Evaluation of the Fixed-dose Combination of Irbesartan/Atorvastatin in Type 2 Diabetic Patients Diagnosed With Hyperlipidemia and Hypertension
Evaluation of the Fixed-dose Combination of Irbesartan/Atorvastatin in Type 2 Diabetic Patients Diagnosed With Hyperlipidemia and Hypertension
Primary Objective:

 To evaluate the effect of irbesartan/atorvastatin fixed-dose combination comparing to each
 irbesartan and atorvastatin on flow mediated dilation change in type 2 diabetic patients
 diagnosed with hyperlipidemia, hypertension.

 Secondary Objective:

 To evaluate efficacy of blood pressure and hyperlipidemic factors of irbesartan/atorvastatin
 fixed-dose combination in type 2 diabetic patients diagnosed with hyperlipidemia and
 hypertension, with adequately controlled blood glucose levels in groups.
The total study duration per patient is up to maximum of 7 weeks.
Inclusion criteria:

 -  Patients aged ≥19 years to <75 years.

 -  Patients without medication history of hyperlipidemia and hypertension within 3 months
 following registration, among type 2 diabetic patients diagnosed with hyperlipidemia
 and stage I hypertension (systolic blood pressure: ≥140mmHg, ≤159 mmHg or diastolic
 blood pressure: ≥90 mmHg, ≤99mmHg), with adequately controlled hemoglobin levels.

 -  Patients who signed a written consent to data utilization.

 -  Diagnosis of diabetes:

 -  HemoglobinA1c ≥6.5% or;

 -  Fasting plasma glucose level above 8 hour ≥126 mg/dL or;

 -  Plasma glucose ≥200 mg/dL ( 11.1 mmol/l) 2 hours after a 75g glucose load or;

 -  Symptoms (such as polyuria, polydipsia, unexplained weight loss) and a random plasma
 glucose ≥200 mg/dL (11.1 mmol/L).

 Exclusion criteria:

 -  Patients indicated as contraindication in the approved labeling of Rovelito.

 -  Pregnant/nursing women.

 -  Patients with difference in blood pressure systolic blood pressure ≥20 mmHg or
 diastolic blood pressure ≥10mmHg in the arm selected during screening at Visit 1.

 -  Patients who were administered Angiotensin II receptor blockers, angiotensin
 converting enzyme inhibitors, or HMG-CoA reductase inhibitors in 2 months.

 -  Patients who had taken antidiabetics in the past.

 -  Patients who have to or may take any drug suggested in the prohibited concomitant
 medications during the study period.

 -  Patients with tolerance or hypersensitivity to angiotensin II receptor blocker or
 HMGCoA reductase inhibitor, or an ingredient of this drug, or with history of
 multi-drug allergy.

 -  Patients with genetic angioedema, or medical history of angioedema when treating with
 angiotensin converting enzyme inhibitor or angiotensin II receptor antagonist

 -  Patients who have suffered from fibromyalgia, myopathy, rhabdomyolysis, or sudden
 arthralgia, or adverse events while taking statins in the past.

 -  Creatine phosphokinase (CPK) >5 times of the upper limit of normal (ULN).

 -  Patients diagnosed with secondary hypertension or suspected of secondary hypertension
 by the Investigator (coarctation of aorta, primary aldosteronism, renal artery
 stenosis, renal hypertension, pheochromocytoma, Cushing syndrome, etc.).

 -  Patients with poorly controlled hypothyroidism despite treatment

 -  Type 1 diabetic patients or poorly controlled type 2 diabetic patients (HemoglobinA1c
 ≥7.5%)

 -  Patients with arrhythmia requiring separate treatment.

 -  Patients with the following past history:

 -  Severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.),
 hypertensive encephalopathy, transient ischemic attack (TIA), which occurred in the
 recent 6 months.

 -  Severe heart disease (NYHA class III-IV heart failure), clinically significant
 valvular disease of the heart, myocardial infarction and unstable angina in the recent
 6 months.

 -  Angioplasty or coronary artery bypass graft (CABG) surgery.

 -  If patients have clinically significant renal or hepatic diseases , or significant
 hematologic test findings at screening (serum creatinine ≥ 2mg/dL, AST or ALT
 [aspartate transaminase or alanine transaminase] ≥3 times of the ULN).

 -  Patients suspected of pancreatitis or active gall bladder disease by the Investigator.

 -  Surgical or internal disease likely to significantly change absorption, distribution,
 metabolism, and elimination of drug, which falls under one of the followings (but not
 limited to):

 -  Major gastrointestinal surgical history such as gastrectomy, gastro-enterostomy or
 bowel resection, gastric bypass, gastrointestinal stapling, or gastrointestinal
 banding, medical history of active inflammatory bowel syndrome at present or in the
 past 12 months, current active gastritis, ulcer, gastrointestinal/rectal hemorrhage,
 or urinary tract obstruction that is deemed clinically significant by the
 Investigator.

 -  Patients with volume depletion, as clinically judged by the Investigator, using vital
 signs, skin turgor pressure, mucous membrane wettability, and laboratory values.

 -  All chronic inflammatory patients requiring chronic inflammatory treatment.

 -  Patients with past history of autoimmune disease, such as chronic rheumatoid
 arthritis, systemic lupus erythematosus, etc.

 -  Patients with past clinical history of alcohol or drug abuse.

 -  Patients with history of malignant tumors including leukemia and lymphoma in the past
 5 years.

 -  Patients who have been administered another investigational product within 30 days
 prior to participation in this clinical study (from the time when they signed the
 informed consent form).

 -  Patients who may not be measured for flow mediated dilatation in Investigator's
 judgment for a congenital or secondary reason in the bilateral brachial artery.

 -  Patients who are deemed ineligible as subject in Investigator's judgment for other
 reasons.

 The above information is not intended to contain all considerations relevant to a patient's
 potential participation in a clinical trial.