Four-Hour Evaluation of a Medical Food in Subjects With Type 2 Diabetes

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate the efficacy of a nutritional formula in patients with type 2 diabetes.

Official Title
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Four-Hour Evaluation of a Medical Food in Subjects With Type 2 Diabetes

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Other: Experimental nutritional formula #M979
* Other: Standard food


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has type 2 diabetes. Subject is over 18 years of age. Subject is a male, or a non-pregnant, non-lactating female. Subject's BMI is > 20 kg/m2 and < 40 kg/m2. Subject's HbA1c level is 6.5 - 11%. If on a chronic thyroid medication or hormone replacement therapy, subject has been on constant dosage for at least two months prior to Screening Visit. Subject's weight is stable for the past two months prior to Screening Visit. Exclusion Criteria: Subject uses exogenous insulin, Byetta or alpha-glucosidase inhibitor for glucose control. Subject has type 1 diabetes. Subject has history of diabetic ketoacidosis. Subject has the following: current infection ; has had inpatient surgery or received systemic corticosteroid treatment in the last 3 months; or antibiotics in the last 3 weeks prior to screening. Subject has an active malignancy. Subject has had significant cardiovascular event <6 months prior to study entry or history of congestive heart failure. Subject has end stage organ failure. Subject has history of severe gastroparesis, renal or hepatic disease. Subject has an active metabolic, hepatic, or gastrointestinal disease or condition that may interfere with nutrient absorption, distribution, metabolism, or excretion, excluding diabetes. Subject has a chronic, contagious, infectious disease. Taking daily medications at doses that would interfere with nutrient absorption, metabolism, excretion, gastric motility, or blood glucose. Subject has fainted or experienced other adverse event in response to blood collection prior to enrollment into this study. Clotting or bleeding disorders. Allergic or intolerant to any ingredient found in the test meal.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutritional Formula #M979<br>nutritional formula | Other: Experimental nutritional formula #M979<br>* One two hundred and forty mL serving at test time, taken orally<br>|
| Active Comparator: Regular standard meal<br>standard meal | Other: Standard food<br>* Standard meal prior to test time<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary variable is glucose concentration |  | 0 to 240 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Additional measures of glucose concentration |  | 0 to 240 mins |