Post Prandial Glucose Control Proof-of-Principle

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Post Prandial Glucose Control Proof-of-Principle

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01326299
• Other study ID #: BK92
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 28, 2011
• Last updated: March 29, 2011
• Start date: August 2010
• Est. completion date: September 2010

Study information

• Verified date: March 2011
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Other:
• Carbohydrate placebo
dissolve in water and consume with meal
• Nutritional ingredient
Dissolve in water and consume with meals
• #1 Nutritional ingredient +Fiber
Dissolve in water and consume with meal
• #2 Nutritional ingredient + Fiber
Dissolve in water and consume with meal
• #3 Nutritional ingredient + Fiber
Dissolve in water and consume with meal

Locations

Country	Name	City	State
United States	Radiant Research	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive AUC from 0 to 240 minutes for plasma glucose.		0 to 240 minutes	No
Secondary	Plasma glucose concentrations		0 to 240 minutes	No