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Retrospective Study of Patients With Type 2 Diabetes Mellitus on Dapagliflozin Therapy in Taiwan

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT03084965
Collaborator
(none)
1,987
Enrollment
8
Locations
9.7
Actual Duration (Months)
248.4
Patients Per Site
25.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Retrospective Study of Patients With Type 2 Diabetes Mellitus on Dapagliflozin Therapy in Taiwan.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1987 participants
    Observational Model:
    Other
    Time Perspective:
    Retrospective
    Official Title:
    Retrospective Study of Patients With Type 2 Diabetes Mellitus on Dapagliflozin Therapy in Taiwan
    Actual Study Start Date :
    May 12, 2017
    Actual Primary Completion Date :
    Mar 2, 2018
    Actual Study Completion Date :
    Mar 2, 2018

    Outcome Measures

    Primary Outcome Measures

    1. Change in HbA1c [6 months]

      To assess the change from baseline (time to initiate dapagliflozin*) in HbA1c at 6 months

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Outpatient equal to or more than 20 years of age.

    2. T2DM patient initiated dapagliflozin after May 1st 2016 as a second line or third line oral anti-diabetic therapy, either as add-on or switching from one to another. Or initiating dapagliflozin as adjunctive therapy for T2DM subjects treated with insulin.

    3. Completed follow-up of at least 6 months regardless of continuation on dapagliflozin therapy.

    4. Will provide completed and signed written informed consents.

    Exclusion Criteria:

    1. Subjects with a history of SGLT2 inhibitor therapy other than dapagliflozin prior to Baseline.

    2. Subjects with Type 1 diabetes.

    3. Treatment with other investigational drugs concurrently during the retrospective data collection period.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Changhua Taiwan
    2 Research Site Chiayi Taiwan
    3 Research Site Kaohsiung Taiwan
    4 Research Site New Taipei Taiwan
    5 Research Site Taichung Taiwan
    6 Research Site Tainan Taiwan
    7 Research Site Taipei Taiwan
    8 Research Site Taoyuan Taiwan

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT03084965
    Other Study ID Numbers:
    • D1690R00022
    First Posted:
    Mar 21, 2017
    Last Update Posted:
    Feb 26, 2019
    Last Verified:
    Feb 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2

    Study Results

    No Results Posted as of Feb 26, 2019