NCT02079805已完成4 期
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
Takeda0 个研究点目标入组 33 人开始时间: 2014年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 主要终点
- Change in Insulin Resistance Index (HOMA-R) From Baseline at the End of the Treatment Period (Week 12)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Azilsartan 20 mg
Experimental
Participants will receive azilsartan 20 mg once daily in the morning before or after breakfast.
干预措施: Azilsartan (Drug)
Telmisartan 40 mg
Active Comparator
Participants will receive telmisartan 40 mg once daily in the morning before or after breakfast.
干预措施: Telmisartan (Drug)
结局指标
主要结局
Change in Insulin Resistance Index (HOMA-R) From Baseline at the End of the Treatment Period (Week 12)
时间窗: Baseline and 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).
次要结局
- Change in Fasting Blood Glucose From Baseline at the End of the Treatment Period (Week 12)(Baseline and Week 12)
- Change in Fasting Insulin From Baseline at the End of the Treatment Period (Week 12)(Baseline and Week 12)
- Change in Glycosylated Hemoglobin (HbA1c) From Baseline at the End of the Treatment Period (Week 12)(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)(Baseline and Week 12)
- Change in 1,5-anhydroglucitol (1,5-AG) From Baseline at the End of the Treatment Period (Week 12)(Baseline and Week 12)
- Number of Participants With Treatment-Emergent Adverse Events(Up to Week 12)
研究者
相似试验
未知
Unknown
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 (AT-HOMA)Essential hypertension complicated by type 2 diabetes mellitusJPRN-jRCT1080222411TAKEDA PHARMACEUTICAL COMPANY LTD.40
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