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ASSIST-K: Safety and Efficacy of Sitagliptin Added to Insulin Therapy for Type 2 Diabetes

Sponsor
Kanagawa Physicians Association (Other)
Overall Status
Completed
CT.gov ID
NCT01855087
Collaborator
The Japan Kidney Foundation (Other)
1
Location

Study Details

Study Description

Brief Summary

There is paucity of information about the combination therapy with dipeptidyl peptidase-4 inhibitor sitagliptin and insulin. This study aimed to retrospectively investigate the safety and efficacy of this therapeutic modality in Japanese patients with type 2 diabetes.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    A Study of Safety and Efficacy of Sitagliptin Added to Insulin Therapy in the Treatment of Type 2 Diabetes in Kanagawa
    Actual Primary Completion Date :
    Mar 1, 2013

    Outcome Measures

    Primary Outcome Measures

    1. Blood glucose level [Six months after starting sitagliptin-insulin combination therapy]

    Eligibility Criteria

    Criteria

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

    • outpatients with type 2 diabetes

    • addition of sitagliptin to insulin therapy

    • aged 20 years or older

    • HbA1c of 6.9% or higher (NGSP) at the time of adding sitagliptin

    Exclusion Criteria:

    • history of hypersensitivity to sitagliptin

    • severe ketosis, diabetic coma, and/or precoma within 6 months before sitagliptin administration

    • sever infection and/or severe trauma, and/or patients who are scheduled to undergo / have recently underwent surgery

    • severe renal dysfunction (serum creatinine [mg/dL]: 2.5 or higher for men; 2.0 or higher for women)

    • ongoing treatment with glinide(s)

    • judgment as ineligible for the study by the attending physician

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Takai Naika Clinic Kamakura Kanagawa Japan 247-0056

    Sponsors and Collaborators

    • Kanagawa Physicians Association
    • The Japan Kidney Foundation

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ikuro Matsuba, Chairperson, Kanagawa Physicians Association
    ClinicalTrials.gov Identifier:
    NCT01855087
    Other Study ID Numbers:
    • R875
    First Posted:
    May 16, 2013
    Last Update Posted:
    May 16, 2013
    Last Verified:
    May 1, 2013
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2

    Study Results

    No Results Posted as of May 16, 2013