NCT00663884已完成4 期
A Prospective, Randomized and Multi-center Clinical Study to Evaluate Efficacy and Safety of Combination Therapy of Mitiglinide or Voglibose With Long-acting Insulin in Type 2 Diabetic Patients
JW Pharmaceutical1 个研究点 分布在 1 个国家目标入组 167 人开始时间: 2008年2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
- 167
- 试验地点
- 1
- 主要终点
- Change of HbA1c before and after administration of test drug
研究概览
简要总结
We will evaluate the efficacy and safety of combination therapy of 10 mg mitiglinide or 0.2mg voglibose with insulin glargine for 16 weeks after single administration of insulin glargine for 4 weeks in type 2 diabetic patients whose glycemic control were not enough despite administration of oral antidiabetic drug or insulin glargine.
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
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The type 2 diabetic patients aged between 30 and 70
- •The patients whose Hb1Ac is over 7.0% despite administration of two or more oral antidiabetic drugs over 6 months or only insulin glargine over 3 months before registration
- •Outpatients whose BMI is between 21 and 40 kg/㎡
- •The patients who consented to participate in the clinical study in writing
排除标准
- •The patients who have been using insulin formulation except insulin glargine
- •The patients whose fasting blood glucose is over 270 mg/dL
- •The patients whose C-peptide is under 1ng/ml on an empty stomach
- •The patients who was surgically operated of gastrointestinal tract
- •The patients who need additional treatment or who underwent operation within 3 months for severe complication such as diabetic foot ulcer, retinopathy and neuropathy
- •The patients with severe hepatic dysfunction : uncompensated hepatic cirrhosis, or the case where aspartate aminotransferase (AST) or alanine aminotransferase (ALT) is over 2.5 times higher than the normal limit ( ≥ 2.5 x normal ranges)
- •The patients with unstable angina or acute myocardial infarction occurred within 3months
- •The patients with renal failure or severe hypertension : diastolic blood pressure is over 110mmHg despite drug treatment
- •The patients who have a life-threatening disease such as cancer or severe infection
- •The patients with a history of drug allergy
- •Pregnant or breast feeding or the women who are likely to be pregnant
- •The patients who need oral or parenteral corticosteroids
- •The patients who were judged to be unsuitable to the clinical study by other reasons
研究组 & 干预措施
M
Experimental
Mitiglinide
干预措施: Mitiglinide (Drug)
V
Active Comparator
Voglibose
干预措施: Voglibose (Drug)
结局指标
主要结局
Change of HbA1c before and after administration of test drug
时间窗: 20 weeks
次要结局
- Change of self-monitoring of blood glucose before and after administration of test drug(20 weeks)
- Change of insulin dose before and after administration of test drug(20 weeks)
- Achievement rate of HbA1c target level (rate of the patients whose HbA1c were improved under 6.5% after administration)(20 weeks)
- Change of CRP, 8-OHdG and Nitrotyrosine before and after administration of test drug(20 weeks)
研究者
研究点 (1)
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