Last updated: 11/04/2018 04:33:24

A Study To Assess GW677954 Used In Combination With Insulin In Subjects Who Have Type 2 Diabetes Mellitus

GSK study ID
ADG106149
Clinicaltrials.gov ID
NCT00437164
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Randomized, Double-blind, Parallel, Placebo-Controlled, Study to Evaluate the Safety and Tolerability of Oral GW677954 Capsules (15 mg) in Combination With Insulin in Subjects with Type 2 Diabetes Mellitus
Trial description: Many drugs used for the treatment of Type 2 Diabetes Mellitus cause the body to retain water. This study will assess whether or not GW677954 causes the body to retain fluid.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

changes in fluid related parameters as measured by hematocrit and hemoglobin levels and body weight

Timeframe: up to 24 weeks

Secondary outcomes:

safety/tolerability, as measured by adverse events, clinical laboratory, edema & glycemic measures, ophthalmic assessments; & changes in weight, waist & hip circumference

Timeframe: up to 24 weeks

Interventions:
  • Drug: Insulin
  • Drug: Oral GW677954 Capsules (15 mg)
    • Enrollment:
    1
    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
    sodelglitazar
    Collaborators
    Not applicable
    Study date(s)
    September 2006 to November 2006
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    30 - 65 years
    Accepts healthy volunteers
    No
    • Have been diagnosed by a doctor with Type 2 Diabetes Mellitus at least 3 months before Screening
    • Have a body mass index within range 25 to 40.0kg/m2 inclusive
    • Significant weight loss or gain in the 3 months before screening
    • Have used insulin to treat hyperglycemia within 3 months before screening
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Have been diagnosed by a doctor with Type 2 Diabetes Mellitus at least 3 months before Screening
    • Have a body mass index within range 25 to 40.0kg/m2 inclusive
    • Females who meet above criteria must be physiologically incapable of becoming pregnant (ie., surgically sterilized, or post-menopausal per protocol definition)
    Exclusion criteria:
    • Significant weight loss or gain in the 3 months before screening
    • Have used insulin to treat hyperglycemia within 3 months before screening
    • Have a history of fluid retention
    • Have uncontrolled high blood pressure
    • Have liver disease
    • Take loop diuretics (water pills), certain blood thinners, and/or St. Johns Wort.
    • Have or have had certain kinds of cancer

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Beverly Hills, California, United States, 90211
    Status
    Terminated/Withdrawn
    Contact us

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Other
    Actual primary completion date
    Not applicable
    Actual study completion date
    2006-10-11

    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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