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

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

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.

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.

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.