The Efficacy of Glucerna SR in Chinese Drug-naïve Subjects With Type 2 Diabetes

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the effect of Glucerna SR treating newly-diagnosed type 2 diabetes patients (NDM) on glycemic stability, with the application of CGMS (continuous glucose monitoring system) and to further realize the safety and effect of Glucerna SR on daily and day-to-day amplitude of blood glucose fluctuation.

Detailed Description
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Glucerna SR (Abbott Laboratories, Columbus, USA) is a nutritional product with lower glycemic response. About 24% of the total energy provided by Glucerna SR is due to monounsaturated fatty acids, which can help keep good metabolic state in accordance with the recommendations of the American Heart Association. The aim of the study is to evaluate the effect of Glucerna SR treating newly-diagnosed type 2 diabetes patients (NDM) on glycemic stability, with the application of CGMS (continuous glucose monitoring system) and to further realize the safety and effect of Glucerna SR consumed as a meal replacement at breakfast meal on daily and day-to-day amplitude of blood glucose fluctuation.

Official Title
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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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Dietary Supplement: Glucerna SR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newly diagnosed type 2 diabetes mellitus FPG≤13mmol/l and/or 2hPG≤18mmol/l HbA1c≥7.0% BMI (Body Mass Index)≥18.5kg/m2 Exclusion Criteria: Patients taking any class of injectible or oral hypoglycemia agents to manage their hyperglycemia. Female patients are in gestation, lactation or intend to be pregnant in the study period. Patients are with type 1 diabetes, or other special types of diabetes, or gestational diabetes mellitus. Patients with drug hypersensitivity. Patients with obvious hepatic or renal diseases (ALT, T-Bil>1.5 times of upper limit) Patients with severe or unstable angina, or heart failure (NYHA class III/IV) Patients having acute complications, or chronic complications maintained insulin therapy or insulin therapy under stress. Patients with chronic consumptive diseases like cerebrovascular disease, tumor, tuberculosis, or hematopathy, psychosis, autoimmune disease or severe digestive dysfunction.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study arm<br>Use Glucerna SR as a meal replacement at breakfast meal in the study group, meanwhile patients receive diabetes diet management (Each subject will be individually instructed by a dedicating dietitian how to implement the daily diabetes diet before starting the study.) | Dietary Supplement: Glucerna SR<br>* Glucerna SR (Abbott Laboratories, Columbus, USA) is a nutritional product with lower glycemic response.<br>|
| No Intervention: Control arm<br>Patients only receive diabetes diet management according to the instruction of dedicating dietitian on how to implement the daily diabetes diet. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in AUCpp | Subjects will perform continues blood glucose monitoring using CGMS for 72 hours at the beginning of the study and within the last three days during a 4-week treatment interval and AUCpp based on CGMS data 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. | 4 weeks | 
| Change From Baseline in SDBG | Subjects will perform continues blood glucose monitoring using CGMS for 72 hours at the beginning of the study and within the last three days during a 4-week treatment interval and SDBG will be calculated based on CGMS data. | 4 weeks | 
| Change From Baseline in MAGE | Subjects will perform continues blood glucose monitoring using CGMS for 72 hours at the beginning of the study and within the last three days during a 4-week treatment interval and MAGE will be calculated based on CGMS data. | 4 weeks | 
| Change From Baseline in Glucose Coefficient of Variation(CV) | Subjects will perform continues blood glucose monitoring using CGMS for 72 hours at the beginning of the study and within the last three days during a 4-week treatment interval and glucose coefficient of variation(CV) will be calculated based on CGMS data dividing the standard deviation of blood glucose values by the mean of the corresponding glucose readings. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in BMI | the change of BMI between the end and the beginning of the study | 4 weeks | 
| Change From Baseline in Systolic Blood Pressure | the change of systolic blood pressure between the end and the beginning of the study | 4 weeks | 
| Change From Baseline in Diastolic Blood Pressure | the change of diastolic blood pressure between the end and the beginning of the study | 4 weeks | 
| Change From Baseline in TC | the change of total cholesterol between the end and the beginning of the study | 4 weeks | 
| Change From Baseline in Triglycerides | the change of triglycerides between the end and the beginning of the study | 4 weeks | 
| Change From Baseline in HDL-c | the change of HDL-c between the end and the beginning of the study | 4 weeks | 
| Change From Baseline in LDL-c | the change of LDL-c between the end and the beginning of the study | 4 weeks | 
| Change From Baseline in FPG | the change of FPG between the end and the beginning of the study | 4 weeks | 
| Change From Baseline in 2h-PG | the change of 2h-PG between the end and the beginning of the study | 4 weeks | 
| Change From Baseline in HbA1c | the change of HbA1c between the end and the beginning of the study | 4 weeks | 
| Change From Baseline in GA | the change of GA between the end and the beginning of the study | 4 weeks | 
| Change From Baseline in HOMA-IR | the change of HOMA-IR between the end and the beginning of the study | 4 weeks |