Status:
COMPLETED
The Efficacy of Glucerna SR in Chinese Drug-naïve Subjects With Type 2 Diabetes
Lead Sponsor:
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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 monito...
Detailed 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, whi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
131 Patients enrolled
Trial Details
Trial ID
NCT02248714
Start Date
March 1 2014
End Date
December 1 2018
Last Update
July 1 2019
Active Locations (1)
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1
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Shanghai, Shanghai Municipality, China, 200023