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

Abbott Nutrition2 sites in 1 countryJune 2013

ConditionsDiabetes

Overview

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

Registry

clinicaltrials.gov

Start Date

June 2013

End Date

July 2013

Last Updated

9 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 \> 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.