NCT00461617已完成3 期
Multicentre, Double-Dummy, Randomized, Double-Blind Comparison Between Mitiglinide and Nateglinide in the Patients With Type 2 Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 291
- 主要终点
- Hemoglobin A1C (HbA1C)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Mitiglinide compared to Nateglinide for the treatment of type 2 diabetes.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes patients with inadequate control of blood glucose with diet and/or exercise therapy
排除标准
- •Type 1 diabetes patients
- •Patients who require treatment with insulin
- •Patients with severe diabetic complications (neuropathy, retinopathy or nephropathy)
- •Patients with severe ketosis, diabetic coma or precoma
- •Patients complicated with severe hepatic diseases
- •Patients complicated with severe renal diseases
- •Patients complicated with severe hypertension
- •Patients complicated with severe cardiac disease
- •Pregnant women or women possible to be pregnant, nursing women, or women who want to become pregnant during the study period
研究组 & 干预措施
2
Active Comparator
Nateglinide 120 mg TID
干预措施: Mitiglinide (Drug)
结局指标
主要结局
Hemoglobin A1C (HbA1C)
时间窗: -2, 0, 4, 8, 10, 12, 16, 20 week
次要结局
- Two-hour postprandial glucose level (PPG2)(0, 12, 20 week)
- One-hour postprandial glucose level (PPG1)(0, 12, 20 week)
- Fasting plasma glucose level (FPG)(0, 4, 8, 12, 16, 20 week)
研究者
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