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

Abbott Nutrition11 sites in 1 country168 target enrollmentDecember 2009

Overview

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

Registry

clinicaltrials.gov

Start Date

December 2009

End Date

June 2010

Last Updated

15 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Sponsor

•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/m
•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.

•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.