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Study of Combination Therapy With SYR-322

Sponsor
Takeda (Industry)
Overall Status
Completed
CT.gov ID
NCT01521962
Collaborator
(none)
67
Enrollment
33
Locations
2
Arms
12.9
Duration (Months)
2
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To determine the efficacy and safety of SYR-322 (alogliptin) 25-mg, once daily (QD), in patients with diabetes when used in combination with insulin.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
67 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Official Title:
A Phase 3 Study to Investigate the Efficacy and Safety of SYR-322 When Used in Combination With Insulin Preparation in Subjects With Type 2 Diabetes in Japan
Study Start Date :
Feb 1, 2012
Actual Primary Completion Date :
Mar 1, 2013
Actual Study Completion Date :
Mar 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: SYR-322 (Alogliptin) QD

SYR-322 25 mg, orally.

Drug: Alogliptin
Alogliptin tablets
Other Names:
  • SYR-322

    		•
    Placebo Comparator: Insulin

    injection

    Drug: Insulin
    Insulin injection

    Outcome Measures

    Primary Outcome Measures

    1. Change in glycosylated hemoglobin (HbA1c; Japan Diabetes Society value) [Baseline and Week 12]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. The subject is an outpatient.

    2. The subject 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 subject has any serious cardiac disease, serious cerebrovascular disorder, or any serious pancreatic or hematological disease.

    2. The subject 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 Aomori-shi Aomori Japan
    2 Hirosaki-shi Aomori Japan
    3 Kashiwa-shi Chiba Japan
    4 Kisarazu-shi Chiba Japan
    5 Kitakyushu-shi Fukuoka Japan
    6 Aki-gun Hiroshima Japan
    7 Fukuyama-shi Hiroshima Japan
    8 Nishinomiya-shi Hyogo Japan
    9 Koga-shi Ibaraki Japan
    10 Ushiku-shi Ibaraki Japan
    11 Kahoku-gun Ishikawa Japan
    12 Hanamaki-shi Iwate Japan
    13 Morioka-shi Iwate Japan
    14 Kagoshima-shi Kagoshima Japan
    15 Satsuma-sendai-shi Kagoshima Japan
    16 Kumamoto-shi Kumamoto Japan
    17 Minamata-shi Kumamoto Japan
    18 Miyazaki-shi Miyazaki Japan
    19 Nigata-shi Nigata Japan
    20 Hirakata-shi Osaka Japan
    21 Osaka-sayama-shi Osaka Japan
    22 Osaka-shi Osaka Japan
    23 Takatsuki-shi Osaka Japan
    24 Yao-shi Osaka Japan
    25 Kuki-shi Saitama Japan
    26 Otsu-shi Shiga Japan
    27 Hamamatsu-shi Shizuoka Japan
    28 Shizuoka-shi Shizuoka Japan
    29 Shimotsuke-shi Tochigi Japan
    30 Shinagawa-ku Tokyo Japan
    31 Toyama-shi Toyama Japan
    32 Sagae-shi Yamagata Japan
    33 Yamagata-shi Yamagata Japan

    Sponsors and Collaborators

    • Takeda

    Investigators

    • Study Director: Senior Manager, Takeda

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Takeda
    ClinicalTrials.gov Identifier:
    NCT01521962
    Other Study ID Numbers:
    • SYR-322/CCT-901
    • U1111-1127-1525
    • JapicCTI-121736
    First Posted:
    Jan 31, 2012
    Last Update Posted:
    Nov 13, 2013
    Last Verified:
    Nov 1, 2013
    Additional relevant MeSH terms:
    Alogliptin

    Study Results

    No Results Posted as of Nov 13, 2013