A Study to Explore the Effects of Azilsartan Compared to Telmisartan on Insulin Resistance of Patients With Essential Hypertension on Type 2 Diabetes Mellitus by HOMA-R

Inclusion Criteria

• The participant was given the diagnosis of grade I or II essential hypertension and was judged by the principal investigator or investigator that they can be appropriately treated with azilsartan 20 mg and telmisartan 40 mg.
• Sitting systolic blood pressure of ≥ 130 mmHg and < 180 mmHg or sitting diastolic blood pressure of ≥ 80 mmHg and < 110 mmHg at the start of the treatment period (Week 0) Sitting blood pressure will be measured until 2 consecutive stable measurements are obtained (i.e., the difference between 2 measurements: diastolic blood pressure of <5 mmHg and systolic blood pressure of < 10 mmHg) after resting in a sitting position for at least 5 minutes. The average value of the last 2 measurements will be recorded (the first the decimal place is rounded off).
• Type 2 diabetes mellitus
• HbA1c (NGSP (National Glycohemoglobin Standardization Program) value) of < 8.4% during 3 months before informed consent, with a ≤ 0.3% change in HbA1c (peak minus nadir) during 3 months before informed consent
• No change in diet/exercise therapy during the 3 months before the informed consent in a participant who has been on diet/exercise therapy and instructed to improve life style (e.g., diet and exercise)
• Age ≥ 20 years at the time of consent
• Outpatients
• Capable of providing written consent before participation in this study.

Exclusion Criteria

• Grade III essential hypertension (i.e., sitting systolic blood pressure 180 mmHg or sitting diastolic blood pressure ≥ 110 mmHg), secondary hypertension, or malignant hypertension.
• Grade II essential hypertension (i.e., sitting systolic blood pressure ≥ 160 mmHg or sitting diastolic blood pressure ≥ 100 mmHg) for which antihypertensive drug(s) are used
• Use of oral antihypertensive medication within 2 weeks before the start of the treatment period Participants who are on any antihypertensive agent at the time of informed consent can be enrolled in the study only after 2-week washout following informed consent.
• Use of RAS inhibitors or thiazolidines within 3 months before the start of the treatment period
• Type 1 diabetes mellitus
• Fasting blood glucose of < 180 mg/dL and HOMA-R of ≤ 1.6 at the start of the treatment period (Week 0)
• Receiving or requiring any of the following at the time of informed consent:
• Insulin, glucagon-like peptide-1 (GLP-1) receptor agonists, or other parenteral hypoglycemic agents
• Combination therapy with 3 or more oral hypoglycemic agents
• Change of antidiabetic medication (including dosage change) within 3 months before the start of the treatment period
• Having diagnosed/treated any of the following cardiovascular diseases within 3 months before the start of the treatment period:
• Cardiac disease/condition: myocardial infarction, coronary revascularization procedure
• Cerebrovascular disease: cerebral infarction, cerebral haemorrhage, transient ischaemic attack
• Advanced hypertensive retinopathy (retinal bleeding or oozing, papilloedema)
• Having diagnosed/treated for any of the following cardiovascular diseases more than 3 months before the start of the treatment period, and is now still in unstable condition.
• Cardiac disease/condition: myocardial infarction, coronary revascularization procedure
• Cerebrovascular disease: cerebral infarction, cerebral haemorrhage, transient ischaemic attack
• Past or current history of any of the following cardiovascular diseases.
• Cardiac valve stenosis
• Angina pectoris requiring medication
• Congestive cardiac failure requiring medication
• Arrhythmia requiring medication (e.g., paroxysmal atrial fibrillation, severe bradycardia, torsade de pointes, and ventricular fibrillation)
• Arteriosclerosis obliterans with intermittent claudication or other symptoms
• Have severe ketosis, diabetic coma or precoma, severe infection, or serious trauma
• Clinically evident renal disorder (e.g., eGFR <30 mL/min/1.73 m2)
• Markedly low bile secretion or