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
The primary objective of the present study is to explore the effects of azilsartan 20 mg, compared with telmisartan 40 mg, once daily orally for 12 weeks on insulin resistance in participants with essential hypertension complicated by type 2 diabetes mellitus.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Azilsartan tablets
Telmisartan tablets
Unnamed facility
Kyoto, Kyoto, Japan
Change in Insulin Resistance Index (HOMA-R) From Baseline at the End of the Treatment Period (Week 12)
Change from the start of the treatment period (baseline) at the end of the treatment period (Week 12) was reported. Insulin Resistance Index (HOMA-R) measures insulin resistance, calculated by fasting insulin (μU/mL) multiplied by fasting glucose (mg/dL), and divided by a constant (405).
Time frame: Baseline and Week 12
Change in Fasting Blood Glucose From Baseline at the End of the Treatment Period (Week 12)
Change from baseline in fasting blood glucose values collected at week 12 or final visit relative to baseline was reported.
Time frame: Baseline and Week 12
Change in Fasting Insulin From Baseline at the End of the Treatment Period (Week 12)
Change from baseline in fasting insulin values collected at week 12 or final visit relative to baseline was reported.
Time frame: Baseline and Week 12
Change in Glycosylated Hemoglobin (HbA1c) From Baseline at the End of the Treatment Period (Week 12)
Change from baseline in the values 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 was reported.
Time frame: Baseline and Week 12
Change in Homeostasis Model Assessment of Beta Cell Function (HOMA-β) From Baseline at the End of the Treatment Period (Week 12)
Change from baseline in HOMA-β collected at week 12 or final visit relative to baseline was reported. Homeostasis model assessment of beta cell function measures as following; HOMA-β = fasting insulin (μU/mL) ×360/{fasting glucose (mg/dL) - 63}.
Time frame: Baseline and Week 12
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Change in 1,5-anhydroglucitol (1,5-AG) From Baseline at the End of the Treatment Period (Week 12)
Change from baseline in 1,5-G concentration collected at week 12 or final visit relative to baseline was reported.
Time frame: Baseline and Week 12
Number of Participants With Treatment-Emergent Adverse Events
Time frame: Up to Week 12