NCT01582243已完成4 期
A Prospective, Open-label, Interventional Study to Assess the HbA1c Change an 24-hr Glucose Fluctuation After Vildagliptin Plus Metformain (SPC) Treatment in Metformin Monotherapy Uncontrolled Type 2 Diabetes Mellitus Patients
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24
研究概览
简要总结
This study will assess the efficacy of vildagliptin plus metformin (SPC) treatment in type 2 diabetes mellitus patients uncontrolled by metformin monotherapy after 24 weeks treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Vildagliptin plus metformin (SPC)
Experimental
Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
干预措施: Vildagliptin (Drug)
结局指标
主要结局
Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24
时间窗: Baseline, Week 24
HbA1c analysis will be performed on a blood sample obtained by study personnel.
次要结局
- Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12(Baseline, week 12)
- Mean Change From Baseline in Fasting Plasma Glucose(FPG) at Week 12 and 24(Baseline, week 12, week 24)
- Mean Change From Baseline in Postprandial Plasma Glucose(PPG) at Week 12 and 24(Baseline, week, week 24)
- Mean Change From Baseline in Mean Amplitude of Glycemic Excursions (MAGE) Detected by Continuous Glucose Monitoring System (CGMS) After 24-week(Baseline, week 24)
- The Percentage of Patients Achieving the Two Glycemic Goals After 12- and 24-week Treatment(week 12, week 24)
研究者
研究点 (1)
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