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

NCT02248714 | Completed Results DMC

• 1 other identifier: 2010-32
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (4)

• 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.

  4 weeks

• Change From Baseline in SDBG

  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.

  4 weeks

• Change From Baseline in MAGE

  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 weeks

• Change From Baseline in Glucose Coefficient of Variation(CV)

  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.

  4 weeks

Secondary Outcomes (12)

• Change From Baseline in BMI

  4 weeks

• Change From Baseline in Systolic Blood Pressure

  4 weeks

• Change From Baseline in Diastolic Blood Pressure

  4 weeks

• Change From Baseline in TC

  4 weeks

• Change From Baseline in Triglycerides

  4 weeks

Study Arms (2)

Study arm

EXPERIMENTAL

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

Control arm

NO INTERVENTION

Patients only receive diabetes diet management according to the instruction of dedicating dietitian on how to implement the daily diabetes diet.

Interventions

Glucerna SR DIETARY_SUPPLEMENT

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

Study arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed type 2 diabetes mellitus
• FPG≤13mmol/l and/or 2hPG≤18mmol/l
• HbA1c≥7.0%
• BMI (Body Mass Index)≥18.5kg/m2

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Jiao Tong University Affiliated Sixth People's Hospital: lead

Study Sites (1)

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Shanghai, Shanghai Municipality, 200023, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Glucerna

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

1.The intervention period was relatively short. 2. The open-label design of the current study may introduce some extent of bias. 3.Only untreated T2D patients were admitted in the study.

Results Point of Contact

• Title: Dr. Yuqian Bao
• Organization: 6thShanghaiJiaotongU

byq522@163.com

(021)64369181

Study Officials

• Yuqian Bao, MD

  Shanghai Jiao Tong University Affiliated Sixth People's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Study Record Dates

• First Submitted: September 23, 2014
• First Posted: September 25, 2014
• Study Start: March 1, 2014
• Primary Completion: June 1, 2018
• Study Completion: December 1, 2018
• Last Updated: July 1, 2019
• Results First Posted: July 1, 2019

Record last verified: 2019-04

Locations

CN (1)