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

September 11, 2025 updated by: Boryung Pharmaceutical Co., Ltd

A Multicenter, Prospective, Non-interventional, Observational Study to Evaluate the Efficacy and Safety of Dapagliflozin in Patient With Type 2 Diabetes Mellitus and Hypertension

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

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

9000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • South Korea
    • Namdong-gu
      • Incheon, Namdong-gu, South Korea, 21565
        • Recruiting
        • Gachon University Gil Medical Center
        • Contact:
          • Ki-young Lee

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Target blood pressure control rate
Time Frame: 12weeks after administration
12weeks after administration
Target blood glucose achievement rate
Time Frame: 12weeks after administration
12weeks after administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boryung Pharmaceutical Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 26, 2023

Primary Completion (Estimated)

October 21, 2025

Study Completion (Estimated)

October 21, 2025

Study Registration Dates

First Submitted

July 24, 2023

First Submitted That Met QC Criteria

July 24, 2023

First Posted (Actual)

August 1, 2023

Study Record Updates

Last Update Posted (Estimated)

September 15, 2025

Last Update Submitted That Met QC Criteria

September 11, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BR-DGF-OS-401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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