Clinical trial: Evaluation of the Fixed-dose Combination of Irbesartan/Atorvastatin in Type 2 Diabetic Patients Diagnosed With Hyperlipidemia and Hypertension (NCT02842359)

Eligibility criteria:
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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 19 Years old.
Subject must be at most 74 Years

Patient description (medical language): A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear.  Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus.  Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane.  Conduction hearing loss is noted in the left ear.  The remainder of the ear, nose, and throat examination is normal.

Patient description (patient's own words): I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal.

Does the patient match the trial criteria? Entailment