A Study to Evaluate the Postprandial Metabolic Response After Use of Glucerna SR in Obese Type 2 Diabetes
Condition: Type 2 Diabetes; Obesity
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

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
    

Detailed description: 
      A sufficient number of Asian subjects (expected to be approximately 90) 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. The
      eligible obese subjects with type 2 diabetes will be entered into a 2-week lead-in period
      with EDP after individual diet/lifestyle consultation to implement nutrition therapy into
      their existing diabetes management. The diet recommendations of the EDP at the lead-in period
      will be based on the nutrition recommendations from the ADA including carbohydrate and
      monounsaturated fat together provided 60-70 % of energy intake, reduced intakes of saturated
      fat (< 10 % of total calories) and cholesterol (< 300 mg/day) and protein intake around 15-20
      % of total daily energy.

      Approximately 60 participants will be randomized at Week 0 (Visit 3) in a 1:1 ratio to
      receive either (1) a meal replacement program with Glucerna SR on top of the EDP or (2) an
      caloric-matched EDP only. The participants will receive an educational program of diet,
      exercise, and behavioral strategies at randomization. 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 EDP only will receive a meal plan like
      they have in the lead-in period. All study subjects will be placed on a diet plan with 500 ~
      800 kcal/day less than their estimated daily maintenance energy requirement and receive an
      individualized exercise prescription to facilitate an optimal diabetes management. The
      participants will visit the clinics at 4-week intervals for 24 weeks after randomization to
      evaluate the efficacy and the safety parameters. The participants will receive two different
      meal tests at both the baseline and the end of the study. The macronutrient composition in
      the meal test protocol 1 is a 480 Kcal Glucerna SR breakfast with 50 % CHO, 20 % protein, and
      30 % fat. The test meal protocol 2 is a 480 Kcal sandwich breakfast with 63 % CHO, 20 %
      protein, and 17 % fat. The primary efficacy variable will be the change from baseline in
      incremental area under curve (∆AUC) of glucose response after a Glucerna-SR test meal between
      the two groups.

      A telephone follow-up will be performed 2 weeks after the study to evaluate any condition
      related to the study.
    

Intervention name(s): Glucerna SR
Intervention type(s): Dietary Supplement
Intervention description(s): 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.
Other intervention name(s): exchange-diet plan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: type 2 diabetes; meal replacement; postprandial response; Glucerna SR