- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02079805
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
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Kyoto
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Kyoto-Shi, Kyoto, Japan
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 severe hepatic disorder
- History of hypersensitivity or allergy to azilsartan or telmisartan or to both.
- Presence of hyperkalemia (potassium level ≥ 5.5 mEq/L on laboratory testing)
- Currently participating in any other clinical study.
- Pregnant women, women with possible pregnancy, or breast-feeding women.
- Other participants who are inappropriate for participation in this study in the opinion of the principal investigator or investigator.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Azilsartan 20 mg
Participants will receive azilsartan 20 mg once daily in the morning before or after breakfast.
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Azilsartan tablets
Other Names:
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Active Comparator: Telmisartan 40 mg
Participants will receive telmisartan 40 mg once daily in the morning before or after breakfast.
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Telmisartan tablets
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Insulin Resistance Index (HOMA-R) From Baseline at the End of the Treatment Period (Week 12)
Time Frame: Baseline and Week 12
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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).
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Baseline and Week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Fasting Blood Glucose From Baseline at the End of the Treatment Period (Week 12)
Time Frame: Baseline and Week 12
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Change from baseline in fasting blood glucose values collected at week 12 or final visit relative to baseline was reported.
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Baseline and Week 12
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Change in Fasting Insulin From Baseline at the End of the Treatment Period (Week 12)
Time Frame: Baseline and Week 12
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Change from baseline in fasting insulin values collected at week 12 or final visit relative to baseline was reported.
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Baseline and Week 12
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Change in Glycosylated Hemoglobin (HbA1c) From Baseline at the End of the Treatment Period (Week 12)
Time Frame: Baseline and Week 12
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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.
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Baseline and Week 12
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Change in Homeostasis Model Assessment of Beta Cell Function (HOMA-β) From Baseline at the End of the Treatment Period (Week 12)
Time Frame: Baseline and Week 12
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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}.
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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)
Time Frame: Baseline and Week 12
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Change from baseline in 1,5-G concentration collected at week 12 or final visit relative to baseline was reported.
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Baseline and Week 12
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Number of Participants With Treatment-Emergent Adverse Events
Time Frame: Up to Week 12
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Up to Week 12
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Hyperinsulinism
- Hypertension
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Insulin Resistance
- Essential Hypertension
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Azilsartan medoxomil
- Telmisartan
Other Study ID Numbers
- 279/NRP-001
- U1111-1151-7168 (Registry Identifier: UTN (WHO))
- AZI-P4-004 (Other Identifier: Takeda)
- JapicCTI-142461 (Registry Identifier: JapicCTI)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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