Last updated: 11/04/2018 06:12:01

GW823093C For The Treatment Of Type 2 Diabetes Mellitus

GSK study ID
DPB106652
Clinicaltrials.gov ID
NCT00370942
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: GW823093 Japan Phase IIa Mono
Trial description: This study was designed to find dose response and as extension in treatment of GW823093C.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Efficacy variables Dose response (change from baseline in HbA1c) at stipulated date in each treatment group

Timeframe: 12 weeks

Secondary outcomes:

Long term safety variables

Timeframe: 64 weeks

Interventions:
  • Drug: GW823093C A
  • Drug: GW823093C B
  • Drug: GW823093C C
    • Enrollment:
    159
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Diabetes Mellitus, Type 2
    Product
    denagliptin
    Collaborators
    GSK
    Study date(s)
    April 2006 to November 2006
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    20 - 74 years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Type 2 diabetes mellitus.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Type 2 diabetes mellitus.
    • Managed by diet therapy or receiving treatment with oral anti-diabetic monotherapy (excluding TZD (Thiazolidinediones)) Exclusion criteria:
    • Patients who have metabolic disease judged by investigator as a clinically significance
    • Serious cardiovascular disease or serious hepatic disease

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Unknown, Japan
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Miyagi, Japan, 985-0852
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Tokyo, Japan, 130-0004
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Tokyo, Japan, 160-0017
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Hokkaido, Japan, 051-0005
    Status
    Study Complete
    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
    2006-25-11

    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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