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

Shanghai Jiao Tong University

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Dietary Supplement: Glucerna SR

Study type: Interventional

Funder types: Other

Identifiers

NCT02248714

2010-32

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 131 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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131 participants in 2 patient groups

Study arm

Experimental group

Description:

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.)

Treatment:

Dietary Supplement: Glucerna SR

Control arm

No Intervention group

Description:

Patients only receive diabetes diet management according to the instruction of dedicating dietitian on how to implement the daily diabetes diet.