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Effects of Nateglinide on Postprandial Glucose Excursion by Restoring Early Phase Insulin Secretion

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ClinicalTrials.gov Identifier: NCT01030952
Recruitment Status : Completed
First Posted : December 14, 2009
Results First Posted : October 19, 2012
Last Update Posted : October 19, 2012
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE December 11, 2009
First Posted Date  ICMJE December 14, 2009
Results First Submitted Date  ICMJE February 20, 2012
Results First Posted Date  ICMJE October 19, 2012
Last Update Posted Date October 19, 2012
Study Start Date  ICMJE December 2009
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2012)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 11, 2009)
Area under curve of 0-4 hours postprandial glucose in standardized meal test [ Time Frame: 3 weeks ]
Change History Complete list of historical versions of study NCT01030952 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2012)
  • 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
  • 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.
  • Change in Standard Deviation (SD) From Baseline of Mean Blood Glucose (MBG) Over 24 Hours. [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ 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
  • 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
  • Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) [ Time Frame: baseline, 3 weeks (end of study) ]
    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 Frame: 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 [ Time Frame: baseline, 3 weeks (end of study) ]
    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 [ Time Frame: 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 in Mean Amplitude of Glycaemic Excursion (MAGE) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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)]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2009)
  • Incremental glucose peak [ Time Frame: 3 weeks ]
  • Mean blood glucose [ Time Frame: 3 weeks ]
  • Standardized difference of daily blood glucose excursion [ Time Frame: 3 weeks ]
  • Mean amplitude glycaemic excursion [ Time Frame: 3 weeks ]
  • Mean of the daily difference of paired blood glucose value [ Time Frame: 3 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Nateglinide on Postprandial Glucose Excursion by Restoring Early Phase Insulin Secretion
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Drug: Nateglinide
    Nateglinide tablets, oral administration, three times daily, 120 mg orally 10 minutes immediately before 3 meals three times daily.
  • Drug: Acarbose
    Acarbose tablets, oral administration, three times daily, dosage of 50 mg orally chewing with the first bite of a meal three times daily.
Study Arms  ICMJE
  • Experimental: Nateglinide
    Nateglinide tablets, oral administration, three times daily, 120 mg orally 10 minutes immediately before 3 meals three times daily.
    Intervention: Drug: Nateglinide
  • 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.
    Intervention: Drug: Acarbose
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 18, 2012)
103
Original Estimated Enrollment  ICMJE
 (submitted: December 11, 2009)
108
Actual Study Completion Date  ICMJE February 2011
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01030952
Other Study ID Numbers  ICMJE CDJN608ACN07
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP