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Study Of GW823093 In Japanese Subjects With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00372957
First received: September 5, 2006
Last updated: October 1, 2010
Last verified: October 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Non-Insulin-Dependent Diabetes Mellitus
 Drug: GW823093
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Pharmacokinetic and Pharmacodynamic measurements during 7 days of dosing.

Secondary Outcome Measures:
  • Adverse events Changes in clinical laboratory tests Vital signs 12-lead ECG during 7 days of dosing.

Estimated Enrollment: 30
Study Start Date: March 2006
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: GW823093
    Other Name: GW823093
  Eligibility

Ages Eligible for Study:   20 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00372957

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00372957     History of Changes
Other Study ID Numbers: DPB106653
Study First Received: September 5, 2006
Last Updated: October 1, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:
Diabetes
pharmacodynamics
pharmacokinetics

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 16, 2013