A 4-week, Single-center, Randomized, Open-label, Parallel Group Study to Evaluate the Efficacy of Glucerna SR Using Continuous Glucose Monitoring System(CGMS) in Chinese Drug-naïve Subjects With Type 2 Diabetes
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital

 
 
 
 
The Efficacy of Glucerna SR in Chinese Drug-naïve 
Subjects With Type 2 Diabetes 
    
 
Study Protocol and Statistical Analysis Plan 
 
NCT：02248714 
 
 
 
 
 
 
 
 
Date: 2018.12.31

Study Protocol： 
Following study enrolment (visit 1), each subject underwent a 75-g oral glucose 
tolerance test (OGTT). Participants who met the eligibility criteria were then 
continuously monitored for 72 hours (visit 2 to visit 3) with a retrospective continuous 
glucose monitoring (CGM) system (Medtronics, Northridge, CA). After 3 days of CGM 
(visit 3), the subjects were randomized (1:1) to receive either study group or control 
group for 4 weeks. Participants in the study group were instructed to replace breakfast 
with Glucerna SR (Abbot Nutrition) powder 52 g dissolved in 200 ml of warm water 
and both groups received lifestyle education. At the end of the 4-week intervention, 
subjects underwent another CGM from visit 4 (Day 29) to visit 5 (Day 32), at which a 
final OGTT in the fasting state was conducted. The schematic outline of study 
conduction is illustrated in the figure below. 
 
The incremental area under the curve of postprandial blood glucose (AUCpp) 
during CGM was calculated as the area between the glucose concentration-time curve, 
and the pre-prandial baseline glucose value measured at 4 h after each meal. Intra-day 
glycaemic variability (GV) parameters include the standard deviation of blood glucose 
values (SDBG), glucose coefficient of variation (CV), and the mean amplitude of 
glycaemic excursions (MAGE). CV was calculated by dividing the SDBG by the mean 
of the corresponding glucose readings. MAGE was calculated as the arithmetic mean 
of the differences between consecutive peaks and nadirs. Only excursions of more than 

1 SDBG of the mean glycaemic values were considered for the calculation of MAGE.  
Anthropometric and biochemical parameters were measured at visit 1 (baseline) 
and visit 4 (post-intervention). Body mass index (BMI) was calculated as the weight 
(kg) divided by squared height (m). Blood pressure (BP) was measured twice using a 
standard mercury sphygmomanometer, and the average was documented. Venous 
blood samples were collected after an overnight fast. Biochemical parameters including 
fasting plasma glucose (FPG), 2-h plasma glucose (2h-PG) during OGTT, glycated 
haemoglobin A1c (HbA1c), glycated albumin (GA), insulin, triglycerides (TG), total 
cholesterol (TC), high density lipoprotein cholesterol (HDL-C), and low-density 
lipoprotein cholesterol (LDL-C) were assayed. Insulin sensitivity was evaluated by 
homeostasis model assessments of insulin resistance (HOMA-IR): HOMA-IR = fasting 
insulin (in mU/L) × FPG (in mmol/L)/22.5.  
Statistical analyses 
Continuous variables at baseline were compared between the two groups by 
Student’s t test. Comparison of categorical variables between groups was performed by 
χ2 tests. Differences in the parameters before and after treatment were analysed by 
paired t test. The changes (△) in variables were compared with Student’s t test. 
Statistical analyses were performed using SPSS software version 17.0 (SPSS Inc., 
Chicago, IL, USA). A P value of < 0.05 (two-tailed) was considered statistically 
significant.