Diabetes MellitusNCT05970237
A Study to Evaluate the Efficacy and Safety of Dapagliflozin in Patient With Type 2 Diabetes Mellitus and Hypertension
An observational study of Diabetes Mellitus and Hypertension, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Diabetes Mellitus, Hypertension
- How many people
- 9,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Jul 2023to 21 Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with type 2 diabetes mellitus accompanied by hypertension who are scheduled to be administrated Trudapa Tab. or Trudapa M SR Tab.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Gachon University Gil Medical Center
Incheon, Namdong-gu, 21565
Ki-young Lee
About this study
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
The purpose of this clinical trial is to evaluate the efficacy and safety of dapagliflozin in patient with type 2 diabetes mellitus and hypertension
- Conditions
- Diabetes Mellitus, Hypertension
- Medical subject headings
- Diabetes Mellitus, Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
Target blood pressure control rate
Measured: 12weeks after administration
Target blood glucose achievement rate
Measured: 12weeks after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start26 Jul 2023
- Primary completion21 Oct 2025 (estimated)
- Study completion21 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Boryung Pharmaceutical Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05970237
- Sponsor's protocol ID
- BR-DGF-OS-401
- Status last verified
- Sep 2025
- First submitted
- 24 Jul 2023
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05970237
- Acronym / sponsor ID
- BR-DGF-OS-401
- Conditions
- Diabetes Mellitus, Hypertension
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 9,000 participants (estimated)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 26 Jul 2023 (actual)
- Primary completion
- 21 Oct 2025 (estimated)
- Study completion
- 21 Oct 2025 (estimated)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with type 2 diabetes mellitus accompanied by hypertension who are scheduled to be administrated Trudapa Tab. or Trudapa M SR Tab.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Target blood pressure control rate
Time frame: 12weeks after administration
Target blood glucose achievement rate
Time frame: 12weeks after administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Hypertension, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shinyoung Oh (+82-2-708-8000, syoh@boryung.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target blood pressure control rate (time frame: 12weeks after administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.