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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 131
- 试验地点
- 1
- 主要终点
- Change From Baseline in MAGE
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed type 2 diabetes mellitus
- •FPG≤13mmol/l and/or 2hPG≤18mmol/l
- •HbA1c≥7.0%
- •BMI (Body Mass Index)≥18.5kg/m2
排除标准
- •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.
研究组 & 干预措施
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.)
干预措施: Glucerna SR (Dietary Supplement)
Control arm
Patients only receive diabetes diet management according to the instruction of dedicating dietitian on how to implement the daily diabetes diet.
结局指标
主要结局
Change From Baseline in MAGE
时间窗: 4 weeks
Subjects will perform continues blood glucose monitoring using CGMS for 72 hours at the beginning of the study and within the last three days during a 4-week treatment interval and MAGE will be calculated based on CGMS data.
Change From Baseline in Glucose Coefficient of Variation(CV)
时间窗: 4 weeks
Subjects will perform continues blood glucose monitoring using CGMS for 72 hours at the beginning of the study and within the last three days during a 4-week treatment interval and glucose coefficient of variation(CV) will be calculated based on CGMS data dividing the standard deviation of blood glucose values by the mean of the corresponding glucose readings.
Change From Baseline in SDBG
时间窗: 4 weeks
Subjects will perform continues blood glucose monitoring using CGMS for 72 hours at the beginning of the study and within the last three days during a 4-week treatment interval and SDBG will be calculated based on CGMS data.
Change From Baseline in AUCpp
时间窗: 4 weeks
Subjects will perform continues blood glucose monitoring using CGMS for 72 hours at the beginning of the study and within the last three days during a 4-week treatment interval and AUCpp based on CGMS data was calculated as the area between the glucose concentration-time curve, and the pre-prandial baseline glucose value measured at 4 h after each meal.
次要结局
- Change From Baseline in LDL-c(4 weeks)
- Change From Baseline in FPG(4 weeks)
- Change From Baseline in HDL-c(4 weeks)
- Change From Baseline in Systolic Blood Pressure(4 weeks)
- Change From Baseline in TC(4 weeks)
- Change From Baseline in BMI(4 weeks)
- Change From Baseline in Diastolic Blood Pressure(4 weeks)
- Change From Baseline in Triglycerides(4 weeks)
- Change From Baseline in 2h-PG(4 weeks)
- Change From Baseline in HbA1c(4 weeks)
- Change From Baseline in GA(4 weeks)
- Change From Baseline in HOMA-IR(4 weeks)
研究者
Yuqian Bao
Director of the Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Shanghai Jiao Tong University Affiliated Sixth People's Hospital