Back to resultsEffects of Nateglinide on Postprandial Glucose Excursion by Restoring Early Phase Insulin Secretion
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Nateglinide
Acarbose
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes Mellitus, Type 2, Nateglinide, Acarbose, glucose fluctuation
Eligibility Criteria
Inclusion criteria
- Patients must give written informed consent before any assessment is performed.
- Male, non-fertile female or female of childbearing potential using a medically approved birth control method based on local regulations.
- 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.
- Age in the range of 18-75 years inclusive.
- HbA1c in the range of > 6.5 to ≤9.0% at Visit 1.
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,
- type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g., Cushing's syndrome and acromegaly.
- acute metabolic diabetic complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months.
- Torsades de pointes, sustained and clinically relevant ventricular tachycardia or ventricular fibrillation.
- percutaneous coronary intervention within the past 3 months.
- any of the following within the past 6 months: myocardial infarction (MI), coronary artery bypass surgery, unstable angina, or stroke.
- 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)
Sites / Locations
- Sir Run Run Shaw Hospital, 3 East Qingchun Road
- Shanghai Tongji Hospital, 389 Xinchun Road
- Shanghai Sixth People's Hospital, 600 Xuanshan Road
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Nateglinide
Acarbose
Arm Description
Nateglinide tablets, oral administration, three times daily, 120 mg orally 10 minutes immediately before 3 meals three times daily.
Acarbose tablets, oral administration, three times daily, dosage of 50 mg orally chewing with the first bite of a meal three times daily.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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.
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.
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.
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.
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
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
Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
change in LDL-C at 0, 30 and 120 minutes
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
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
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.
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
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)]
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)]
Full Information
NCT ID
NCT01030952
First Posted
December 11, 2009
Last Updated
September 18, 2012
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01030952
Brief Title
Effects of Nateglinide on Postprandial Glucose Excursion by Restoring Early Phase Insulin Secretion
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Diabetes Mellitus, Type 2, Nateglinide, Acarbose, glucose fluctuation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
103 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nateglinide
Arm Type
Experimental
Arm Description
Nateglinide tablets, oral administration, three times daily, 120 mg orally 10 minutes immediately before 3 meals three times daily.
Arm Title
Acarbose
Arm Type
Active Comparator
Arm Description
Acarbose tablets, oral administration, three times daily, dosage of 50 mg orally chewing with the first bite of a meal three times daily.
Intervention Type
Drug
Intervention Name(s)
Nateglinide
Intervention Description
Nateglinide tablets, oral administration, three times daily, 120 mg orally 10 minutes immediately before 3 meals three times daily.
Intervention Type
Drug
Intervention Name(s)
Acarbose
Intervention Description
Acarbose tablets, oral administration, three times daily, dosage of 50 mg orally chewing with the first bite of a meal three times daily.
Primary Outcome Measure Information:
Title
Change in Area Under Curve of 0-4 Hours Postprandial Glucose (AUCpp0-4hours) in Standardized Meal Test Using Continuous Glucose Monitoring System (CGMS)
Description
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
Secondary Outcome Measure Information:
Title
Change in Incremental Glucose Peak (IGP) From Baseline
Description
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)
Title
Change in Mean Blood Glucose (MBG)
Description
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)
Title
Change in Standard Deviation (SD) From Baseline of Mean Blood Glucose (MBG) Over 24 Hours.
Description
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)
Title
Change in Mean of Daily Difference of Paired Blood Glucose Value (MODD)
Description
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)
Title
Changes in 24 Hour Glucose Area Under Curve (AUCpp)
Description
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)
Title
Change in Glycated Serum Albumin (GSA) Levels From Baseline After Treatment
Description
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)
Title
Change in Insulin Levels (μU/ml) During Standardized Meal Test at Endpoint From Baseline
Description
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)
Title
Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Description
change in LDL-C at 0, 30 and 120 minutes
Time Frame
baseline, 3 weeks (end of study)
Title
Change of Total Cholesterol in Blood Lipids Levels During Standardized Meal Test at Endpoint From Baseline at Each Time Point
Description
time to change in Total Cholesterol blood lipids level at 0, 30, 120 minutes
Time Frame
baseline, 3 weeks (end of study)
Title
Change in Triglyceride (TG)Levels in Blood Lipid Levels During Standardized Meal Test at Endpoint
Description
TG change in blood lipids level from baseline to endpoint
Time Frame
baseline, 3 weeks (end of study)
Title
Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the End of the Study
Description
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)
Title
Change in Mean Amplitude of Glycaemic Excursion (MAGE)
Description
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)
Title
The Percent of 24 Hour Hypoglycemic Measurements
Description
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)
Title
Change in Percent of 24 Hour Hyperglycemic Measurements
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria
Patients must give written informed consent before any assessment is performed.
Male, non-fertile female or female of childbearing potential using a medically approved birth control method based on local regulations.
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.
Age in the range of 18-75 years inclusive.
HbA1c in the range of > 6.5 to ≤9.0% at Visit 1.
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,
type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g., Cushing's syndrome and acromegaly.
acute metabolic diabetic complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months.
Torsades de pointes, sustained and clinically relevant ventricular tachycardia or ventricular fibrillation.
percutaneous coronary intervention within the past 3 months.
any of the following within the past 6 months: myocardial infarction (MI), coronary artery bypass surgery, unstable angina, or stroke.
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Sir Run Run Shaw Hospital, 3 East Qingchun Road
City
Hangzhou
ZIP/Postal Code
310016
Country
China
Facility Name
Shanghai Tongji Hospital, 389 Xinchun Road
City
Shanghai
ZIP/Postal Code
200065
Country
China
Facility Name
Shanghai Sixth People's Hospital, 600 Xuanshan Road
City
Shanghai
ZIP/Postal Code
200233
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
17376293
Citation
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.
Results Reference
background
PubMed Identifier
25781235
Citation
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.
Results Reference
derived
PubMed Identifier
23631607
Citation
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.
Results Reference
derived
Learn more about this trial
Effects of Nateglinide on Postprandial Glucose Excursion by Restoring Early Phase Insulin Secretion
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