Effects of Nateglinide vs Acarbose on Postprandial Glucose Fluctuation, Dyslipidemia, and Inflammatory Factors

Study Overview
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Brief Summary
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This study was conducted to demonstrate superiority of nateglinide in postprandial glucose fluctuation, dyslipidemia, and inflammatory status improvement.

Official Title
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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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Nateglinide 120 mg
* Drug: Acarbose 50 mg


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nateglinide 120 mg<br>Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks. | Drug: Nateglinide 120 mg<br>* Nateglinide 120 mg was supplied as tablets.<br>* Other names: Starlix;|
| Active Comparator: Acarbose 50 mg<br>Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks. | Drug: Acarbose 50 mg<br>* Acarbose 50 mg was supplied as tablets.<br>* Other names: Glucobay;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes mellitus, type 2, nateglinide, acarbose, hyperglycemia, dyslipidemias, C-reactive protein