Glucose/Insulin Responses:Subjects With Type 2 Diabetes Consuming Diabetes-Specific vs Standard Nutritional Formulas

Abbott

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus Type 2

Treatments: Other: Adult enteral formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT00540488

SRDB09

Details and patient eligibility

About

To measure and compare the glycemic and insulinemic responses of subjects consuming a standard and two diabetes-specific products.

Enrollment: 54 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• signed and dated informed consent
• 18-75 years of age
• history of type 2 diabetes
• males and non-pregnant, non-lactating females

Exclusion criteria

• subject uses insulin for glucose control
• significant cardiovascular event <12 weeks prior to study entry
• active malignancies
• history of end stage renal disease
• history of organ transplant
• current hepatic disease
• intervention for HIB
• takes niacin
• history of gastroparesis
• active disease that may interfere with nutrient intake
• allergy or intolerance to ingredients in the study products

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind