Effects of Nateglinide on Postprandial Glucose Excursion by Restoring Early Phase Insulin Secretion
- Registration Number
- NCT01030952
- Lead Sponsor
- Novartis Pharmaceuticals
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 103
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nateglinide Nateglinide Nateglinide tablets, oral administration, three times daily, 120 mg orally 10 minutes immediately before 3 meals three times daily. Acarbose Acarbose 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 Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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 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
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 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 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 \[100% \* ((X-Y)/Y)\]
Trial Locations
- Locations (3)
Shanghai Sixth People's Hospital, 600 Xuanshan Road
🇨🇳Shanghai, China
Sir Run Run Shaw Hospital, 3 East Qingchun Road
🇨🇳Hangzhou, China
Shanghai Tongji Hospital, 389 Xinchun Road
🇨🇳Shanghai, China