Trial Outcomes & Findings for The Efficacy of Glucerna SR in Chinese Drug-naïve Subjects With Type 2 Diabetes (NCT NCT02248714)
NCT ID: NCT02248714
Last Updated: 2019-07-01
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
131 participants
Primary outcome timeframe
4 weeks
Results posted on
2019-07-01
Participant Flow
Participant milestones
| Measure |
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.
|
Control Arm
Patients only receive diabetes diet management according to the instruction of dedicating dietitian on how to implement the daily diabetes diet.
|
|---|---|---|
|
Overall Study
STARTED
|
66
|
65
|
|
Overall Study
COMPLETED
|
62
|
61
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Study Arm
n=62 Participants
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.
|
Control Arm
n=61 Participants
Patients only receive diabetes diet management according to the instruction of dedicating dietitian on how to implement the daily diabetes diet.
|
Total
n=123 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.9 years
STANDARD_DEVIATION 9.1 • n=62 Participants
|
56.5 years
STANDARD_DEVIATION 8.4 • n=61 Participants
|
56.7 years
STANDARD_DEVIATION 8.8 • n=123 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=62 Participants
|
25 Participants
n=61 Participants
|
57 Participants
n=123 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=62 Participants
|
36 Participants
n=61 Participants
|
66 Participants
n=123 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Body Mass Index (BMI)
|
24.6 kg/m2
STANDARD_DEVIATION 3.0 • n=62 Participants
|
25.3 kg/m2
STANDARD_DEVIATION 2.9 • n=61 Participants
|
24.9 kg/m2
STANDARD_DEVIATION 2.9 • n=123 Participants
|
|
Systolic Blood Pressure
|
131.7 mmHg
STANDARD_DEVIATION 14.8 • n=62 Participants
|
128.9 mmHg
STANDARD_DEVIATION 12.1 • n=61 Participants
|
130.4 mmHg
STANDARD_DEVIATION 13.6 • n=123 Participants
|
|
Diastolic Blood Pressure
|
80.4 mmHg
STANDARD_DEVIATION 9.2 • n=62 Participants
|
79.7 mmHg
STANDARD_DEVIATION 9.0 • n=61 Participants
|
80.1 mmHg
STANDARD_DEVIATION 9.1 • n=123 Participants
|
|
Total Cholesterol (TC)
|
5.1 mmol/l
STANDARD_DEVIATION 0.8 • n=62 Participants
|
5.1 mmol/l
STANDARD_DEVIATION 1.0 • n=61 Participants
|
5.1 mmol/l
STANDARD_DEVIATION 0.9 • n=123 Participants
|
|
Triglycerides
|
1.9 mmol/l
STANDARD_DEVIATION 1.6 • n=62 Participants
|
1.6 mmol/l
STANDARD_DEVIATION 0.6 • n=61 Participants
|
1.7 mmol/l
STANDARD_DEVIATION 1.2 • n=123 Participants
|
|
High Density Lipoprotein Cholesterol(HDL-c)
|
1.2 mmol/l
STANDARD_DEVIATION 0.3 • n=62 Participants
|
1.2 mmol/l
STANDARD_DEVIATION 0.2 • n=61 Participants
|
1.2 mmol/l
STANDARD_DEVIATION 0.3 • n=123 Participants
|
|
Low Density Lipoprotein Cholesterol(LDL-c)
|
3.2 mmol/l
STANDARD_DEVIATION 0.8 • n=62 Participants
|
3.2 mmol/l
STANDARD_DEVIATION 0.8 • n=61 Participants
|
3.2 mmol/l
STANDARD_DEVIATION 0.8 • n=123 Participants
|
|
Fasting Plasma Glucose (FPG)
|
7.4 mmol/l
STANDARD_DEVIATION 0.8 • n=62 Participants
|
7.4 mmol/l
STANDARD_DEVIATION 1.2 • n=61 Participants
|
7.4 mmol/l
STANDARD_DEVIATION 1.0 • n=123 Participants
|
|
2-h Plasma Glucose (2h-PG)
|
15.0 mmol/l
STANDARD_DEVIATION 2.7 • n=62 Participants
|
15.0 mmol/l
STANDARD_DEVIATION 2.6 • n=61 Participants
|
15.0 mmol/l
STANDARD_DEVIATION 2.6 • n=123 Participants
|
|
Glycated Hemoglobin A1c (HbA1c)
|
7.2 percentage of glycated hemoglobin A1c
STANDARD_DEVIATION 0.6 • n=62 Participants
|
7.2 percentage of glycated hemoglobin A1c
STANDARD_DEVIATION 0.6 • n=61 Participants
|
7.2 percentage of glycated hemoglobin A1c
STANDARD_DEVIATION 0.6 • n=123 Participants
|
|
Glycated Albumin (GA)
|
18.1 percentage of glycated albumin
STANDARD_DEVIATION 2.8 • n=62 Participants
|
17.7 percentage of glycated albumin
STANDARD_DEVIATION 2.9 • n=61 Participants
|
17.9 percentage of glycated albumin
STANDARD_DEVIATION 2.8 • n=123 Participants
|
|
Homeostasis Model Assessments of Insulin Resistance (HOMA-IR)
|
4.2 mU/L*mmol/L
STANDARD_DEVIATION 2.9 • n=62 Participants
|
4.3 mU/L*mmol/L
STANDARD_DEVIATION 2.4 • n=61 Participants
|
4.3 mU/L*mmol/L
STANDARD_DEVIATION 2.6 • n=123 Participants
|
|
Incremental AUC of Postprandial Blood Glucose (AUCpp)
|
522.5 min*mmol/l
STANDARD_DEVIATION 335.9 • n=62 Participants
|
479.4 min*mmol/l
STANDARD_DEVIATION 236.8 • n=61 Participants
|
501.1 min*mmol/l
STANDARD_DEVIATION 290.6 • n=123 Participants
|
|
Standard Deviation of Blood Glucose (SDBG)
|
1.9 mmol/l
STANDARD_DEVIATION 0.7 • n=62 Participants
|
1.8 mmol/l
STANDARD_DEVIATION 0.6 • n=61 Participants
|
1.8 mmol/l
STANDARD_DEVIATION 0.7 • n=123 Participants
|
|
Mean Amplitude of Glycaemic Excursions (MAGE)
|
5.0 mmol/l
STANDARD_DEVIATION 2.0 • n=62 Participants
|
4.8 mmol/l
STANDARD_DEVIATION 1.7 • n=61 Participants
|
4.9 mmol/l
STANDARD_DEVIATION 1.9 • n=123 Participants
|
|
Glucose Coefficient of Variation(CV)
|
21.5 percentage of CV
STANDARD_DEVIATION 7.3 • n=62 Participants
|
20.9 percentage of CV
STANDARD_DEVIATION 5.6 • n=61 Participants
|
21.2 percentage of CV
STANDARD_DEVIATION 6.5 • n=123 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: The analysis population is subjects who completed the whole study.
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.
Outcome measures
| Measure |
Study Arm
n=62 Participants
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.
|
Control Arm
n=61 Participants
Patients only receive diabetes diet management according to the instruction of dedicating dietitian on how to implement the daily diabetes diet.
|
|---|---|---|
|
Change From Baseline in AUCpp
|
-287.8 min*mmol/L
Standard Deviation 368.7
|
-31.2 min*mmol/L
Standard Deviation 301.6
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: The analysis population is subjects who completed the whole study.
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.
Outcome measures
| Measure |
Study Arm
n=62 Participants
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.
|
Control Arm
n=61 Participants
Patients only receive diabetes diet management according to the instruction of dedicating dietitian on how to implement the daily diabetes diet.
|
|---|---|---|
|
Change From Baseline in SDBG
|
-0.6 mmol/L
Standard Deviation 0.8
|
-0.2 mmol/L
Standard Deviation 0.7
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: The analysis population is subjects who completed the whole study.
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.
Outcome measures
| Measure |
Study Arm
n=62 Participants
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.
|
Control Arm
n=61 Participants
Patients only receive diabetes diet management according to the instruction of dedicating dietitian on how to implement the daily diabetes diet.
|
|---|---|---|
|
Change From Baseline in MAGE
|
-1.6 mmol/L
Standard Deviation 2.3
|
-0.6 mmol/L
Standard Deviation 2.1
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: The analysis population is subjects who completed the whole study.
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.
Outcome measures
| Measure |
Study Arm
n=62 Participants
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.
|
Control Arm
n=61 Participants
Patients only receive diabetes diet management according to the instruction of dedicating dietitian on how to implement the daily diabetes diet.
|
|---|---|---|
|
Change From Baseline in Glucose Coefficient of Variation(CV)
|
-4.7 percentage of CV
Standard Deviation 8.1
|
-0.2 percentage of CV
Standard Deviation 7.6
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: The analysis population is subjects who completed the whole study.
the change of BMI between the end and the beginning of the study
Outcome measures
| Measure |
Study Arm
n=62 Participants
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.
|
Control Arm
n=61 Participants
Patients only receive diabetes diet management according to the instruction of dedicating dietitian on how to implement the daily diabetes diet.
|
|---|---|---|
|
Change From Baseline in BMI
|
-0.5 kg/m2
Standard Deviation 0.5
|
-0.5 kg/m2
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: The analysis population is subjects who completed the whole study.
the change of systolic blood pressure between the end and the beginning of the study
Outcome measures
| Measure |
Study Arm
n=62 Participants
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.
|
Control Arm
n=61 Participants
Patients only receive diabetes diet management according to the instruction of dedicating dietitian on how to implement the daily diabetes diet.
|
|---|---|---|
|
Change From Baseline in Systolic Blood Pressure
|
-7.5 mmHg
Standard Deviation 11.8
|
-2.8 mmHg
Standard Deviation 14.0
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: The analysis population is subjects who completed the whole study.
the change of diastolic blood pressure between the end and the beginning of the study
Outcome measures
| Measure |
Study Arm
n=62 Participants
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.
|
Control Arm
n=61 Participants
Patients only receive diabetes diet management according to the instruction of dedicating dietitian on how to implement the daily diabetes diet.
|
|---|---|---|
|
Change From Baseline in Diastolic Blood Pressure
|
-4.4 mmHg
Standard Deviation 10.8
|
-1.1 mmHg
Standard Deviation 8.8
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: The analysis population is subjects who completed the whole study.
the change of total cholesterol between the end and the beginning of the study
Outcome measures
| Measure |
Study Arm
n=62 Participants
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.
|
Control Arm
n=61 Participants
Patients only receive diabetes diet management according to the instruction of dedicating dietitian on how to implement the daily diabetes diet.
|
|---|---|---|
|
Change From Baseline in TC
|
-0.1 mmol/L
Standard Deviation 0.7
|
-0.2 mmol/L
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: The analysis population is subjects who completed the whole study.
the change of triglycerides between the end and the beginning of the study
Outcome measures
| Measure |
Study Arm
n=62 Participants
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.
|
Control Arm
n=61 Participants
Patients only receive diabetes diet management according to the instruction of dedicating dietitian on how to implement the daily diabetes diet.
|
|---|---|---|
|
Change From Baseline in Triglycerides
|
-0.4 mmol/L
Standard Deviation 1.3
|
-0.2 mmol/L
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: The analysis population is subjects who completed the whole study.
the change of HDL-c between the end and the beginning of the study
Outcome measures
| Measure |
Study Arm
n=62 Participants
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.
|
Control Arm
n=61 Participants
Patients only receive diabetes diet management according to the instruction of dedicating dietitian on how to implement the daily diabetes diet.
|
|---|---|---|
|
Change From Baseline in HDL-c
|
-0.0 mmol/L
Standard Deviation 0.1
|
0.0 mmol/L
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: The analysis population is subjects who completed the whole study.
the change of LDL-c between the end and the beginning of the study
Outcome measures
| Measure |
Study Arm
n=62 Participants
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.
|
Control Arm
n=61 Participants
Patients only receive diabetes diet management according to the instruction of dedicating dietitian on how to implement the daily diabetes diet.
|
|---|---|---|
|
Change From Baseline in LDL-c
|
-0.1 mmol/L
Standard Deviation 0.6
|
-0.1 mmol/L
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: The analysis population is subjects who completed the whole study.
the change of FPG between the end and the beginning of the study
Outcome measures
| Measure |
Study Arm
n=62 Participants
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.
|
Control Arm
n=61 Participants
Patients only receive diabetes diet management according to the instruction of dedicating dietitian on how to implement the daily diabetes diet.
|
|---|---|---|
|
Change From Baseline in FPG
|
-0.7 mmol/L
Standard Deviation 0.9
|
-0.6 mmol/L
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: The analysis population is subjects who completed the whole study.
the change of 2h-PG between the end and the beginning of the study
Outcome measures
| Measure |
Study Arm
n=62 Participants
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.
|
Control Arm
n=61 Participants
Patients only receive diabetes diet management according to the instruction of dedicating dietitian on how to implement the daily diabetes diet.
|
|---|---|---|
|
Change From Baseline in 2h-PG
|
-2.9 mmol/L
Standard Deviation 3.3
|
-2.0 mmol/L
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: The analysis population is subjects who completed the whole study.
the change of HbA1c between the end and the beginning of the study
Outcome measures
| Measure |
Study Arm
n=62 Participants
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.
|
Control Arm
n=61 Participants
Patients only receive diabetes diet management according to the instruction of dedicating dietitian on how to implement the daily diabetes diet.
|
|---|---|---|
|
Change From Baseline in HbA1c
|
-0.5 percentage of HbA1c
Standard Deviation 0.4
|
-0.5 percentage of HbA1c
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: The analysis population is subjects who completed the whole study.
the change of GA between the end and the beginning of the study
Outcome measures
| Measure |
Study Arm
n=62 Participants
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.
|
Control Arm
n=61 Participants
Patients only receive diabetes diet management according to the instruction of dedicating dietitian on how to implement the daily diabetes diet.
|
|---|---|---|
|
Change From Baseline in GA
|
-2.3 percentage of GA
Standard Deviation 2.6
|
-1.8 percentage of GA
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: The analysis population is subjects who completed the whole study.
the change of HOMA-IR between the end and the beginning of the study
Outcome measures
| Measure |
Study Arm
n=62 Participants
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.
|
Control Arm
n=61 Participants
Patients only receive diabetes diet management according to the instruction of dedicating dietitian on how to implement the daily diabetes diet.
|
|---|---|---|
|
Change From Baseline in HOMA-IR
|
-1.3 mU/L*mmol/L
Standard Deviation 2.2
|
-1.0 mU/L*mmol/L
Standard Deviation 1.9
|
Adverse Events
Study Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place