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This study was conducted to demonstrate superiority of nateglinide in postprandial glucose fluctuation, dyslipidemia, and inflammatory status improvement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nateglinide 120 mg | Experimental | Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks. |
|
| Acarbose 50 mg | Active Comparator | Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nateglinide 120 mg | Drug | Nateglinide 120 mg was supplied as tablets. |
|
| 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) |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria applied to the study.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| People's Liberation Army. The Military General Hospital of BeiJing | Beijing | 100020 | China | |||
| Peiking University First Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17376293 | Background | Gao HW, Xie C, Wang HN, Lin YJ, Hong TP. Beneficial metabolic effects of nateglinide versus acarbose in patients with newly-diagnosed type 2 diabetes. Acta Pharmacol Sin. 2007 Apr;28(4):534-9. doi: 10.1111/j.1745-7254.2007.00534.x. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nateglinide 120 mg | Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks. |
| FG001 | Acarbose 50 mg | Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nateglinide 120 mg | Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks. |
| BG001 | Acarbose 50 mg | Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable. | Posted | Mean | Standard Deviation | mmol/L | Baseline to the end of the study (Week 4) |
|
Baseline to the end of the study (Week 4)
Safety Population.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nateglinide 120 mg | Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862 778-8300 |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D006943 | Hyperglycemia |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077715 | Nateglinide |
| D020909 | Acarbose |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| Acarbose 50 mg | Drug | Acarbose 50 mg was supplied as tablets. |
|
|
| 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) |
| 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 |
| Adverse Event |
|
| Other |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
| OG001 | Acarbose 50 mg | Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks. |
|
|
| 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. | Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable. | Posted | Mean | Standard Deviation | mmol/L | Baseline to the end of the study (Week 4) |
|
|
|
| Secondary | 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. | Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable. | Posted | Mean | Standard Deviation | mmol*min/L | Baseline to the end of the study (Week 4) |
|
|
|
| Secondary | 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. | Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable. | Posted | Mean | Standard Deviation | mmol/L | Baseline to the end of the study (Week 4) |
|
|
|
| Secondary | 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. | Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable. | Posted | Mean | Standard Deviation | mmol/L | Baseline to the end of the study (Week 4) |
|
|
|
| Secondary | 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. | Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable. | Posted | Mean | Standard Deviation | mmol/L | Baseline to the end of the study (Week 4) |
|
|
|
| Secondary | 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. | Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable. | Posted | Mean | Standard Deviation | mmol/L | Baseline to the end of the study (Week 4) |
|
|
|
| Secondary | 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. | Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable. | Posted | Mean | Standard Deviation | mmol/L | Baseline to the end of the study (Week 4) |
|
|
|
| Secondary | 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. | Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable. | Posted | Mean | Standard Deviation | mg/dL | Baseline to the end of the study (Week 4) |
|
|
|
| Secondary | 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. | Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable. | Posted | Mean | Standard Deviation | Percentage | Baseline to the end of the study (Week 4) |
|
|
|
| 0 |
| 80 |
| 5 |
| 80 |
| EG001 | Acarbose 50 mg | Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks. | 0 | 80 | 7 | 80 |
| Flatulence | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
| D004700 | Endocrine System Diseases |
| D052439 | Lipid Metabolism Disorders |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014312 | Trisaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| 60 minutes, N=72, 75 |
|
| 90 minutes, N=72, 75 |
|
| 120 minutes, N=73, 75 |
|
| 60 minutes, N=72, 75 |
|
| 90 minutes, N=72, 75 |
|
| 120 minutes, N=72, 74 |
|