Effects of Nateglinide vs Acarbose on Postprandial Glucose Fluctuation, Dyslipidemia, and Inflammatory Factors (ENERGY)
2012年5月7日 更新者：Novartis Pharmaceuticals
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
This study was conducted to demonstrate superiority of nateglinide in postprandial glucose fluctuation, dyslipidemia, and inflammatory status improvement.
研究概览
研究类型
介入性
注册 (实际的)
160
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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BeiJing、中国、100020
- People's Liberation Army. The Military General Hospital of BeiJing
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BeiJing、中国、100034
- Peiking University First Hospital
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Beijing、中国、100853
- Chinese PLA General Hospital
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Guangzhou、中国、510080
- The First Affiliated Hospital, Zhongshan (Sun Yat-sen) University
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Guangzhou、中国、510120
- The Second Affiliated Hospital, Zhongshan (Sun Yat-sen) University
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Guangzhou、中国、510515
- Nanfang Hospital, the Affiliated South Hospital of the Southern Medical University
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Nateglinide 120 mg
Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
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Nateglinide 120 mg was supplied as tablets.
其他名称：
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有源比较器：Acarbose 50 mg
Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
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Acarbose 50 mg was supplied as tablets.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change From Baseline in Postprandial Glucose Excursion (PPGE) at the End of the Study (Week 4)
大体时间：Baseline to the end of the study (Week 4)
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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.
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Baseline to the end of the study (Week 4)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change From Baseline in Peak Postprandial Glucose at the End of the Study (Week 4)
大体时间：Baseline to the end of the study (Week 4)
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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. The peak postprandial glucose values were used in the calculation of change from Baseline at Week 4. 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.
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Baseline to the end of the study (Week 4)
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Change From Baseline in Postprandial Glucose Area Under the Curve at the End of the Study (Week 4)
大体时间：Baseline to the end of the study (Week 4)
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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. The postprandial glucose area under the curve was calculated using values from the 4 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.
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Baseline to the end of the study (Week 4)
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Change From Baseline in Total Cholesterol at the End of the Study (Week 4)
大体时间：Baseline to the end of the study (Week 4)
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Blood samples were collected for measurement of total cholesterol prior to (fasting) and 120 minutes following the start of a standardized meal test at Baseline and Week 4. 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.
Total cholesterol was assessed at each study site using the same method and same reference value.
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Baseline to the end of the study (Week 4)
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Change From Baseline in Triglycerides at the End of the Study (Week 4)
大体时间：Baseline to the end of the study (Week 4)
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Blood samples were collected for measurement of triglycerides prior to (fasting) and 120 minutes following the start of a standardized meal test at Baseline and Week 4. 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.
Triglycerides were assessed at each study site using the same method and same reference value.
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Baseline to the end of the study (Week 4)
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Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at the End of the Study (Week 4)
大体时间：Baseline to the end of the study (Week 4)
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Blood samples were collected for measurement of LDL-C prior to (fasting) and 120 minutes following the start of a standardized meal test at Baseline and Week 4. 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.
LDL-C was assessed at each study site using the same method and same reference value.
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Baseline to the end of the study (Week 4)
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Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the End of the Study (Week 4)
大体时间：Baseline to the end of the study (Week 4)
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Blood samples were collected for measurement of HDL-C prior to (fasting) and 120 minutes following the start of a standardized meal test at Baseline and Week 4. 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.
HDL-C was assessed at each study site using the same method and same reference value.
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Baseline to the end of the study (Week 4)
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Change From Baseline in Free Fatty Acids (FFA) at the End of the Study (Week 4)
大体时间：Baseline to the end of the study (Week 4)
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Blood samples were collected for measurement of FFA prior to (fasting) and 30, 60, 90, and 120 minutes following the start of a standardized meal test at Baseline and Week 4. 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.
FFA was assayed at a central laboratory.
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Baseline to the end of the study (Week 4)
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Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) at the End of the Study (Week 4)
大体时间：Baseline to the end of the study (Week 4)
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Blood samples were collected for measurement of hsCRP prior to (fasting) and 30, 60, 90, and 120 minutes following the start of a standardized meal test at Baseline and Week 4. 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. hsCRP was assayed at a central laboratory.
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Baseline to the end of the study (Week 4)
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Change From Baseline in Glycosylated Serum Albumin (GSA) at the End of the Study (Week 4)
大体时间：Baseline to the end of the study (Week 4)
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Blood samples were collected for measurement of GSA prior to (fasting) the start of a standardized meal test at Baseline and Week 4. 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.
GSA was assayed at a central laboratory.
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Baseline to the end of the study (Week 4)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2009年7月1日
初级完成 (实际的)
2010年6月1日
研究完成 (实际的)
2010年6月1日
研究注册日期
首次提交
2009年6月25日
首先提交符合 QC 标准的
2009年6月25日
首次发布 (估计)
2009年6月26日
研究记录更新
最后更新发布 (估计)
2012年5月10日
上次提交的符合 QC 标准的更新
2012年5月7日
最后验证
2012年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.