Actively Recruiting
A Multicenter, Prospective, Non-interventional, Observational Study to Evaluate the Efficacy and Safety of Dapagliflozin in Patient With Type 2 Diabetes Mellitus and Hypertension
Led by Boryung Pharmaceutical Co., Ltd · Updated on 2025-09-15
9000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of dapagliflozin in people who have type 2 diabetes along with high blood pressure. This observational study focuses on how well dapagliflozin helps control blood sugar and blood pressure in this patient population. The study is sponsored by Boryung Pharmaceutical Co., Ltd and involves monitoring patients over a set period to assess these health outcomes. Participants in this study are those prescribed dapagliflozin (under the brand names Trudapa Tab. or Trudapa M SR Tab.) as part of their treatment plan. As an observational study, patients receive their usual care and dapagliflozin as prescribed by their doctors, without additional experimental interventions. The study tracks patients from the time they start dapagliflozin and observes their health over at least 12 weeks. During the study, researchers will gather data on blood pressure control and blood sugar levels 12 weeks after starting dapagliflozin. Participants will be asked to cooperate fully and continue in the study to its completion. The study also monitors safety and any side effects that may arise. The total participation lasts at least 12 weeks, with assessments focused on how well the treatments control diabetes and hypertension.
CONDITIONS
Brief Title
A Study to Evaluate the Efficacy and Safety of Dapagliflozin in Patient With Type 2 Diabetes Mellitus and Hypertension
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with type 2 diabetes mellitus and hypertension and scheduled to take Trudapa Tab. or Trudapa M SR Tab.
- Voluntarily signed written personal information agreement to participate in this study.
- Able to understand the study, cooperate with procedures, and participate until completion.
You will not qualify if you...
- Have secondary hypertension from specific diseases such as coarctation of the aorta, hyperaldosteronism, renal artery stenosis, pheochromocytoma, Cushing's syndrome, or polycystic kidney disease.
- Have taken dapagliflozin within 4 weeks before the study start.
- Expected to need insulin treatment during the study period.
- Are pregnant or breastfeeding.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 weeks
Participants who undergo routine care are observed to evaluate blood pressure and blood glucose control while taking prescribed medication.
1 baseline visit and 1 follow-up visit
Trial Site Locations
Total: 1 location
1
Gachon University Gil Medical Center
Incheon, Namdong-gu, South Korea, 21565
Actively Recruiting
Research Team
S
Shinyoung Oh
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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