Multi-center, Randomized, Open Label Study of the Durability of Glycemic Control With Nateglinide Versus Glimepiride as Monotherapy in Type 2 Diabetic Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 7
- 主要终点
- The Durability of Nateglinide in Comparison With Those of Glimepiride Based on the Withdrawal Rate
研究概览
简要总结
This multi-center, randomized controlled study aims to evaluate the durability and efficacy of nateglinide therapy for long term glycemic control compared with glimepiride.
详细描述
Selected patients will be randomly assigned to receive nateglinide or glimepiride.
Previous treatment with oral antidiabetic drugs (metformin, a-glucosidase inhibitor, nateglinide or sulfonylurea) will be discontinued. After a 1 month wash-out period (if 6.5 ≤ HbA1c ≤ 8.5), patients will take randomly assigned drugs for 24 months.
Patients will be met by the trial investigator every 3 months following randomization. At each visit, patients whose HbA1c is > 8.0% will be retested 2 weeks later, and if the retested HbA1c is also above 8.0%, those patients will be withdrawn considering monotherapy failure. We will evaluate the durability of nateglinide in comparison with that of glimepiride based on the withdrawal rate.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 2 diabetes mellitus
- •age>=18years
- •no anti hyperglycemic agent for 3 months or low-dose oral hypoglycemic therapy
- •metformin≤1g/day, acarbose≤300mg/day, voglibose≤0.9mg/day, nateglinide≤270mg/day, gliclazide≤80mg/day, glimepiride≤2mg/day, glibenclamide≤5mg/day (nateglinide or sulfonylurea <6months)
- •6.5% ≤ HbA1c ≤ 8.5%
- •patients on no anti hyperglycemic agent for 3 months : HbA1c at screening
- •patients on oral hypoglycemic therapy in 3months : HbA1c after wash-out
排除标准
- •attending other clinical trials in 3months
- •type I diabetes mellitus
- •taking systemic steroid in 1month or requiring steroid therapy during clinical trial
- •acute myocardial infarction in 6months
- •alcoholics, pituitary or adrenal insufficiency, severe ketosis, diabetic ketoacidosis
- •severe liver disease or AST, ALT ≥ 2.5 x ULN
- •renal insufficiency (serum creatinine > 2.0mg/dl)
- •other severe diabetic complication
- •drug hypersensitivity history to nateglinide or sulfonylurea
- •pregnant or plan to become pregnant during the clinical trial, lactation
研究组 & 干预措施
Nateglinide
Nateglinide 90~120mg three times a day
干预措施: Nateglinide (Drug)
Glimepiride
Glimepiride 1~2mg once a day
干预措施: Glimepiride (Drug)
结局指标
主要结局
The Durability of Nateglinide in Comparison With Those of Glimepiride Based on the Withdrawal Rate
时间窗: every 3 months following randomization, for 24 months
% monotherapy failure, that means % number of participants who withdrew from the study due to high HbA1c (\>8.0%)
次要结局
- HbA1c(at 24 months)
- Fasting Glucose(at 24 months)
- HOMA-IR(at 24 months)
- C-peptide(at 24 months)
研究者
Kwan Woo Lee
Professor
Ajou University School of Medicine