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Double-blind Comparative Study of SYR-472

Sponsor
Takeda (Industry)
Overall Status
Completed
CT.gov ID
NCT01632007
Collaborator
(none)
245
Enrollment
22
Locations
3
Arms
14
Duration (Months)
11.1
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of treatment with SYR-472 in diabetic patients.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
245 participants
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Study Start Date :
May 1, 2012
Actual Primary Completion Date :
Jul 1, 2013
Actual Study Completion Date :
Jul 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: SYR-472 100 mg

Drug: SYR-472
Active Comparator: Alogliptin 25 mg

Drug: Alogliptin 25 mg
Other Names:
  • SYR-322

    		•
    Placebo Comparator: Placebo

    Drug: Placebo

    Outcome Measures

    Primary Outcome Measures

    1. Glycosylated hemoglobin (HbA1c) [24 weeks.]

      Measurement of change in HbA1c (ratio of hemoglobin bound to glucose).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    1. The participant is an outpatient.

    2. The participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.

    Exclusion Criteria:

    1. The participant has any serious cardiac disease, serious cerebrovascular disorder, or any serious pancreatic or hematological disease.（e.g., subjects who require hospitalization or subjects who were hospitalized within 24 weeks prior to the commencement of the observation period)

    2. The participant is considered ineligible for the study for any other reason by the investigator or subinvestigator.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Akita-shi Akita Japan
    2 Matsudo-shi Chiba Japan
    3 Fukuoka-shi Fukuoka Japan
    4 Fukuyama-shi Hiroshima Japan
    5 Ishikari-shi Hokkaido Japan
    6 Nakagawa-gun Hokkaido Japan
    7 Sapporo-shi Hokkaido Japan
    8 Naka-shi Ibaragi Japan
    9 Sagamihara-shi Kanagawa Japan
    10 Kumamoto-shi Kumamoto Japan
    11 Kashiwara-shi Osaka Japan
    12 Osaka-shi Osaka Japan
    13 Suita-shi Osaka Japan
    14 Arakawa-ku Tokyo Japan
    15 Bunkyo-ku Tokyo Japan
    16 Chiyoda-ku Tokyo Japan
    17 Chuo-ku Tokyo Japan
    18 Itabashi-ku Tokyo Japan
    19 Katsushika-ku Tokyo Japan
    20 Mitaka-shi Tokyo Japan
    21 Shinjuku-ku Tokyo Japan
    22 Shunan-shi Yamaguchi Japan

    Sponsors and Collaborators

    • Takeda

    Investigators

    • Study Director: Medical Director, Takeda

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Takeda
    ClinicalTrials.gov Identifier:
    NCT01632007
    Other Study ID Numbers:
    • SYR-472/CCT-002
    • U1111-1128-6104
    • JapicCTI-121839
    First Posted:
    Jun 29, 2012
    Last Update Posted:
    Jan 14, 2014
    Last Verified:
    Jan 1, 2014
    Additional relevant MeSH terms:
    Alogliptin

    Study Results

    No Results Posted as of Jan 14, 2014