Essential hypertension complicated by type 2 diabetes mellitus
Conditions
Interventions
investigational material(s)
Generic name etc : Azilsartan (trade name: Azilva)
INN of investigational material :
Therapeutic category code : 214 Antihypertensives
Dosage and Administration for Invest
Sponsors
TAKEDA PHARMACEUTICAL COMPANY LTD.
Eligibility
Sex/Gender
All
Inclusion 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 = 80 mmHg and = 20 years at the time of consent 7. Outpatients 8. Capable of providing written consent before participation in this study.
Exclusion criteria
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 = 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 patients who are inappropriate for participation in this study in the opinion of the principal investigator or investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in insulin resistance index (HOMA-R) Primary timeframeBaseline and Week 12 Change from the start of the treatment period at the end of the treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Efficacy: 1) Change in fasting blood glucose from the start of the treatment period at the end of the treatment period (Week 12) 2) Change in fasting insulin 3) Change in of glycosylated hemoglobin (HbA1c) 4) HOMA-beta HOMA-beta=fasting insulin (microU/mL)*360/{fasting glucose (mg/dL) - 63} 5) Change in 1,5-AG (2) Safety: Adverse events Secondary timeframe (1): Baseline and Week 12 (2): For 12 weeks (1) 1) The change between the fasting plasma glucose value collected at week 12 or final visit relative to baseline. 2) The change between the fasting insulin value collected at week 12 or final visit relative to baseline. 3) The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 or final visit relative to baseline. 4) Change from the start of the treatment period to the end of the treatment period 5) Change from the start of the treatment period to the end of the treatment period (2) The frequencies of all adverse drug reactions observed during the observation period will be tabulated by type and seriousness. Adverse events are defined as unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, regardless of relationship to the medicinal product. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions. | — |
Outcome results
None listed