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A Study to Evaluate the Efficacy and Safety of Dapagliflozin in Patient With Type 2 Diabetes Mellitus and Hypertension

Sponsor
Boryung Pharmaceutical Co., Ltd (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05970237
Collaborator
(none)
9,000
Enrollment
1
Location
17.1
Anticipated Duration (Months)
527.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this clinical trial is to evaluate the efficacy and safety of dapagliflozin in patient with type 2 diabetes mellitus and hypertension

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    9000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Multicenter, Prospective, Non-interventional, Observational Study to Evaluate the Efficacy and Safety of Dapagliflozin in Patient With Type 2 Diabetes Mellitus and Hypertension
    Anticipated Study Start Date :
    Jul 1, 2023
    Anticipated Primary Completion Date :
    Dec 1, 2024
    Anticipated Study Completion Date :
    Dec 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Target blood pressure control rate [12weeks after administration]

    2. Target blood glucose achievement rate [12weeks after administration]

    Eligibility Criteria

    Criteria

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

    • Those diagnosed with type 2 diabetes mellitus accompanied by hypertension who are scheduled to be administrated Trudapa Tab. or Trudapa M SR Tab.

    • Those who voluntarily signed a written personal information agreement to participate in this clinical study.

    • Those able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion.

    Exclusion Criteria:

    • Patients with secondary hypertension: Secondary hypertension is not limited to the following diseases; (e.g., coarctation of the aorta, hyperaldosteronism, renal artery stenosis, pheochromocytoma, Cushing's syndrome and polycystic kidney disease, etc.)

    • Those who have a history of taking dapagliflozin within 4 weeks of baseline (Visit 1)

    • Those who are expected to need insulin prescription during the study period

    • Pregnant women, breast-feeding women

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gachon University Gil Medical Center Incheon Namdong-gu Korea, Republic of 21565

    Sponsors and Collaborators

    • Boryung Pharmaceutical Co., Ltd

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Boryung Pharmaceutical Co., Ltd
    ClinicalTrials.gov Identifier:
    NCT05970237
    Other Study ID Numbers:
    • BR-DGF-OS-401
    First Posted:
    Aug 1, 2023
    Last Update Posted:
    Aug 1, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hypertension
    Diabetes Mellitus
    Diabetes Mellitus, Type 2

    Study Results

    No Results Posted as of Aug 1, 2023