The Efficacy of Glucerna SR in Chinese Drug-naïve Subjects With Type 2 Diabetes
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|ClinicalTrials.gov Identifier: NCT02248714|
Recruitment Status : Recruiting
First Posted : September 25, 2014
Last Update Posted : January 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Dietary Supplement: Glucerna SR||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||March 2014|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: 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.)
Dietary Supplement: Glucerna SR
Glucerna SR (Abbott Laboratories, Columbus, USA) is a nutritional product with lower glycemic response.
No Intervention: Control arm
Patients only receive diabetes diet management according to the instruction of dedicating dietitian on how to implement the daily diabetes diet.
- Change of mean IAUC for postprandial glucose (0-4hours) [ Time Frame: 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.
Mean incremental are under the curve(IAUC) for postprandial glucose after 4 weeks treatment will be calculated based on CGMS data.
- Mean amplitude glucose excursion(MAGE) [ Time Frame: 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.
- Mean of daily difference(MODD) [ Time Frame: 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 MODD will be calculated based on CGMS data.
- Adverse events [ Time Frame: 4 weeks ]An adverse event can be any unfavourable and unintended sign(including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical product, whether or not considered related to the medical product
- Hypoglycaemia [ Time Frame: 4 weeks ]Hypoglycaemia based on CGMS readings or hypoglycaemia based on self-reported episodes. The frequency of hypoglycaemic episodes will be derived as the number of the CGMS readings that come below 3.9 and 2.8 mmol/l respectively over 72-hour monitoring period. Due to fluctuations in CGMS readings around the threshold, two episodes must be separated by at least 15 minutes. The duration of the hypoglycaemic episodes will be quantified by accumulating the total time the CGMS profiles stays below the defined threshold.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02248714
|Contact: Yuqian Bao, MD||＋firstname.lastname@example.org|
|Shanghai Jiao Tong University Affiliated Sixth People's Hospital||Recruiting|
|Shanghai, Shanghai, China, 200023|
|Contact: Yuqian Bao, MD,PHD +8602164369181 email@example.com|
|Principal Investigator:||Yuqian Bao, MD||Shanghai Jiao Tong University Affiliated Sixth People’s Hospital|