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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
Sponsor:
Information provided by (Responsible Party):
Yuqian Bao, Shanghai Jiao Tong University Affiliated Sixth People’s Hospital

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Dietary Supplement: Glucerna SR Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Yuqian Bao, MD +8602164369181 byq522@163.com

Locations
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China, Shanghai
Shanghai Jiao Tong University Affiliated Sixth People's Hospital Recruiting
Shanghai, Shanghai, China, 200023
Contact: Yuqian Bao, MD,PHD    +8602164369181    byq522@163.com   
Sponsors and Collaborators
Shanghai Jiao Tong University Affiliated Sixth People’s Hospital
Investigators
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Principal Investigator: Yuqian Bao, MD Shanghai Jiao Tong University Affiliated Sixth People’s Hospital

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Responsible Party: Yuqian Bao, Director of the Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai Jiao Tong University Affiliated Sixth People’s Hospital
ClinicalTrials.gov Identifier: NCT02248714     History of Changes
Other Study ID Numbers: 2010-32
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases