NCT00369148已完成4 期
Evaluation of Usefulness of Combination Therapy of Rapid Acting Insulin Secretagogue (Glinide) With Premixed Insulin in Type 2 Diabetes
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 12
- 主要终点
- glycohemoglobin
研究概览
简要总结
Combination therapy of glinides with premixed insulin provides better glycemic control than premixed insulin alone.
详细描述
Type 2 diabetic patients undergoing twice daily injections of premixed insulin are administered glinides (10mg of mitiglinide or 90 mg of nateglinide) at lunchtime without changing their insulin regimen. Twelve weeks after administration of the glinides, they are discontinued. HbA1c levels at the start of glinide administration, 12 weeks after administration, and 12 weeks after discontinuation are measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of type 2 diabetes
- •Who undergoes twice daily injection of premixed insulin
- •Whose HbA1c is more than 6.5% and less than 8.0%
排除标准
- •Whose change of HbA1c is more than 1.0% during 12 weeks observational period
结局指标
主要结局
glycohemoglobin
次要结局
- anhydroglucitol
- lipid profile
- body weight
- blood pressure
研究者
研究点 (12)
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