Last updated: 11/04/2018 06:12:18

Study Of Denagliptin In Subjects With Type 2 Diabetes Mellitus (T2DM)

GSK study ID
DPB107246
Clinicaltrials.gov ID
NCT00387972
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 multi-center, double-blind, parallel-group, randomized, placebo-controlled study to evaluate the efficacy, safety, and tolerability of denagliptin in subjects with type 2 diabetes mellitus
Trial description: GW823093 is a selective DPP-IV Inhibitor and is being investigated as a once a day oral therapy. The purpose of the Study is to evaluate the effectiveness, safety, and tolerability of 2 doses of GW823093, compared to placebo, taken once daily in patients with Type 2 diabetes mellitus.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Drug: denagliptin (GW823093)
    • Enrollment:
    0
    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
    denagliptin
    Collaborators
    Not applicable
    Study date(s)
    October 2006 to October 2007
    Type
    Interventional
    Phase
    2/3

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 75 Years
    Accepts healthy volunteers
    no
    • Inclusion criteria:
    • Type 2 diabetes mellitus treated with diet and exercise or oral anti-diabetic treatment
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Type 2 diabetes mellitus treated with diet and exercise or oral anti-diabetic treatment
    • Body mass index between 20 and 40
    • Females of childbearing potential must use adequate birth control. Exclusion criteria:
    • Subjects with previous use of insulin
    • Type 1 diabetes
    • Uncontrolled thyroid disease
    • History of drug or alcohol abuse in the past year
    • Any other clinically significant disease.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Clinical Trials Call Center
    Calhoun, GA, United States, 30701
    Status
    Study Stopped
    Contact us
    Location
    GSK Clinical Trials Call Center
    Hollywood, FL, United States, 33023
    Status
    Study Stopped
    Contact us
    Location
    GSK Clinical Trials Call Center
    Charlotte, NC, United States, 28277
    Status
    Study Stopped
    Contact us
    Location
    GSK Clinical Trials Call Center
    Lake Zurich, IL, United States, 60047
    Status
    Study Stopped
    Contact us
    Location
    GSK Clinical Trials Call Center
    Hialeah, FL, United States, 33010
    Status
    Study Stopped
    Contact us
    Location
    GSK Clinical Trials Call Center
    Baton Rouge, LA, United States, 70809
    Status
    Study Stopped
    Contact us
    Showing 1 - 6 of 57 Results

    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
    Not applicable

    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
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website