Clinical trial NCT02248714: The Efficacy of Glucerna SR in Chinese Drug-naïve Subjects With Type 2 Diabetes
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Sponsor class: OTHER
First posted: 2014-09-25
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in AUCpp
timeFrame: 4 weeks
measure: Change From Baseline in SDBG
timeFrame: 4 weeks
measure: Change From Baseline in MAGE
timeFrame: 4 weeks
measure: Change From Baseline in Glucose Coefficient of Variation(CV)
timeFrame: 4 weeks
Secondary outcomes:
measure: Change From Baseline in BMI
timeFrame: 4 weeks
measure: Change From Baseline in Systolic Blood Pressure
timeFrame: 4 weeks
measure: Change From Baseline in Diastolic Blood Pressure
timeFrame: 4 weeks
measure: Change From Baseline in TC
timeFrame: 4 weeks
measure: Change From Baseline in Triglycerides
timeFrame: 4 weeks
measure: Change From Baseline in HDL-c
timeFrame: 4 weeks
measure: Change From Baseline in LDL-c
timeFrame: 4 weeks
measure: Change From Baseline in FPG
timeFrame: 4 weeks
measure: Change From Baseline in 2h-PG
timeFrame: 4 weeks
measure: Change From Baseline in HbA1c
timeFrame: 4 weeks
measure: Change From Baseline in GA
timeFrame: 4 weeks
measure: Change From Baseline in HOMA-IR
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
name: Yuqian Bao, MD
role: PRINCIPAL_INVESTIGATOR
References: