A 3-week, Multi-center, Open-label, Randomized, Active-control, Parallel-group Study to Compare Effects of Nateglinide and Acarbose on Postprandial Glucose Fluctuation in Chinese Drug-naive Patients Type 2 Diabetes Mellitus
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 3
- 主要终点
- Change in Area Under Curve of 0-4 Hours Postprandial Glucose (AUCpp0-4hours) in Standardized Meal Test Using Continuous Glucose Monitoring System (CGMS)
研究概览
简要总结
A 3-week, multi-center, open-label, randomized, active-control, parallel-group study to compare effects of Nateglinide and Acarbose on postprandial glucose fluctuation in Chinese drug-naive patients type 2 diabetes mellitus (T2DM). In this study, participants in different groups took Nateglinide at a dose of 120 mg orally three times daily for up to 3 weeks or Acarbose at a dose of 50 mg three times daily for up to 3 weeks, respectively.
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 75 Years（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
Nateglinide
Nateglinide tablets, oral administration, three times daily, 120 mg orally 10 minutes immediately before 3 meals three times daily.
干预措施: Nateglinide (Drug)
Acarbose
Acarbose tablets, oral administration, three times daily, dosage of 50 mg orally chewing with the first bite of a meal three times daily.
干预措施: Acarbose (Drug)
结局指标
主要结局
Change in Area Under Curve of 0-4 Hours Postprandial Glucose (AUCpp0-4hours) in Standardized Meal Test Using Continuous Glucose Monitoring System (CGMS)
时间窗: 3 weeks (end of study) minus baseline
The postprandial glucose area under the curve (AUC)was calculated using values from the 3 time points. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM. 0-4 hours AUC were calculated using trapezoid methods.
次要结局
- Change in Incremental Glucose Peak (IGP) From Baseline(baseline, 3 weeks (end of study))
- Change in Mean Blood Glucose (MBG)(baseline and at 3 weeks (end of study))
- Change in Standard Deviation (SD) From Baseline of Mean Blood Glucose (MBG) Over 24 Hours.(baseline, 3 weeks (end of study))
- Change in Mean of Daily Difference of Paired Blood Glucose Value (MODD)(baseline, 3 weeks (end of study))
- Changes in 24 Hour Glucose Area Under Curve (AUCpp)(baseline, end of study (3 weeks))
- Change in Glycated Serum Albumin (GSA) Levels From Baseline After Treatment(baseline, 3 weeks (end of study))
- Change in Insulin Levels (μU/ml) During Standardized Meal Test at Endpoint From Baseline(baseline, 3 weeks (end of study))
- Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)(baseline, 3 weeks (end of study))
- Change of Total Cholesterol in Blood Lipids Levels During Standardized Meal Test at Endpoint From Baseline at Each Time Point(baseline, 3 weeks (end of study))
- Change in Triglyceride (TG)Levels in Blood Lipid Levels During Standardized Meal Test at Endpoint(baseline, 3 weeks (end of study))
- Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the End of the Study(baseline, 3 weeks (end of study))
- Change in Mean Amplitude of Glycaemic Excursion (MAGE)(baseline, 3 weeks (end of study))
- The Percent of 24 Hour Hypoglycemic Measurements(baseline, 3 weeks (end of study))
- Change in Percent of 24 Hour Hyperglycemic Measurements(baseline, 3 weeks (end of study))