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Completed

NCT Number: NCT02248714

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Shanghai, Shanghai Municipality, 200023, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Glucerna SR

Dietary Supplement

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

Primary outcomes

  1. Change From Baseline in AUCpp

    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 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.

  2. Change From Baseline in SDBG

    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 SDBG will be calculated based on CGMS data.

  3. Change From Baseline in 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.

  4. Change From Baseline in Glucose Coefficient of Variation(CV)

    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 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 outcomes

  1. Change From Baseline in BMI

    Time frame: 4 weeks

    the change of BMI between the end and the beginning of the study

  2. Change From Baseline in Systolic Blood Pressure

    Time frame: 4 weeks

    the change of systolic blood pressure between the end and the beginning of the study

  3. Change From Baseline in Diastolic Blood Pressure

    Time frame: 4 weeks

    the change of diastolic blood pressure between the end and the beginning of the study

  4. Change From Baseline in TC

    Time frame: 4 weeks

    the change of total cholesterol between the end and the beginning of the study

  5. Change From Baseline in Triglycerides

    Time frame: 4 weeks

    the change of triglycerides between the end and the beginning of the study

  6. Change From Baseline in HDL-c

    Time frame: 4 weeks

    the change of HDL-c between the end and the beginning of the study

  7. Change From Baseline in LDL-c

    Time frame: 4 weeks

    the change of LDL-c between the end and the beginning of the study

  8. Change From Baseline in FPG

    Time frame: 4 weeks

    the change of FPG between the end and the beginning of the study

  9. Change From Baseline in 2h-PG

    Time frame: 4 weeks

    the change of 2h-PG between the end and the beginning of the study

  10. Change From Baseline in HbA1c

    Time frame: 4 weeks

    the change of HbA1c between the end and the beginning of the study

  11. Change From Baseline in GA

    Time frame: 4 weeks

    the change of GA between the end and the beginning of the study

  12. Change From Baseline in HOMA-IR

    Time frame: 4 weeks

    the change of HOMA-IR between the end and the beginning of the study

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Sep 25, 2014
Registry last updated
Jul 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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