Last updated: 11/04/2018 07:57:55

Clinical assessment of GSK716155 for Type 2 Diabetes Mellitus

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GSK study ID
GLP107865
See study documents
Clinicaltrials.gov ID
NCT00530309
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Clinical assessment of GSK716155 for Type 2 Diabetes Mellitus -A Phase I/II study to investigate the safety, pharmacokinetics and pharmacodynamics of GSK716155 in Japanese subjects with type 2 diabetes mellitus
Trial description: A Phase I/II study to investigate the safety, pharmacokinetics and pharmacodynamics of GSK716155 in Japanese subjects with type 2 diabetes mellitus
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

Plasma concentrations and PD parameters over time and at the end of study

Timeframe: Up to Week 9

Secondary outcomes:

Other metabolic parameters at the end of study

Timeframe: Up to Week 9

Interventions:
  • Drug: GSK716155 for injection
  • Drug: Placebo
    • Enrollment:
    40
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Yutaka Seino, Hiromu Nakajima, Hajima Miyahara, Takashi Kurita, Mark Bush, Fred Yang, and Murray Stewart for the Albiglutide Study Group.Safety, tolerability, pharmacokinetics and pharmacodynamics of albiglutide, a long-acting GLP 1-receptor agonist in Japanese subjects with type 2 diabetes mellitus.Current Medical Research and Opinion; Published online 29th October 2009; doi:10.1185/03007990903372999.2009;29(12):3049–3057;
    Medical condition
    Diabetes Mellitus, Type 2
    Product
    albiglutide
    Collaborators
    Not applicable
    Study date(s)
    August 2007 to April 2008
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    20 - 70 years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Type 2 diabetes mellitus diagnosed at least 3 months with FPG level <=240mg/dL and HbA1c between 6.5% and 10% inclusive.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Type 2 diabetes mellitus diagnosed at least 3 months with FPG level <=240mg/dL and HbA1c between 6.5% and 10% inclusive.
    • Must be diet controlled
    • OR
    • taking a single oral antidiabetic agent (other than thiazolidinediones) and willing to withdraw from this treatment from 2 weeks prior to the study.
    • Must have a BMI:<=35kg/m2, 20 to 70 years of age inclusive.
    • Woman must be of non-childbearing potential. Exclusion criteria:
    • Positive test result for either syphilis, HBs antigen, HCV antibody, HIV antigen/antibody, or HTLV-1 antibody.
    • Clinically significant hepatic enzyme elevation.
    • History of metabolic disease other than T2DM.
    • Previous use of insulin as a treatment for diabetes within 3 months.
    • History of severe gastrointestinal disease.
    • Clinically significant cardiovascular disease.
    • Significant renal disease as defined by screening lab test.
    • History of drug (including albumin or albumin containing agents) allergy.
    • History of alcohol or drug abuse.
    • Donation of blood in excess of 400mL within previous 4 months.
    • Previously received any GLP-1 mimetic or any other albumin-containing products.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Tokyo, Japan, 130-0004
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Fukuoka, Japan, 812-0025
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Tokyo, Japan, 160-0017
    Status
    Study Complete
    Contact us

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2008-17-04

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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    Additional information
    Results for study GLP107865 can be found on the GSK Clinical Study Register.
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