Diabetes Mellitus, Type 2
Conditions
Brief summary
The purpose of this study is to demonstrate the efficacy of a nutritional formula in patients with type 2 diabetes.
Interventions
OTHERExperimental nutritional formula #M979
One two hundred and forty mL serving at test time, taken orally
OTHERStandard food
Standard meal prior to test time
Sponsors
Abbott Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject has type 2 diabetes. 2. Subject is over 18 years of age. 3. Subject is a male, or a non-pregnant, non-lactating female. 4. Subject's BMI is \> 20 kg/m2 and \< 40 kg/m2. 5. Subject's HbA1c level is 6.5 - 11%. 6. 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. 7. Subject's weight is stable for the past two months prior to Screening Visit.
Exclusion criteria
1. Subject uses exogenous insulin, Byetta or alpha-glucosidase inhibitor for glucose control. 2. Subject has type 1 diabetes. 3. Subject has history of diabetic ketoacidosis. 4. 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. 5. Subject has an active malignancy. 6. Subject has had significant cardiovascular event \<6 months prior to study entry or history of congestive heart failure. 7. Subject has end stage organ failure. 8. Subject has history of severe gastroparesis, renal or hepatic disease. 9. Subject has an active metabolic, hepatic, or gastrointestinal disease or condition that may interfere with nutrient absorption, distribution, metabolism, or excretion, excluding diabetes. 10. Subject has a chronic, contagious, infectious disease. 11. Taking daily medications at doses that would interfere with nutrient absorption, metabolism, excretion, gastric motility, or blood glucose. 12. Subject has fainted or experienced other adverse event in response to blood collection prior to enrollment into this study. 13. Clotting or bleeding disorders. 14. Allergic or intolerant to any ingredient found in the test meal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary variable is glucose concentration | 0 to 240 minutes |
Secondary
| Measure | Time frame |
|---|---|
| Additional measures of glucose concentration | 0 to 240 mins |
Countries
Russia
Outcome results
None listed