Status:
COMPLETED
Four-Hour Evaluation of a Medical Food in Subjects With Type 2 Diabetes
Lead Sponsor:
Abbott Nutrition
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to demonstrate the efficacy of a nutritional formula in patients with type 2 diabetes.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT01188200
Start Date
December 1 2009
End Date
June 1 2010
Last Update
August 25 2010
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
Kuban State Medical University
Krasnodar, Russia, 350043
2
City Clinical Hospital #68
Moscow, Russia, 109263
3
City Clinical Hospital #52
Moscow, Russia, 123182
4
City Hospital #67
Moscow, Russia, 123423