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

Summary

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

Eligibility

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

Conditions3

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