The Efficacy of Glucerna SR in Chinese Drug-naïve Subjects With Type 2 Diabetes
NCT ID: NCT02248714
Last Updated: 2019-07-01
Study Results
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View full resultsBasic Information
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COMPLETED
NA
131 participants
INTERVENTIONAL
2014-03-31
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Study arm
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.)
Glucerna SR
Glucerna SR (Abbott Laboratories, Columbus, USA) is a nutritional product with lower glycemic response.
Control arm
Patients only receive diabetes diet management according to the instruction of dedicating dietitian on how to implement the daily diabetes diet.
No interventions assigned to this group
Interventions
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Glucerna SR
Glucerna SR (Abbott Laboratories, Columbus, USA) is a nutritional product with lower glycemic response.
Eligibility Criteria
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Inclusion Criteria
* FPG≤13mmol/l and/or 2hPG≤18mmol/l
* HbA1c≥7.0%
* BMI (Body Mass Index)≥18.5kg/m2
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Shanghai Jiao Tong University Affiliated Sixth People's Hospital
OTHER
Responsible Party
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Yuqian Bao
Director of the Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Principal Investigators
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Yuqian Bao, MD
Role: PRINCIPAL_INVESTIGATOR
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Locations
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Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Shanghai, Shanghai Municipality, China
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2010-32
Identifier Type: -
Identifier Source: org_study_id
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