DRUG
GSK716155 subcutaneous injections
albiglutide subcutaneous injection
Status
Completed
Phase
Phase 2
Enrollment
60
Locations
5
Results
Not posted
Publications
1
Study summary
This study is a placebo-controlled study in patients with Type 2 Diabetes Mellitus to assess safety and tolerability parameters, the levels of GSK716155 in the bloodstream when it is given at the same dose 7 days apart, and the impact this medication has on various substances in the blood. Assessments include ECGs, vital signs, repeat blood sampling and monitoring of any side effects.
Interventions
DRUG
albiglutide subcutaneous injection
BIOLOGICAL
placebo injection
Timeline
First posted
Jul 20, 2006
Study start
Feb 2006
Primary completion
Sep 2006
Study completion
Sep 2006
Results posted
Not reported
Registry updated
Oct 26, 2016
Outcomes
blood plasma levels of GSK716155
Time frame · on days 2 & 9
blood plasma levels of GSK716155
Time frame · on days 2 & 9
Eligibility
Inclusion criteria: * Subjects must have type 2 diabetes mellitus that has been diagnosed for at least three months. * 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: * Laboratory values that meet certain criteria (for example, total cholesterol \> 240 mg/dL). * 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.
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
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
Publications
Related trials
Brigham and Women's Hospital · Cardiovascular Events · Type2 Diabetes
Not applicable
Active, not recruiting
781,430
2026-05
Ohio State University · Cardiovascular Kidney Metabolic Syndrome
Not applicable
Active, not recruiting
23,280,000
2025-09
Janssen · Diabetes Mellitus, Type 2 · Cardiovascular Diseases
Not applicable
Completed
714,582
2025-06
Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders · Type2diabetes
Phase 4
Unknown
938
2024-07
Sanofi · Type 2 Diabetes Mellitus
Phase 3
Completed
514
2022-03
GlaxoSmithKline · Diabetes Mellitus, Type 2
Phase 3
Completed
814
2020-11
University of California, San Francisco · Type 2 Diabetes Mellitus
Not applicable
Completed
22
2020-11
GlaxoSmithKline · Diabetes Mellitus, Type 2
Phase 4
Terminated
4
2020-10
Related PeptideStat pages
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.