| Trial ID: | L2634 |
| Source ID: | NCT00928889
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| Associated Drug: |
Nateglinide 120 Mg
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| Title: |
Effects of Nateglinide vs Acarbose on Postprandial Glucose Fluctuation, Dyslipidemia, and Inflammatory Factors
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| Acronym: |
ENERGY
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| Status: |
COMPLETED
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| Study Results: |
YES
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| Results: |
https://ClinicalTrials.gov/show/NCT00928889/results
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| Conditions: |
Diabetes Mellitus, Type 2
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| Interventions: |
DRUG: Nateglinide 120 mg|DRUG: Acarbose 50 mg
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| Outcome Measures: |
Primary: Change From Baseline in Postprandial Glucose Excursion (PPGE) at 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., Baseline to the end of the study (Week 4) | Secondary: Change From Baseline in Peak Postprandial Glucose at 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. 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., 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), 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., Baseline to the end of the study (Week 4)|Change From Baseline in Total Cholesterol at the End of the Study (Week 4), 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., Baseline to the end of the study (Week 4)|Change From Baseline in Triglycerides at the End of the Study (Week 4), 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., 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), 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., 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), 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., 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), 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., 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), 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., 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), 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., Baseline to the end of the study (Week 4)
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| Sponsor/Collaborators: |
Sponsor: Novartis Pharmaceuticals
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE4
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| Enrollment: |
160
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
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| Start Date: |
2009-07
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| Completion Date: |
2010-06
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| Results First Posted: |
2011-07-07
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| Last Update Posted: |
2012-05-10
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| Locations: |
People's Liberation Army. The Military General Hospital of BeiJing, BeiJing, 100020, China|Peiking University First Hospital, BeiJing, 100034, China|Chinese PLA General Hospital, Beijing, 100853, China|The First Affiliated Hospital, Zhongshan (Sun Yat-sen) University, Guangzhou, 510080, China|The Second Affiliated Hospital, Zhongshan (Sun Yat-sen) University, Guangzhou, 510120, China|Nanfang Hospital, the Affiliated South Hospital of the Southern Medical University, Guangzhou, 510515, China
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| URL: |
https://clinicaltrials.gov/show/NCT00928889
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