Glycemic Excursions in Type 2 Diabetic Patients Treated With Vildagliptin and Metformin (GalvusMet) Versus Glimepiride and Metformin
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
- Glycemic Variability Measured by Mean Amplitude of Glucose Excursions (MAGE)
研究概览
简要总结
The purpose of this study was to compare the effect of a fixed dose combination of vildagliptin plus metformin versus combination therapy of glimepiride plus metformin in glycemic variability in patients with type 2 diabetes who have not achieved adequate control of their disease prior to treatment with metformin monotherapy in optimal doses.
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
- •HbA1c between 8%-10.5% in stable metformin dose (>1500 mg/day), four weeks prior visit 1
排除标准
- •Use of other antidiabetic oral therapy during the last 3 months (sulphonylurea, glitazones, GLP-1 analogues, DPP-4 inhibitors), except metformin
研究组 & 干预措施
vildagliptin and metformin
Based on basal dose of metformin, administration of vildagliptin/metformin 50 mg/850 mg twice daily (bid) or 50 mg/1000 mg bid for 12 weeks
干预措施: vildagliptin and metformin (combination) (Drug)
glimepiride and metformin
Protocol specified dosage and frequency of glimepiride + metformin for 12 weeks based on basal dose of metformin
干预措施: glimepiride (Drug)
glimepiride and metformin
Protocol specified dosage and frequency of glimepiride + metformin for 12 weeks based on basal dose of metformin
干预措施: Metformin (Drug)
结局指标
主要结局
Glycemic Variability Measured by Mean Amplitude of Glucose Excursions (MAGE)
时间窗: Week 12
Mean Amplitude of Glycemic Excursions (MAGE) , which determines the average blood glucose excursions either above or below a value of one standard deviation of the average value of glucose in a given day. MAGE is calculated from the data of continuous tissue glucose monitoring obtained during the measurement period. MAGE is calculated with the formula Σ λ / χ if λ\> ν (where λ = changes in blood glucose from peak to nadir, χ = number of valid observations, ν = 1 standard deviation of the mean glucose during a period of 24 hours) from the data of continuous monitoring of the tissue glucose, obtained during the period of measurement.
次要结局
- Glycemic Variability Measured by Continuous Overlapping Net Glycemic Action (CONGA)(Week 12)
- Glycemic Variability Measured by Total Standard Deviation (TSD)(Week 12)
- Percentage of Patients Who Achieved a Decrease Equal to or Greater Than 0.3% in Value of HbA1c at Week 12(Screening visit , 12 weeks of treatment)
- Change in HbA1c at Week 12 of Treatment in Comparison to HbA1c at Baseline(baseline, 12 weeks of treatment)
- Number of Patients With Incidence of Hypoglycemia(12 weeks)
- Mean Amplitude of Glycemic Excursions (MAGE) for Patients With Hypoglycemia Incidence After 12 Weeks of Treatment(12 weeks)
- Number of Patients With Any Adverse Events, Serious Adverse Events and Death(12 weeks)