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
Condition: Essential Hypertension Complicated by Type 2 Diabetes Mellitus
MeSH terms: Hypertension; Essential Hypertension; Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance
Intervention: Azilsartan; Telmisartan
Intervention description: Azilsartan tablets; Telmisartan tablets
Intervention MeSH terms: Telmisartan; Azilsartan medoxomil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      Multicenter, randomized, open-label, parallel-group exploratory study to explore the effects
      of azilsartan (Azirva), compared with telmisartan, on insulin resistance in participants with
      essential hypertension complicated by type 2 diabetes mellitus
    

Eligibility criteria:

        Inclusion Criteria:

          1. 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.

          2. 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).

          3. Type 2 diabetes mellitus

          4. 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

          5. 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)

          6. Age ≥ 20 years at the time of consent

          7. Outpatients

          8. Capable of providing written consent before participation in this study.

        Exclusion Criteria:

          1. Grade III essential hypertension (i.e., sitting systolic blood pressure 180 mmHg or
             sitting diastolic blood pressure ≥ 110 mmHg), secondary hypertension, or malignant
             hypertension.

          2. 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

          3. 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.

          4. Use of RAS inhibitors or thiazolidines within 3 months before the start of the
             treatment period

          5. Type 1 diabetes mellitus

          6. Fasting blood glucose of < 180 mg/dL and HOMA-R of ≤ 1.6 at the start of the treatment
             period (Week 0)

          7. 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

          8. Change of antidiabetic medication (including dosage change) within 3 months before the
             start of the treatment period

          9. 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)

         10. 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

         11. 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

         12. Have severe ketosis, diabetic coma or precoma, severe infection, or serious trauma

         13. Clinically evident renal disorder (e.g., eGFR <30 mL/min/1.73 m2)

         14. Markedly low bile secretion or severe hepatic disorder

         15. History of hypersensitivity or allergy to azilsartan or telmisartan or to both.

         16. Presence of hyperkalemia (potassium level ≥ 5.5 mEq/L on laboratory testing)

         17. Currently participating in any other clinical study.

         18. Pregnant women, women with possible pregnancy, or breast-feeding women.

         19. Other participants who are inappropriate for participation in this study in the
             opinion of the principal investigator or investigator.