Evaluating dapagliflozin for patients with type 2 diabetes and hypertension
A Multicenter, Prospective, Non-interventional, Observational Study to Evaluate the Efficacy and Safety of Dapagliflozin in Patient With Type 2 Diabetes Mellitus and Hypertension
This study tests if dapagliflozin can help people with type 2 diabetes and high blood pressure manage their blood sugar and blood pressure better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 9000 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Boryung Pharmaceutical Co., Ltd Industry-sponsored |
| Locations | 1 site (Incheon, Namdong-gu) |
| Trial ID | NCT05970237 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the efficacy and safety of dapagliflozin in patients diagnosed with type 2 diabetes mellitus who also have hypertension. Participants will be monitored for their response to the medication, specifically focusing on its impact on blood sugar levels and blood pressure. The study will include individuals who are scheduled to receive specific formulations of dapagliflozin and will require their cooperation throughout the trial duration.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with type 2 diabetes mellitus and hypertension who are scheduled to receive dapagliflozin.
Not a fit: Patients with secondary hypertension or those requiring insulin during the study period may not benefit from this trial.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for managing both diabetes and hypertension in patients.
How similar studies have performed: Other studies have shown positive outcomes with dapagliflozin in managing diabetes, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Incheon, Namdong-gu
- Gachon University Gil Medical Center — Incheon, Namdong-gu, South Korea (Recruiting)
Study contacts
- Study coordinator: Shinyoung Oh
- Email: syoh@boryung.co.kr
- Phone: +82-2-708-8000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.