A Multi-center, Open-label, Randomized, Active-control, Parallel-group Designed Study to Compare Effects of Nateglinide and Acarbose on Postprandial Status in Chinese Drug-naive Type 2 Diabetes Mellitus Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 6
- 主要终点
- Change From Baseline in Postprandial Glucose Excursion (PPGE) at the End of the Study (Week 4)
研究概览
简要总结
This study was conducted to demonstrate superiority of nateglinide in postprandial glucose fluctuation, dyslipidemia, and inflammatory status improvement.
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
- •Newly diagnosed type 2 diabetes mellitus patients
- •HbA1c > 6.5 and < 9.0%
- •Fasting fingertip capillary blood glucose (FCBG) < 9 mmol/L after 2 weeks diet control
排除标准
- •History of acute metabolic complications in the past 3 months or of severe diabetic complications or severe infections or active substance abuse
- •Liver disease
- •Patients under oral hypoglycemic drugs and/or insulin treatment, or corticosteroid treatment within past 4 weeks
- •Other protocol-defined inclusion/exclusion criteria applied to the study.
研究组 & 干预措施
Nateglinide 120 mg
Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
干预措施: Nateglinide 120 mg (Drug)
Acarbose 50 mg
Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
干预措施: Acarbose 50 mg (Drug)
结局指标
主要结局
Change From Baseline in Postprandial Glucose Excursion (PPGE) at the End of the Study (Week 4)
时间窗: Baseline to the end of the study (Week 4)
Blood samples were collected for measurement of plasma glucose at 30, 60, 90, and 120 minutes following the start of a standardized meal test at Baseline and Week 4. PPGE was defined as the mean difference between the preprandial glucose value and the postprandial glucose value measured at 2 hours in a standardized meal test. 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.
次要结局
- Change From Baseline in Peak Postprandial Glucose at the End of the Study (Week 4)(Baseline to the end of the study (Week 4))
- Change From Baseline in Postprandial Glucose Area Under the Curve at the End of the Study (Week 4)(Baseline to the end of the study (Week 4))
- Change From Baseline in Total Cholesterol at the End of the Study (Week 4)(Baseline to the end of the study (Week 4))
- Change From Baseline in Triglycerides at the End of the Study (Week 4)(Baseline to the end of the study (Week 4))
- Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at the End of the Study (Week 4)(Baseline to the end of the study (Week 4))
- Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the End of the Study (Week 4)(Baseline to the end of the study (Week 4))
- Change From Baseline in Free Fatty Acids (FFA) at the End of the Study (Week 4)(Baseline to the end of the study (Week 4))
- Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) at the End of the Study (Week 4)(Baseline to the end of the study (Week 4))
- Change From Baseline in Glycosylated Serum Albumin (GSA) at the End of the Study (Week 4)(Baseline to the end of the study (Week 4))