Comparison of Nutritional Products for People With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT00797069
First received: November 23, 2008
Last updated: July 29, 2010
Last verified: March 2010

November 23, 2008
July 29, 2010
November 2008
February 2009   (final data collection date for primary outcome measure)
To compare the postprandial glycemic response of patients with type 2 diabetes consuming single servings of a standard liquid nutrition product and two diabetes-specific liquid nutrition products. [ Time Frame: Three crossover periods ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00797069 on ClinicalTrials.gov Archive Site
To compare the postprandial insulinemic response of patients with type 2 diabetes consuming single servings of a standard liquid nutrition product and two diabetes-specific liquid nutrition products. [ Time Frame: Three crossover periods ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparison of Nutritional Products for People With Type 2 Diabetes
Comparison of Nutritional Products for People With Type 2 Diabetes

Compare the glycemic and insulinemic responses of a standard nutritional product with two diabetes-specific nutritional products in patients with type 2 diabetes.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Other: standard nutritional product (medical food)
    once during crossover
  • Other: nutritional product for diabetes (medical food)
    once during crossover
  • Other: diabetes specific experimental nutritional product (medical food)
    once during crossover
  • Active Comparator: standard nutritional product
    Standard nutritional product not specific for diabetes
    Intervention: Other: standard nutritional product (medical food)
  • Active Comparator: diabetes specific product
    Diabetes specific nutritional product
    Intervention: Other: nutritional product for diabetes (medical food)
  • Experimental: Experimental diabetes specific product
    Diabetes specific experimental nutritional product
    Intervention: Other: diabetes specific experimental nutritional product (medical food)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
July 2009
February 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Subject states that he/she has type 2 diabetes (as evidenced by use of oral hypoglycemic medication for at least two months).
  2. Subject is between 18 and 75 years of age, inclusive.
  3. Subject is a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit.
  4. If female is of childbearing potential, is practicing a method of birth control.
  5. Subject's BMI is > 18.5 kg/m2 and < 35 kg/m2.
  6. If on a chronic medication such as anti-hypertensive, lipid-lowering, thyroid medication or hormone therapy, subject has been on constant dosage for at least two months prior to screening visit.

Exclusion Criteria:

  1. Subject uses exogenous insulin for glucose control.
  2. Subject states that he/she has type 1 diabetes.
  3. Subject states that he/she has a history of diabetic ketoacidosis.
  4. Subject takes an alpha-glucosidase inhibitor.
  5. Subject states that he/she has a current infection ; has had inpatient surgery, or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks prior to screening visit.
  6. Subject states that he/she has an active malignancy (excluding the following dermal malignancies: basal cell carcinoma, squamous cell carcinoma, carcinoma in-situ of the cervix).
  7. Subject states that he/she has had a significant cardiovascular event ≤ six months prior to screening visit; or stated history of congestive heart failure.
  8. Subject states that he/she has end stage organ failure or is status post organ transplant.
  9. Subject states that he/she has a history of renal disease.
  10. Subject states that he/she has current hepatic disease.
  11. Subject states that he/she has a history of severe gastroparesis.
  12. Subject states that he/she has a chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
  13. Subject has taken/is currently taking any herbals, dietary supplements, or medications, other than oral hypoglycemic medications, during the past four weeks prior to screening visit that could profoundly affect blood glucose.
  14. Subject states that he/she has clotting or bleeding disorders.
  15. Subject is known to be allergic or intolerant to any ingredient found in the study products.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00797069
BK20
No
Bobbie Swearengin, Director Clinical Research, Abbott Nutrition
Abbott Nutrition
Not Provided
Study Chair: Jennifer Williams, MS Abbott Nutrition
Abbott Nutrition
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP