A Study to Evaluate the Postprandial Metabolic Response After Use of Glucerna SR in Obese Type 2 Diabetes

NCT00631774 | Completed

• 1 other identifier: GSR Version 2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase 4, 24-week, randomized, parallel, open-label study of a meal replacement program with Glucerna SR in obese Asian participants with type 2 diabetes. The duration of each subject's participation will be approximately 28 weeks, including a lead-in period of 2 weeks and a 2-week post-treatment telephone follow-up. A sufficient number of Asian subjects with type 2 diabetes who have a BMI 18 between 25-40 kg/m2 and meet all the inclusion criteria and none of the exclusion criteria will be entered into the study to randomize approximately 60 subjects. Approximately 60 participants will be randomized to receive either (1) a meal replacement program with Glucerna SR on top of the Exchange-diet plan (EDP) or (2) an caloric-matched EDP only. The primary objective of this study is to evaluate the effect of a diet program including Glucerna SR as a meal replacement on postprandial glucose response after using Glucerna SR for 24 weeks in obese Asian subjects with type 2 diabetes

Conditions

Type 2 Diabetes; Obesity

Keywords

type 2 diabetes; meal replacement; postprandial response; Glucerna SR

Outcome Measures

Primary Outcomes (1)

• The primary objective of this study is to evaluate the effect of a diet program including Glucerna SR as a meal replacement on postprandial glucose response after using Glucerna SR for 24 weeks in obese Asian subjects with type 2 diabetes

  24 weeks

Secondary Outcomes (1)

• evaluate the efficacy and safety of a meal replacement program with Glucerna SR vs. an EDP based on the nutrition therapy recommendations from the ADA on anthropometric measurements, lipid profile, meal-related metabolic changes and quality of life

  24 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

a meal replacement program with Glucerna SR on top of the exchange-diet plan

Dietary Supplement: Glucerna SR

2

ACTIVE COMPARATOR

an caloric-matched exchange-diet plan only.

Dietary Supplement: Glucerna SR

Interventions

Glucerna SR DIETARY_SUPPLEMENT

Each randomized subject in the meal replacement group will receive Glucerna SR to replace one meal (breakfast) and one pre-sleep snack for 24 weeks. The subjects in the group with exchange-diet plan only will receive a meal plan like they have in the lead-in period.

Also known as: exchange-diet plan

1; 2

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Asians
• Diagnosed type 2 diabetes
• BMI between 25 and 40 kgm2
• Aged between 20 and 75 years old
• Current HbA1c between 6.0 and 8.5 percents
• Men and non-pregnant women. If woman, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile, or is of childbearing potential and practicing one of the following methods of birth control-condoms, sponge, foams, jellies, diaphragm or intrauterine device or on contraceptives for the 3-month period prior to Screening-a vasectomized partner-total abstinence from sexual intercourse. If woman, the results of a urine pregnancy test performed at Screening are negative. If woman, subject is not breast-feeding
• Subject is able and willing to replace breakfast and one snack before bed with Glucerna SR
• Subject has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board or Independent Ethics Committee, prior to undertaking any study-specific procedures

You may not qualify if:

• History or evidence of type 1 diabetes
• Screening fasting glucose greater than 240 mgdL
• Treatment with insulin, alpha-glucosidase inhibitor, incretin mimetics, or DPP-IV inhibitors in the past 8 weeks
• History of severe hypoglycemia in the past 12 weeks
• History of severe diabetes complications e.g. amputation, blindness, diabetic coma
• Stated history of severe gastroparesis
• Stated significant cardiovascular event e.g., myocardial infarction, stroke within 6 weeks prior to study entry; or stated history of congestive heart failure
• Current use of glucocorticoid steroids with the exception of topical use.
• History of renal insufficiency serum creatinine greater than 1.4 mgdL for women and greater than 1.5 for men
• Subjects with the following laboratory values: hemoglobin less than 10 gdL, WBC less than 3000mL, platelet less than 100,000mL, ALT greater than 3x ULN, total bilirubin greater than 2x ULN
• Stated current severe hepatic disease
• History or evidence of alcoholism or drug abuse
• History or evidence of hyperthyroidism or hypothyroidism
• History of malignancy within the last 5 years
• Consumption of any investigational drug within 30 days prior to enrollment.

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead
• Abbott: collaborator

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Interventions

Glucerna

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Low-Tone Ho, MD

  Taipei Veterans eneral Hospital

  STUDY CHAIR

• Chii-Min Hwu, MD

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: March 2, 2008
• First Posted: March 10, 2008
• Study Start: November 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: December 6, 2011

Record last verified: 2011-12

Locations

TW (1)