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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 )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Diabetes Mellitus, Type 2
Interventions Drug: Nateglinide
Drug: Acarbose
Enrollment 103
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Nateglinide Acarbose
Hide Arm/Group Description 120 mg by mouth, three times daily 10 minutes immediately before 3 meals patients in Acarbose group received Acarbose 50 mg by mouth, three times daily with the first bite of a meal
Period Title: Overall Study
Started 51 52
Completed 49 49
Not Completed 2 3
Reason Not Completed
Protocol Violation             0             1
Informed consent withdrawal             1             0
Lost to Follow-up             0             1
Unexplained             1             1
Arm/Group Title Nateglinide Acarbose Total
Hide Arm/Group Description 120 mg by mouth, three times daily 10 minutes immediately before 3 meals patients in Acarbose group received Acarbose 50 mg by mouth, three times daily with the first bite of a meal Total of all reporting groups
Overall Number of Baseline Participants 51 52 103
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 51 participants 52 participants 103 participants
53.4  (10.34) 53.7  (9.36) 53.5  (9.81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 52 participants 103 participants
Female
20
  39.2%
23
  44.2%
43
  41.7%
Male
31
  60.8%
29
  55.8%
60
  58.3%
1.Primary Outcome
Title Change in Area Under Curve of 0-4 Hours Postprandial Glucose (AUCpp0-4hours) in Standardized Meal Test Using Continuous Glucose Monitoring System (CGMS)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Nateglinide Acarbose
Hide Arm/Group Description:
120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
Overall Number of Participants Analyzed 39 42
Least Squares Mean (95% Confidence Interval)
Unit of Measure: millimoles hours per litre (mmol*hr/L)
-9.20
(-11.780 to -6.621)
-9.92
(-12.407 to -7.438)
2.Secondary Outcome
Title Change in Incremental Glucose Peak (IGP) From Baseline
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Nateglinide Acarbose
Hide Arm/Group Description:
120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
Overall Number of Participants Analyzed 51 52
Mean (Standard Deviation)
Unit of Measure: millimoles per litre (mmol/L)
-2.72  (2.86) -1.89  (2.76)
3.Secondary Outcome
Title Change in Mean Blood Glucose (MBG)
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Nateglinide Acarbose
Hide Arm/Group Description:
120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
Overall Number of Participants Analyzed 51 52
Mean (Standard Deviation)
Unit of Measure: millimoles per litre (mmol/l)
-1.16  (1.24) -0.78  (1.29)
4.Secondary Outcome
Title Change in Standard Deviation (SD) From Baseline of Mean Blood Glucose (MBG) Over 24 Hours.
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Nateglinide Acarbose
Hide Arm/Group Description:
120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
Overall Number of Participants Analyzed 51 52
Mean (Standard Deviation)
Unit of Measure: mmol/l
-0.48  (0.63) -0.63  (0.59)
5.Secondary Outcome
Title Change in Mean of Daily Difference of Paired Blood Glucose Value (MODD)
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Nateglinide Acarbose
Hide Arm/Group Description:
120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
Overall Number of Participants Analyzed 51 52
Mean (Standard Deviation)
Unit of Measure: millimoles per litre (mmol/l)
-0.06  (0.95) -0.21  (0.86)
6.Secondary Outcome
Title Changes in 24 Hour Glucose Area Under Curve (AUCpp)
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Nateglinide Acarbose
Hide Arm/Group Description:
120 mg by mouth, three times daily (P.O. t.i.d.) 10 minutes immediately before 3 meals
50 mg by mouth, three times daily (P.O. t.i.d.) with the first bite of a meal
Overall Number of Participants Analyzed 51 52
Mean (Standard Deviation)
Unit of Measure: mmol*min/L
-1.16  (1.24) -0.78  (1.29)
7.Secondary Outcome
Title Change in Glycated Serum Albumin (GSA) Levels From Baseline After Treatment
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Nateglinide Acarbose
Hide Arm/Group Description:
120 mg by mouth, three times daily (P.O. t.i.d.) 10 minutes immediately before 3 meals
50 mg by mouth, three times daily (P.O. t.i.d.) with the first bite of a meal
Overall Number of Participants Analyzed 51 51
Mean (Standard Deviation)
Unit of Measure: percent
-2.22  (1.90) -1.74  (1.50)
8.Secondary Outcome
Title Change in Insulin Levels (μU/ml) During Standardized Meal Test at Endpoint From Baseline
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent to Treat (ITT) population consists of all patients randomized and who have at least one dose of study medication.
Arm/Group Title Nateglinide Acarbose
Hide Arm/Group Description:
120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
Overall Number of Participants Analyzed 51 52
Mean (Standard Deviation)
Unit of Measure: (μU/ml)
0 minutes 0.32  (5.88) -0.21  (3.16)
30 minutes 13.87  (20.98) -6.64  (6.44)
120 minutes 15.03  (31.22) -16.24  (22.01)
9.Secondary Outcome
Title Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Hide Description change in LDL-C at 0, 30 and 120 minutes
Time Frame baseline, 3 weeks (end of study)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Nateglinide Acarbose
Hide Arm/Group Description:
120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
Overall Number of Participants Analyzed 51 52
Mean (Standard Deviation)
Unit of Measure: millimoles per litre (mmol/l)
0 minutes -0.04  (0.65) 0.064  (0.44)
30 minutes -0.06  (0.63) 0.09  (0.44)
120 minutes -0.04  (0.56) 0.13  (0.42)
10.Secondary Outcome
Title Change of Total Cholesterol in Blood Lipids Levels During Standardized Meal Test at Endpoint From Baseline at Each Time Point
Hide Description time to change in Total Cholesterol blood lipids level at 0, 30, 120 minutes
Time Frame baseline, 3 weeks (end of study)
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent to Treat (ITT) population consists of all patients randomized and who have at least one dose of study medication.
Arm/Group Title Nateglinide Acarbose
Hide Arm/Group Description:
120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
Overall Number of Participants Analyzed 51 52
Mean (Standard Deviation)
Unit of Measure: millimoles per litre (mmol/l)
0 minutes -0.03  (0.67) -0.09  (0.55)
30 minutes -0.06  (0.70) 0.56  (0.04)
120 minutes -0.01  (0.61) 0.03  (0.68)
11.Secondary Outcome
Title Change in Triglyceride (TG)Levels in Blood Lipid Levels During Standardized Meal Test at Endpoint
Hide Description TG change in blood lipids level from baseline to endpoint
Time Frame baseline, 3 weeks (end of study)
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent to Treat (ITT) population consists of all patients randomized and who have at least one dose of study medication.
Arm/Group Title Nateglinide Acarbose
Hide Arm/Group Description:
120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
Overall Number of Participants Analyzed 51 52
Mean (Standard Deviation)
Unit of Measure: millimoles per litre (mmol/l)
0 minutes -0.19  (0.63) -0.48  (1.16)
30 minutes -0.23  (0.68) -0.39  (0.81)
120 minutes -0.19  (0.83) -0.47  (1.02)
12.Secondary Outcome
Title Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the End of the Study
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Nateglinide Acarbose
Hide Arm/Group Description:
120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
Overall Number of Participants Analyzed 51 52
Mean (Standard Deviation)
Unit of Measure: millimoles per litre (mmol/l)
0 minutes 0.20  (0.10) -0.02  (0.31)
30 minutes 0.02  (0.10) 0.01  (0.16)
120 minutes 0.03  (0.09) 0.00  (0.17)
13.Secondary Outcome
Title Change in Mean Amplitude of Glycaemic Excursion (MAGE)
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Nateglinide Acarbose
Hide Arm/Group Description:
120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
Overall Number of Participants Analyzed 51 52
Mean (Standard Deviation)
Unit of Measure: mmol/l
5.27  (2.09) 5.03  (1.82)
14.Secondary Outcome
Title The Percent of 24 Hour Hypoglycemic Measurements
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Nateglinide Acarbose
Hide Arm/Group Description:
120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
Overall Number of Participants Analyzed 39 42
Mean (Standard Deviation)
Unit of Measure: percent of measurements
0.82  (2.22) -0.57  (1.77)
15.Secondary Outcome
Title Change in Percent of 24 Hour Hyperglycemic Measurements
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Nateglinide Acarbose
Hide Arm/Group Description:
120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
Overall Number of Participants Analyzed 39 42
Mean (Standard Deviation)
Unit of Measure: percent of measurements
-50.83  (64.62) -33.82  (75.39)
Time Frame 3 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nateglinide Acarbose
Hide Arm/Group Description 120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals 50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
All-Cause Mortality
Nateglinide Acarbose
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Nateglinide Acarbose
Affected / at Risk (%) Affected / at Risk (%)
Total   0/51 (0.00%)   0/52 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Nateglinide Acarbose
Affected / at Risk (%) Affected / at Risk (%)
Total   7/51 (13.73%)   16/52 (30.77%) 
Gastrointestinal disorders     
Abdominal distension  1  0/51 (0.00%)  4/52 (7.69%) 
Frequency bowel movements  1  0/51 (0.00%)  2/52 (3.85%) 
Gastrointestinal flatulence  1  0/51 (0.00%)  7/52 (13.46%) 
Diarrhoea  1  0/51 (0.00%)  1/52 (1.92%) 
Hepatobiliary disorders     
Hepatic function abnormal  1  0/51 (0.00%)  1/52 (1.92%) 
Infections and infestations     
Bronchopneumonia  1  0/51 (0.00%)  1/52 (1.92%) 
Oral herpes  1  1/51 (1.96%)  0/52 (0.00%) 
Urinary tract infection  1  0/51 (0.00%)  1/52 (1.92%) 
Injury, poisoning and procedural complications     
Ulna fracture  1  1/51 (1.96%)  0/52 (0.00%) 
Investigations     
White blood cells count decrease  1  0/51 (0.00%)  1/52 (1.92%) 
White blood cells count increase  1  1/51 (1.96%)  0/52 (0.00%) 
White blood cells urine positive  1  0/51 (0.00%)  4/52 (7.69%) 
Metabolism and nutrition disorders     
Hypoglycemia  1  3/51 (5.88%)  0/52 (0.00%) 
Diabetic ketoacidosis  1  1/51 (1.96%)  0/52 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Upper respiratory tract infection  1  0/51 (0.00%)  2/52 (3.85%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: +1-800-244-7668
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01030952     History of Changes
Other Study ID Numbers: CDJN608ACN07
First Submitted: December 11, 2009
First Posted: December 14, 2009
Results First Submitted: February 20, 2012
Results First Posted: October 19, 2012
Last Update Posted: October 19, 2012