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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02248714
• Other study ID #: 2010-32
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: December 2018

Study information

• Verified date: April 2019
• Source: Shanghai Jiao Tong University Affiliated Sixth People’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: December 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Dietary Supplement:
• Glucerna SR
Glucerna SR (Abbott Laboratories, Columbus, USA) is a nutritional product with lower glycemic response.

Locations

Country	Name	City	State
China	Shanghai Jiao Tong University Affiliated Sixth People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University Affiliated Sixth People’s Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in AUCpp	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.	4 weeks
Primary	Change From Baseline in SDBG	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.	4 weeks
Primary	Change From Baseline in MAGE	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.	4 weeks
Primary	Change From Baseline in Glucose Coefficient of Variation(CV)	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.	4 weeks
Secondary	Change From Baseline in BMI	the change of BMI between the end and the beginning of the study	4 weeks
Secondary	Change From Baseline in Systolic Blood Pressure	the change of systolic blood pressure between the end and the beginning of the study	4 weeks
Secondary	Change From Baseline in Diastolic Blood Pressure	the change of diastolic blood pressure between the end and the beginning of the study	4 weeks
Secondary	Change From Baseline in TC	the change of total cholesterol between the end and the beginning of the study	4 weeks
Secondary	Change From Baseline in Triglycerides	the change of triglycerides between the end and the beginning of the study	4 weeks
Secondary	Change From Baseline in HDL-c	the change of HDL-c between the end and the beginning of the study	4 weeks
Secondary	Change From Baseline in LDL-c	the change of LDL-c between the end and the beginning of the study	4 weeks
Secondary	Change From Baseline in FPG	the change of FPG between the end and the beginning of the study	4 weeks
Secondary	Change From Baseline in 2h-PG	the change of 2h-PG between the end and the beginning of the study	4 weeks
Secondary	Change From Baseline in HbA1c	the change of HbA1c between the end and the beginning of the study	4 weeks
Secondary	Change From Baseline in GA	the change of GA between the end and the beginning of the study	4 weeks
Secondary	Change From Baseline in HOMA-IR	the change of HOMA-IR between the end and the beginning of the study	4 weeks