A Study to Evaluate the Efficacy and Safety of BR1019A and BR1019B Combination Therapy

Boryung

Status and phase: Enrolling; Phase 3

Conditions: Type 2 Diabetes Mellitus; Essential Hypertension

Treatments: Drug: BR1019C-1; Drug: BR1019A-1; Drug: BR1019B; Drug: BR1019C; Drug: BR1019A; Drug: BR1019B-1

Study type: Interventional

Funder types: Industry

Identifiers

NCT06220773

BR-FDC-CT-301

Details and patient eligibility

About

The objective of this clinical study is to Evaluate the Efficacy and Safety of BR1019A and BR1019B combination therapy in Patients with Essential Hypertension and Type 2 Diabetes Mellitus

Enrollment: 276 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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276 participants in 4 patient groups

BR1019A + BR1019B + BR1019C-1

Experimental group

Treatment:

Drug: BR1019A

Drug: BR1019B

Drug: BR1019C-1

BR1019A + BR1019B-1 + BR1019C-1

Active Comparator group

Treatment:

Drug: BR1019A

Drug: BR1019B-1

Drug: BR1019C-1

BR1019A-1 + BR1019B + BR1019C-1

Active Comparator group

Treatment:

Drug: BR1019A-1

Drug: BR1019B

Drug: BR1019C-1

BR1019A-1 + BR1019B + BR1019C

Other group

Treatment:

Drug: BR1019A-1

Drug: BR1019C

Drug: BR1019B