Effects of Fimasartan on Insulin Secretion, and Interaction With DPP4 Inhibitors in Patients With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Insulinogenic index
研究概览
简要总结
This study was designed to evaluate the effect of ARB in improving insulin secretion in patients with type 2 diabetes. The investigators also aimed to evaluate if there are potential synergisms between ARB and DPP4 inhibitors in improving insulin secretion and urinary albumin secretion in diabetic patients.
详细描述
Angiotensin II has been reported to insulin secretion in beta cells. Angiotensin II indirectly improves insulin secretion in beta cells via vasoconstriction and reduced islet blood flow. Chronic exposure to high glucose or high fat increases expression of AT1R (angiotensin type 1 receptor), leading to reactive oxidative stresses, inflammation, and apoptosis in beta cells, finally decreased insulin formation and secretion. Some studies showed the beneficial effect of blocking AT1R on insulin secretion and beta cell proliferation in animal models using angiotensin receptor blocker (ARB). Furthermore, 26 weeks of valsartan treatment improved insulin secretion in humans with impaired glucose regulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 20~80 years
- •Type 2 diabetic patients diagnosed more than 6 months ago
- •HbA1c ≤8.5% at screening
- •No change of OAD within the 3 months before screening
- •SBP <140 mmHg and DBP <90 mmHg with anti-hypertensive drug at screening
- •SBP ≥140 mmHg or DBP ≥80 mmHg without anti-hypertensive drug at screening
排除标准
- •Type 1 diabetic patients or active insulin treatment at screening
- •Treatment with ARB or ACEi within 1 month prior to screening
- •Uncontrolled hypertension with SBP >170 mmHg or DBP >100 mmHg
- •Pregnancy or lactation
- •Elevated liver enzyme (AST or ALT > 3 times the UNL) or elevated serum Cr (≥1.5 mg/dL in men and 1.4 mg/dL in women)
研究组 & 干预措施
Fimasartan
Expreimental drug is fimasartan.
干预措施: Fimasartan (Drug)
Amlodipine
Active comparator is amlodipine.
干预措施: Amlodipine (Drug)
结局指标
主要结局
Insulinogenic index
时间窗: 16 week
次要结局
- HOMA β-cell function(16 week)
- Insulin resistance(16 week)
- Urinary albumin creatinine ratio, urinary protein creatinine ratio(16 week)
研究者
Hye Seung Jung
Associate professor
Seoul National University Hospital