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

NCT ID: NCT05970237

Last Updated: 2025-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

9000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-26

Study Completion Date

2025-10-21

Brief Summary

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

Detailed Description

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Conditions

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Diabetes Mellitus Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boryung Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Gachon University Gil Medical Center

Incheon, Namdong-gu, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Shinyoung Oh

Role: CONTACT

+82-2-708-8000

Facility Contacts

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Ki-young Lee

Role: primary

Other Identifiers

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BR-DGF-OS-401

Identifier Type: -

Identifier Source: org_study_id

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