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

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.