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
Information source: Takeda
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Essential Hypertension Complicated by Type 2 Diabetes Mellitus
Intervention: Azilsartan (Drug); Telmisartan (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Takeda Official(s) and/or principal investigator(s):
General Manager, Study Director, Affiliation: Takeda
Overall contact:
Takeda Study Registration Call Center, Phone: +1-800-778-2860, Email: medicalinformation@tpna.com
Summary
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
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change in insulin resistance index (HOMA-R)
Secondary outcome: Change in fasting blood glucose from the start of the treatment period at the end of the treatment period (Week 12)Change in fasting insulin Change in of glycosylated hemoglobin (HbA1c) HOMA-β Change in 1,5-AG Adverse events
Detailed description:
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
patients with essential hypertension complicated by type 2 diabetes mellitus.
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
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 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.
Locations and Contacts
Takeda Study Registration Call Center, Phone: +1-800-778-2860, Email: medicalinformation@tpna.com
Kyoto-Shi, Kyoto, Japan; Recruiting
Additional Information
Starting date: March 2014
Last updated: March 4, 2014
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