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
1 other identifier
interventional
361
3 countries
163
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 diabetes-mellitus-type-2
Started Apr 2007
163 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 17, 2007
CompletedFirst Posted
Study publicly available on registry
August 20, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedResults Posted
Study results publicly available
June 23, 2014
CompletedDecember 16, 2016
November 1, 2016
1.1 years
August 17, 2007
May 1, 2014
November 3, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 (17)
Change From Baseline in HbA1c at Weeks 4, 5, 7, 8, 9, 12, 15, and 16
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
Weeks (W) 4, 5, 7, 8, 9, 12, 15, and 16
Change From Baseline in Waist Circumference at Week 16
Baseline and Week 16
Change From Baseline in Body Weight at Week 16
Baseline and Week 16
Percent Change From Baseline in Body Weight at Week 16
Baseline and Week 16
- +12 more secondary outcomes
Interventions
Albiglutide weekly subcutaneous injection or exenatide twice daily injection
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (163)
GSK Investigational Site
Anniston, Alabama, 36207, United States
GSK Investigational Site
Birmingham, Alabama, 35233, United States
GSK Investigational Site
Mobile, Alabama, 36617, United States
GSK Investigational Site
Bull Shoals, Arizona, 72619, United States
GSK Investigational Site
Glendale, Arizona, 85306, United States
GSK Investigational Site
Jonesboro, Arizona, 72401, United States
GSK Investigational Site
Phoenix, Arizona, 85032, United States
GSK Investigational Site
Harrisburg, Arkansas, 72432, United States
GSK Investigational Site
Jonesboro, Arkansas, 72401, United States
GSK Investigational Site
Little Rock, Arkansas, 72205, United States
GSK Investigational Site
Little Rock, Arkansas, 72211-3733, United States
GSK Investigational Site
Searcy, Arkansas, 72143, United States
GSK Investigational Site
Castro Valley, California, 94546, United States
GSK Investigational Site
Culver City, California, 90232, United States
GSK Investigational Site
Fullerton, California, 92835, United States
GSK Investigational Site
Garden Grove, California, 92843, United States
GSK Investigational Site
Huntington Beach, California, 92646, United States
GSK Investigational Site
Huntington Beach, California, 92648, United States
GSK Investigational Site
Huntington Park, California, 90255, United States
GSK Investigational Site
Lake Forest, California, 92630, United States
GSK Investigational Site
Loma Linda, California, 92354, United States
GSK Investigational Site
Los Angeles, California, 90022, United States
GSK Investigational Site
Orange, California, 92868, United States
GSK Investigational Site
Redwood City, California, 94062, United States
GSK Investigational Site
Reedley, California, 93654, United States
GSK Investigational Site
Riverside, California, 92506, United States
GSK Investigational Site
Sacramento, California, 95823, United States
GSK Investigational Site
Torrance, California, 90503, United States
GSK Investigational Site
Van Buys, California, 91405, United States
GSK Investigational Site
Ventura, California, 93003, United States
GSK Investigational Site
Victorville, California, 92395, United States
GSK Investigational Site
Denver, Colorado, 80220, United States
GSK Investigational Site
Trumbull, Connecticut, 06611, United States
GSK Investigational Site
Bradenton, Florida, 34205, United States
GSK Investigational Site
Clearwater, Florida, 33756, United States
GSK Investigational Site
Fort Lauderdale, Florida, 33316, United States
GSK Investigational Site
Gainesville, Florida, 32601, United States
GSK Investigational Site
Jacksonville, Florida, 32204, United States
GSK Investigational Site
Marianna, Florida, 32446, United States
GSK Investigational Site
Miami, Florida, 33144, United States
GSK Investigational Site
Oviedo, Florida, 32765, United States
GSK Investigational Site
Palm Harbor, Florida, 34684, United States
GSK Investigational Site
Plantation, Florida, 33317, United States
GSK Investigational Site
Tallahassee, Florida, 32308, United States
GSK Investigational Site
Tampa, Florida, 33603, United States
GSK Investigational Site
Winter Haven, Florida, 33881, United States
GSK Investigational Site
Winter Park, Florida, 32789, United States
GSK Investigational Site
Athens, Georgia, 30606, United States
GSK Investigational Site
Atlanta, Georgia, 30308, United States
GSK Investigational Site
Atlanta, Georgia, 30312, United States
GSK Investigational Site
Atlanta, Georgia, 30338, United States
GSK Investigational Site
Augusta, Georgia, 30909, United States
GSK Investigational Site
Columbus, Georgia, 31904, United States
GSK Investigational Site
Decatur, Georgia, 30032, United States
GSK Investigational Site
Perry, Georgia, 31069, United States
GSK Investigational Site
Suwanee, Georgia, 30024, United States
GSK Investigational Site
Tucker, Georgia, 30084, United States
GSK Investigational Site
Honolulu, Hawaii, 96813, United States
GSK Investigational Site
Meridian, Idaho, 83642, United States
GSK Investigational Site
Aurora, Illinois, 60504, United States
GSK Investigational Site
Evergreen Park, Illinois, 60805, United States
GSK Investigational Site
La Grange, Illinois, 60525, United States
GSK Investigational Site
Libertyville, Illinois, 60048, United States
GSK Investigational Site
Oak Brook, Illinois, 60523, United States
GSK Investigational Site
Watseka, Illinois, 60970, United States
GSK Investigational Site
Anderson, Indiana, 46011, United States
GSK Investigational Site
Indianapolis, Indiana, 46256, United States
GSK Investigational Site
South Bend, Indiana, 46601, United States
GSK Investigational Site
South Bend, Indiana, 46628, United States
GSK Investigational Site
Ames, Iowa, 50010, United States
GSK Investigational Site
Dubuque, Iowa, 52002, United States
GSK Investigational Site
Kansas City, Kansas, 66160, United States
GSK Investigational Site
Topeka, Kansas, 66606, United States
GSK Investigational Site
Lexington, Kentucky, 40504, United States
GSK Investigational Site
Covington, Louisiana, 70433, United States
GSK Investigational Site
Lacombe, Louisiana, 70433, United States
GSK Investigational Site
Metairie, Louisiana, 70006, United States
GSK Investigational Site
Haverhill, Massachusetts, 01831-2451, United States
GSK Investigational Site
Caro, Michigan, 48723, United States
GSK Investigational Site
Dearborn, Michigan, 48126, United States
GSK Investigational Site
Kalamazoo, Michigan, 49048, United States
GSK Investigational Site
Picayune, Mississippi, 39446, United States
GSK Investigational Site
Rolling Fork, Mississippi, 39159, United States
GSK Investigational Site
City of Saint Peters, Missouri, 63376, United States
GSK Investigational Site
Jefferson City, Missouri, 65109, United States
GSK Investigational Site
Springfield, Missouri, 65807, United States
GSK Investigational Site
Billings, Montana, 59101, United States
GSK Investigational Site
Lincoln, Nebraska, 68516, United States
GSK Investigational Site
North Platte, Nebraska, 69101, United States
GSK Investigational Site
Omaha, Nebraska, 68152, United States
GSK Investigational Site
Las Vegas, Nevada, 89106, United States
GSK Investigational Site
Las Vegas, Nevada, 89128, United States
GSK Investigational Site
Buffalo, New York, 14209, United States
GSK Investigational Site
Glens Falls, New York, 12801, United States
GSK Investigational Site
Rochester, New York, 14609, United States
GSK Investigational Site
Syracuse, New York, 13210, United States
GSK Investigational Site
Williamsville, New York, 14221, United States
GSK Investigational Site
Asheville, North Carolina, 28801, United States
GSK Investigational Site
Chadbourn, North Carolina, 28431, United States
GSK Investigational Site
Charlotte, North Carolina, 28204, United States
GSK Investigational Site
Charlotte, North Carolina, 28227, United States
GSK Investigational Site
Greensboro, North Carolina, 27455, United States
GSK Investigational Site
Mint Hill, North Carolina, 28227, United States
GSK Investigational Site
Raleigh, North Carolina, 27609, United States
GSK Investigational Site
Wilmington, North Carolina, 28401, United States
GSK Investigational Site
Winston-Salem, North Carolina, 27103, United States
GSK Investigational Site
Bismarck, North Dakota, 58503, United States
GSK Investigational Site
Bismarck, North Dakota, 58504, United States
GSK Investigational Site
Fargo, North Dakota, 58104, United States
GSK Investigational Site
Fargo, North Dakota, 58122, United States
GSK Investigational Site
Grand Forks, North Dakota, 58201, United States
GSK Investigational Site
Cleveland, Ohio, 44122, United States
GSK Investigational Site
Columbus, Ohio, 43235, United States
GSK Investigational Site
Toledo, Ohio, 43606, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73104, United States
GSK Investigational Site
Bend, Oregon, 97701, United States
GSK Investigational Site
Bensalem, Pennsylvania, 19020, United States
GSK Investigational Site
Harrisburg, Pennsylvania, 17112, United States
GSK Investigational Site
Morrisville, Pennsylvania, 19067, United States
GSK Investigational Site
Uniontown, Pennsylvania, 15401, United States
GSK Investigational Site
Watertown, South Dakota, 57201, United States
GSK Investigational Site
Bristol, Tennessee, 37620, United States
GSK Investigational Site
Clarksville, Tennessee, 37043, United States
GSK Investigational Site
Johnson City, Tennessee, 37604, United States
GSK Investigational Site
Knoxville, Tennessee, 37923, United States
GSK Investigational Site
Memphis, Tennessee, 38119, United States
GSK Investigational Site
Milan, Tennessee, 38358, United States
GSK Investigational Site
Nashville, Tennessee, 37203, United States
GSK Investigational Site
Cleburne, Texas, 76033, United States
GSK Investigational Site
Dallas, Texas, 75230, United States
GSK Investigational Site
Euless, Texas, 76040, United States
GSK Investigational Site
Houston, Texas, 77006, United States
GSK Investigational Site
Houston, Texas, 77030, United States
GSK Investigational Site
Houston, Texas, 77056, United States
GSK Investigational Site
Houston, Texas, 77070, United States
GSK Investigational Site
Houston, Texas, 77082, United States
GSK Investigational Site
LaPorte, Texas, 77571, United States
GSK Investigational Site
Lewisville, Texas, 75067, United States
GSK Investigational Site
Longview, Texas, 75605, United States
GSK Investigational Site
Midland, Texas, 79707, United States
GSK Investigational Site
Missouri City, Texas, 77459, United States
GSK Investigational Site
Pasadena, Texas, 77504, United States
GSK Investigational Site
Pearland, Texas, 77584, United States
GSK Investigational Site
Pharr, Texas, 78577, United States
GSK Investigational Site
Round Rock, Texas, 78664, United States
GSK Investigational Site
San Antonio, Texas, 78205, United States
GSK Investigational Site
San Marcos, Texas, 78666, United States
GSK Investigational Site
Spring, Texas, 77379, United States
GSK Investigational Site
Sugar Land, Texas, 77478, United States
GSK Investigational Site
The Woodlands, Texas, 77381, United States
GSK Investigational Site
Tomball, Texas, 77375, United States
GSK Investigational Site
Salt Lake City, Utah, 84107, United States
GSK Investigational Site
South Burlington, Vermont, 05403, United States
GSK Investigational Site
Chester, Virginia, 23836, United States
GSK Investigational Site
Manassas, Virginia, 20110, United States
GSK Investigational Site
Salem, Virginia, 24153, United States
GSK Investigational Site
Madison, Washington, 53717, United States
GSK Investigational Site
Spokane, Washington, 99204, United States
GSK Investigational Site
Concepción, Región Del Biobio, 4070038, Chile
GSK Investigational Site
Buin, Región Metro de Santiago, 9500645, Chile
GSK Investigational Site
Santiago, Región Metro de Santiago, 7500010, Chile
GSK Investigational Site
Santiago, Región Metro de Santiago, 8320268, Chile
GSK Investigational Site
Santo Domingo, Dominican Republic
Related Publications (2)
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.
PMID: 19592625BACKGROUNDYoung 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.
PMID: 25387217DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2007
First Posted
August 20, 2007
Study Start
April 1, 2007
Primary Completion
May 1, 2008
Study Completion
May 1, 2008
Last Updated
December 16, 2016
Results First Posted
June 23, 2014
Record last verified: 2016-11
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.