In-patient Study With GSK716155 In Patients With Type 2 Diabetes Mellitus
A Single-blinded Randomized, Placebo-controlled, Staggered-parallel, Escalating-dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous Injections of GSK 716155 in Subjects With Type 2 Diabetes Mellitus
1 other identifier
interventional
60
1 country
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 diabetes-mellitus-type-2
Started Feb 2006
Shorter than P25 for phase_2 diabetes-mellitus-type-2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 18, 2006
CompletedFirst Posted
Study publicly available on registry
July 20, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedOctober 26, 2016
October 1, 2016
7 months
July 18, 2006
October 24, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
blood plasma levels of GSK716155
on days 2 & 9
Secondary Outcomes (1)
blood plasma levels of GSK716155
on days 2 & 9
Study Arms (2)
albiglutide
ACTIVE COMPARATORalbiglutide injection
albiglutide placebo
PLACEBO COMPARATORplacebo injection
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (5)
GSK Investigational Site
Miramar, Florida, 33025, United States
GSK Investigational Site
Orlando, Florida, 32809, United States
GSK Investigational Site
Honolulu, Hawaii, 96814-4224, United States
GSK Investigational Site
Portland, Oregon, 97239, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
Related Publications (1)
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.
PMID: 25387217DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2006
First Posted
July 20, 2006
Study Start
February 1, 2006
Primary Completion
September 1, 2006
Study Completion
September 1, 2006
Last Updated
October 26, 2016
Record last verified: 2016-10
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.