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A 3-week, multi-center, open-label, randomized, active-control, parallel-group study to compare effects of Nateglinide and Acarbose on postprandial glucose fluctuation in Chinese drug-naive patients type 2 diabetes mellitus (T2DM). In this study, participants in different groups took Nateglinide at a dose of 120 mg orally three times daily for up to 3 weeks or Acarbose at a dose of 50 mg three times daily for up to 3 weeks, respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nateglinide | Experimental | Nateglinide tablets, oral administration, three times daily, 120 mg orally 10 minutes immediately before 3 meals three times daily. |
|
| Acarbose | Active Comparator | Acarbose tablets, oral administration, three times daily, dosage of 50 mg orally chewing with the first bite of a meal three times daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nateglinide | Drug | Nateglinide tablets, oral administration, three times daily, 120 mg orally 10 minutes immediately before 3 meals three times daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Area Under Curve of 0-4 Hours Postprandial Glucose (AUCpp0-4hours) in Standardized Meal Test Using Continuous Glucose Monitoring System (CGMS) | The postprandial glucose area under the curve (AUC)was calculated using values from the 3 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. 0-4 hours AUC were calculated using trapezoid methods. | 3 weeks (end of study) minus baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Incremental Glucose Peak (IGP) From Baseline | Incremental glucose peak (IGP) was the maximal incremental increase in blood glucose obtained at any point after meal | baseline, 3 weeks (end of study) |
| Change in Mean Blood Glucose (MBG) |
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Inclusion criteria
Exclusion criteria
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (>5 mIU/mL).
With known hypersensitivity to Nateglinide, Acarbose or any of the excipients.
A history of,
Evidence of significant diabetic complications, e.g., symptomatic autonomic neuropathy or gastroparesis.
Acute infections which may affect blood glucose control within 4 weeks prior to visit 1.
Congestive heart failure requiring pharmacologic treatment. mg/dL (123μmol/L)
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sir Run Run Shaw Hospital, 3 East Qingchun Road | Hangzhou | 310016 | China | |||
| Shanghai Tongji Hospital, 389 Xinchun Road |
| 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. | |
| 25781235 | Derived | Zhou J, Deng Z, Lu J, Li H, Zhang X, Peng Y, Mo Y, Bao Y, Jia W. Differential therapeutic effects of nateglinide and acarbose on fasting and postprandial lipid profiles: a randomized trial. Diabetes Technol Ther. 2015 Apr;17(4):229-34. doi: 10.1089/dia.2014.0299. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nateglinide | 120 mg by mouth, three times daily 10 minutes immediately before 3 meals |
| FG001 | Acarbose | patients in Acarbose group received Acarbose 50 mg by mouth, three times daily with the first bite of a meal |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nateglinide | 120 mg by mouth, three times daily 10 minutes immediately before 3 meals |
| BG001 | Acarbose | patients in Acarbose group received Acarbose 50 mg by mouth, three times daily with the first bite of a meal |
| 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 in Area Under Curve of 0-4 Hours Postprandial Glucose (AUCpp0-4hours) in Standardized Meal Test Using Continuous Glucose Monitoring System (CGMS) | The postprandial glucose area under the curve (AUC)was calculated using values from the 3 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. 0-4 hours AUC were calculated using trapezoid methods. | Intent to Treat population - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline. | Posted | Least Squares Mean | 95% Confidence Interval | millimoles hours per litre (mmol*hr/L) | 3 weeks (end of study) minus baseline |
|
3 weeks
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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 by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | +1-800-244-7668 |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| 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 | Drug | Acarbose tablets, oral administration, three times daily, dosage of 50 mg orally chewing with the first bite of a meal three times daily. |
|
The 24 hour mean blood glucose (MBG) level was calculated as the mean of all the consecutive readings on baseline and end of study(3 weeks later) separately.
| baseline and at 3 weeks (end of study) |
| Change in Standard Deviation (SD) From Baseline of Mean Blood Glucose (MBG) Over 24 Hours. | Change in standard deviation (SD) from baseline of mean blood glucose (MBG) describes the range of blood glucose fluctuation over 24 hours. | baseline, 3 weeks (end of study) |
| Change in Mean of Daily Difference of Paired Blood Glucose Value (MODD) | The mean of the daily differences (MODD), calculated as the average absolute difference of paired glucose values during two successive 24 hour periods, was used to assess day-to-day glycaemic variability. | baseline, 3 weeks (end of study) |
| Changes in 24 Hour Glucose Area Under Curve (AUCpp) | 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, end of study (3 weeks) |
| Change in Glycated Serum Albumin (GSA) Levels From Baseline After Treatment | GSA levels were to be determined by CGMS at 7:00~10:00 am in the 4-hour standardized meal test before treatment after overnight fasting for efficacy assessments | baseline, 3 weeks (end of study) |
| Change in Insulin Levels (μU/ml) During Standardized Meal Test at Endpoint From Baseline | This outcome measure calculated the change in insulin levels between groups over time at 0, 30 then 120 minutes | baseline, 3 weeks (end of study) |
| Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | change in LDL-C at 0, 30 and 120 minutes | baseline, 3 weeks (end of study) |
| Change of Total Cholesterol in Blood Lipids Levels During Standardized Meal Test at Endpoint From Baseline at Each Time Point | time to change in Total Cholesterol blood lipids level at 0, 30, 120 minutes | baseline, 3 weeks (end of study) |
| Change in Triglyceride (TG)Levels in Blood Lipid Levels During Standardized Meal Test at Endpoint | TG change in blood lipids level from baseline to endpoint | baseline, 3 weeks (end of study) |
| Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the End of the Study | 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 3. 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, 3 weeks (end of study) |
| Change in Mean Amplitude of Glycaemic Excursion (MAGE) | mean amplitude of glycaemic excursion (MAGE) is an average of the amplitudes of all glycemic excursions greater than a prespecified threshold size | baseline, 3 weeks (end of study) |
| The Percent of 24 Hour Hypoglycemic Measurements | Measures/compares changes in percentage of hypoglycemia(<3.9mmol/l or <70 mg/dl) in glucose measurements in 24hours by continuous glucose monitoring system (CGMS) at endpoint from baseline between groups. Reported values are percent change of the base absolute values [100% * ((X-Y)/Y)] | baseline, 3 weeks (end of study) |
| Change in Percent of 24 Hour Hyperglycemic Measurements | Measures/compares changes in percentage of hyperglycemia (>7.8mmol/l or 140 mg/dl) in glucose measurements in 24 hours by continuous glucose monitoring system (CGMS) at endpoint from baseline between groups. Reported values are percent change of the base absolute values [100% * ((X-Y)/Y)] | baseline, 3 weeks (end of study) |
| Shanghai |
| 200065 |
| China |
| Shanghai Sixth People's Hospital, 600 Xuanshan Road | Shanghai | 200233 | China |
| 23631607 | Derived | Zhou J, Li H, Zhang X, Peng Y, Mo Y, Bao Y, Jia W. Nateglinide and acarbose are comparably effective reducers of postprandial glycemic excursions in chinese antihyperglycemic agent-naive subjects with type 2 diabetes. Diabetes Technol Ther. 2013 Jun;15(6):481-8. doi: 10.1089/dia.2013.0046. Epub 2013 Apr 30. |
| Lost to Follow-up |
|
| Unexplained |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Acarbose | 50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal |
|
|
| Secondary | Change in Incremental Glucose Peak (IGP) From Baseline | Incremental glucose peak (IGP) was the maximal incremental increase in blood glucose obtained at any point after meal | Intent to Treat population - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline. | Posted | Mean | Standard Deviation | millimoles per litre (mmol/L) | baseline, 3 weeks (end of study) |
|
|
|
| Secondary | Change in Mean Blood Glucose (MBG) | The 24 hour mean blood glucose (MBG) level was calculated as the mean of all the consecutive readings on baseline and end of study(3 weeks later) separately. | Intent to Treat population - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline | Posted | Mean | Standard Deviation | millimoles per litre (mmol/l) | baseline and at 3 weeks (end of study) |
|
|
|
| Secondary | Change in Standard Deviation (SD) From Baseline of Mean Blood Glucose (MBG) Over 24 Hours. | Change in standard deviation (SD) from baseline of mean blood glucose (MBG) describes the range of blood glucose fluctuation over 24 hours. | Intent to Treat population - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline | Posted | Mean | Standard Deviation | mmol/l | baseline, 3 weeks (end of study) |
|
|
|
| Secondary | Change in Mean of Daily Difference of Paired Blood Glucose Value (MODD) | The mean of the daily differences (MODD), calculated as the average absolute difference of paired glucose values during two successive 24 hour periods, was used to assess day-to-day glycaemic variability. | 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 | millimoles per litre (mmol/l) | baseline, 3 weeks (end of study) |
|
|
|
| Secondary | Changes in 24 Hour Glucose Area Under Curve (AUCpp) | 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, end of study (3 weeks) |
|
|
|
| Secondary | Change in Glycated Serum Albumin (GSA) Levels From Baseline After Treatment | GSA levels were to be determined by CGMS at 7:00~10:00 am in the 4-hour standardized meal test before treatment after overnight fasting for efficacy assessments | Intent to Treat population - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline. During different time points, participants with observations at that time point were included in the analysis. | Posted | Mean | Standard Deviation | percent | baseline, 3 weeks (end of study) |
|
|
|
| Secondary | Change in Insulin Levels (μU/ml) During Standardized Meal Test at Endpoint From Baseline | This outcome measure calculated the change in insulin levels between groups over time at 0, 30 then 120 minutes | The Intent to Treat (ITT) population consists of all patients randomized and who have at least one dose of study medication. | Posted | Mean | Standard Deviation | (μU/ml) | baseline, 3 weeks (end of study) |
|
|
|
| Secondary | Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | change in LDL-C at 0, 30 and 120 minutes | Intent to Treat population - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline. During different time points, participants with observations at that time point were included in the analysis. | Posted | Mean | Standard Deviation | millimoles per litre (mmol/l) | baseline, 3 weeks (end of study) |
|
|
|
| Secondary | Change of Total Cholesterol in Blood Lipids Levels During Standardized Meal Test at Endpoint From Baseline at Each Time Point | time to change in Total Cholesterol blood lipids level at 0, 30, 120 minutes | The Intent to Treat (ITT) population consists of all patients randomized and who have at least one dose of study medication. | Posted | Mean | Standard Deviation | millimoles per litre (mmol/l) | baseline, 3 weeks (end of study) |
|
|
|
| Secondary | Change in Triglyceride (TG)Levels in Blood Lipid Levels During Standardized Meal Test at Endpoint | TG change in blood lipids level from baseline to endpoint | The Intent to Treat (ITT) population consists of all patients randomized and who have at least one dose of study medication. | Posted | Mean | Standard Deviation | millimoles per litre (mmol/l) | baseline, 3 weeks (end of study) |
|
|
|
| Secondary | Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the End of the Study | 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 3. 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 - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline. During different time points, participants with observations at that time point were included in the analysis. | Posted | Mean | Standard Deviation | millimoles per litre (mmol/l) | baseline, 3 weeks (end of study) |
|
|
|
| Secondary | Change in Mean Amplitude of Glycaemic Excursion (MAGE) | mean amplitude of glycaemic excursion (MAGE) is an average of the amplitudes of all glycemic excursions greater than a prespecified threshold size | Intent to Treat population - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline. During different time points, participants with observations at that time point were included in the analysis. | Posted | Mean | Standard Deviation | mmol/l | baseline, 3 weeks (end of study) |
|
|
|
| Secondary | The Percent of 24 Hour Hypoglycemic Measurements | Measures/compares changes in percentage of hypoglycemia(<3.9mmol/l or <70 mg/dl) in glucose measurements in 24hours by continuous glucose monitoring system (CGMS) at endpoint from baseline between groups. Reported values are percent change of the base absolute values [100% * ((X-Y)/Y)] | 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. During different time points, participants with observations at that time point were included in the analysis | Posted | Mean | Standard Deviation | percent of measurements | baseline, 3 weeks (end of study) |
|
|
|
| Secondary | Change in Percent of 24 Hour Hyperglycemic Measurements | Measures/compares changes in percentage of hyperglycemia (>7.8mmol/l or 140 mg/dl) in glucose measurements in 24 hours by continuous glucose monitoring system (CGMS) at endpoint from baseline between groups. Reported values are percent change of the base absolute values [100% * ((X-Y)/Y)] | Intent to Treat population - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline. | Posted | Mean | Standard Deviation | percent of measurements | baseline, 3 weeks (end of study) |
|
|
|
| 0 |
| 51 |
| 7 |
| 51 |
| EG001 | Acarbose | 50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal | 0 | 52 | 16 | 52 |
| Frequency bowel movements | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Gastrointestinal flatulence | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| White blood cells count decrease | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| White blood cells count increase | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| White blood cells urine positive | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 14.0 | 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 (i.e., data from all sites) in the clinical trial.
| D004700 | Endocrine System Diseases |
| 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 |
| 120 minutes |
|
| 120 minutes |
|
| 120 minutes |
|
| 120 minutes |
|
| 120 minutes |
|