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

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

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

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