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

Study Of GW823093 In Japanese Subjects With Type 2 Diabetes Mellitus

GSK study ID
DPB106653
Clinicaltrials.gov ID
NCT00372957
See results summary
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: PK/PD study of GW823093 in Japanese subjects with T2DM: A single-blind, placebo controlled, randomized, multi-dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of GW823093C administered orally for 7 days in Japanese subjects with type 2 diabetes
Trial description: To investigate the preliminary pharmacokinetics, pharmacodynamics, safety and tolerability of GW823093 at doses of 15mg and 30mg given once daily for 7 days in Japanese Type 2 diabetes mellitus (T2DM) patients.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

Standard pharmacokinetic (PK) parameter: Maximum observed plasma drug concentration (Cmax)

Timeframe: Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hours [hr]), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr)

Standard PK parameter: Time at which Cmax was observed (Tmax)

Timeframe: Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr)

Standard PK parameter: Half life of terminal elimination phase (t1/2)

Timeframe: Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr)

Standard PK parameter: Area under the plasma drug concentration versus time curve extrapolated to infinity (AUC[0-inf]), AUC from 0 to the last measurable concentration (AUC[0-t])

Timeframe: Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr)

Standard PK parameter: Percentage of AUC(0-inf) obtained by extrapolation (%AUCex)

Timeframe: Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr)

Standard PK parameter: Constant rate of elimination (lambda_z)

Timeframe: Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr)

Standard PK parameter: Total clearance (CL/F)

Timeframe: Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr)

Standard PK parameter: Apparent volume of distribution (Vz/F)

Timeframe: Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr)

Standard PK parameter: R[Cmax], Extent of accumulation (Ro), Steady state accumulation ratio (Rs)

Timeframe: Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr)

Percent Dipeptidyl-peptidase IV (DPP-IV) Inhibition by Dose (Day 7)

Timeframe: Day 7

DPP-IV activity weighted mean AUCs at Baseline (Day -1) and Day 7

Timeframe: Baseline (Day -1) and Day 7

Active Glucagon-like peptide-1 (GLP-1) weighted mean AUCs at Baseline (Day -1) and Day 7

Timeframe: Baseline (Day -1) and Day 7

Insulin Weighted Mean AUCs at Baseline (Day -1) and Day 7

Timeframe: Baseline (Day -1) and Day 7

Glucagon Weighted Mean AUCs at Baseline (Day -1) and Day 7

Timeframe: Baseline (Day -1) and Day 7

C-peptide Weighted Mean AUCs at Baseline (Day -1) and Day 7

Timeframe: Baseline (Day -1) and Day 7

Glucose Weighted Mean AUCs at Baseline (Day -1) and Day 7

Timeframe: Baseline (Day -1) and Day 7

Secondary outcomes:

Number of participants with adverse events (AEs) and serious adverse events (SAEs)

Timeframe: Up to post-study screen (Follow-up [7 days after the last dose of study medication])

Interventions:
  • Drug: GW823093 15mg
  • Drug: GW823093 placebo capsule
  • Drug: GW823093 30mg
    • Enrollment:
    30
    Primary completion date:
    2006-28-06
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Diabetes Mellitus, Type 2
    Product
    denagliptin
    Collaborators
    Not applicable
    Study date(s)
    March 2006 to June 2006
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    20 - 64 years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • T2DM diagnosed at least 3 months prior to Screening and fasting plasma glucose (FPG) level <280mg/dL at the Screening visit.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • T2DM diagnosed at least 3 months prior to Screening and fasting plasma glucose (FPG) level <280mg/dL at the Screening visit.
    • Concurrent T2DM therapy: Must be diet controlled
    • OR
    • not taking more than 2 oral anti-diabetic agents, and willing to withdraw from these treatments 2 weeks prior to the first dosing. Exclusion criteria:
    • Must not have any other major illness other than diabetes

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Unknown, Japan
    Status
    Study Complete
    Contact us

    Study documents

    No study documents available.

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2006-28-06
    Actual study completion date
    2006-28-06

    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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