Evaluating a new combination therapy for high blood pressure and diabetes
A Randomized, Double-blind, Multi-center, Phase 3 Study to Evaluate the Efficacy and Safety of BR1019A and BR1019B Combination Therapy in Patients With Essential Hypertension and Type 2 Diabetes Mellitus
This study is testing a new combination treatment for people with high blood pressure and type 2 diabetes to see if it works better and is safe compared to their current medications.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 276 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Boryung Pharmaceutical Co., Ltd Industry-sponsored |
| Locations | 2 sites (Seoul and 1 other locations) |
| Trial ID | NCT06220773 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the efficacy and safety of a combination therapy involving BR1019A and BR1019B in patients suffering from essential hypertension and type 2 diabetes mellitus. Participants will be required to discontinue their current antihypertensive and/or oral hypoglycemic medications, except for Metformin, to evaluate the effects of the new treatment. The study is designed as a Phase 3 interventional trial, indicating a focus on confirming the effectiveness and monitoring the safety of the therapy in a larger patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with type 2 diabetes mellitus and essential hypertension who can safely discontinue their current medications.
Not a fit: Patients with secondary hypertension or those experiencing significant orthostatic hypotension may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a new effective treatment option for patients with both essential hypertension and type 2 diabetes.
How similar studies have performed: While this specific combination therapy is novel, similar approaches in treating hypertension and diabetes have shown promise in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Those with type 2 diabetes mellitus \& essential hypertension * Those who agree to discontinue existing antihypertensive and/or oral hypoglycemic drugs during the clinical trial * Those who are judged medically reasonable by investigator to be able to discontinue existing antihypertensive and/or oral hypoglycemic drugs(except for Metformin) during the clinical trial Exclusion Criteria: * Those who meet the following criteria * Those with a history of secondary hypertension or suspected secondary hypertension; (Including but not limited to; e.g., renovascular disease, adrenal medullary and cortical hyperfunctions, coarctation of the aorta, primary hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's syndrome, pheochromocytoma and polycystic kidney disease, etc.) * Those with clinical significant orthostatic hypotension accompanied by symptoms * Those with diabetes mellitus taking renin inhibitors(Aliskiren) or moderate to severe renal impairment * Those with diabetic nephropathy taking ACE inhibitors * Those with type 1 diabetes mellitus, secondary diabetes mellitus, severe insulin-dependent diabetes, diabetic ketoacidosis or lactic acidosis * Those with uncontrolled, severe diabetic complications (Micro-vascular complications(e.g., nephropathy, retinopathy, neuropathy, etc.), Macro-vascular complications) * Diabetic coma or pre-coma
Where this trial is running
Seoul and 1 other locations
- Severance Hospital — Seoul, South Korea (Recruiting)
- Severance Hospital — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Shin-young 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.