- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01030952
Effects of Nateglinide on Postprandial Glucose Excursion by Restoring Early Phase Insulin Secretion
September 18, 2012 updated by: Novartis Pharmaceuticals
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
103
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hangzhou, China, 310016
- Sir Run Run Shaw Hospital, 3 East Qingchun Road
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Shanghai, China, 200065
- Shanghai Tongji Hospital, 389 Xinchun Road
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Shanghai, China, 200233
- Shanghai Sixth People's Hospital, 600 Xuanshan Road
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Nateglinide
Nateglinide tablets, oral administration, three times daily, 120 mg orally 10 minutes immediately before 3 meals three times daily.
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Nateglinide tablets, oral administration, three times daily, 120 mg orally 10 minutes immediately before 3 meals three times daily.
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Active Comparator: Acarbose
Acarbose tablets, oral administration, three times daily, dosage of 50 mg orally chewing with the first bite of a meal three times daily.
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Acarbose tablets, oral administration, three times daily, dosage of 50 mg orally chewing with the first bite of a meal three times daily.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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)
Time Frame: 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. |
3 weeks (end of study) minus baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Incremental Glucose Peak (IGP) From Baseline
Time Frame: baseline, 3 weeks (end of study)
|
Incremental glucose peak (IGP) was the maximal incremental increase in blood glucose obtained at any point after meal
|
baseline, 3 weeks (end of study)
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Change in Mean Blood Glucose (MBG)
Time Frame: 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.
|
baseline and at 3 weeks (end of study)
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Change in Standard Deviation (SD) From Baseline of Mean Blood Glucose (MBG) Over 24 Hours.
Time Frame: baseline, 3 weeks (end of study)
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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)
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Change in Mean of Daily Difference of Paired Blood Glucose Value (MODD)
Time Frame: baseline, 3 weeks (end of study)
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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.
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baseline, 3 weeks (end of study)
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Changes in 24 Hour Glucose Area Under Curve (AUCpp)
Time Frame: baseline, end of study (3 weeks)
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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)
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Change in Glycated Serum Albumin (GSA) Levels From Baseline After Treatment
Time Frame: 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
|
baseline, 3 weeks (end of study)
|
Change in Insulin Levels (μU/ml) During Standardized Meal Test at Endpoint From Baseline
Time Frame: 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
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baseline, 3 weeks (end of study)
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Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Time Frame: baseline, 3 weeks (end of study)
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change in LDL-C at 0, 30 and 120 minutes
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baseline, 3 weeks (end of study)
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Change of Total Cholesterol in Blood Lipids Levels During Standardized Meal Test at Endpoint From Baseline at Each Time Point
Time Frame: baseline, 3 weeks (end of study)
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time to change in Total Cholesterol blood lipids level at 0, 30, 120 minutes
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baseline, 3 weeks (end of study)
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Change in Triglyceride (TG)Levels in Blood Lipid Levels During Standardized Meal Test at Endpoint
Time Frame: baseline, 3 weeks (end of study)
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TG change in blood lipids level from baseline to endpoint
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baseline, 3 weeks (end of study)
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Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the End of the Study
Time Frame: baseline, 3 weeks (end of study)
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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.
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baseline, 3 weeks (end of study)
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Change in Mean Amplitude of Glycaemic Excursion (MAGE)
Time Frame: baseline, 3 weeks (end of study)
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mean amplitude of glycaemic excursion (MAGE) is an average of the amplitudes of all glycemic excursions greater than a prespecified threshold size
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baseline, 3 weeks (end of study)
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The Percent of 24 Hour Hypoglycemic Measurements
Time Frame: baseline, 3 weeks (end of study)
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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)]
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baseline, 3 weeks (end of study)
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Change in Percent of 24 Hour Hyperglycemic Measurements
Time Frame: baseline, 3 weeks (end of study)
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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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2009
Primary Completion (Actual)
February 1, 2011
Study Completion (Actual)
February 1, 2011
Study Registration Dates
First Submitted
December 11, 2009
First Submitted That Met QC Criteria
December 11, 2009
First Posted (Estimate)
December 14, 2009
Study Record Updates
Last Update Posted (Estimate)
October 19, 2012
Last Update Submitted That Met QC Criteria
September 18, 2012
Last Verified
September 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDJN608ACN07
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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