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

Abbott

Status and phase

Completed

Phase 3

Conditions

Diabetes Mellitus, Type 2

Treatments

Other: Standard food

Other: Experimental nutritional formula #M979

Study type

Interventional

Funder types

Industry

Identifiers

BK79

Details and patient eligibility

About

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

Enrollment

168 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.