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Delfa

← All trials/NCT00518115

CompletedPhase 2Results posted

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

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

Lead sponsor

GlaxoSmithKline

Assets

Albiglutide / Exenatide

Listed sites

163

Recruiting sites

-

Actual enrollment

361

Study population

Type 2 diabetes

Eligibility highlights

BMI 20-40HbA1c 7-10%

Primary endpoint

HbA1c, change

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT00518115
Org study IDGLP110125

Timeline

Milestones

Study first posted2007-08-20estimated
Results first posted2014-06-23estimated
Last update posted2016-12-16estimated
Study start2007-04 (month precision)
Primary completion2008-05actual (month precision)
Study completion2008-05actual (month precision)

Assets

Investigational agents

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (18)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes
8
Safety / tolerability / PK
4
Weight & body composition
3
Patient-reported / QoL
2
Cardiometabolic biomarkers
1

Weight & body composition

3 endpoints
Secondary/protocol endpoint

Change From Baseline in Waist Circumference at Week 16

Time frame:Baseline and Week 16

Waist circumference, change

change from baseline, improvement

Posted result

GroupMean · Centimeters95% CI
Placebo-0.51-
Exenatide BID-3.53-
Albiglutide 4 mg Weekly-1.50-
Albiglutide 15 mg Weekly-3.16-
Albiglutide 30 mg Weekly-1.14-
Albiglutide 15 mg Bi-weekly-1.83-
Albiglutide 30 mg Bi-weekly-0.47-
Albiglutide 50 mg Bi-weekly-2.00-
Albiglutide 50 mg Every 4 Weeks-0.88-
Albiglutide 100 mg Every 4 Weeks-0.77-
Secondary/protocol endpoint

Change From Baseline in Body Weight at Week 16

Time frame:Baseline and Week 16

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupMean · Kilograms (Kg)95% CI
Placebo-0.71-
Exenatide BID-2.41-
Albiglutide 4 mg Weekly-0.91-
Albiglutide 15 mg Weekly-0.90-
Albiglutide 30 mg Weekly-1.43-
Albiglutide 15 mg Bi-weekly-1.76-
Albiglutide 30 mg Bi-weekly-1.59-
Albiglutide 50 mg Bi-weekly-1.14-
Albiglutide 50 mg Every 4 Weeks-1.08-
Albiglutide 100 mg Every 4 Weeks-1.65-
Secondary/protocol endpoint

Percent Change From Baseline in Body Weight at Week 16

Time frame:Baseline and Week 16

Body weight, % change

percent change from baseline, improvement

Posted result

GroupMean · Percent change95% CI
Placebo-0.72-
Exenatide BID-2.53-
Albiglutide 4 mg Weekly-0.94-
Albiglutide 15 mg Weekly-1.04-
Albiglutide 30 mg Weekly-1.59-
Albiglutide 15 mg Bi-weekly-1.97-
Albiglutide 30 mg Bi-weekly-1.69-
Albiglutide 50 mg Bi-weekly-1.32-
Albiglutide 50 mg Every 4 Weeks-1.37-
Albiglutide 100 mg Every 4 Weeks-1.89-

Glycemic / diabetes

8 endpoints
Primary/protocol endpoint

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 16

Time frame:Baseline and Week 16

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

GroupLeast-squares mean · Percentage of HbA1c in the blood95% CI
Placebo-0.46-
Albiglutide 4 mg Weekly-0.25-
Albiglutide 15 mg Weekly-0.71-
Albiglutide 30 mg Weekly-1.08-
Albiglutide 15 mg Bi-weekly-0.68-
Albiglutide 30 mg Bi-weekly-1.01-
Albiglutide 50 mg Bi-weekly-1.03-
Albiglutide 50 mg Every 4 Weeks-0.80-
Albiglutide 100 mg Every 4 Weeks-1.06-
Mean difference (final values)0.2095% CI-0.18 - 0.59p0.2968ANCOVA
Mean difference (final values)-0.2695% CI-0.64 - 0.12p0.1860ANCOVA
Mean difference (final values)-0.6295% CI-1.03 - -0.22p0.0027ANCOVA
Mean difference (final values)-0.2295% CI-0.62 - 0.18p0.2766ANCOVA
Mean difference (final values)-0.5595% CI-0.94 - -0.16p0.0057ANCOVA
Mean difference (final values)-0.5795% CI-0.96 - -0.19p0.0032ANCOVA
Mean difference (final values)-0.3495% CI-0.72 - 0.04p0.0786ANCOVA
Mean difference (final values)-0.6095% CI-0.99 - -0.22p0.0022ANCOVA
Secondary/protocol endpoint

Change From Baseline in HbA1c at Weeks 4, 5, 7, 8, 9, 12, 15, and 16

Time frame:Baseline and Weeks 4, 5, 7, 8, 9, 12, 15, and 16

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

GroupMean · Percentage of HbA1c in the blood95% CI
PlaceboWeek 4, n=47,34,33,34,28,29,31,34,34,30-0.14-
Week 5, n=49,34,34,34,29,30,32,34,35,31-0.09-
Week 7, n=50,34,34,34,29,30,32,34,35,32-0.15-
Week 8, n=50,34,34,34,29,30,32,34,35,32-0.17-
Week 9, n=50,34,34,34,29,30,32,34,35,32-0.21-
Week 12, n=50,34,34,34,29,30,32,34,35,33-0.19-
Week 15, n=50,34,34,34,29,30,32,34,35,33-0.27-
Week 16, n=50,34,34,34,29,30,32,34,35,33-0.17-
Exenatide BIDWeek 4, n=47,34,33,34,28,29,31,34,34,30-0.23-
Week 5, n=49,34,34,34,29,30,32,34,35,31-0.32-
Week 7, n=50,34,34,34,29,30,32,34,35,32-0.36-
Week 8, n=50,34,34,34,29,30,32,34,35,32-0.45-
Week 9, n=50,34,34,34,29,30,32,34,35,32-0.51-
Week 12, n=50,34,34,34,29,30,32,34,35,33-0.56-
Week 15, n=50,34,34,34,29,30,32,34,35,33-0.53-
Week 16, n=50,34,34,34,29,30,32,34,35,33-0.54-
Albiglutide 4 mg WeeklyWeek 4, n=47,34,33,34,28,29,31,34,34,30-0.12-
Week 5, n=49,34,34,34,29,30,32,34,35,31-0.16-
Week 7, n=50,34,34,34,29,30,32,34,35,32-0.19-
Week 8, n=50,34,34,34,29,30,32,34,35,32-0.24-
Week 9, n=50,34,34,34,29,30,32,34,35,32-0.19-
Week 12, n=50,34,34,34,29,30,32,34,35,33-0.18-
Week 15, n=50,34,34,34,29,30,32,34,35,33-0.19-
Week 16, n=50,34,34,34,29,30,32,34,35,33-0.11-
Albiglutide 15 mg WeeklyWeek 4, n=47,34,33,34,28,29,31,34,34,30-0.33-
Week 5, n=49,34,34,34,29,30,32,34,35,31-0.39-
Week 7, n=50,34,34,34,29,30,32,34,35,32-0.44-
Week 8, n=50,34,34,34,29,30,32,34,35,32-0.50-
Week 9, n=50,34,34,34,29,30,32,34,35,32-0.55-
Week 12, n=50,34,34,34,29,30,32,34,35,33-0.58-
Week 15, n=50,34,34,34,29,30,32,34,35,33-0.49-
Week 16, n=50,34,34,34,29,30,32,34,35,33-0.49-
Albiglutide 30 mg WeeklyWeek 4, n=47,34,33,34,28,29,31,34,34,30-0.56-
Week 5, n=49,34,34,34,29,30,32,34,35,31-0.62-
Week 7, n=50,34,34,34,29,30,32,34,35,32-0.79-
Week 8, n=50,34,34,34,29,30,32,34,35,32-0.77-
Week 9, n=50,34,34,34,29,30,32,34,35,32-0.85-
Week 12, n=50,34,34,34,29,30,32,34,35,33-0.96-
Week 15, n=50,34,34,34,29,30,32,34,35,33-0.86-
Week 16, n=50,34,34,34,29,30,32,34,35,33-0.87-
Albiglutide 15 mg Bi-weeklyWeek 4, n=47,34,33,34,28,29,31,34,34,30-0.35-
Week 5, n=49,34,34,34,29,30,32,34,35,31-0.42-
Week 7, n=50,34,34,34,29,30,32,34,35,32-0.52-
Week 8, n=50,34,34,34,29,30,32,34,35,32-0.54-
Week 9, n=50,34,34,34,29,30,32,34,35,32-0.56-
Week 12, n=50,34,34,34,29,30,32,34,35,33-0.59-
Week 15, n=50,34,34,34,29,30,32,34,35,33-0.61-
Week 16, n=50,34,34,34,29,30,32,34,35,33-0.56-
Albiglutide 30 mg Bi-weeklyWeek 4, n=47,34,33,34,28,29,31,34,34,30-0.34-
Week 5, n=49,34,34,34,29,30,32,34,35,31-0.51-
Week 7, n=50,34,34,34,29,30,32,34,35,320.64-
Week 8, n=50,34,34,34,29,30,32,34,35,32-0.67-
Week 9, n=50,34,34,34,29,30,32,34,35,32-0.71-
Week 12, n=50,34,34,34,29,30,32,34,35,33-0.71-
Week 15, n=50,34,34,34,29,30,32,34,35,33-0.79-
Week 16, n=50,34,34,34,29,30,32,34,35,33-0.79-
Albiglutide 50 mg Bi-weeklyWeek 4, n=47,34,33,34,28,29,31,34,34,30-0.45-
Week 5, n=49,34,34,34,29,30,32,34,35,31-0.58-
Week 7, n=50,34,34,34,29,30,32,34,35,32-0.68-
Week 8, n=50,34,34,34,29,30,32,34,35,32-0.71-
Week 9, n=50,34,34,34,29,30,32,34,35,32-0.77-
Week 12, n=50,34,34,34,29,30,32,34,35,33-0.79-
Week 15, n=50,34,34,34,29,30,32,34,35,33-0.80-
Week 16, n=50,34,34,34,29,30,32,34,35,33-0.79-
Albiglutide 50 mg Every 4 WeeksWeek 4, n=47,34,33,34,28,29,31,34,34,30-0.41-
Week 5, n=49,34,34,34,29,30,32,34,35,31-0.47-
Week 7, n=50,34,34,34,29,30,32,34,35,32-0.45-
Week 8, n=50,34,34,34,29,30,32,34,35,32-0.41-
Week 9, n=50,34,34,34,29,30,32,34,35,32-0.54-
Week 12, n=50,34,34,34,29,30,32,34,35,33-0.51-
Week 15, n=50,34,34,34,29,30,32,34,35,33-0.58-
Week 16, n=50,34,34,34,29,30,32,34,35,33-0.55-
Albiglutide 100 mg Every 4 WeeksWeek 4, n=47,34,33,34,28,29,31,34,34,30-0.42-
Week 5, n=49,34,34,34,29,30,32,34,35,31-0.65-
Week 7, n=50,34,34,34,29,30,32,34,35,32-0.63-
Week 8, n=50,34,34,34,29,30,32,34,35,32-0.68-
Week 9, n=50,34,34,34,29,30,32,34,35,32-0.82-
Week 12, n=50,34,34,34,29,30,32,34,35,33-0.84-
Week 15, n=50,34,34,34,29,30,32,34,35,33-0.88-
Week 16, n=50,34,34,34,29,30,32,34,35,33-0.87-
Secondary/protocol endpoint

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

Time frame:Weeks (W) 4, 5, 7, 8, 9, 12, 15, and 16

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

GroupNumber · Participants95% CI
PlaceboW4: <6.5%, n=47,34,33,34,28,29,31,34,34,301-
W4: >=6.5% to <7%, n=47,34,33,34,28,29,31,34,34,308-
W5: <6.5%, n=49,34,34,34,29,30,32,34,35,312-
W5: >=6.5% to <7%, n=49,34,34,34,29,30,32,34,35,314-
W7: <6.5%, n=50,34,34,34,29,30,32,34,35,321-
W7: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,329-
W8: <6.5%, n=50,34,34,34,29,30,32,34,35,321-
W8: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,3210-
W9: <6.5%, n=50,34,34,34,29,30,32,34,35,323-
W9: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,329-
W12: <6.5%, n=50,34,34,34,29,30,32,34,35,333-
W12:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,337-
W15: <6.5%, n=50,34,34,34,29,30,32,34,35,333-
W15:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,338-
W16: <6.5%, n=50,34,34,34,29,30,32,34,35,332-
W16:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,338-
Exenatide BIDW4: <6.5%, n=47,34,33,34,28,29,31,34,34,300-
W4: >=6.5% to <7%, n=47,34,33,34,28,29,31,34,34,305-
W5: <6.5%, n=49,34,34,34,29,30,32,34,35,310-
W5: >=6.5% to <7%, n=49,34,34,34,29,30,32,34,35,317-
W7: <6.5%, n=50,34,34,34,29,30,32,34,35,321-
W7: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,329-
W8: <6.5%, n=50,34,34,34,29,30,32,34,35,322-
W8: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,327-
W9: <6.5%, n=50,34,34,34,29,30,32,34,35,322-
W9: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,329-
W12: <6.5%, n=50,34,34,34,29,30,32,34,35,333-
W12:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,338-
W15: <6.5%, n=50,34,34,34,29,30,32,34,35,334-
W15:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,336-
W16: <6.5%, n=50,34,34,34,29,30,32,34,35,334-
W16:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,338-
Albiglutide 4 mg WeeklyW4: <6.5%, n=47,34,33,34,28,29,31,34,34,300-
W4: >=6.5% to <7%, n=47,34,33,34,28,29,31,34,34,305-
W5: <6.5%, n=49,34,34,34,29,30,32,34,35,311-
W5: >=6.5% to <7%, n=49,34,34,34,29,30,32,34,35,315-
W7: <6.5%, n=50,34,34,34,29,30,32,34,35,321-
W7: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,324-
W8: <6.5%, n=50,34,34,34,29,30,32,34,35,321-
W8: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,326-
W9: <6.5%, n=50,34,34,34,29,30,32,34,35,322-
W9: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,325-
W12: <6.5%, n=50,34,34,34,29,30,32,34,35,332-
W12:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,334-
W15: <6.5%, n=50,34,34,34,29,30,32,34,35,332-
W15:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,335-
W16: <6.5%, n=50,34,34,34,29,30,32,34,35,333-
W16:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,333-
Albiglutide 15 mg WeeklyW4: <6.5%, n=47,34,33,34,28,29,31,34,34,301-
W4: >=6.5% to <7%, n=47,34,33,34,28,29,31,34,34,308-
W5: <6.5%, n=49,34,34,34,29,30,32,34,35,312-
W5: >=6.5% to <7%, n=49,34,34,34,29,30,32,34,35,317-
W7: <6.5%, n=50,34,34,34,29,30,32,34,35,324-
W7: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,324-
W8: <6.5%, n=50,34,34,34,29,30,32,34,35,324-
W8: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,328-
W9: <6.5%, n=50,34,34,34,29,30,32,34,35,326-
W9: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,327-
W12: <6.5%, n=50,34,34,34,29,30,32,34,35,335-
W12:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,338-
W15: <6.5%, n=50,34,34,34,29,30,32,34,35,334-
W15:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,338-
W16: <6.5%, n=50,34,34,34,29,30,32,34,35,334-
W16:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,338-
Albiglutide 30 mg WeeklyW4: <6.5%, n=47,34,33,34,28,29,31,34,34,304-
W4: >=6.5% to <7%, n=47,34,33,34,28,29,31,34,34,308-
W5: <6.5%, n=49,34,34,34,29,30,32,34,35,314-
W5: >=6.5% to <7%, n=49,34,34,34,29,30,32,34,35,318-
W7: <6.5%, n=50,34,34,34,29,30,32,34,35,328-
W7: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,325-
W8: <6.5%, n=50,34,34,34,29,30,32,34,35,326-
W8: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,328-
W9: <6.5%, n=50,34,34,34,29,30,32,34,35,328-
W9: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,325-
W12: <6.5%, n=50,34,34,34,29,30,32,34,35,3311-
W12:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,335-
W15: <6.5%, n=50,34,34,34,29,30,32,34,35,338-
W15:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,337-
W16: <6.5%, n=50,34,34,34,29,30,32,34,35,3310-
W16:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,335-
Albiglutide 15 mg Bi-weeklyW4: <6.5%, n=47,34,33,34,28,29,31,34,34,300-
W4: >=6.5% to <7%, n=47,34,33,34,28,29,31,34,34,306-
W5: <6.5%, n=49,34,34,34,29,30,32,34,35,311-
W5: >=6.5% to <7%, n=49,34,34,34,29,30,32,34,35,315-
W7: <6.5%, n=50,34,34,34,29,30,32,34,35,321-
W7: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,329-
W8: <6.5%, n=50,34,34,34,29,30,32,34,35,321-
W8: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,329-
W9: <6.5%, n=50,34,34,34,29,30,32,34,35,321-
W9: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,3210-
W12: <6.5%, n=50,34,34,34,29,30,32,34,35,333-
W12:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,337-
W15: <6.5%, n=50,34,34,34,29,30,32,34,35,334-
W15:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,337-
W16: <6.5%, n=50,34,34,34,29,30,32,34,35,335-
W16:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,333-
Albiglutide 30 mg Bi-weeklyW4: <6.5%, n=47,34,33,34,28,29,31,34,34,300-
W4: >=6.5% to <7%, n=47,34,33,34,28,29,31,34,34,308-
W5: <6.5%, n=49,34,34,34,29,30,32,34,35,311-
W5: >=6.5% to <7%, n=49,34,34,34,29,30,32,34,35,319-
W7: <6.5%, n=50,34,34,34,29,30,32,34,35,323-
W7: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,3211-
W8: <6.5%, n=50,34,34,34,29,30,32,34,35,324-
W8: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,3212-
W9: <6.5%, n=50,34,34,34,29,30,32,34,35,323-
W9: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,3211-
W12: <6.5%, n=50,34,34,34,29,30,32,34,35,333-
W12:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,3313-
W15: <6.5%, n=50,34,34,34,29,30,32,34,35,336-
W15:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,338-
W16: <6.5%, n=50,34,34,34,29,30,32,34,35,334-
W16:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,3312-
Albiglutide 50 mg Bi-weeklyW4: <6.5%, n=47,34,33,34,28,29,31,34,34,303-
W4: >=6.5% to <7%, n=47,34,33,34,28,29,31,34,34,305-
W5: <6.5%, n=49,34,34,34,29,30,32,34,35,312-
W5: >=6.5% to <7%, n=49,34,34,34,29,30,32,34,35,3111-
W7: <6.5%, n=50,34,34,34,29,30,32,34,35,326-
W7: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,329-
W8: <6.5%, n=50,34,34,34,29,30,32,34,35,327-
W8: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,3210-
W9: <6.5%, n=50,34,34,34,29,30,32,34,35,327-
W9: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,3210-
W12: <6.5%, n=50,34,34,34,29,30,32,34,35,338-
W12:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,3311-
W15: <6.5%, n=50,34,34,34,29,30,32,34,35,3310-
W15:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,339-
W16: <6.5%, n=50,34,34,34,29,30,32,34,35,3310-
W16:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,338-
Albiglutide 50 mg Every 4 WeeksW4: <6.5%, n=47,34,33,34,28,29,31,34,34,301-
W4: >=6.5% to <7%, n=47,34,33,34,28,29,31,34,34,306-
W5: <6.5%, n=49,34,34,34,29,30,32,34,35,311-
W5: >=6.5% to <7%, n=49,34,34,34,29,30,32,34,35,317-
W7: <6.5%, n=50,34,34,34,29,30,32,34,35,322-
W7: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,328-
W8: <6.5%, n=50,34,34,34,29,30,32,34,35,322-
W8: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,324-
W9: <6.5%, n=50,34,34,34,29,30,32,34,35,322-
W9: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,329-
W12: <6.5%, n=50,34,34,34,29,30,32,34,35,332-
W12:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,339-
W15: <6.5%, n=50,34,34,34,29,30,32,34,35,333-
W15:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,338-
W16: <6.5%, n=50,34,34,34,29,30,32,34,35,333-
W16:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,335-
Albiglutide 100 mg Every 4 WeeksW4: <6.5%, n=47,34,33,34,28,29,31,34,34,303-
W4: >=6.5% to <7%, n=47,34,33,34,28,29,31,34,34,306-
W5: <6.5%, n=49,34,34,34,29,30,32,34,35,314-
W5: >=6.5% to <7%, n=49,34,34,34,29,30,32,34,35,3112-
W7: <6.5%, n=50,34,34,34,29,30,32,34,35,325-
W7: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,328-
W8: <6.5%, n=50,34,34,34,29,30,32,34,35,325-
W8: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,3211-
W9: <6.5%, n=50,34,34,34,29,30,32,34,35,329-
W9: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,328-
W12: <6.5%, n=50,34,34,34,29,30,32,34,35,337-
W12:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,338-
W15: <6.5%, n=50,34,34,34,29,30,32,34,35,339-
W15:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,337-
W16: <6.5%, n=50,34,34,34,29,30,32,34,35,338-
W16:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,338-
Secondary/protocol endpoint

Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 4, 5, 7, 8, 9, 12, 15, and 16

Time frame:Baseline and Weeks 4, 5, 7, 8, 9, 12, 15, and 16

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

GroupMean · Millimoles per liter (mmol/L)95% CI
PlaceboWeek 4, n=47,33,32,32,29,28,32,32,34,32-0.40-
Week 5, n=47,33,32,32,29,28,32,32,34,32-0.40-
Week 7, n=47,33,32,32,29,28,32,32,34,33-0.19-
Week 8, n=47,33,32,32,29,28,32,32,34,33-0.44-
Week 9, n=47,33,32,32,29,28,32,32,34,33-0.25-
Week 12, n=47,33,32,32,29,28,32,32,34,33-0.27-
Week 15, n=47,33,32,32,29,28,32,32,34,33-0.44-
Week 16, n=47,33,32,32,29,28,32,32,34,33-0.10-
Exenatide BIDWeek 4, n=47,33,32,32,29,28,32,32,34,32-1.11-
Week 5, n=47,33,32,32,29,28,32,32,34,32-1.06-
Week 7, n=47,33,32,32,29,28,32,32,34,33-1.25-
Week 8, n=47,33,32,32,29,28,32,32,34,33-1.43-
Week 9, n=47,33,32,32,29,28,32,32,34,33-1.54-
Week 12, n=47,33,32,32,29,28,32,32,34,33-1.32-
Week 15, n=47,33,32,32,29,28,32,32,34,33-1.27-
Week 16, n=47,33,32,32,29,28,32,32,34,33-0.80-
Albiglutide 4 mg WeeklyWeek 4, n=47,33,32,32,29,28,32,32,34,32-0.99-
Week 5, n=47,33,32,32,29,28,32,32,34,32-1.02-
Week 7, n=47,33,32,32,29,28,32,32,34,33-0.80-
Week 8, n=47,33,32,32,29,28,32,32,34,33-1.22-
Week 9, n=47,33,32,32,29,28,32,32,34,33-1.13-
Week 12, n=47,33,32,32,29,28,32,32,34,33-1.04-
Week 15, n=47,33,32,32,29,28,32,32,34,33-0.67-
Week 16, n=47,33,32,32,29,28,32,32,34,33-0.47-
Albiglutide 15 mg WeeklyWeek 4, n=47,33,32,32,29,28,32,32,34,32-0.58-
Week 5, n=47,33,32,32,29,28,32,32,34,32-1.05-
Week 7, n=47,33,32,32,29,28,32,32,34,33-0.13-
Week 8, n=47,33,32,32,29,28,32,32,34,33-0.80-
Week 9, n=47,33,32,32,29,28,32,32,34,33-0.71-
Week 12, n=47,33,32,32,29,28,32,32,34,33-0.70-
Week 15, n=47,33,32,32,29,28,32,32,34,33-0.70-
Week 16, n=47,33,32,32,29,28,32,32,34,33-0.72-
Albiglutide 30 mg WeeklyWeek 4, n=47,33,32,32,29,28,32,32,34,32-1.39-
Week 5, n=47,33,32,32,29,28,32,32,34,32-1.53-
Week 7, n=47,33,32,32,29,28,32,32,34,33-1.54-
Week 8, n=47,33,32,32,29,28,32,32,34,33-1.60-
Week 9, n=47,33,32,32,29,28,32,32,34,33-1.49-
Week 12, n=47,33,32,32,29,28,32,32,34,33-1.85-
Week 15, n=47,33,32,32,29,28,32,32,34,33-1.54-
Week 16, n=47,33,32,32,29,28,32,32,34,33-1.44-
Albiglutide 15 mg Bi-weeklyWeek 4, n=47,33,32,32,29,28,32,32,34,32-1.06-
Week 5, n=47,33,32,32,29,28,32,32,34,32-1.41-
Week 7, n=47,33,32,32,29,28,32,32,34,33-1.16-
Week 8, n=47,33,32,32,29,28,32,32,34,33-1.29-
Week 9, n=47,33,32,32,29,28,32,32,34,33-1.29-
Week 12, n=47,33,32,32,29,28,32,32,34,33-1.11-
Week 15, n=47,33,32,32,29,28,32,32,34,33-1.45-
Week 16, n=47,33,32,32,29,28,32,32,34,33-1.28-
Albiglutide 30 mg Bi-weeklyWeek 4, n=47,33,32,32,29,28,32,32,34,32-0.97-
Week 5, n=47,33,32,32,29,28,32,32,34,32-1.72-
Week 7, n=47,33,32,32,29,28,32,32,34,33-1.51-
Week 8, n=47,33,32,32,29,28,32,32,34,33-1.27-
Week 9, n=47,33,32,32,29,28,32,32,34,33-1.64-
Week 12, n=47,33,32,32,29,28,32,32,34,33-1.57-
Week 15, n=47,33,32,32,29,28,32,32,34,33-1.71-
Week 16, n=47,33,32,32,29,28,32,32,34,33-1.58-
Albiglutide 50 mg Bi-weeklyWeek 4, n=47,33,32,32,29,28,32,32,34,32-1.35-
Week 5, n=47,33,32,32,29,28,32,32,34,32-2.17-
Week 7, n=47,33,32,32,29,28,32,32,34,33-1.87-
Week 8, n=47,33,32,32,29,28,32,32,34,33-1.29-
Week 9, n=47,33,32,32,29,28,32,32,34,33-1.68-
Week 12, n=47,33,32,32,29,28,32,32,34,33-1.49-
Week 15, n=47,33,32,32,29,28,32,32,34,33-1.66-
Week 16, n=47,33,32,32,29,28,32,32,34,33-1.32-
Albiglutide 50 mg Every 4 WeeksWeek 4, n=47,33,32,32,29,28,32,32,34,32-0.14-
Week 5, n=47,33,32,32,29,28,32,32,34,32-1.55-
Week 7, n=47,33,32,32,29,28,32,32,34,33-0.41-
Week 8, n=47,33,32,32,29,28,32,32,34,33-0.66-
Week 9, n=47,33,32,32,29,28,32,32,34,33-1.48-
Week 12, n=47,33,32,32,29,28,32,32,34,33-0.49-
Week 15, n=47,33,32,32,29,28,32,32,34,33-0.79-
Week 16, n=47,33,32,32,29,28,32,32,34,33-0.72-
Albiglutide 100 mg Every 4 WeeksWeek 4, n=47,33,32,32,29,28,32,32,34,32-0.61-
Week 5, n=47,33,32,32,29,28,32,32,34,32-2.12-
Week 7, n=47,33,32,32,29,28,32,32,34,33-1.07-
Week 8, n=47,33,32,32,29,28,32,32,34,33-1.29-
Week 9, n=47,33,32,32,29,28,32,32,34,33-2.25-
Week 12, n=47,33,32,32,29,28,32,32,34,33-1.50-
Week 15, n=47,33,32,32,29,28,32,32,34,33-1.27-
Week 16, n=47,33,32,32,29,28,32,32,34,33-1.22-
Secondary/protocol endpoint

Change From Baseline in Fasting Fructosamine at Weeks 5, 8, 12, and 16

Time frame:Baseline and Weeks 5, 8, 12, and 16

change from baseline, improvement

Posted result

GroupMean · Micromoles per liter (µmol/L)95% CI
PlaceboWeek 5, n=48,34,32,33,28,29,32,34,35,29-8.3-
Week 8, n=50,34,33,34,28,29,32,34,35,31-10.1-
Week 12, n=50,34,33,34,28,29,32,34,35,33-11.2-
Week 16, n=50,34,33,34,28,29,32,34,35,33-3.2-
Exenatide BIDWeek 5, n=48,34,32,33,28,29,32,34,35,29-24.7-
Week 8, n=50,34,33,34,28,29,32,34,35,31-30.6-
Week 12, n=50,34,33,34,28,29,32,34,35,33-30.1-
Week 16, n=50,34,33,34,28,29,32,34,35,33-24.6-
Albiglutide 4 mg WeeklyWeek 5, n=48,34,32,33,28,29,32,34,35,29-11.9-
Week 8, n=50,34,33,34,28,29,32,34,35,31-13.1-
Week 12, n=50,34,33,34,28,29,32,34,35,33-12.5-
Week 16, n=50,34,33,34,28,29,32,34,35,33-7.8-
Albiglutide 15 mg WeeklyWeek 5, n=48,34,32,33,28,29,32,34,35,29-23.8-
Week 8, n=50,34,33,34,28,29,32,34,35,31-25.7-
Week 12, n=50,34,33,34,28,29,32,34,35,33-26.7-
Week 16, n=50,34,33,34,28,29,32,34,35,33-18.2-
Albiglutide 30 mg WeeklyWeek 5, n=48,34,32,33,28,29,32,34,35,29-30.7-
Week 8, n=50,34,33,34,28,29,32,34,35,31-35.5-
Week 12, n=50,34,33,34,28,29,32,34,35,33-31.8-
Week 16, n=50,34,33,34,28,29,32,34,35,33-30.8-
Albiglutide 15 mg Bi-weeklyWeek 5, n=48,34,32,33,28,29,32,34,35,29-21.3-
Week 8, n=50,34,33,34,28,29,32,34,35,31-28.9-
Week 12, n=50,34,33,34,28,29,32,34,35,33-25.2-
Week 16, n=50,34,33,34,28,29,32,34,35,33-23.0-
Albiglutide 30 mg Bi-weeklyWeek 5, n=48,34,32,33,28,29,32,34,35,29-34.4-
Week 8, n=50,34,33,34,28,29,32,34,35,31-40.9-
Week 12, n=50,34,33,34,28,29,32,34,35,33-40.2-
Week 16, n=50,34,33,34,28,29,32,34,35,33-38.1-
Albiglutide 50 mg Bi-weeklyWeek 5, n=48,34,32,33,28,29,32,34,35,29-30.1-
Week 8, n=50,34,33,34,28,29,32,34,35,31-32.7-
Week 12, n=50,34,33,34,28,29,32,34,35,33-32.7-
Week 16, n=50,34,33,34,28,29,32,34,35,33-29.4-
Albiglutide 50 mg Every 4 WeeksWeek 5, n=48,34,32,33,28,29,32,34,35,29-29.2-
Week 8, n=50,34,33,34,28,29,32,34,35,31-24.9-
Week 12, n=50,34,33,34,28,29,32,34,35,33-26.4-
Week 16, n=50,34,33,34,28,29,32,34,35,33-26.5-
Albiglutide 100 mg Every 4 WeeksWeek 5, n=48,34,32,33,28,29,32,34,35,29-32.5-
Week 8, n=50,34,33,34,28,29,32,34,35,31-29.5-
Week 12, n=50,34,33,34,28,29,32,34,35,33-31.1-
Week 16, n=50,34,33,34,28,29,32,34,35,33-24.9-
Secondary/protocol endpoint

Change From Baseline in Fasting C-peptide at Weeks 5, 8, 12, and 16

Time frame:Baseline and Weeks 5, 8, 12, and 16

change from baseline, improvement

Posted result

GroupMean · Nanomoles per liter (nmol/L)95% CI
PlaceboWeek 5, n=48,33,32,33,27,28,32,33,35,300.004-
Week 8, n=50,34,33,34,28,29,32,33,35,31-0.019-
Week 12, n=50,34,33,34,28,29,32,33,35,33-0.092-
Week 16, n=50,34,33,34,28,29,32,33,35,33-0.091-
Exenatide BIDWeek 5, n=48,33,32,33,27,28,32,33,35,300.274-
Week 8, n=50,34,33,34,28,29,32,33,35,310.104-
Week 12, n=50,34,33,34,28,29,32,33,35,330.174-
Week 16, n=50,34,33,34,28,29,32,33,35,330.216-
Albiglutide 4 mg WeeklyWeek 5, n=48,33,32,33,27,28,32,33,35,30-0.020-
Week 8, n=50,34,33,34,28,29,32,33,35,31-0.073-
Week 12, n=50,34,33,34,28,29,32,33,35,33-0.044-
Week 16, n=50,34,33,34,28,29,32,33,35,33-0.051-
Albiglutide 15 mg WeeklyWeek 5, n=48,33,32,33,27,28,32,33,35,30-0.034-
Week 8, n=50,34,33,34,28,29,32,33,35,31-0.026-
Week 12, n=50,34,33,34,28,29,32,33,35,33-0.046-
Week 16, n=50,34,33,34,28,29,32,33,35,33-0.075-
Albiglutide 30 mg WeeklyWeek 5, n=48,33,32,33,27,28,32,33,35,300.089-
Week 8, n=50,34,33,34,28,29,32,33,35,310.095-
Week 12, n=50,34,33,34,28,29,32,33,35,330.023-
Week 16, n=50,34,33,34,28,29,32,33,35,330.171-
Albiglutide 15 mg Bi-weeklyWeek 5, n=48,33,32,33,27,28,32,33,35,300.015-
Week 8, n=50,34,33,34,28,29,32,33,35,31-0.038-
Week 12, n=50,34,33,34,28,29,32,33,35,33-0.098-
Week 16, n=50,34,33,34,28,29,32,33,35,33-0.059-
Albiglutide 30 mg Bi-weeklyWeek 5, n=48,33,32,33,27,28,32,33,35,30-0.128-
Week 8, n=50,34,33,34,28,29,32,33,35,31-0.015-
Week 12, n=50,34,33,34,28,29,32,33,35,33-0.153-
Week 16, n=50,34,33,34,28,29,32,33,35,33-0.137-
Albiglutide 50 mg Bi-weeklyWeek 5, n=48,33,32,33,27,28,32,33,35,300.004-
Week 8, n=50,34,33,34,28,29,32,33,35,31-0.062-
Week 12, n=50,34,33,34,28,29,32,33,35,33-0.076-
Week 16, n=50,34,33,34,28,29,32,33,35,33-0.066-
Albiglutide 50 mg Every 4 WeeksWeek 5, n=48,33,32,33,27,28,32,33,35,300.072-
Week 8, n=50,34,33,34,28,29,32,33,35,310.031-
Week 12, n=50,34,33,34,28,29,32,33,35,330.155-
Week 16, n=50,34,33,34,28,29,32,33,35,330.076-
Albiglutide 100 mg Every 4 WeeksWeek 5, n=48,33,32,33,27,28,32,33,35,300.230-
Week 8, n=50,34,33,34,28,29,32,33,35,310.007-
Week 12, n=50,34,33,34,28,29,32,33,35,330.062-
Week 16, n=50,34,33,34,28,29,32,33,35,33-0.005-
Secondary/protocol endpoint

Change From Baseline in Fasting Glucagon at Weeks 5, 8, 12, and 16

Time frame:Baseline and Weeks 5, 8, 12, and 16

fasting glucagon

change from baseline, improvement

Posted result

GroupMean · Nanograms per liter (ng/L)95% CI
PlaceboWeek 5, n=48,33,33,33,27,28,32,34,35,303.8-
Week 8, n=50,34,34,34,28,29,32,34,35,316.9-
Week 12, n=50,34,34,34,28,29,32,34,35,330.1-
Week 16, n=50,34,34,34,28,29,32,34,35,33-2.1-
Exenatide BIDWeek 5, n=48,33,33,33,27,28,32,34,35,30-3.9-
Week 8, n=50,34,34,34,28,29,32,34,35,31-14.8-
Week 12, n=50,34,34,34,28,29,32,34,35,33-5.5-
Week 16, n=50,34,34,34,28,29,32,34,35,33-4.5-
Albiglutide 4 mg WeeklyWeek 5, n=48,33,33,33,27,28,32,34,35,30-3.2-
Week 8, n=50,34,34,34,28,29,32,34,35,31-5.6-
Week 12, n=50,34,34,34,28,29,32,34,35,33-8.6-
Week 16, n=50,34,34,34,28,29,32,34,35,33-3.9-
Albiglutide 15 mg WeeklyWeek 5, n=48,33,33,33,27,28,32,34,35,30-13.9-
Week 8, n=50,34,34,34,28,29,32,34,35,31-15.6-
Week 12, n=50,34,34,34,28,29,32,34,35,33-20.1-
Week 16, n=50,34,34,34,28,29,32,34,35,33-20.5-
Albiglutide 30 mg WeeklyWeek 5, n=48,33,33,33,27,28,32,34,35,30-3.6-
Week 8, n=50,34,34,34,28,29,32,34,35,31-2.4-
Week 12, n=50,34,34,34,28,29,32,34,35,33-4.5-
Week 16, n=50,34,34,34,28,29,32,34,35,33-2.6-
Albiglutide 15 mg Bi-weeklyWeek 5, n=48,33,33,33,27,28,32,34,35,30-6.0-
Week 8, n=50,34,34,34,28,29,32,34,35,31-12.4-
Week 12, n=50,34,34,34,28,29,32,34,35,33-11.1-
Week 16, n=50,34,34,34,28,29,32,34,35,33-7.1-
Albiglutide 30 mg Bi-weeklyWeek 5, n=48,33,33,33,27,28,32,34,35,30-7.6-
Week 8, n=50,34,34,34,28,29,32,34,35,31-3.1-
Week 12, n=50,34,34,34,28,29,32,34,35,330.2-
Week 16, n=50,34,34,34,28,29,32,34,35,33-5.0-
Albiglutide 50 mg Bi-weeklyWeek 5, n=48,33,33,33,27,28,32,34,35,30-11.6-
Week 8, n=50,34,34,34,28,29,32,34,35,31-10.7-
Week 12, n=50,34,34,34,28,29,32,34,35,33-3.3-
Week 16, n=50,34,34,34,28,29,32,34,35,33-10.9-
Albiglutide 50 mg Every 4 WeeksWeek 5, n=48,33,33,33,27,28,32,34,35,30-9.3-
Week 8, n=50,34,34,34,28,29,32,34,35,31-0.3-
Week 12, n=50,34,34,34,28,29,32,34,35,33-3.7-
Week 16, n=50,34,34,34,28,29,32,34,35,33-11.5-
Albiglutide 100 mg Every 4 WeeksWeek 5, n=48,33,33,33,27,28,32,34,35,301.9-
Week 8, n=50,34,34,34,28,29,32,34,35,310.5-
Week 12, n=50,34,34,34,28,29,32,34,35,33-2.1-
Week 16, n=50,34,34,34,28,29,32,34,35,33-4.7-
Secondary/protocol endpoint

Change From Baseline in Fasting Insulin at Weeks 5, 8, 12, and 16

Time frame:Baseline and Weeks 5, 8, 12, and 16

change from baseline, improvement

Posted result

GroupMean · Picomoles per liter (pmol/L)95% CI
PlaceboWeek 5, n=47,31,32,33,27,28,31,30,33,305.1-
Week 8, n=49,32,33,34,28,29,32,31,33,319.2-
Week 12, n=49,32,33,34,28,29,32,31,33,338.8-
Week 16, n=49,32,33,34,28,29,32,31,33,33-5.8-
Exenatide BIDWeek 5, n=47,31,32,33,27,28,31,30,33,3029.6-
Week 8, n=49,32,33,34,28,29,32,31,33,315.4-
Week 12, n=49,32,33,34,28,29,32,31,33,3318.0-
Week 16, n=49,32,33,34,28,29,32,31,33,3317.4-
Albiglutide 4 mg WeeklyWeek 5, n=47,31,32,33,27,28,31,30,33,30-12.4-
Week 8, n=49,32,33,34,28,29,32,31,33,31-16.5-
Week 12, n=49,32,33,34,28,29,32,31,33,33-12.4-
Week 16, n=49,32,33,34,28,29,32,31,33,332.9-
Albiglutide 15 mg WeeklyWeek 5, n=47,31,32,33,27,28,31,30,33,30-16.4-
Week 8, n=49,32,33,34,28,29,32,31,33,31-8.5-
Week 12, n=49,32,33,34,28,29,32,31,33,33-7.9-
Week 16, n=49,32,33,34,28,29,32,31,33,33-19.9-
Albiglutide 30 mg WeeklyWeek 5, n=47,31,32,33,27,28,31,30,33,300.4-
Week 8, n=49,32,33,34,28,29,32,31,33,312.4-
Week 12, n=49,32,33,34,28,29,32,31,33,33-1.1-
Week 16, n=49,32,33,34,28,29,32,31,33,3325.1-
Albiglutide 15 mg Bi-weeklyWeek 5, n=47,31,32,33,27,28,31,30,33,3028.5-
Week 8, n=49,32,33,34,28,29,32,31,33,3118.6-
Week 12, n=49,32,33,34,28,29,32,31,33,3317.8-
Week 16, n=49,32,33,34,28,29,32,31,33,3321.9-
Albiglutide 30 mg Bi-weeklyWeek 5, n=47,31,32,33,27,28,31,30,33,30-38.3-
Week 8, n=49,32,33,34,28,29,32,31,33,31-14.4-
Week 12, n=49,32,33,34,28,29,32,31,33,33-26.1-
Week 16, n=49,32,33,34,28,29,32,31,33,33-24.0-
Albiglutide 50 mg Bi-weeklyWeek 5, n=47,31,32,33,27,28,31,30,33,30-8.4-
Week 8, n=49,32,33,34,28,29,32,31,33,31-16.8-
Week 12, n=49,32,33,34,28,29,32,31,33,330.2-
Week 16, n=49,32,33,34,28,29,32,31,33,33-17.4-
Albiglutide 50 mg Every 4 WeeksWeek 5, n=47,31,32,33,27,28,31,30,33,3011.1-
Week 8, n=49,32,33,34,28,29,32,31,33,3112.9-
Week 12, n=49,32,33,34,28,29,32,31,33,3338.0-
Week 16, n=49,32,33,34,28,29,32,31,33,3312.9-
Albiglutide 100 mg Every 4 WeeksWeek 5, n=47,31,32,33,27,28,31,30,33,3036.2-
Week 8, n=49,32,33,34,28,29,32,31,33,316.6-
Week 12, n=49,32,33,34,28,29,32,31,33,3311.6-
Week 16, n=49,32,33,34,28,29,32,31,33,3318.4-

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

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

Time frame:Baseline and Weeks 5, 8, 12, and 16

change from baseline, improvement

componentsTriglycerides, change, Free fatty acids, change, Total cholesterol, change, LDL-C, change, HDL-C, change

Posted result

GroupMean · mmol/L95% CI
PlaceboTG, Week 5, n=45,31,34,31,27,29,31,34,35,30-0.225-
TG, Week 8, n=50,33,34,34,27,30,32,34,35,31-0.222-
TG, Week 12, n=50,34,34,34,28,30,32,34,35,33-0.329-
TG, Week 16, n=50,34,34,34,28,30,32,34,35,33-0.377-
FFA, Week 5, n=48,33,32,33,27,28,32,34,35,290.029-
FFA, Week 8, n=50,34,33,34,28,29,32,34,35,310.034-
FFA, Week 12, n=50,34,33,34,28,29,32,34,35,330.075-
FFA, Week 16, n=50,34,33,34,28,29,32,34,35,330.078-
Total CL, Week 5, n=45,31,34,31,27,29,31,34,35,30-0.023-
Total CL, Week 8, n=50,33,34,34,27,30,32,34,35,31-0.050-
Total CL, Week 12, n=50,34,34,34,28,30,32,34,35,330.045-
Total CL, Week 16, n=50,34,34,34,28,30,32,34,35,330.095-
LDL-C, Week 5, n=41,29,31,29,26,28,29,27,32,290.066-
LDL-C, Week 8, n=45,32,32,32,26,30,31,28,32,300.066-
LDL-C, Week 12, n=45,33,32,32,28,30,31,28,32,320.138-
LDL-C, Week 16, n=46,33,32,32,28,30,31,28,32,320.190-
HDL-C, Week 5, n=45,31,34,31,27,29,31,34,35,30-0.020-
HDL-C, Week 8, n=50,33,34,34,27,30,32,34,35,31-0.005-
HDL-C, Week 12, n=50,34,34,34,28,30,32,34,35,33-0.011-
HDL-C, Week 16, n=50,34,34,34,28,30,32,34,35,33-0.002-
Exenatide BIDTG, Week 5, n=45,31,34,31,27,29,31,34,35,30-0.068-
TG, Week 8, n=50,33,34,34,27,30,32,34,35,31-0.238-
TG, Week 12, n=50,34,34,34,28,30,32,34,35,330.094-
TG, Week 16, n=50,34,34,34,28,30,32,34,35,33-0.149-
FFA, Week 5, n=48,33,32,33,27,28,32,34,35,29-0.038-
FFA, Week 8, n=50,34,33,34,28,29,32,34,35,31-0.045-
FFA, Week 12, n=50,34,33,34,28,29,32,34,35,33-0.007-
FFA, Week 16, n=50,34,33,34,28,29,32,34,35,33-0.031-
Total CL, Week 5, n=45,31,34,31,27,29,31,34,35,30-0.239-
Total CL, Week 8, n=50,33,34,34,27,30,32,34,35,31-0.182-
Total CL, Week 12, n=50,34,34,34,28,30,32,34,35,330.054-
Total CL, Week 16, n=50,34,34,34,28,30,32,34,35,33-0.031-
LDL-C, Week 5, n=41,29,31,29,26,28,29,27,32,29-0.153-
LDL-C, Week 8, n=45,32,32,32,26,30,31,28,32,30-0.014-
LDL-C, Week 12, n=45,33,32,32,28,30,31,28,32,320.105-
LDL-C, Week 16, n=46,33,32,32,28,30,31,28,32,320.096-
HDL-C, Week 5, n=45,31,34,31,27,29,31,34,35,30-0.047-
HDL-C, Week 8, n=50,33,34,34,27,30,32,34,35,31-0.058-
HDL-C, Week 12, n=50,34,34,34,28,30,32,34,35,33-0.003-
HDL-C, Week 16, n=50,34,34,34,28,30,32,34,35,33-0.025-
Albiglutide 4 mg WeeklyTG, Week 5, n=45,31,34,31,27,29,31,34,35,300.303-
TG, Week 8, n=50,33,34,34,27,30,32,34,35,310.178-
TG, Week 12, n=50,34,34,34,28,30,32,34,35,330.221-
TG, Week 16, n=50,34,34,34,28,30,32,34,35,330.122-
FFA, Week 5, n=48,33,32,33,27,28,32,34,35,29-0.032-
FFA, Week 8, n=50,34,33,34,28,29,32,34,35,310.033-
FFA, Week 12, n=50,34,33,34,28,29,32,34,35,330.022-
FFA, Week 16, n=50,34,33,34,28,29,32,34,35,330.020-
Total CL, Week 5, n=45,31,34,31,27,29,31,34,35,30-0.153-
Total CL, Week 8, n=50,33,34,34,27,30,32,34,35,31-0.060-
Total CL, Week 12, n=50,34,34,34,28,30,32,34,35,33-0.025-
Total CL, Week 16, n=50,34,34,34,28,30,32,34,35,33-0.032-
LDL-C, Week 5, n=41,29,31,29,26,28,29,27,32,29-0.294-
LDL-C, Week 8, n=45,32,32,32,26,30,31,28,32,30-0.132-
LDL-C, Week 12, n=45,33,32,32,28,30,31,28,32,32-0.096-
LDL-C, Week 16, n=46,33,32,32,28,30,31,28,32,32-0.109-
HDL-C, Week 5, n=45,31,34,31,27,29,31,34,35,300.001-
HDL-C, Week 8, n=50,33,34,34,27,30,32,34,35,310.006-
HDL-C, Week 12, n=50,34,34,34,28,30,32,34,35,330.004-
HDL-C, Week 16, n=50,34,34,34,28,30,32,34,35,33-0.007-
Albiglutide 15 mg WeeklyTG, Week 5, n=45,31,34,31,27,29,31,34,35,30-0.376-
TG, Week 8, n=50,33,34,34,27,30,32,34,35,31-0.408-
TG, Week 12, n=50,34,34,34,28,30,32,34,35,33-0.341-
TG, Week 16, n=50,34,34,34,28,30,32,34,35,33-0.296-
FFA, Week 5, n=48,33,32,33,27,28,32,34,35,29-0.008-
FFA, Week 8, n=50,34,33,34,28,29,32,34,35,31-0.048-
FFA, Week 12, n=50,34,33,34,28,29,32,34,35,33-0.013-
FFA, Week 16, n=50,34,33,34,28,29,32,34,35,330.016-
Total CL, Week 5, n=45,31,34,31,27,29,31,34,35,30-0.139-
Total CL, Week 8, n=50,33,34,34,27,30,32,34,35,31-0.162-
Total CL, Week 12, n=50,34,34,34,28,30,32,34,35,33-0.140-
Total CL, Week 16, n=50,34,34,34,28,30,32,34,35,33-0.037-
LDL-C, Week 5, n=41,29,31,29,26,28,29,27,32,29-0.155-
LDL-C, Week 8, n=45,32,32,32,26,30,31,28,32,30-0.157-
LDL-C, Week 12, n=45,33,32,32,28,30,31,28,32,32-0.152-
LDL-C, Week 16, n=46,33,32,32,28,30,31,28,32,32-0.045-
HDL-C, Week 5, n=45,31,34,31,27,29,31,34,35,30-0.010-
HDL-C, Week 8, n=50,33,34,34,27,30,32,34,35,310.019-
HDL-C, Week 12, n=50,34,34,34,28,30,32,34,35,33-0.019-
HDL-C, Week 16, n=50,34,34,34,28,30,32,34,35,33-0.010-
Albiglutide 30 mg WeeklyTG, Week 5, n=45,31,34,31,27,29,31,34,35,300.112-
TG, Week 8, n=50,33,34,34,27,30,32,34,35,31-0.009-
TG, Week 12, n=50,34,34,34,28,30,32,34,35,330.106-
TG, Week 16, n=50,34,34,34,28,30,32,34,35,330.099-
FFA, Week 5, n=48,33,32,33,27,28,32,34,35,290.014-
FFA, Week 8, n=50,34,33,34,28,29,32,34,35,310.046-
FFA, Week 12, n=50,34,33,34,28,29,32,34,35,330.043-
FFA, Week 16, n=50,34,33,34,28,29,32,34,35,330.050-
Total CL, Week 5, n=45,31,34,31,27,29,31,34,35,30-0.113-
Total CL, Week 8, n=50,33,34,34,27,30,32,34,35,310.002-
Total CL, Week 12, n=50,34,34,34,28,30,32,34,35,33-0.020-
Total CL, Week 16, n=50,34,34,34,28,30,32,34,35,330.009-
LDL-C, Week 5, n=41,29,31,29,26,28,29,27,32,29-0.068-
LDL-C, Week 8, n=45,32,32,32,26,30,31,28,32,300.089-
LDL-C, Week 12, n=45,33,32,32,28,30,31,28,32,320.004-
LDL-C, Week 16, n=46,33,32,32,28,30,31,28,32,320.003-
HDL-C, Week 5, n=45,31,34,31,27,29,31,34,35,30-0.063-
HDL-C, Week 8, n=50,33,34,34,27,30,32,34,35,31-0.061-
HDL-C, Week 12, n=50,34,34,34,28,30,32,34,35,33-0.061-
HDL-C, Week 16, n=50,34,34,34,28,30,32,34,35,33-0.046-
Albiglutide 15 mg Bi-weeklyTG, Week 5, n=45,31,34,31,27,29,31,34,35,30-0.266-
TG, Week 8, n=50,33,34,34,27,30,32,34,35,31-0.219-
TG, Week 12, n=50,34,34,34,28,30,32,34,35,33-0.380-
TG, Week 16, n=50,34,34,34,28,30,32,34,35,33-0.258-
FFA, Week 5, n=48,33,32,33,27,28,32,34,35,290.025-
FFA, Week 8, n=50,34,33,34,28,29,32,34,35,310.017-
FFA, Week 12, n=50,34,33,34,28,29,32,34,35,330.010-
FFA, Week 16, n=50,34,33,34,28,29,32,34,35,330.034-
Total CL, Week 5, n=45,31,34,31,27,29,31,34,35,30-0.372-
Total CL, Week 8, n=50,33,34,34,27,30,32,34,35,31-0.172-
Total CL, Week 12, n=50,34,34,34,28,30,32,34,35,33-0.190-
Total CL, Week 16, n=50,34,34,34,28,30,32,34,35,33-0.225-
LDL-C, Week 5, n=41,29,31,29,26,28,29,27,32,29-0.285-
LDL-C, Week 8, n=45,32,32,32,26,30,31,28,32,30-0.160-
LDL-C, Week 12, n=45,33,32,32,28,30,31,28,32,32-0.034-
LDL-C, Week 16, n=46,33,32,32,28,30,31,28,32,32-0.123-
HDL-C, Week 5, n=45,31,34,31,27,29,31,34,35,30-0.038-
HDL-C, Week 8, n=50,33,34,34,27,30,32,34,35,31-0.018-
HDL-C, Week 12, n=50,34,34,34,28,30,32,34,35,33-0.018-
HDL-C, Week 16, n=50,34,34,34,28,30,32,34,35,33-0.015-
Albiglutide 30 mg Bi-weeklyTG, Week 5, n=45,31,34,31,27,29,31,34,35,30-0.147-
TG, Week 8, n=50,33,34,34,27,30,32,34,35,31-0.150-
TG, Week 12, n=50,34,34,34,28,30,32,34,35,33-0.269-
TG, Week 16, n=50,34,34,34,28,30,32,34,35,33-0.331-
FFA, Week 5, n=48,33,32,33,27,28,32,34,35,29-0.028-
FFA, Week 8, n=50,34,33,34,28,29,32,34,35,31-0.027-
FFA, Week 12, n=50,34,33,34,28,29,32,34,35,33-0.051-
FFA, Week 16, n=50,34,33,34,28,29,32,34,35,33-0.005-
Total CL, Week 5, n=45,31,34,31,27,29,31,34,35,30-0.140-
Total CL, Week 8, n=50,33,34,34,27,30,32,34,35,31-0.094-
Total CL, Week 12, n=50,34,34,34,28,30,32,34,35,33-0.092-
Total CL, Week 16, n=50,34,34,34,28,30,32,34,35,33-0.178-
LDL-C, Week 5, n=41,29,31,29,26,28,29,27,32,29-0.082-
LDL-C, Week 8, n=45,32,32,32,26,30,31,28,32,30-0.052-
LDL-C, Week 12, n=45,33,32,32,28,30,31,28,32,32-0.004-
LDL-C, Week 16, n=46,33,32,32,28,30,31,28,32,32-0.062-
HDL-C, Week 5, n=45,31,34,31,27,29,31,34,35,30-0.045-
HDL-C, Week 8, n=50,33,34,34,27,30,32,34,35,31-0.030-
HDL-C, Week 12, n=50,34,34,34,28,30,32,34,35,33-0.041-
HDL-C, Week 16, n=50,34,34,34,28,30,32,34,35,33-0.031-
Albiglutide 50 mg Bi-weeklyTG, Week 5, n=45,31,34,31,27,29,31,34,35,30-1.423-
TG, Week 8, n=50,33,34,34,27,30,32,34,35,31-1.494-
TG, Week 12, n=50,34,34,34,28,30,32,34,35,33-1.539-
TG, Week 16, n=50,34,34,34,28,30,32,34,35,33-1.469-
FFA, Week 5, n=48,33,32,33,27,28,32,34,35,29-0.012-
FFA, Week 8, n=50,34,33,34,28,29,32,34,35,31-0.004-
FFA, Week 12, n=50,34,33,34,28,29,32,34,35,330.011-
FFA, Week 16, n=50,34,33,34,28,29,32,34,35,330.025-
Total CL, Week 5, n=45,31,34,31,27,29,31,34,35,30-0.451-
Total CL, Week 8, n=50,33,34,34,27,30,32,34,35,31-0.418-
Total CL, Week 12, n=50,34,34,34,28,30,32,34,35,33-0.338-
Total CL, Week 16, n=50,34,34,34,28,30,32,34,35,33-0.447-
LDL-C, Week 5, n=41,29,31,29,26,28,29,27,32,290.026-
LDL-C, Week 8, n=45,32,32,32,26,30,31,28,32,300.053-
LDL-C, Week 12, n=45,33,32,32,28,30,31,28,32,320.156-
LDL-C, Week 16, n=46,33,32,32,28,30,31,28,32,320.059-
HDL-C, Week 5, n=45,31,34,31,27,29,31,34,35,30-0.076-
HDL-C, Week 8, n=50,33,34,34,27,30,32,34,35,31-0.050-
HDL-C, Week 12, n=50,34,34,34,28,30,32,34,35,33-0.029-
HDL-C, Week 16, n=50,34,34,34,28,30,32,34,35,33-0.065-
Albiglutide 50 mg Every 4 WeeksTG, Week 5, n=45,31,34,31,27,29,31,34,35,30-0.725-
TG, Week 8, n=50,33,34,34,27,30,32,34,35,31-0.175-
TG, Week 12, n=50,34,34,34,28,30,32,34,35,33-0.362-
TG, Week 16, n=50,34,34,34,28,30,32,34,35,33-0.426-
FFA, Week 5, n=48,33,32,33,27,28,32,34,35,29-0.001-
FFA, Week 8, n=50,34,33,34,28,29,32,34,35,310.055-
FFA, Week 12, n=50,34,33,34,28,29,32,34,35,33-0.030-
FFA, Week 16, n=50,34,33,34,28,29,32,34,35,330.012-
Total CL, Week 5, n=45,31,34,31,27,29,31,34,35,30-0.407-
Total CL, Week 8, n=50,33,34,34,27,30,32,34,35,31-0.183-
Total CL, Week 12, n=50,34,34,34,28,30,32,34,35,33-0.134-
Total CL, Week 16, n=50,34,34,34,28,30,32,34,35,33-0.217-
LDL-C, Week 5, n=41,29,31,29,26,28,29,27,32,29-0.106-
LDL-C, Week 8, n=45,32,32,32,26,30,31,28,32,30-0.087-
LDL-C, Week 12, n=45,33,32,32,28,30,31,28,32,32-0.061-
LDL-C, Week 16, n=46,33,32,32,28,30,31,28,32,32-0.088-
HDL-C, Week 5, n=45,31,34,31,27,29,31,34,35,30-0.047-
HDL-C, Week 8, n=50,33,34,34,27,30,32,34,35,31-0.054-
HDL-C, Week 12, n=50,34,34,34,28,30,32,34,35,33-0.033-
HDL-C, Week 16, n=50,34,34,34,28,30,32,34,35,33-0.033-
Albiglutide 100 mg Every 4 WeeksTG, Week 5, n=45,31,34,31,27,29,31,34,35,30-0.184-
TG, Week 8, n=50,33,34,34,27,30,32,34,35,31-0.028-
TG, Week 12, n=50,34,34,34,28,30,32,34,35,330.070-
TG, Week 16, n=50,34,34,34,28,30,32,34,35,33-0.114-
FFA, Week 5, n=48,33,32,33,27,28,32,34,35,290.006-
FFA, Week 8, n=50,34,33,34,28,29,32,34,35,310.175-
FFA, Week 12, n=50,34,33,34,28,29,32,34,35,330.123-
FFA, Week 16, n=50,34,33,34,28,29,32,34,35,330.094-
Total CL, Week 5, n=45,31,34,31,27,29,31,34,35,30-0.245-
Total CL, Week 8, n=50,33,34,34,27,30,32,34,35,310.060-
Total CL, Week 12, n=50,34,34,34,28,30,32,34,35,330.015-
Total CL, Week 16, n=50,34,34,34,28,30,32,34,35,330.018-
LDL-C, Week 5, n=41,29,31,29,26,28,29,27,32,29-0.091-
LDL-C, Week 8, n=45,32,32,32,26,30,31,28,32,300.054-
LDL-C, Week 12, n=45,33,32,32,28,30,31,28,32,320.010-
LDL-C, Week 16, n=46,33,32,32,28,30,31,28,32,320.054-
HDL-C, Week 5, n=45,31,34,31,27,29,31,34,35,30-0.053-
HDL-C, Week 8, n=50,33,34,34,27,30,32,34,35,31-0.016-
HDL-C, Week 12, n=50,34,34,34,28,30,32,34,35,33-0.045-
HDL-C, Week 16, n=50,34,34,34,28,30,32,34,35,33-0.048-

Patient-reported / QoL

2 endpoints
Secondary/protocol endpoint

Change From Baseline in Functional Living Index - Emesis (FLIE) Scores at Week 16

Time frame:Baseline and Week 16

change from baseline, improvement

Posted result

GroupMean · Score on a scale95% CI
PlaceboFLIEQ1-0.1-
FLIEQ20.2-
FLIEQ315.6-
FLIEQ40.4-
FLIEQ5-0.3-
FLIEQ611.2-
FLIEQ70.4-
FLIEQ8-0.6-
FLIEQ9-0.1-
FLIEQ10-0.3-
FLIEQ1115.3-
FLIEQ120.1-
FLIEQ130.1-
FLIEQ14-0.3-
FLIEQ1515.5-
FLIEQ16-0.4-
FLIEQ170.1-
FLIEQ1818.1-
Exenatide BIDFLIEQ1-4.4-
FLIEQ2-3.5-
FLIEQ37.8-
FLIEQ4-3.5-
FLIEQ5-4.0-
FLIEQ63.6-
FLIEQ7-3.1-
FLIEQ8-3.5-
FLIEQ9-3.4-
FLIEQ10-4.9-
FLIEQ113.3-
FLIEQ12-3.1-
FLIEQ13-4.0-
FLIEQ14-4.1-
FLIEQ157.0-
FLIEQ16-3.8-
FLIEQ17-4.1-
FLIEQ186.9-
Albiglutide 4 mg WeeklyFLIEQ15.7-
FLIEQ25.5-
FLIEQ310.3-
FLIEQ46.4-
FLIEQ56.4-
FLIEQ69.4-
FLIEQ75.7-
FLIEQ85.7-
FLIEQ95.3-
FLIEQ105.8-
FLIEQ1113.8-
FLIEQ126.4-
FLIEQ136.3-
FLIEQ146.4-
FLIEQ1514.2-
FLIEQ166.3-
FLIEQ176.3-
FLIEQ1814.2-
Albiglutide 15 mg WeeklyFLIEQ11.0-
FLIEQ22.6-
FLIEQ3-4.0-
FLIEQ4-2.8-
FLIEQ5-1.8-
FLIEQ6-0.5-
FLIEQ71.5-
FLIEQ8-1.0-
FLIEQ9-0.5-
FLIEQ10-1.6-
FLIEQ11-0.5-
FLIEQ12-0.8-
FLIEQ13-2.2-
FLIEQ14-1.4-
FLIEQ15-4.9-
FLIEQ16-1.4-
FLIEQ17-1.2-
FLIEQ18-3.2-
Albiglutide 30 mg WeeklyFLIEQ14.6-
FLIEQ23.0-
FLIEQ318.6-
FLIEQ41.5-
FLIEQ52.9-
FLIEQ620.0-
FLIEQ70.2-
FLIEQ82.6-
FLIEQ92.3-
FLIEQ10-0.1-
FLIEQ1121.9-
FLIEQ121.8-
FLIEQ131.0-
FLIEQ141.8-
FLIEQ1519.7-
FLIEQ16-0.5-
FLIEQ17-1.2-
FLIEQ1814.9-
Albiglutide 15 mg Bi-weeklyFLIEQ18.6-
FLIEQ25.9-
FLIEQ310.3-
FLIEQ45.6-
FLIEQ50.2-
FLIEQ610.2-
FLIEQ75.7-
FLIEQ810.1-
FLIEQ95.6-
FLIEQ104.5-
FLIEQ117.9-
FLIEQ125.3-
FLIEQ139.8-
FLIEQ145.3-
FLIEQ155.6-
FLIEQ168.2-
FLIEQ174.5-
FLIEQ1810.1-
Albiglutide 30 mg Bi-weeklyFLIEQ1-1.0-
FLIEQ2-0.8-
FLIEQ33.9-
FLIEQ4-1.6-
FLIEQ5-1.3-
FLIEQ64.2-
FLIEQ7-1.0-
FLIEQ8-0.7-
FLIEQ9-0.7-
FLIEQ10-0.3-
FLIEQ113.6-
FLIEQ12-0.2-
FLIEQ13-0.3-
FLIEQ14-0.1-
FLIEQ153.5-
FLIEQ16-0.1-
FLIEQ17-0.2-
FLIEQ187.1-
Albiglutide 50 mg Bi-weeklyFLIEQ18.2-
FLIEQ24.7-
FLIEQ318.2-
FLIEQ45.9-
FLIEQ54.5-
FLIEQ618.0-
FLIEQ74.9-
FLIEQ86.2-
FLIEQ94.0-
FLIEQ104.3-
FLIEQ1118.3-
FLIEQ124.4-
FLIEQ134.3-
FLIEQ144.3-
FLIEQ1518.4-
FLIEQ164.5-
FLIEQ174.3-
FLIEQ1818.5-
Albiglutide 50 mg Every 4 WeeksFLIEQ1-0.3-
FLIEQ2-0.6-
FLIEQ34.5-
FLIEQ4-1.9-
FLIEQ51.5-
FLIEQ65.6-
FLIEQ7-0.1-
FLIEQ8-0.4-
FLIEQ9-0.1-
FLIEQ100.2-
FLIEQ117.2-
FLIEQ12-0.4-
FLIEQ130.0-
FLIEQ14-0.1-
FLIEQ151.5-
FLIEQ160.9-
FLIEQ17-1.1-
FLIEQ185.7-
Albiglutide 100 mg Every 4 WeeksFLIEQ1-2.8-
FLIEQ2-0.2-
FLIEQ37.3-
FLIEQ4-1.8-
FLIEQ5-1.4-
FLIEQ63.9-
FLIEQ7-1.9-
FLIEQ8-2.3-
FLIEQ9-3.2-
FLIEQ10-2.0-
FLIEQ114.0-
FLIEQ12-0.8-
FLIEQ13-2.1-
FLIEQ14-2.1-
FLIEQ154.0-
FLIEQ16-1.5-
FLIEQ17-0.6-
FLIEQ186.9-
Secondary/protocol endpoint

Number of Participants With the Indicated Response to Questions on the Hunger, Craving, and Fullness Questionnaire (HCFQ) at Week 16

Time frame:Week 16

threshold achievement, improvement

Posted result

GroupNumber · Participants95% CI
PlaceboQ1: Always1-
Q1: Often5-
Q1: Sometimes28-
Q1: Rarely4-
Q1: Never1-
Q2: Always1-
Q2: Often4-
Q2: Sometimes28-
Q2: Rarely5-
Q2: Never1-
Q3: Always3-
Q3: Often7-
Q3: Sometimes26-
Q3: Rarely3-
Q3: Never0-
Q4: Yes, definitely4-
Q4: Yes, probably15-
Q4: I don't know10-
Q4: Probably not7-
Q4: Definitely not3-
Q5: Always1-
Q5: Often2-
Q5: Sometimes19-
Q5: Rarely16-
Q5: Never1-
Q6: Much too full0-
Q6: Very full10-
Q6: Comfortably full26-
Q6: Slightly hungry3-
Q6: Very hungry0-
Q7: Extremely satisfied3-
Q7: Satisfied27-
Q7: Neither satisfied nor dissatisfied9-
Q7: Dissatisfied0-
Q7: Extremely dissatisfied0-
Exenatide BIDQ1: Always0-
Q1: Often5-
Q1: Sometimes17-
Q1: Rarely7-
Q1: Never1-
Q2: Always1-
Q2: Often5-
Q2: Sometimes19-
Q2: Rarely4-
Q2: Never1-
Q3: Always0-
Q3: Often5-
Q3: Sometimes20-
Q3: Rarely5-
Q3: Never0-
Q4: Yes, definitely1-
Q4: Yes, probably8-
Q4: I don't know5-
Q4: Probably not12-
Q4: Definitely not4-
Q5: Always1-
Q5: Often2-
Q5: Sometimes15-
Q5: Rarely8-
Q5: Never4-
Q6: Much too full0-
Q6: Very full2-
Q6: Comfortably full28-
Q6: Slightly hungry0-
Q6: Very hungry0-
Q7: Extremely satisfied0-
Q7: Satisfied27-
Q7: Neither satisfied nor dissatisfied3-
Q7: Dissatisfied0-
Q7: Extremely dissatisfied0-
Albiglutide 4 mg WeeklyQ1: Always0-
Q1: Often2-
Q1: Sometimes15-
Q1: Rarely3-
Q1: Never1-
Q2: Always0-
Q2: Often2-
Q2: Sometimes14-
Q2: Rarely5-
Q2: Never0-
Q3: Always0-
Q3: Often4-
Q3: Sometimes16-
Q3: Rarely1-
Q3: Never0-
Q4: Yes, definitely0-
Q4: Yes, probably8-
Q4: I don't know2-
Q4: Probably not10-
Q4: Definitely not1-
Q5: Always0-
Q5: Often2-
Q5: Sometimes5-
Q5: Rarely11-
Q5: Never3-
Q6: Much too full0-
Q6: Very full3-
Q6: Comfortably full18-
Q6: Slightly hungry0-
Q6: Very hungry0-
Q7: Extremely satisfied1-
Q7: Satisfied17-
Q7: Neither satisfied nor dissatisfied3-
Q7: Dissatisfied0-
Q7: Extremely dissatisfied0-
Albiglutide 15 mg WeeklyQ1: Always0-
Q1: Often7-
Q1: Sometimes14-
Q1: Rarely4-
Q1: Never0-
Q2: Always0-
Q2: Often7-
Q2: Sometimes13-
Q2: Rarely5-
Q2: Never0-
Q3: Always1-
Q3: Often4-
Q3: Sometimes18-
Q3: Rarely2-
Q3: Never0-
Q4: Yes, definitely2-
Q4: Yes, probably9-
Q4: I don't know1-
Q4: Probably not9-
Q4: Definitely not4-
Q5: Always0-
Q5: Often4-
Q5: Sometimes13-
Q5: Rarely4-
Q5: Never4-
Q6: Much too full1-
Q6: Very full5-
Q6: Comfortably full17-
Q6: Slightly hungry2-
Q6: Very hungry0-
Q7: Extremely satisfied1-
Q7: Satisfied17-
Q7: Neither satisfied nor dissatisfied5-
Q7: Dissatisfied2-
Q7: Extremely dissatisfied0-
Albiglutide 30 mg WeeklyQ1: Always0-
Q1: Often6-
Q1: Sometimes14-
Q1: Rarely2-
Q1: Never0-
Q2: Always0-
Q2: Often7-
Q2: Sometimes11-
Q2: Rarely4-
Q2: Never0-
Q3: Always1-
Q3: Often7-
Q3: Sometimes13-
Q3: Rarely1-
Q3: Never0-
Q4: Yes, definitely2-
Q4: Yes, probably9-
Q4: I don't know1-
Q4: Probably not7-
Q4: Definitely not3-
Q5: Always2-
Q5: Often1-
Q5: Sometimes14-
Q5: Rarely5-
Q5: Never0-
Q6: Much too full0-
Q6: Very full3-
Q6: Comfortably full18-
Q6: Slightly hungry1-
Q6: Very hungry0-
Q7: Extremely satisfied1-
Q7: Satisfied19-
Q7: Neither satisfied nor dissatisfied1-
Q7: Dissatisfied1-
Q7: Extremely dissatisfied0-
Albiglutide 15 mg Bi-weeklyQ1: Always2-
Q1: Often3-
Q1: Sometimes8-
Q1: Rarely6-
Q1: Never0-
Q2: Always1-
Q2: Often3-
Q2: Sometimes10-
Q2: Rarely4-
Q2: Never1-
Q3: Always1-
Q3: Often4-
Q3: Sometimes10-
Q3: Rarely4-
Q3: Never0-
Q4: Yes, definitely2-
Q4: Yes, probably9-
Q4: I don't know2-
Q4: Probably not4-
Q4: Definitely not2-
Q5: Always0-
Q5: Often1-
Q5: Sometimes7-
Q5: Rarely8-
Q5: Never3-
Q6: Much too full0-
Q6: Very full4-
Q6: Comfortably full13-
Q6: Slightly hungry2-
Q6: Very hungry0-
Q7: Extremely satisfied0-
Q7: Satisfied15-
Q7: Neither satisfied nor dissatisfied3-
Q7: Dissatisfied1-
Q7: Extremely dissatisfied0-
Albiglutide 30 mg Bi-weeklyQ1: Always2-
Q1: Often5-
Q1: Sometimes17-
Q1: Rarely0-
Q1: Never1-
Q2: Always3-
Q2: Often6-
Q2: Sometimes15-
Q2: Rarely0-
Q2: Never1-
Q3: Always4-
Q3: Often4-
Q3: Sometimes16-
Q3: Rarely1-
Q3: Never0-
Q4: Yes, definitely2-
Q4: Yes, probably12-
Q4: I don't know4-
Q4: Probably not4-
Q4: Definitely not3-
Q5: Always2-
Q5: Often6-
Q5: Sometimes15-
Q5: Rarely2-
Q5: Never0-
Q6: Much too full1-
Q6: Very full4-
Q6: Comfortably full20-
Q6: Slightly hungry0-
Q6: Very hungry0-
Q7: Extremely satisfied2-
Q7: Satisfied22-
Q7: Neither satisfied nor dissatisfied1-
Q7: Dissatisfied0-
Q7: Extremely dissatisfied0-
Albiglutide 50 mg Bi-weeklyQ1: Always2-
Q1: Often2-
Q1: Sometimes11-
Q1: Rarely4-
Q1: Never2-
Q2: Always2-
Q2: Often3-
Q2: Sometimes9-
Q2: Rarely4-
Q2: Never3-
Q3: Always3-
Q3: Often2-
Q3: Sometimes12-
Q3: Rarely2-
Q3: Never2-
Q4: Yes, definitely2-
Q4: Yes, probably5-
Q4: I don't know2-
Q4: Probably not5-
Q4: Definitely not7-
Q5: Always0-
Q5: Often3-
Q5: Sometimes9-
Q5: Rarely6-
Q5: Never3-
Q6: Much too full1-
Q6: Very full2-
Q6: Comfortably full18-
Q6: Slightly hungry0-
Q6: Very hungry0-
Q7: Extremely satisfied1-
Q7: Satisfied15-
Q7: Neither satisfied nor dissatisfied5-
Q7: Dissatisfied0-
Q7: Extremely dissatisfied0-
Albiglutide 50 mg Every 4 WeeksQ1: Always2-
Q1: Often6-
Q1: Sometimes20-
Q1: Rarely2-
Q1: Never0-
Q2: Always3-
Q2: Often6-
Q2: Sometimes16-
Q2: Rarely4-
Q2: Never1-
Q3: Always3-
Q3: Often6-
Q3: Sometimes17-
Q3: Rarely4-
Q3: Never0-
Q4: Yes, definitely7-
Q4: Yes, probably9-
Q4: I don't know2-
Q4: Probably not10-
Q4: Definitely not2-
Q5: Always0-
Q5: Often5-
Q5: Sometimes11-
Q5: Rarely9-
Q5: Never5-
Q6: Much too full2-
Q6: Very full7-
Q6: Comfortably full18-
Q6: Slightly hungry2-
Q6: Very hungry1-
Q7: Extremely satisfied2-
Q7: Satisfied23-
Q7: Neither satisfied nor dissatisfied4-
Q7: Dissatisfied1-
Q7: Extremely dissatisfied0-
Albiglutide 100 mg Every 4 WeeksQ1: Always1-
Q1: Often6-
Q1: Sometimes12-
Q1: Rarely2-
Q1: Never1-
Q2: Always2-
Q2: Often6-
Q2: Sometimes11-
Q2: Rarely2-
Q2: Never1-
Q3: Always0-
Q3: Often9-
Q3: Sometimes11-
Q3: Rarely1-
Q3: Never1-
Q4: Yes, definitely3-
Q4: Yes, probably12-
Q4: I don't know2-
Q4: Probably not4-
Q4: Definitely not1-
Q5: Always0-
Q5: Often3-
Q5: Sometimes8-
Q5: Rarely8-
Q5: Never3-
Q6: Much too full1-
Q6: Very full2-
Q6: Comfortably full17-
Q6: Slightly hungry2-
Q6: Very hungry0-
Q7: Extremely satisfied1-
Q7: Satisfied14-
Q7: Neither satisfied nor dissatisfied5-
Q7: Dissatisfied2-
Q7: Extremely dissatisfied0-

Safety / tolerability / PK

4 endpoints
Secondary/protocol endpoint

Mean Clearance of Albiglutide

Time frame:Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27

descriptive

Posted result

GroupMean · milliliters per hour95% CI
All Participants Receiving Any Dose of Albiglutide94.290.1 - 98.9
Secondary/protocol endpoint

Mean Volume of Distribution of Albiglutide

Time frame:Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27

descriptive

Posted result

GroupMean · Liters95% CI
All Participants Receiving Any Dose of Albiglutide1640015600 - 17300
Secondary/protocol endpoint

Mean Absorption Rate of Albiglutide

Time frame:Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27

concentration, descriptive

Posted result

GroupMean · hour^-195% CI
All Participants Receiving Any Dose of Albiglutide0.01930.017 - 0.022
Secondary/protocol endpoint

Mean Half-maximal Effective Concentration (EC50) of Albiglutide for HbA1c and FPG

Time frame:Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27

concentration, descriptive

Posted result

GroupMean · nanograms per milliliter95% CI
All Participants Receiving Any Dose of AlbiglutideHbA1c, Treatment-naïve group1140483 - 2990
HbA1c, Prior monotherapy group1230403 - 3560
FPG1970950 - 5410

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 6, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.