Clinical trial NCT00518115: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Keywords: GLP-1,
Type 2 Diabetes,
pharmacokinetics,
pharmacodynamics,
GSK716155,
metformin,
exenatide
Type 2 Diabetes Mellitus
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-08-20
Enrollment: 361
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 16
timeFrame: Baseline and Week 16
Secondary outcomes:
measure: Change From Baseline in HbA1c at Weeks 4, 5, 7, 8, 9, 12, 15, and 16
timeFrame: Baseline and Weeks 4, 5, 7, 8, 9, 12, 15, and 16
measure: 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
timeFrame: Weeks (W) 4, 5, 7, 8, 9, 12, 15, and 16
measure: Change From Baseline in Waist Circumference at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in Body Weight at Week 16
timeFrame: Baseline and Week 16
measure: Percent Change From Baseline in Body Weight at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 4, 5, 7, 8, 9, 12, 15, and 16
timeFrame: Baseline and Weeks 4, 5, 7, 8, 9, 12, 15, and 16
measure: Change From Baseline in Fasting Fructosamine at Weeks 5, 8, 12, and 16
timeFrame: Baseline and Weeks 5, 8, 12, and 16
measure: Change From Baseline in Fasting C-peptide at Weeks 5, 8, 12, and 16
timeFrame: Baseline and Weeks 5, 8, 12, and 16
measure: Change From Baseline in Fasting Glucagon at Weeks 5, 8, 12, and 16
timeFrame: Baseline and Weeks 5, 8, 12, and 16
measure: Change From Baseline in Fasting Insulin at Weeks 5, 8, 12, and 16
timeFrame: Baseline and Weeks 5, 8, 12, and 16
measure: 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
timeFrame: Baseline and Weeks 5, 8, 12, and 16
measure: Change From Baseline in Functional Living Index - Emesis (FLIE) Scores at Week 16
timeFrame: Baseline and Week 16
measure: Number of Participants With the Indicated Response to Questions on the Hunger, Craving, and Fullness Questionnaire (HCFQ) at Week 16
timeFrame: Week 16
measure: Mean Clearance of Albiglutide
timeFrame: Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27
measure: Mean Volume of Distribution of Albiglutide
timeFrame: Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27
measure: Mean Absorption Rate of Albiglutide
timeFrame: Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27
measure: Mean Half-maximal Effective Concentration (EC50) of Albiglutide for HbA1c and FPG
timeFrame: Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27
Other outcomes:
Locations:
city: Anniston
country: United States
facility: GSK Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Mobile
country: United States
facility: GSK Investigational Site
state: Alabama
city: Bull Shoals
country: United States
facility: GSK Investigational Site
state: Arizona
city: Glendale
country: United States
facility: GSK Investigational Site
state: Arizona
city: Jonesboro
country: United States
facility: GSK Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Harrisburg
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Jonesboro
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Little Rock
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Little Rock
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Searcy
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Castro Valley
country: United States
facility: GSK Investigational Site
state: California
city: Culver City
country: United States
facility: GSK Investigational Site
state: California
city: Fullerton
country: United States
facility: GSK Investigational Site
state: California
city: Garden Grove
country: United States
facility: GSK Investigational Site
state: California
city: Huntington Beach
country: United States
facility: GSK Investigational Site
state: California
city: Huntington Beach
country: United States
facility: GSK Investigational Site
state: California
city: Huntington Park
country: United States
facility: GSK Investigational Site
state: California
city: Lake Forest
country: United States
facility: GSK Investigational Site
state: California
city: Loma Linda
country: United States
facility: GSK Investigational Site
state: California
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: Orange
country: United States
facility: GSK Investigational Site
state: California
city: Redwood City
country: United States
facility: GSK Investigational Site
state: California
city: Reedley
country: United States
facility: GSK Investigational Site
state: California
city: Riverside
country: United States
facility: GSK Investigational Site
state: California
city: Sacramento
country: United States
facility: GSK Investigational Site
state: California
city: Torrance
country: United States
facility: GSK Investigational Site
state: California
city: Van Buys
country: United States
facility: GSK Investigational Site
state: California
city: Ventura
country: United States
facility: GSK Investigational Site
state: California
city: Victorville
country: United States
facility: GSK Investigational Site
state: California
city: Denver
country: United States
facility: GSK Investigational Site
state: Colorado
city: Trumbull
country: United States
facility: GSK Investigational Site
state: Connecticut
city: Bradenton
country: United States
facility: GSK Investigational Site
state: Florida
city: Clearwater
country: United States
facility: GSK Investigational Site
state: Florida
city: Ft. Lauderdale
country: United States
facility: GSK Investigational Site
state: Florida
city: Gainesville
country: United States
facility: GSK Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: GSK Investigational Site
state: Florida
city: Marianna
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Oviedo
country: United States
facility: GSK Investigational Site
state: Florida
city: Palm Harbor
country: United States
facility: GSK Investigational Site
state: Florida
city: Plantation
country: United States
facility: GSK Investigational Site
state: Florida
city: Tallahassee
country: United States
facility: GSK Investigational Site
state: Florida
city: Tampa
country: United States
facility: GSK Investigational Site
state: Florida
city: Winter Haven
country: United States
facility: GSK Investigational Site
state: Florida
city: Winter Park
country: United States
facility: GSK Investigational Site
state: Florida
city: Athens
country: United States
facility: GSK Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Augusta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Columbus
country: United States
facility: GSK Investigational Site
state: Georgia
city: Decatur
country: United States
facility: GSK Investigational Site
state: Georgia
city: Perry
country: United States
facility: GSK Investigational Site
state: Georgia
city: Suwanee
country: United States
facility: GSK Investigational Site
state: Georgia
city: Tucker
country: United States
facility: GSK Investigational Site
state: Georgia
city: Honolulu
country: United States
facility: GSK Investigational Site
state: Hawaii
city: Meridian
country: United States
facility: GSK Investigational Site
state: Idaho
city: Aurora
country: United States
facility: GSK Investigational Site
state: Illinois
city: Evergreen Park
country: United States
facility: GSK Investigational Site
state: Illinois
city: La Grange
country: United States
facility: GSK Investigational Site
state: Illinois
city: Libertyville
country: United States
facility: GSK Investigational Site
state: Illinois
city: Oak Brook
country: United States
facility: GSK Investigational Site
state: Illinois
city: Watseka
country: United States
facility: GSK Investigational Site
state: Illinois
city: Anderson
country: United States
facility: GSK Investigational Site
state: Indiana
city: Indianapolis
country: United States
facility: GSK Investigational Site
state: Indiana
city: South Bend
country: United States
facility: GSK Investigational Site
state: Indiana
city: South Bend
country: United States
facility: GSK Investigational Site
state: Indiana
city: Ames
country: United States
facility: GSK Investigational Site
state: Iowa
city: Dubuque
country: United States
facility: GSK Investigational Site
state: Iowa
city: Kansas City
country: United States
facility: GSK Investigational Site
state: Kansas
city: Topeka
country: United States
facility: GSK Investigational Site
state: Kansas
city: Lexington
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Covington
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Lacombe
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Metairie
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Haverhill
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Caro
country: United States
facility: GSK Investigational Site
state: Michigan
city: Dearborn
country: United States
facility: GSK Investigational Site
state: Michigan
city: Kalamazoo
country: United States
facility: GSK Investigational Site
state: Michigan
city: Picayune
country: United States
facility: GSK Investigational Site
state: Mississippi
city: Rolling Fork
country: United States
facility: GSK Investigational Site
state: Mississippi
city: Jefferson City
country: United States
facility: GSK Investigational Site
state: Missouri
city: Springfield
country: United States
facility: GSK Investigational Site
state: Missouri
city: St. Peters
country: United States
facility: GSK Investigational Site
state: Missouri
city: Billings
country: United States
facility: GSK Investigational Site
state: Montana
city: Lincoln
country: United States
facility: GSK Investigational Site
state: Nebraska
city: North Platte
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Omaha
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Las Vegas
country: United States
facility: GSK Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: GSK Investigational Site
state: Nevada
city: Buffalo
country: United States
facility: GSK Investigational Site
state: New York
city: Glens Falls
country: United States
facility: GSK Investigational Site
state: New York
city: Rochester
country: United States
facility: GSK Investigational Site
state: New York
city: Syracuse
country: United States
facility: GSK Investigational Site
state: New York
city: Williamsville
country: United States
facility: GSK Investigational Site
state: New York
city: Asheville
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Chadbourn
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Greensboro
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Mint Hill
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Wilmington
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Bismarck
country: United States
facility: GSK Investigational Site
state: North Dakota
city: Bismarck
country: United States
facility: GSK Investigational Site
state: North Dakota
city: Fargo
country: United States
facility: GSK Investigational Site
state: North Dakota
city: Fargo
country: United States
facility: GSK Investigational Site
state: North Dakota
city: Grand Forks
country: United States
facility: GSK Investigational Site
state: North Dakota
city: Cleveland
country: United States
facility: GSK Investigational Site
state: Ohio
city: Columbus
country: United States
facility: GSK Investigational Site
state: Ohio
city: Toledo
country: United States
facility: GSK Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Bend
country: United States
facility: GSK Investigational Site
state: Oregon
city: Bensalem
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Harrisburg
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Morrisville
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Uniontown
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Watertown
country: United States
facility: GSK Investigational Site
state: South Dakota
city: Bristol
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Clarksville
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Johnson City
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Knoxville
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Milan
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Cleburne
country: United States
facility: GSK Investigational Site
state: Texas
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: Euless
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: LaPorte
country: United States
facility: GSK Investigational Site
state: Texas
city: Lewisville
country: United States
facility: GSK Investigational Site
state: Texas
city: Longview
country: United States
facility: GSK Investigational Site
state: Texas
city: Midland
country: United States
facility: GSK Investigational Site
state: Texas
city: Missouri City
country: United States
facility: GSK Investigational Site
state: Texas
city: Pasadena
country: United States
facility: GSK Investigational Site
state: Texas
city: Pearland
country: United States
facility: GSK Investigational Site
state: Texas
city: Pharr
country: United States
facility: GSK Investigational Site
state: Texas
city: Round Rock
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: San Marcos
country: United States
facility: GSK Investigational Site
state: Texas
city: Spring
country: United States
facility: GSK Investigational Site
state: Texas
city: Sugar Land
country: United States
facility: GSK Investigational Site
state: Texas
city: The Woodlands
country: United States
facility: GSK Investigational Site
state: Texas
city: Tomball
country: United States
facility: GSK Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: GSK Investigational Site
state: Utah
city: South Burlington
country: United States
facility: GSK Investigational Site
state: Vermont
city: Chester
country: United States
facility: GSK Investigational Site
state: Virginia
city: Manassas
country: United States
facility: GSK Investigational Site
state: Virginia
city: Salem
country: United States
facility: GSK Investigational Site
state: Virginia
city: Madison
country: United States
facility: GSK Investigational Site
state: Washington
city: Spokane
country: United States
facility: GSK Investigational Site
state: Washington
city: Concepcion
country: Chile
facility: GSK Investigational Site
state: Región Del Biobio
city: Buin
country: Chile
facility: GSK Investigational Site
state: Región Metro De Santiago
city: Santiago
country: Chile
facility: GSK Investigational Site
state: Región Metro De Santiago
city: Santiago
country: Chile
facility: GSK Investigational Site
state: Región Metro De Santiago
city: Santo Domingo
country: Dominican Republic
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Young MA, Wald JA, Matthews JE, Scott R, Hodge RJ, Zhi H, Reinhardt RR. Clinical pharmacology of albiglutide, a GLP-1 receptor agonist. Postgrad Med. 2014 Nov;126(7):84-97. doi: 10.3810/pgm.2014.11.2836.