Comparison of Enteral Products for Tube Fed Patients With Type 2 Diabetes

Abbott

Status and phase

Completed

Phase 2

Conditions

Type 2 Diabetes Mellitus

Treatments

Other: standard enteral feeding product

Other: Diabetes specific feeding product

Study type

Interventional

Funder types

Industry

Identifiers

NCT00544206

BK07

Details and patient eligibility

About

To compare the glucose response in tube fed subjects with type 2 diabetes of a standard enteral product to that of a diabetes-specific enteral product

Enrollment

11 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

signed and dated informed consent
diagnosis of type 2 diabetes
HbA1c between 7.0 and 9.0%
18 - 75 years of age
currently receiving a standard enteral product
anticipated duration on tube feeding at least one month
100% of patient's nutrient and energy needs are anticipated to be met by enteral nutrition support
anticipated life expectancy is more than or equal to 6 months
free of infections
no change in medications within 2 weeks prior to screening that could profoundly affect blood glucose

Exclusion criteria

composition of either product is inappropriate for the patient due to allergies or intolerance to any ingredient found in the study products
composition of either product is inappropriate for the patient due to protein, fluid or electrolyte restrictions for concomitant conditions
significant cardiovascular event less than or equal to 2 weeks prior to study entry
major surgery less than or equal to 2 weeks prior to study entry
pre-planned surgery during the study period
active malignancy, including melanoma and excluding cutaneous malignancies
severe dementia
known allergies to medical grade adhesives and/or skin disinfectants
taking octreotide
chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV
participation in a concomitant trial