Diabetes Mellitus, Type 2
Conditions
Keywords
Diabetes Mellitus, Type 2, Nateglinide, Acarbose, glucose fluctuation
Brief summary
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.
Interventions
DRUGNateglinide
Nateglinide tablets, oral administration, three times daily, 120 mg orally 10 minutes immediately before 3 meals three times daily.
DRUGAcarbose
Acarbose tablets, oral administration, three times daily, dosage of 50 mg orally chewing with the first bite of a meal three times daily.
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patients must give written informed consent before any assessment is performed. 2. Male, non-fertile female or female of childbearing potential using a medically approved birth control method based on local regulations. 3. Drug naïve type 2 diabetes patients, defined as who neither take consecutive anti-hyperglycemic drug treatment more than 3 months anytime, nor any anti-hyperglycemic drug treatment in 4 weeks prior to visit 1. 4. Age in the range of 18-75 years inclusive. 5. HbA1c in the range of \> 6.5 to ≤9.0% at Visit 1.
Exclusion criteria
1. 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). 2. With known hypersensitivity to Nateglinide, Acarbose or any of the excipients. 3. A history of, 1. type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g., Cushing's syndrome and acromegaly. 2. acute metabolic diabetic complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months. 3. Torsades de pointes, sustained and clinically relevant ventricular tachycardia or ventricular fibrillation. 4. percutaneous coronary intervention within the past 3 months. 5. any of the following within the past 6 months: myocardial infarction (MI), coronary artery bypass surgery, unstable angina, or stroke. 4. Evidence of significant diabetic complications, e.g., symptomatic autonomic neuropathy or gastroparesis. 5. Acute infections which may affect blood glucose control within 4 weeks prior to visit 1. 6. Congestive heart failure requiring pharmacologic treatment. mg/dL (123μmol/L)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Area Under Curve of 0-4 Hours Postprandial Glucose (AUCpp0-4hours) in Standardized Meal Test Using Continuous Glucose Monitoring System (CGMS) | 3 weeks (end of study) minus baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean Blood Glucose (MBG) | baseline and at 3 weeks (end of study) | 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. |
| Change in Standard Deviation (SD) From Baseline of Mean Blood Glucose (MBG) Over 24 Hours. | baseline, 3 weeks (end of study) | Change in standard deviation (SD) from baseline of mean blood glucose (MBG) describes the range of blood glucose fluctuation over 24 hours. |
| Change in Mean of Daily Difference of Paired Blood Glucose Value (MODD) | baseline, 3 weeks (end of study) | 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. |
| Changes in 24 Hour Glucose Area Under Curve (AUCpp) | baseline, end of study (3 weeks) | 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. |
| Change in Glycated Serum Albumin (GSA) Levels From Baseline After Treatment | baseline, 3 weeks (end of study) | 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 |
| Change in Insulin Levels (μU/ml) During Standardized Meal Test at Endpoint From Baseline | baseline, 3 weeks (end of study) | This outcome measure calculated the change in insulin levels between groups over time at 0, 30 then 120 minutes |
| Change in Incremental Glucose Peak (IGP) From Baseline | baseline, 3 weeks (end of study) | Incremental glucose peak (IGP) was the maximal incremental increase in blood glucose obtained at any point after meal |
| Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the End of the Study | baseline, 3 weeks (end of 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. |
| Change of Total Cholesterol in Blood Lipids Levels During Standardized Meal Test at Endpoint From Baseline at Each Time Point | baseline, 3 weeks (end of study) | time to change in Total Cholesterol blood lipids level at 0, 30, 120 minutes |
| Change in Triglyceride (TG)Levels in Blood Lipid Levels During Standardized Meal Test at Endpoint | baseline, 3 weeks (end of study) | TG change in blood lipids level from baseline to endpoint |
| Change in Mean Amplitude of Glycaemic Excursion (MAGE) | baseline, 3 weeks (end of study) | mean amplitude of glycaemic excursion (MAGE) is an average of the amplitudes of all glycemic excursions greater than a prespecified threshold size |
| The Percent of 24 Hour Hypoglycemic Measurements | baseline, 3 weeks (end of study) | 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 \[100% \* ((X-Y)/Y)\] |
| Change in Percent of 24 Hour Hyperglycemic Measurements | baseline, 3 weeks (end of study) | 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 \[100% \* ((X-Y)/Y)\] |
| Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | baseline, 3 weeks (end of study) | change in LDL-C at 0, 30 and 120 minutes |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nateglinide 120 mg by mouth, three times daily 10 minutes immediately before 3 meals | 51 |
| Acarbose patients in Acarbose group received Acarbose 50 mg by mouth, three times daily with the first bite of a meal | 52 |
| Total | 103 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Informed consent withdrawal | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Unexplained | 1 | 1 |
Baseline characteristics
| Characteristic | Nateglinide | Acarbose | Total |
|---|---|---|---|
| Age Continuous | 53.4 years STANDARD_DEVIATION 10.34 | 53.7 years STANDARD_DEVIATION 9.36 | 53.5 years STANDARD_DEVIATION 9.81 |
| Sex: Female, Male Female | 20 Participants 39.22 | 23 Participants 44.23 | 43 Participants |
| Sex: Female, Male Male | 31 Participants 60.78 | 29 Participants 55.7 | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 51 | 16 / 52 |
| serious Total, serious adverse events | 0 / 51 | 0 / 52 |
Outcome results
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.
Time frame: 3 weeks (end of study) minus baseline
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Nateglinide | Change in Area Under Curve of 0-4 Hours Postprandial Glucose (AUCpp0-4hours) in Standardized Meal Test Using Continuous Glucose Monitoring System (CGMS) | -9.20 millimoles hours per litre (mmol*hr/L) | 95% Confidence Interval 11.71 |
| Acarbose | Change in Area Under Curve of 0-4 Hours Postprandial Glucose (AUCpp0-4hours) in Standardized Meal Test Using Continuous Glucose Monitoring System (CGMS) | -9.92 millimoles hours per litre (mmol*hr/L) | 95% Confidence Interval 9.97 |
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.
Time frame: baseline, 3 weeks (end of study)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nateglinide | Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the End of the Study | 0 minutes | 0.20 millimoles per litre (mmol/l) | Standard Deviation 0.1 |
| Nateglinide | Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the End of the Study | 30 minutes | 0.02 millimoles per litre (mmol/l) | Standard Deviation 0.1 |
| Nateglinide | Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the End of the Study | 120 minutes | 0.03 millimoles per litre (mmol/l) | Standard Deviation 0.09 |
| Acarbose | Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the End of the Study | 0 minutes | -0.02 millimoles per litre (mmol/l) | Standard Deviation 0.31 |
| Acarbose | Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the End of the Study | 30 minutes | 0.01 millimoles per litre (mmol/l) | Standard Deviation 0.16 |
| Acarbose | Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the End of the Study | 120 minutes | 0.00 millimoles per litre (mmol/l) | Standard Deviation 0.17 |
Secondary
Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
change in LDL-C at 0, 30 and 120 minutes
Time frame: baseline, 3 weeks (end of study)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nateglinide | Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | 0 minutes | -0.04 millimoles per litre (mmol/l) | Standard Deviation 0.65 |
| Nateglinide | Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | 30 minutes | -0.06 millimoles per litre (mmol/l) | Standard Deviation 0.63 |
| Nateglinide | Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | 120 minutes | -0.04 millimoles per litre (mmol/l) | Standard Deviation 0.56 |
| Acarbose | Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | 120 minutes | 0.13 millimoles per litre (mmol/l) | Standard Deviation 0.42 |
| Acarbose | Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | 0 minutes | 0.064 millimoles per litre (mmol/l) | Standard Deviation 0.44 |
| Acarbose | Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | 30 minutes | 0.09 millimoles per litre (mmol/l) | Standard Deviation 0.44 |
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
Time frame: baseline, 3 weeks (end of study)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nateglinide | Change in Glycated Serum Albumin (GSA) Levels From Baseline After Treatment | -2.22 percent | Standard Deviation 1.9 |
| Acarbose | Change in Glycated Serum Albumin (GSA) Levels From Baseline After Treatment | -1.74 percent | Standard Deviation 1.5 |
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
Time frame: baseline, 3 weeks (end of study)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nateglinide | Change in Incremental Glucose Peak (IGP) From Baseline | -2.72 millimoles per litre (mmol/L) | Standard Deviation 2.86 |
| Acarbose | Change in Incremental Glucose Peak (IGP) From Baseline | -1.89 millimoles per litre (mmol/L) | Standard Deviation 2.76 |
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
Time frame: baseline, 3 weeks (end of study)
Population: The Intent to Treat (ITT) population consists of all patients randomized and who have at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nateglinide | Change in Insulin Levels (μU/ml) During Standardized Meal Test at Endpoint From Baseline | 0 minutes | 0.32 (μU/ml) | Standard Deviation 5.88 |
| Nateglinide | Change in Insulin Levels (μU/ml) During Standardized Meal Test at Endpoint From Baseline | 30 minutes | 13.87 (μU/ml) | Standard Deviation 20.98 |
| Nateglinide | Change in Insulin Levels (μU/ml) During Standardized Meal Test at Endpoint From Baseline | 120 minutes | 15.03 (μU/ml) | Standard Deviation 31.22 |
| Acarbose | Change in Insulin Levels (μU/ml) During Standardized Meal Test at Endpoint From Baseline | 0 minutes | -0.21 (μU/ml) | Standard Deviation 3.16 |
| Acarbose | Change in Insulin Levels (μU/ml) During Standardized Meal Test at Endpoint From Baseline | 30 minutes | -6.64 (μU/ml) | Standard Deviation 6.44 |
| Acarbose | Change in Insulin Levels (μU/ml) During Standardized Meal Test at Endpoint From Baseline | 120 minutes | -16.24 (μU/ml) | Standard Deviation 22.01 |
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
Time frame: baseline, 3 weeks (end of study)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nateglinide | Change in Mean Amplitude of Glycaemic Excursion (MAGE) | 5.27 mmol/l | Standard Deviation 2.09 |
| Acarbose | Change in Mean Amplitude of Glycaemic Excursion (MAGE) | 5.03 mmol/l | Standard Deviation 1.82 |
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.
Time frame: baseline and at 3 weeks (end of study)
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nateglinide | Change in Mean Blood Glucose (MBG) | -1.16 millimoles per litre (mmol/l) | Standard Deviation 1.24 |
| Acarbose | Change in Mean Blood Glucose (MBG) | -0.78 millimoles per litre (mmol/l) | Standard Deviation 1.29 |
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.
Time frame: baseline, 3 weeks (end of study)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nateglinide | Change in Mean of Daily Difference of Paired Blood Glucose Value (MODD) | -0.06 millimoles per litre (mmol/l) | Standard Deviation 0.95 |
| Acarbose | Change in Mean of Daily Difference of Paired Blood Glucose Value (MODD) | -0.21 millimoles per litre (mmol/l) | Standard Deviation 0.86 |
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 \[100% \* ((X-Y)/Y)\]
Time frame: baseline, 3 weeks (end of study)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nateglinide | Change in Percent of 24 Hour Hyperglycemic Measurements | -50.83 percent of measurements | Standard Deviation 64.62 |
| Acarbose | Change in Percent of 24 Hour Hyperglycemic Measurements | -33.82 percent of measurements | Standard Deviation 75.39 |
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.
Time frame: baseline, 3 weeks (end of study)
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nateglinide | Change in Standard Deviation (SD) From Baseline of Mean Blood Glucose (MBG) Over 24 Hours. | -0.48 mmol/l | Standard Deviation 0.63 |
| Acarbose | Change in Standard Deviation (SD) From Baseline of Mean Blood Glucose (MBG) Over 24 Hours. | -0.63 mmol/l | Standard Deviation 0.59 |
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
Time frame: baseline, 3 weeks (end of study)
Population: The Intent to Treat (ITT) population consists of all patients randomized and who have at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nateglinide | Change in Triglyceride (TG)Levels in Blood Lipid Levels During Standardized Meal Test at Endpoint | 0 minutes | -0.19 millimoles per litre (mmol/l) | Standard Deviation 0.63 |
| Nateglinide | Change in Triglyceride (TG)Levels in Blood Lipid Levels During Standardized Meal Test at Endpoint | 30 minutes | -0.23 millimoles per litre (mmol/l) | Standard Deviation 0.68 |
| Nateglinide | Change in Triglyceride (TG)Levels in Blood Lipid Levels During Standardized Meal Test at Endpoint | 120 minutes | -0.19 millimoles per litre (mmol/l) | Standard Deviation 0.83 |
| Acarbose | Change in Triglyceride (TG)Levels in Blood Lipid Levels During Standardized Meal Test at Endpoint | 0 minutes | -0.48 millimoles per litre (mmol/l) | Standard Deviation 1.16 |
| Acarbose | Change in Triglyceride (TG)Levels in Blood Lipid Levels During Standardized Meal Test at Endpoint | 30 minutes | -0.39 millimoles per litre (mmol/l) | Standard Deviation 0.81 |
| Acarbose | Change in Triglyceride (TG)Levels in Blood Lipid Levels During Standardized Meal Test at Endpoint | 120 minutes | -0.47 millimoles per litre (mmol/l) | Standard Deviation 1.02 |
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
Time frame: baseline, 3 weeks (end of study)
Population: The Intent to Treat (ITT) population consists of all patients randomized and who have at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nateglinide | Change of Total Cholesterol in Blood Lipids Levels During Standardized Meal Test at Endpoint From Baseline at Each Time Point | 0 minutes | -0.03 millimoles per litre (mmol/l) | Standard Deviation 0.67 |
| Nateglinide | Change of Total Cholesterol in Blood Lipids Levels During Standardized Meal Test at Endpoint From Baseline at Each Time Point | 30 minutes | -0.06 millimoles per litre (mmol/l) | Standard Deviation 0.7 |
| Nateglinide | Change of Total Cholesterol in Blood Lipids Levels During Standardized Meal Test at Endpoint From Baseline at Each Time Point | 120 minutes | -0.01 millimoles per litre (mmol/l) | Standard Deviation 0.61 |
| Acarbose | Change of Total Cholesterol in Blood Lipids Levels During Standardized Meal Test at Endpoint From Baseline at Each Time Point | 0 minutes | -0.09 millimoles per litre (mmol/l) | Standard Deviation 0.55 |
| Acarbose | Change of Total Cholesterol in Blood Lipids Levels During Standardized Meal Test at Endpoint From Baseline at Each Time Point | 30 minutes | 0.56 millimoles per litre (mmol/l) | Standard Deviation 0.04 |
| Acarbose | Change of Total Cholesterol in Blood Lipids Levels During Standardized Meal Test at Endpoint From Baseline at Each Time Point | 120 minutes | 0.03 millimoles per litre (mmol/l) | Standard Deviation 0.68 |
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.
Time frame: baseline, end of study (3 weeks)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nateglinide | Changes in 24 Hour Glucose Area Under Curve (AUCpp) | -1.16 mmol*min/L | Standard Deviation 1.24 |
| Acarbose | Changes in 24 Hour Glucose Area Under Curve (AUCpp) | -0.78 mmol*min/L | Standard Deviation 1.29 |
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 \[100% \* ((X-Y)/Y)\]
Time frame: baseline, 3 weeks (end of study)
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nateglinide | The Percent of 24 Hour Hypoglycemic Measurements | 0.82 percent of measurements | Standard Deviation 2.22 |
| Acarbose | The Percent of 24 Hour Hypoglycemic Measurements | -0.57 percent of measurements | Standard Deviation 1.77 |