Evaluation of a Nutritional Product for People With Type 2 Diabetes (T2DM)

Abbott Nutrition1 site in 1 country33 target enrollmentMay 2013

ConditionsDiabetes

Overview

The objective of this trial is to evaluate a nutritional product for people with Diabetes.

Registry

clinicaltrials.gov

Start Date

May 2013

End Date

August 2013

Last Updated

11 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Sponsor

Responsible Party

Sponsor

•Subjects will be eligible for the study if they meet all of the following inclusion criteria:
•Diagnosis of Type 2 Diabetes.
•Age between 18 and 75 years.
•HbA1c \> 6.0 but ≤ 8.5
•If female and of childbearing potential , subject is non-pregnant, non- lactating, at least 6 weeks postpartum and agrees to practice birth control throughout study duration.
•BMI is \> 18.5 kg/m2 and \< 40.0 kg/m
•Chronic medication dosage must be stable for at least two months prior to Screening Visit.
•Subject states that they are a habitual consumer of a morning meal.

•Subjects will be excluded from the study if they meet any of the following criteria:
•Use of exogenous insulin or GLP-1 agonists for glucose control.
•Diagnosis of Type 1 diabetes.
•History of diabetic ketoacidosis.
•Current infection (requiring medication or hospitalization), has received corticosteroid treatment in the last 3 months, or has had surgery or received antibiotics in the last 3 weeks.
•Active malignancy.
•Significant cardiovascular event \< 12 weeks prior to study entry.
•End stage organ failure or status post organ transplant.
•Active metabolic, hepatic, or gastrointestinal disease.
•Chronic, contagious, infectious disease.