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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Glucerna SR
Sponsored by
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Study arm

Control arm

Arm Description

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.)

Patients only receive diabetes diet management according to the instruction of dedicating dietitian on how to implement the daily diabetes diet.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Change From Baseline in BMI
the change of BMI between the end and the beginning of the study
Change From Baseline in Systolic Blood Pressure
the change of systolic blood pressure between the end and the beginning of the study
Change From Baseline in Diastolic Blood Pressure
the change of diastolic blood pressure between the end and the beginning of the study
Change From Baseline in TC
the change of total cholesterol between the end and the beginning of the study
Change From Baseline in Triglycerides
the change of triglycerides between the end and the beginning of the study
Change From Baseline in HDL-c
the change of HDL-c between the end and the beginning of the study
Change From Baseline in LDL-c
the change of LDL-c between the end and the beginning of the study
Change From Baseline in FPG
the change of FPG between the end and the beginning of the study
Change From Baseline in 2h-PG
the change of 2h-PG between the end and the beginning of the study
Change From Baseline in HbA1c
the change of HbA1c between the end and the beginning of the study
Change From Baseline in GA
the change of GA between the end and the beginning of the study
Change From Baseline in HOMA-IR
the change of HOMA-IR between the end and the beginning of the study

Full Information

First Posted
September 23, 2014
Last Updated
April 6, 2019
Sponsor
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02248714
Brief Title
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

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University Affiliated Sixth People's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
131 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study arm
Arm Type
Experimental
Arm Description
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.)
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
Patients only receive diabetes diet management according to the instruction of dedicating dietitian on how to implement the daily diabetes diet.
Intervention Type
Dietary Supplement
Intervention Name(s)
Glucerna SR
Intervention Description
Glucerna SR (Abbott Laboratories, Columbus, USA) is a nutritional product with lower glycemic response.
Primary Outcome Measure Information:
Title
Change From Baseline in AUCpp
Description
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.
Time Frame
4 weeks
Title
Change From Baseline in SDBG
Description
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.
Time Frame
4 weeks
Title
Change From Baseline in MAGE
Description
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.
Time Frame
4 weeks
Title
Change From Baseline in Glucose Coefficient of Variation(CV)
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in BMI
Description
the change of BMI between the end and the beginning of the study
Time Frame
4 weeks
Title
Change From Baseline in Systolic Blood Pressure
Description
the change of systolic blood pressure between the end and the beginning of the study
Time Frame
4 weeks
Title
Change From Baseline in Diastolic Blood Pressure
Description
the change of diastolic blood pressure between the end and the beginning of the study
Time Frame
4 weeks
Title
Change From Baseline in TC
Description
the change of total cholesterol between the end and the beginning of the study
Time Frame
4 weeks
Title
Change From Baseline in Triglycerides
Description
the change of triglycerides between the end and the beginning of the study
Time Frame
4 weeks
Title
Change From Baseline in HDL-c
Description
the change of HDL-c between the end and the beginning of the study
Time Frame
4 weeks
Title
Change From Baseline in LDL-c
Description
the change of LDL-c between the end and the beginning of the study
Time Frame
4 weeks
Title
Change From Baseline in FPG
Description
the change of FPG between the end and the beginning of the study
Time Frame
4 weeks
Title
Change From Baseline in 2h-PG
Description
the change of 2h-PG between the end and the beginning of the study
Time Frame
4 weeks
Title
Change From Baseline in HbA1c
Description
the change of HbA1c between the end and the beginning of the study
Time Frame
4 weeks
Title
Change From Baseline in GA
Description
the change of GA between the end and the beginning of the study
Time Frame
4 weeks
Title
Change From Baseline in HOMA-IR
Description
the change of HOMA-IR between the end and the beginning of the study
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuqian Bao, MD
Organizational Affiliation
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200023
Country
China

12. IPD Sharing Statement

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

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