Multicenter Trial on Effects of Alogliptin on Pancreatic Beta Cell Function
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- beta cell function evaluated from 75 g OGTT
研究概览
简要总结
It is reported that pancreatic beta cell function is already declined at pre-diabetic stage, impaired glucose tolerance (IGT). It has not been clarified whether inhibitors of the dipeptidyl peptidase IV enzyme (DPP-IV inhibitors) improve beta cell function on human pancreas, however, if efficacy is ensured, they may become the first medicine to be chosen for treatments of type 2 diabetes and IGT.
In this trial, a DPP-IV inhibitor, Alogliptin, or Metformin are given to diabetic patients whose HbA1c level is below 7.9%. Oral glucose tolerance test (OGTT) will be conducted before, a year after, and two years after the beginning of the trial and beta cell function will be evaluated.
详细描述
Patients will be randomly allocated to two groups. They will receive either Alogliptin or Metformin.
Alogliptin: The investigators will start with 25 mg QD and the dose will be maintained.
Metformin: The investigators will start with 250 mg QD and the dose will be slowly increased to 750 mg TID. The dose increase is possible up to its maximum, 2250 mg, so that HbA1c is maintained below 6.9%. However, increase in dose with elder patients requires careful consideration.
Participants taking part in this study will receive dietary and exercise coaching. Participation in this study is expected to last up to 2 years.
Patients will terminate from the trial when their HbA1c exceeds 8.4% for more than three months.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are diagnosed as type 2 diabetes with HbA1c level below 7.9% and haven't received oral hypoglycemic agents or insulin treatments for the past three months.
排除标准
- •Patients whose 75 g OGTT 30-minutes insulin secretion exceeds 100 μU/ml
- •Patients with renal failure with serum creatinine level ≧ 1.2
- •Patients with hepatocirrhosis
- •Patients with proliferative diabetic retinopathy or worse
- •Patients with acute infectious disease
- •Patients who are treated with steroids
- •Patients with cancer
- •Pregnant patients
- •Patients with malfunction of the heart (NYHA classification III-IV)
- •Patients who are decided to be inappropriate subjects by study physicians
研究组 & 干预措施
Alogliptin
Alogliptin 25 mg
干预措施: Alogliptin (Drug)
Metformin
Metformin 750 mg
干预措施: Metformin 750 mg (Drug)
结局指标
主要结局
beta cell function evaluated from 75 g OGTT
时间窗: 2 years
75 g OGTT: glucose level, blood insulin level, c-peptide immunoreactivity (pre-test, 30 mins, 60 mins, 120 mins), fasting blood proinsulin Oral glucose tolerance test ( OGTT ) will be conducted before, a year after, and two years after the beginning of the trial.
次要结局
- 1,5-AG level(2 years)