Nateglinide: a Double Blind Add-on Study With Pioglitazone for Type 2 Diabetic Patients

Sponsor
Astellas Pharma Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT00189774
Collaborator
Ajinomoto USA, INC. (Industry)
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Study Details

Study Description

Brief Summary

The purpose of this study is to investigate the superiority of nateglinide over placebo for inadequately controlled type 2 diabetic patients with pioglitazone treatment.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Type 2 diabetes mellitus under the treatment with pioglitazone
    Exclusion Criteria:
    • Patients who cannot follow the diet therapy and/or exercise therapy

    • Type 1 diabetes mellitus

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chubu region Japan
    2 Chugoku region Japan
    3 Hokkaido region Japan
    4 Kanto region Japan
    5 Kinki region Japan
    6 Kyushu region Japan
    7 Tohoku region Japan

    Sponsors and Collaborators

    • Astellas Pharma Inc
    • Ajinomoto USA, INC.

    Investigators

    • Study Director: Study Director, Astellas Pharma Inc

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00189774
    Other Study ID Numbers:
    • 026-CL-004
    First Posted:
    Sep 19, 2005
    Last Update Posted:
    Mar 13, 2008
    Last Verified:
    Mar 1, 2008

    Study Results

    No Results Posted as of Mar 13, 2008