30 mg Weekly
Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG005
Albiglutide 15 mg Bi-weekly
Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG006
Albiglutide 30 mg Bi-weekly
Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG007
Albiglutide 50 mg Bi-weekly
Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG008
Albiglutide 50 mg Every 4 Weeks
Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG009
Albiglutide 100 mg Every 4 Weeks
Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
Units
Counts
Participants
OG00050
OG00134
OG00234
OG00334
OG00429
OG00530
OG00632
OG00734
OG00835
OG00933
Title
Denominators
Categories
Title
Measurements
OG000-0.51± 3.847
OG001-3.53± 8.532
OG002-1.50± 3.902
OG003-3.16± 6.901
OG004-1.14± 3.856
OG005-1.83± 3.392
OG006-0.47± 3.589
OG007-2.00± 5.454
OG008-0.88± 5.146
OG009-0.77± 4.161
OG002
Albiglutide 4 mg Weekly
Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG003
Albiglutide 15 mg Weekly
Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG004
Albiglutide 30 mg Weekly
Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG005
Albiglutide 15 mg Bi-weekly
Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG006
Albiglutide 30 mg Bi-weekly
Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG007
Albiglutide 50 mg Bi-weekly
Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG008
Albiglutide 50 mg Every 4 Weeks
Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG009
Albiglutide 100 mg Every 4 Weeks
Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
Units
Counts
Participants
OG00050
OG00134
OG00234
OG00334
OG00429
OG00530
OG00632
OG00734
OG00835
OG00933
Title
Denominators
Categories
Title
Measurements
OG000-0.71± 2.883
OG001-2.41± 3.527
OG002-0.91± 1.733
OG003-0.90± 2.901
OG004-1.43± 2.371
OG005-1.76± 2.828
OG006-1.59± 2.455
OG007-1.14± 2.872
OG008-1.08± 3.177
OG009-1.65± 3.570
OG002
Albiglutide 4 mg Weekly
Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG003
Albiglutide 15 mg Weekly
Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG004
Albiglutide 30 mg Weekly
Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG005
Albiglutide 15 mg Bi-weekly
Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG006
Albiglutide 30 mg Bi-weekly
Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG007
Albiglutide 50 mg Bi-weekly
Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG008
Albiglutide 50 mg Every 4 Weeks
Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG009
Albiglutide 100 mg Every 4 Weeks
Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
Units
Counts
Participants
OG00050
OG00134
OG00234
OG00334
OG00429
OG00530
OG00632
OG00734
OG00835
OG00933
Title
Denominators
Categories
Title
Measurements
OG000-0.72± 3.403
OG001-2.53± 4.307
OG002-0.94± 1.838
OG003-1.04± 3.261
OG004-1.59± 2.663
OG005-1.97± 2.908
OG006-1.69± 2.773
OG007-1.32± 3.160
OG008-1.37± 3.571
OG009-1.89± 3.190
Exenatide BID
Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
OG002
Albiglutide 4 mg Weekly
Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG003
Albiglutide 15 mg Weekly
Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG004
Albiglutide 30 mg Weekly
Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG005
Albiglutide 15 mg Bi-weekly
Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG006
Albiglutide 30 mg Bi-weekly
Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG007
Albiglutide 50 mg Bi-weekly
Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG008
Albiglutide 50 mg Every 4 Weeks
Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG009
Albiglutide 100 mg Every 4 Weeks
Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
Units
Counts
Participants
OG00050
OG00134
OG00234
OG00334
OG00429
OG00530
OG00632
OG00734
OG00835
OG00933
Title
Denominators
Categories
Week 4, n=47,33,32,32,29,28,32,32,34,32
Title
Measurements
OG000-0.40± 2.565
OG001-1.11± 1.953
OG002-0.99± 3.037
OG003-0.58± 1.693
OG004-1.39± 1.968
OG005-1.06± 2.110
OG006-0.97± 1.629
OG007-1.35± 2.533
OG008-0.14± 3.192
OG009-0.61± 2.267
Week 5, n=47,33,32,32,29,28,32,32,34,32
Title
Measurements
OG000-0.40± 2.774
OG001-1.06± 2.377
OG002-1.02± 2.964
OG003
Week 7, n=47,33,32,32,29,28,32,32,34,33
Title
Measurements
OG000-0.19± 2.924
OG001-1.25± 2.204
OG002-0.80± 2.942
OG003
Week 8, n=47,33,32,32,29,28,32,32,34,33
Title
Measurements
OG000-0.44± 2.689
OG001-1.43± 2.258
OG002-1.22± 2.958
OG003
Week 9, n=47,33,32,32,29,28,32,32,34,33
Title
Measurements
OG000-0.25± 3.185
OG001-1.54± 2.044
OG002-1.13± 2.915
OG003
Week 12, n=47,33,32,32,29,28,32,32,34,33
Title
Measurements
OG000-0.27± 2.833
OG001-1.32± 2.518
OG002-1.04± 2.863
OG003
Week 15, n=47,33,32,32,29,28,32,32,34,33
Title
Measurements
OG000-0.44± 2.733
OG001-1.27± 2.343
OG002-0.67± 2.984
OG003
Week 16, n=47,33,32,32,29,28,32,32,34,33
Title
Measurements
OG000-0.10± 2.895
OG001-0.80± 2.482
OG002-0.47± 3.118
OG003
Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
OG002
Albiglutide 4 mg Weekly
Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG003
Albiglutide 15 mg Weekly
Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG004
Albiglutide 30 mg Weekly
Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG005
Albiglutide 15 mg Bi-weekly
Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG006
Albiglutide 30 mg Bi-weekly
Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG007
Albiglutide 50 mg Bi-weekly
Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG008
Albiglutide 50 mg Every 4 Weeks
Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG009
Albiglutide 100 mg Every 4 Weeks
Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
Units
Counts
Participants
OG00050
OG00134
OG00234
OG00334
OG00429
OG00530
OG00632
OG00734
OG00835
OG00933
Title
Denominators
Categories
Week 5, n=48,34,32,33,28,29,32,34,35,29
Title
Measurements
OG000-8.3± 38.68
OG001-24.7± 38.65
OG002-11.9± 50.55
OG003-23.8± 20.74
OG004-30.7± 31.28
OG005-21.3± 36.67
OG006-34.4± 41.71
OG007-30.1± 41.75
OG008-29.2± 46.57
OG009-32.5± 32.40
Week 8, n=50,34,33,34,28,29,32,34,35,31
Title
Measurements
OG000-10.1± 41.37
OG001-30.6± 32.47
OG002-13.1± 50.64
OG003
Week 12, n=50,34,33,34,28,29,32,34,35,33
Title
Measurements
OG000-11.2± 41.61
OG001-30.1± 35.78
OG002-12.5± 55.41
OG003
Week 16, n=50,34,33,34,28,29,32,34,35,33
Title
Measurements
OG000-3.2± 46.33
OG001-24.6± 41.88
OG002-7.8± 56.38
OG003
Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
OG002
Albiglutide 4 mg Weekly
Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG003
Albiglutide 15 mg Weekly
Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG004
Albiglutide 30 mg Weekly
Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG005
Albiglutide 15 mg Bi-weekly
Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG006
Albiglutide 30 mg Bi-weekly
Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG007
Albiglutide 50 mg Bi-weekly
Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG008
Albiglutide 50 mg Every 4 Weeks
Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG009
Albiglutide 100 mg Every 4 Weeks
Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
Units
Counts
Participants
OG00050
OG00134
OG00234
OG00334
OG00429
OG00530
OG00632
OG00734
OG00835
OG00933
Title
Denominators
Categories
Week 5, n=48,33,32,33,27,28,32,33,35,30
Title
Measurements
OG0000.004± 0.4464
OG0010.274± 0.7431
OG002-0.020± 0.3374
OG003-0.034± 0.6149
OG0040.089± 0.3459
OG0050.015± 0.3782
OG006-0.128± 0.6990
OG0070.004± 0.4130
OG0080.072± 0.4130
OG0090.230± 0.3595
Week 8, n=50,34,33,34,28,29,32,33,35,31
Title
Measurements
OG000-0.019± 0.4044
OG0010.104± 0.4643
OG002-0.073± 0.2813
OG003
Week 12, n=50,34,33,34,28,29,32,33,35,33
Title
Measurements
OG000-0.092± 0.4264
OG0010.174± 0.5445
OG002-0.044± 0.3426
OG003
Week 16, n=50,34,33,34,28,29,32,33,35,33
Title
Measurements
OG000-0.091± 0.3149
OG0010.216± 0.6786
OG002-0.051± 0.3877
OG003
Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
OG002
Albiglutide 4 mg Weekly
Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG003
Albiglutide 15 mg Weekly
Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG004
Albiglutide 30 mg Weekly
Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG005
Albiglutide 15 mg Bi-weekly
Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG006
Albiglutide 30 mg Bi-weekly
Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG007
Albiglutide 50 mg Bi-weekly
Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG008
Albiglutide 50 mg Every 4 Weeks
Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG009
Albiglutide 100 mg Every 4 Weeks
Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
Units
Counts
Participants
OG00050
OG00134
OG00234
OG00334
OG00429
OG00530
OG00632
OG00734
OG00835
OG00933
Title
Denominators
Categories
Week 5, n=48,33,33,33,27,28,32,34,35,30
Title
Measurements
OG0003.8± 43.63
OG001-3.9± 39.26
OG002-3.2± 27.16
OG003-13.9± 29.05
OG004-3.6± 21.95
OG005-6.0± 26.83
OG006-7.6± 20.72
OG007-11.6± 29.48
OG008-9.3± 23.21
OG0091.9± 30.27
Week 8, n=50,34,34,34,28,29,32,34,35,31
Title
Measurements
OG0006.9± 49.05
OG001-14.8± 38.34
OG002-5.6± 22.91
OG003
Week 12, n=50,34,34,34,28,29,32,34,35,33
Title
Measurements
OG0000.1± 49.48
OG001-5.5± 32.41
OG002-8.6± 31.51
OG003
Week 16, n=50,34,34,34,28,29,32,34,35,33
Title
Measurements
OG000-2.1± 45.73
OG001-4.5± 41.10
OG002-3.9± 26.72
OG003
Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
OG002
Albiglutide 4 mg Weekly
Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG003
Albiglutide 15 mg Weekly
Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG004
Albiglutide 30 mg Weekly
Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG005
Albiglutide 15 mg Bi-weekly
Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG006
Albiglutide 30 mg Bi-weekly
Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG007
Albiglutide 50 mg Bi-weekly
Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG008
Albiglutide 50 mg Every 4 Weeks
Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG009
Albiglutide 100 mg Every 4 Weeks
Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
Units
Counts
Participants
OG00050
OG00134
OG00234
OG00334
OG00429
OG00530
OG00632
OG00734
OG00835
OG00933
Title
Denominators
Categories
Week 5, n=47,31,32,33,27,28,31,30,33,30
Title
Measurements
OG0005.1± 106.67
OG00129.6± 104.29
OG002-12.4± 72.90
OG003-16.4± 114.61
OG0040.4± 75.97
OG00528.5± 99.26
OG006-38.3± 104.22
OG007-8.4± 75.38
OG00811.1± 97.92
OG00936.2± 115.31
Week 8, n=49,32,33,34,28,29,32,31,33,31
Title
Measurements
OG0009.2± 106.05
OG0015.4± 52.47
OG002-16.5± 64.88
OG003
Week 12, n=49,32,33,34,28,29,32,31,33,33
Title
Measurements
OG0008.8± 79.93
OG00118.0± 60.31
OG002-12.4± 67.03
OG003
Week 16, n=49,32,33,34,28,29,32,31,33,33
Title
Measurements
OG000-5.8± 42.74
OG00117.4± 52.62
OG0022.9± 81.64
OG003
OG001
Exenatide BID
Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
OG002
Albiglutide 4 mg Weekly
Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG003
Albiglutide 15 mg Weekly
Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG004
Albiglutide 30 mg Weekly
Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG005
Albiglutide 15 mg Bi-weekly
Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG006
Albiglutide 30 mg Bi-weekly
Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG007
Albiglutide 50 mg Bi-weekly
Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG008
Albiglutide 50 mg Every 4 Weeks
Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG009
Albiglutide 100 mg Every 4 Weeks
Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
Units
Counts
Participants
OG00050
OG00134
OG00234
OG00334
OG00429
OG00530
OG00632
OG00734
OG00835
OG00933
Title
Denominators
Categories
TG, Week 5, n=45,31,34,31,27,29,31,34,35,30
Title
Measurements
OG000-0.225± 1.0354
OG001-0.068± 0.7288
OG0020.303± 2.1539
OG003-0.376± 1.1387
OG0040.112± 0.6974
OG005-0.266± 1.2296
OG006-0.147± 1.0251
OG007-1.423± 3.7638
OG008-0.725± 1.3749
OG009-0.184± 0.5912
TG, Week 8, n=50,33,34,34,27,30,32,34,35,31
Title
Measurements
OG000-0.222± 1.5590
OG001-0.238± 0.6205
OG0020.178± 2.1883
OG003
TG, Week 12, n=50,34,34,34,28,30,32,34,35,33
Title
Measurements
OG000-0.329± 1.2941
OG0010.094± 1.4597
OG0020.221± 2.3056
OG003
TG, Week 16, n=50,34,34,34,28,30,32,34,35,33
Title
Measurements
OG000-0.377± 1.6534
OG001-0.149± 0.8423
OG0020.122± 2.1274
OG003
FFA, Week 5, n=48,33,32,33,27,28,32,34,35,29
Title
Measurements
OG0000.029± 0.1867
OG001-0.038± 0.2518
OG002-0.032± 0.1691
OG003
FFA, Week 8, n=50,34,33,34,28,29,32,34,35,31
Title
Measurements
OG0000.034± 0.2021
OG001-0.045± 0.2186
OG0020.033± 0.1699
OG003
FFA, Week 12, n=50,34,33,34,28,29,32,34,35,33
Title
Measurements
OG0000.075± 0.2018
OG001-0.007± 0.1882
OG0020.022± 0.2003
OG003
FFA, Week 16, n=50,34,33,34,28,29,32,34,35,33
Title
Measurements
OG0000.078± 0.2047
OG001-0.031± 0.1631
OG0020.020± 0.2084
OG003
Total CL, Week 5, n=45,31,34,31,27,29,31,34,35,30
Title
Measurements
OG000-0.023± 0.6128
OG001-0.239± 0.6613
OG002-0.153± 0.8765
OG003
Total CL, Week 8, n=50,33,34,34,27,30,32,34,35,31
Title
Measurements
OG000-0.050± 0.5932
OG001-0.182± 0.6517
OG002-0.060± 0.9192
OG003
Total CL, Week 12, n=50,34,34,34,28,30,32,34,35,33
Title
Measurements
OG0000.045± 0.6465
OG0010.054± 0.7723
OG002-0.025± 0.9136
OG003
Total CL, Week 16, n=50,34,34,34,28,30,32,34,35,33
Title
Measurements
OG0000.095± 0.7695
OG001-0.031± 0.8271
OG002-0.032± 0.9312
OG003
LDL-C, Week 5, n=41,29,31,29,26,28,29,27,32,29
Title
Measurements
OG0000.066± 0.5417
OG001-0.153± 0.5479
OG002-0.294± 0.7053
OG003
LDL-C, Week 8, n=45,32,32,32,26,30,31,28,32,30
Title
Measurements
OG0000.066± 0.5123
OG001-0.014± 0.5556
OG002-0.132± 0.7398
OG003
LDL-C, Week 12, n=45,33,32,32,28,30,31,28,32,32
Title
Measurements
OG0000.138± 0.4923
OG0010.105± 0.6259
OG002-0.096± 0.6483
OG003
LDL-C, Week 16, n=46,33,32,32,28,30,31,28,32,32
Title
Measurements
OG0000.190± 0.6025
OG0010.096± 0.6960
OG002-0.109± 0.6558
OG003
HDL-C, Week 5, n=45,31,34,31,27,29,31,34,35,30
Title
Measurements
OG000-0.020± 0.1189
OG001-0.047± 0.1420
OG0020.001± 0.1203
OG003
HDL-C, Week 8, n=50,33,34,34,27,30,32,34,35,31
Title
Measurements
OG000-0.005± 0.1192
OG001-0.058± 0.1606
OG0020.006± 0.1160
OG003
HDL-C, Week 12, n=50,34,34,34,28,30,32,34,35,33
Title
Measurements
OG000-0.011± 0.1341
OG001-0.003± 0.2269
OG0020.004± 0.1258
OG003
HDL-C, Week 16, n=50,34,34,34,28,30,32,34,35,33
Title
Measurements
OG000-0.002± 0.1274
OG001-0.025± 0.2192
OG002-0.007± 0.1366
OG003
OG001
Exenatide BID
Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
OG002
Albiglutide 4 mg Weekly
Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG003
Albiglutide 15 mg Weekly
Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG004
Albiglutide 30 mg Weekly
Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG005
Albiglutide 15 mg Bi-weekly
Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG006
Albiglutide 30 mg Bi-weekly
Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG007
Albiglutide 50 mg Bi-weekly
Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG008
Albiglutide 50 mg Every 4 Weeks
Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG009
Albiglutide 100 mg Every 4 Weeks
Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
Units
Counts
Participants
OG00037
OG00128
OG00219
OG00325
OG00422
OG00519
OG00624
OG00721
OG00829
OG00922
Title
Denominators
Categories
FLIEQ1
Title
Measurements
OG000-0.1± 6.79
OG001-4.4± 19.25
OG0025.7± 23.42
OG0031.0± 19.54
OG0044.6± 11.35
OG0058.6± 24.35
OG006-1.0± 2.22
OG0078.2± 22.66
OG008-0.3± 7.18
OG009-2.8± 8.30
FLIEQ2
Title
Measurements
OG0000.2± 2.15
OG001-3.5± 18.64
OG0025.5± 23.42
OG003
FLIEQ3
Title
Measurements
OG00015.6± 36.34
OG0017.8± 25.52
OG00210.3± 42.11
OG003
FLIEQ4
Title
Measurements
OG0000.4± 2.06
OG001-3.5± 18.32
OG0026.4± 24.11
OG003
FLIEQ5
Title
Measurements
OG000-0.3± 3.46
OG001-4.0± 18.21
OG0026.4± 23.09
OG003
FLIEQ6
Title
Measurements
OG00011.2± 38.64
OG0013.6± 29.76
OG0029.4± 40.77
OG003
FLIEQ7
Title
Measurements
OG0000.4± 2.20
OG001-3.1± 19.16
OG0025.7± 23.46
OG003
FLIEQ8
Title
Measurements
OG000-0.6± 4.46
OG001-3.5± 18.60
OG0025.7± 23.36
OG003
FLIEQ9
Title
Measurements
OG000-0.1± 3.55
OG001-3.4± 17.86
OG0025.3± 23.45
OG003
FLIEQ10
Title
Measurements
OG000-0.3± 3.27
OG001-4.9± 18.81
OG0025.8± 22.70
OG003
FLIEQ11
Title
Measurements
OG00015.3± 36.17
OG0013.3± 30.36
OG00213.8± 34.10
OG003
FLIEQ12
Title
Measurements
OG0000.1± 1.52
OG001-3.1± 17.45
OG0026.4± 23.00
OG003
FLIEQ13
Title
Measurements
OG0000.1± 1.57
OG001-4.0± 18.31
OG0026.3± 23.03
OG003
FLIEQ14
Title
Measurements
OG000-0.3± 2.95
OG001-4.1± 18.18
OG0026.4± 23.12
OG003
FLIEQ15
Title
Measurements
OG00015.5± 36.06
OG0017.0± 23.57
OG00214.2± 34.03
OG003
FLIEQ16
Title
Measurements
OG000-0.4± 2.58
OG001-3.8± 18.20
OG0026.3± 23.02
OG003
FLIEQ17
Title
Measurements
OG0000.1± 1.60
OG001-4.1± 18.14
OG0026.3± 22.97
OG003
FLIEQ18
Title
Measurements
OG00018.1± 37.82
OG0016.9± 23.47
OG00214.2± 33.91
OG003
OG002
Albiglutide 4 mg Weekly
Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG003
Albiglutide 15 mg Weekly
Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG004
Albiglutide 30 mg Weekly
Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG005
Albiglutide 15 mg Bi-weekly
Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG006
Albiglutide 30 mg Bi-weekly
Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG007
Albiglutide 50 mg Bi-weekly
Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG008
Albiglutide 50 mg Every 4 Weeks
Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
OG009
Albiglutide 100 mg Every 4 Weeks
Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.