In-patient Study With GSK716155 In Patients With Type 2 Diabetes Mellitus
NCT ID: NCT00354536
Last Updated: 2016-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2006-02-28
2006-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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albiglutide
albiglutide injection
GSK716155 subcutaneous injections
albiglutide subcutaneous injection
albiglutide placebo
placebo injection
placebo injection
placebo injection
Interventions
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GSK716155 subcutaneous injections
albiglutide subcutaneous injection
placebo injection
placebo injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must be taking either (1) no medication for their diabetes or (2) taking metformin, a sulfonylurea, or metformin and a sulfonylurea.
* Subjects must be willing to wash-out of these medications for 14 days prior to the start of the study.
* Subjects must have a BMII between 25 and 40 kg/m² and weigh at leas 50kg.
* Women must be of non-childbearing potential.
Exclusion Criteria
* Clinically significant hepatic enzyme elevation.
* Fasting plasma glucose greater than 240mg/dL.
* Positive test result for Hepatitis B surface antigen, positive Hepatitis C or HIV.
* Any major illness other than diabetes.
* Previous use of insulin as treatment for diabetes.
* Significant renal disease as defined by screening lab tests.
* History of drug or other allergy, which in the opinion of the investigator contradicts subject participation.
* Smoking or use of nicotine-containing products within the previous 6 months.
* History of alcohol or drug abuse.
* Unwilling to abstain from alcohol during the study.
* Unwilling to abstain from caffeine- or xanthine-containing products during the study.
* Use of St. John's Wort during the study.
* Has donated 500 nL or more blood within 56 days of dosing or plans to donate blood in the month following study participation.
* Previously received any GLP-1 mimetic that has moe than 70% sequence homology to GLP-1.
18 Years
70 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Miramar, Florida, United States
GSK Investigational Site
Orlando, Florida, United States
GSK Investigational Site
Honolulu, Hawaii, United States
GSK Investigational Site
Portland, Oregon, United States
GSK Investigational Site
San Antonio, Texas, United States
Countries
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References
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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.
Study Documents
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Document Type: Clinical Study Report
View DocumentDocument Type: Annotated Case Report Form
View DocumentDocument Type: Informed Consent Form
View DocumentDocument Type: Dataset Specification
View DocumentDocument Type: Study Protocol
View DocumentDocument Type: Statistical Analysis Plan
View DocumentDocument Type: Individual Participant Data Set
View DocumentRelated Links
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Other Identifiers
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GLP106073
Identifier Type: -
Identifier Source: org_study_id