Essential Hypertension Complicated by Type 2 Diabetes Mellitus Clinical Trial
Official title:
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
| Verified date | July 2016 |
| Source | Takeda |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Japan: Ministry of Health, Labor and Welfare |
| Study type | Interventional |
Multicenter, randomized, open-label, parallel-group exploratory study to explore the effects of azilsartan (Azirva), compared with telmisartan, on insulin resistance in patients with essential hypertension complicated by type 2 diabetes mellitus
| Status | Completed |
| Enrollment | 33 |
| Est. completion date | April 2016 |
| Est. primary completion date | April 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years and older |
| Eligibility |
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 subject 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 patients who are inappropriate for participation in this study in the opinion of the principal investigator or investigator. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Takeda |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in insulin resistance index (HOMA-R) | Change from the start of the treatment period at the end of the treatment period | Baseline and Week 12 | No |
| Secondary | Change in fasting blood glucose from the start of the treatment period at the end of the treatment period (Week 12) | The change between the fasting plasma glucose value collected at week 12 or final visit relative to baseline. | Baseline and Week 12 | No |
| Secondary | Change in fasting insulin | The change between the fasting insulin value collected at week 12 or final visit relative to baseline. | Baseline and Week 12 | No |
| Secondary | Change in of glycosylated hemoglobin (HbA1c) | 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. | Baseline and Week 12 | No |
| Secondary | HOMA-ß | Change from the start of the treatment period to the end of the treatment period | Baseline and Week 12 | No |
| Secondary | Change in 1,5-AG | Change from the start of the treatment period to the end of the treatment period | Baseline and Week 12 | No |
| Secondary | Adverse events | 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. | For 12 weeks | Yes |