Clinical trial NCT01188200: Four-Hour Evaluation of a Medical Food in Subjects With Type 2 Diabetes
Official title: Four-Hour Evaluation of a Medical Food in Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2010-08-25
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate the efficacy of a nutritional formula in patients with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

1. Subject has type 2 diabetes.
2. Subject is over 18 years of age.
3. Subject is a male, or a non-pregnant, non-lactating female.
4. Subject's BMI is \> 20 kg/m2 and \< 40 kg/m2.
5. Subject's HbA1c level is 6.5 - 11%.
6. If on a chronic thyroid medication or hormone replacement therapy, subject has been on constant dosage for at least two months prior to Screening Visit.
7. Subject's weight is stable for the past two months prior to Screening Visit.

Exclusion Criteria:

1. Subject uses exogenous insulin, Byetta or alpha-glucosidase inhibitor for glucose control.
2. Subject has type 1 diabetes.
3. Subject has history of diabetic ketoacidosis.
4. Subject has the following: current infection ; has had inpatient surgery or received systemic corticosteroid treatment in the last 3 months; or antibiotics in the last 3 weeks prior to screening.
5. Subject has an active malignancy.
6. Subject has had significant cardiovascular event \<6 months prior to study entry or history of congestive heart failure.
7. Subject has end stage organ failure.
8. Subject has history of severe gastroparesis, renal or hepatic disease.
9. Subject has an active metabolic, hepatic, or gastrointestinal disease or condition that may interfere with nutrient absorption, distribution, metabolism, or excretion, excluding diabetes.
10. Subject has a chronic, contagious, infectious disease.
11. Taking daily medications at doses that would interfere with nutrient absorption, metabolism, excretion, gastric motility, or blood glucose.
12. Subject has fainted or experienced other adverse event in response to blood collection prior to enrollment into this study.
13. Clotting or bleeding disorders.
14. Allergic or intolerant to any ingredient found in the test meal.

Primary outcomes:
measure: The primary variable is glucose concentration
timeFrame: 0 to 240 minutes
Secondary outcomes:
measure: Additional measures of glucose concentration
timeFrame: 0 to 240 mins
Other outcomes:
Locations:
city: Krasnodar
country: Russian Federation
facility: Kuban State Medical University
city: Moscow
country: Russian Federation
facility: City Clinical Hospital #68
city: Moscow
country: Russian Federation
facility: City Clinical Hospital #52
city: Moscow
country: Russian Federation
facility: City Hospital #67
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk State Medical University
city: Novosibirsk
country: Russian Federation
facility: State Novosibirsk Regional Hospital
city: Samara
country: Russian Federation
facility: Diabetes Centre, LLC
city: St. Petersburgh
country: Russian Federation
facility: Medical Centre Twenty First Century
city: St. Petersburg
country: Russian Federation
facility: City Clinical Hospital #3
city: Tyumen
country: Russian Federation
facility: Tyumen State Medical Academy
city: Ufa
country: Russian Federation
facility: Bashkir State Medical University
Study officials:
affiliation: Abbott Nutrition
name: Anne Voss, PhD
role: STUDY_CHAIR
References: