Post Prandial Glucose Control Proof-of-Principle

Abbott

Status and phase: Completed; Phase 3; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Other: Carbohydrate placebo; Other: #3 Nutritional ingredient + Fiber; Other: #1 Nutritional ingredient +Fiber; Other: Nutritional ingredient; Other: #2 Nutritional ingredient + Fiber

Study type: Interventional

Funder types: Industry

Identifiers

NCT01326299

BK92

Details and patient eligibility

About

The purpose of this study is to compare the postprandial glycemic response of subjects with type 2 diabetes when consuming a meal along with beverages containing various combinations of nutritional ingredients and fibers versus control beverage.

Enrollment: 50 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. type 2 diabetes
2. between 21 and 75 years of age
3. male or a non-pregnant, non-lactating female, at least 6 weeks postpartum or postmenopausal or surgically sterile
4. BMI is > 18.5 kg/m2 and <35 kg/m2
5. HbA1c < 9.0%

Exclusion criteria

1. Subject uses exogenous insulin, exenatide, or sitagliptin phosphate
2. type 1 diabetes.
3. history of diabetic ketoacidosis.
4. current infection
5. active malignancy
6. has had a significant cardiovascular event or history of congestive heart failure.
7. end-stage organ failure or post organ transplant.
8. history of renal disease.
9. hepatic disease.
10. history of gastrointestinal disorders
11. chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
12. taking any herbals, dietary supplements, or medications, other than oral hypoglycemic medications
13. clotting or bleeding disorders.
14. allergic or intolerant to any ingredient found in the study products.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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50 participants in 5 patient groups, including a placebo group

Nutritional ingredient

Active Comparator group

Description:

Dissolve in water and consume with meal

Treatment:

Other: Nutritional ingredient

Carbohydrate

Placebo Comparator group

Description:

dissolve in water and consume with meal

Treatment:

Other: Carbohydrate placebo

#1 Nutrtitional ingredient + Fiber

Experimental group

Description:

Dissolve in water and consume with meal

Treatment:

Other: #1 Nutritional ingredient +Fiber

#2 Nutritional ingredient + Fiber

Experimental group

Description:

Dissolve in water and consume with meal

Treatment:

Other: #2 Nutritional ingredient + Fiber

#3 Nutritional ingredient + Fiber

Experimental group

Description:

Dissolve in water and consume with meal

Treatment:

Other: #3 Nutritional ingredient + Fiber