An Open Label, Randomized, and Parallel Study to Evaluate the Postprandial Metabolic Response After 24-Week Use of Glucerna SR in Obese Asian Subjects With Type 2 Diabetes
Sponsor study identifier
interventional
60
1 country
1
Study Start
November 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2009
Actual (reported)Study Completion
January 2009
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2009
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2007
Date type not reportedThis date has not been verified as actual or estimated.
March 2, 2008
Actual (reported)March 10, 2008
Actual (reported)January 2009
Actual (reported)January 2009
Actual (reported)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
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
a meal replacement program with Glucerna SR on top of the exchange-diet plan
an caloric-matched exchange-diet plan only.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Taipei Veterans General Hospital
Taipei, Taiwan
Low-Tone Ho, MD
Taipei Veterans eneral Hospital
Chii-Min Hwu, MD
Taipei Veterans General Hospital, Taiwan
60 participants (actual enrollment reported by the registry).
First Submitted
March 2, 2008
First Posted
March 10, 2008
Study Start
November 2007
Date type not reportedThis date has not been verified as actual or estimated.
Effect of Discontinuation of Sugar Sweetened Beverages
Contact the study team to confirm eligibility.
Primary Completion
January 2009
Actual (reported)Study Completion
January 2009
Actual (reported)Last Updated
December 6, 2011
Record last verified: 2011-12
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Source: ClinicalTrials.gov.
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