Last updated: 11/04/2018 07:55:54

In-patient study in patients with Type 2 Diabetes Mellitus

GSK study ID
GLP105330
See study documents
Clinicaltrials.gov ID
NCT00259896
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: A randomized, open-label, placebo-controlled, repeat-dose study to assess the pharmacokinetics and pharmacodynamics of 5 micrograms exenatide administered subcutaneously twice daily for 7 days in healthy normal volunteers and in subjects with Type 2 Diabetes Mellitus
Trial description: This study is a placebo-controlled study in both healthy normal subjects and patients with Type 2 Diabetes Mellitus to assess the levels of exenatide in the bloodstream when it is given for 7 days, and to assess the impact this medication has on various substances in the blood. Assessments include repeat blood sampling and monitoring of any side effects.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Drug: exenatide
    • Enrollment:
    30
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Type 2 Diabetes Mellitus
    Product
    albiglutide
    Collaborators
    Not applicable
    Study date(s)
    October 2005 to January 2006
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 66 years
    Accepts healthy volunteers
    Yes
    • 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
    • must not have any other major illness other than diabetes
    Inclusion and exclusion criteria
    Inclusion criteria:
    • 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
    • must be willing to wash-out of these medications for 14 days prior to the start of the study
    • must have bloodwork that meets certain criteria (for example, total cholesterol < 240 mg/dL)
    Exclusion criteria:
    • must not have any other major illness other than diabetes

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    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
    2006-26-01

    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

    Additional information
    Not applicable
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