Status:
COMPLETED
Comparison of Nutritional Products for People With Type 2 Diabetes
Lead Sponsor:
Abbott Nutrition
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
Compare the glycemic and insulinemic responses of a standard nutritional product with two diabetes-specific nutritional products in patients with type 2 diabetes.
Eligibility Criteria
Inclusion
- Subject states that he/she has type 2 diabetes (as evidenced by use of oral hypoglycemic medication for at least two months).
- Subject is between 18 and 75 years of age, inclusive.
- Subject is a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit.
- If female is of childbearing potential, is practicing a method of birth control.
- Subject's BMI is \> 18.5 kg/m2 and \< 35 kg/m2.
- 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
- Subject uses exogenous insulin for glucose control.
- Subject states that he/she has type 1 diabetes.
- Subject states that he/she has a history of diabetic ketoacidosis.
- Subject takes an alpha-glucosidase inhibitor.
- 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.
- 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).
- Subject states that he/she has had a significant cardiovascular event ≤ six months prior to screening visit; or stated history of congestive heart failure.
- Subject states that he/she has end stage organ failure or is status post organ transplant.
- Subject states that he/she has a history of renal disease.
- Subject states that he/she has current hepatic disease.
- Subject states that he/she has a history of severe gastroparesis.
- Subject states that he/she has a chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
- 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.
- Subject states that he/she has clotting or bleeding disorders.
- Subject is known to be allergic or intolerant to any ingredient found in the study products.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00797069
Start Date
November 1 2008
End Date
July 1 2009
Last Update
July 30 2010
Active Locations (3)
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1
Hospital Clinico San Carlos
Madrid, Spain, 28040
2
Hospital Universitario Virgen de la Victoria
Málaga, Spain, 29010
3
Hospital Universitario Miguel Servet
Zaragoza, Spain, 50009