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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02248714

Enrollment

131

Registered

2014-09-25

Start date

2014-03-31

Completion date

2018-12-31

Last updated

2019-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

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.

Interventions

DIETARY_SUPPLEMENTGlucerna SR

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline in AUCpp	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.
Change From Baseline in SDBG	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 MAGE	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)	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.

Secondary

Measure	Time frame	Description
Change From Baseline in Triglycerides	4 weeks	the change of triglycerides between the end and the beginning of the study
Change From Baseline in HDL-c	4 weeks	the change of HDL-c between the end and the beginning of the study
Change From Baseline in LDL-c	4 weeks	the change of LDL-c between the end and the beginning of the study
Change From Baseline in FPG	4 weeks	the change of FPG between the end and the beginning of the study
Change From Baseline in BMI	4 weeks	the change of BMI between the end and the beginning of the study
Change From Baseline in HbA1c	4 weeks	the change of HbA1c between the end and the beginning of the study
Change From Baseline in GA	4 weeks	the change of GA between the end and the beginning of the study
Change From Baseline in HOMA-IR	4 weeks	the change of HOMA-IR between the end and the beginning of the study
Change From Baseline in 2h-PG	4 weeks	the change of 2h-PG between the end and the beginning of the study
Change From Baseline in Systolic Blood Pressure	4 weeks	the change of systolic blood pressure between the end and the beginning of the study
Change From Baseline in Diastolic Blood Pressure	4 weeks	the change of diastolic blood pressure between the end and the beginning of the study
Change From Baseline in TC	4 weeks	the change of total cholesterol between the end and the beginning of the study

Countries

China

Participant flow

Participants by arm

Arm	Count
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.	62
Control Arm Patients only receive diabetes diet management according to the instruction of dedicating dietitian on how to implement the daily diabetes diet.	61
Total	123

Baseline characteristics

Characteristic	Total	Study Arm	Control Arm
2-h Plasma Glucose (2h-PG)	15.0 mmol/l STANDARD_DEVIATION 2.6	15.0 mmol/l STANDARD_DEVIATION 2.7	15.0 mmol/l STANDARD_DEVIATION 2.6
Age, Continuous	56.7 years STANDARD_DEVIATION 8.8	56.9 years STANDARD_DEVIATION 9.1	56.5 years STANDARD_DEVIATION 8.4
Body Mass Index (BMI)	24.9 kg/m2 STANDARD_DEVIATION 2.9	24.6 kg/m2 STANDARD_DEVIATION 3	25.3 kg/m2 STANDARD_DEVIATION 2.9
Diastolic Blood Pressure	80.1 mmHg STANDARD_DEVIATION 9.1	80.4 mmHg STANDARD_DEVIATION 9.2	79.7 mmHg STANDARD_DEVIATION 9
Fasting Plasma Glucose (FPG)	7.4 mmol/l STANDARD_DEVIATION 1	7.4 mmol/l STANDARD_DEVIATION 0.8	7.4 mmol/l STANDARD_DEVIATION 1.2
Glucose Coefficient of Variation(CV)	21.2 percentage of CV STANDARD_DEVIATION 6.5	21.5 percentage of CV STANDARD_DEVIATION 7.3	20.9 percentage of CV STANDARD_DEVIATION 5.6
Glycated Albumin (GA)	17.9 percentage of glycated albumin STANDARD_DEVIATION 2.8	18.1 percentage of glycated albumin STANDARD_DEVIATION 2.8	17.7 percentage of glycated albumin STANDARD_DEVIATION 2.9
Glycated Hemoglobin A1c (HbA1c)	7.2 percentage of glycated hemoglobin A1c STANDARD_DEVIATION 0.6	7.2 percentage of glycated hemoglobin A1c STANDARD_DEVIATION 0.6	7.2 percentage of glycated hemoglobin A1c STANDARD_DEVIATION 0.6
High Density Lipoprotein Cholesterol(HDL-c)	1.2 mmol/l STANDARD_DEVIATION 0.3	1.2 mmol/l STANDARD_DEVIATION 0.3	1.2 mmol/l STANDARD_DEVIATION 0.2
Homeostasis Model Assessments of Insulin Resistance (HOMA-IR)	4.3 mU/L*mmol/L STANDARD_DEVIATION 2.6	4.2 mU/L*mmol/L STANDARD_DEVIATION 2.9	4.3 mU/L*mmol/L STANDARD_DEVIATION 2.4
Incremental AUC of Postprandial Blood Glucose (AUCpp)	501.1 min*mmol/l STANDARD_DEVIATION 290.6	522.5 min*mmol/l STANDARD_DEVIATION 335.9	479.4 min*mmol/l STANDARD_DEVIATION 236.8
Low Density Lipoprotein Cholesterol(LDL-c)	3.2 mmol/l STANDARD_DEVIATION 0.8	3.2 mmol/l STANDARD_DEVIATION 0.8	3.2 mmol/l STANDARD_DEVIATION 0.8
Mean Amplitude of Glycaemic Excursions (MAGE)	4.9 mmol/l STANDARD_DEVIATION 1.9	5.0 mmol/l STANDARD_DEVIATION 2	4.8 mmol/l STANDARD_DEVIATION 1.7
Race and Ethnicity Not Collected	0 Participants	—	—
Sex: Female, Male Female	57 Participants	32 Participants	25 Participants
Sex: Female, Male Male	66 Participants	30 Participants	36 Participants
Standard Deviation of Blood Glucose (SDBG)	1.8 mmol/l STANDARD_DEVIATION 0.7	1.9 mmol/l STANDARD_DEVIATION 0.7	1.8 mmol/l STANDARD_DEVIATION 0.6
Systolic Blood Pressure	130.4 mmHg STANDARD_DEVIATION 13.6	131.7 mmHg STANDARD_DEVIATION 14.8	128.9 mmHg STANDARD_DEVIATION 12.1
Total Cholesterol (TC)	5.1 mmol/l STANDARD_DEVIATION 0.9	5.1 mmol/l STANDARD_DEVIATION 0.8	5.1 mmol/l STANDARD_DEVIATION 1
Triglycerides	1.7 mmol/l STANDARD_DEVIATION 1.2	1.9 mmol/l STANDARD_DEVIATION 1.6	1.6 mmol/l STANDARD_DEVIATION 0.6

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 66	0 / 65
other Total, other adverse events	0 / 66	0 / 65
serious Total, serious adverse events	0 / 66	0 / 65

Outcome results

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.

Time frame: 4 weeks