Four-Hour Evaluation of a Medical Food in Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT01188200
First received: August 24, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
  Purpose

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


Condition Intervention Phase
Diabetes Mellitus, Type 2
Other: Experimental nutritional formula #M979
Other: Standard food
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Four-Hour Evaluation of a Medical Food in Subjects With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Abbott Nutrition:

Primary Outcome Measures:
  • The primary variable is glucose concentration [ Time Frame: 0 to 240 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Additional measures of glucose concentration [ Time Frame: 0 to 240 mins ] [ Designated as safety issue: No ]

Enrollment: 168
Study Start Date: December 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nutritional Formula #M979
nutritional formula
Other: Experimental nutritional formula #M979
One two hundred and forty mL serving at test time, taken orally
Active Comparator: Regular standard meal
standard meal
Other: Standard food
Standard meal prior to test time

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01188200

Locations
Russian Federation
Kuban State Medical University
Krasnodar, Russian Federation, 350043
City Clinical Hospital #68
Moscow, Russian Federation, 109263
City Clinical Hospital #52
Moscow, Russian Federation, 123182
City Hospital #67
Moscow, Russian Federation, 123423
Novosibirsk State Medical University
Novosibirsk, Russian Federation, 630047
State Novosibirsk Regional Hospital
Novosibirsk, Russian Federation, 630087
Diabetes Centre, LLC
Samara, Russian Federation, 443046
City Clinical Hospital #3
St. Petersburg, Russian Federation, 195257
Medical Centre Twenty First Century
St. Petersburgh, Russian Federation, 190068
Tyumen State Medical Academy
Tyumen, Russian Federation, 625023
Bashkir State Medical University
Ufa, Russian Federation, 450071
Sponsors and Collaborators
Abbott Nutrition
Investigators
Study Chair: Anne Voss, PhD Abbott Nutrition
  More Information

No publications provided

Responsible Party: Bobbie Swearengin, Director Clinical Research, Abbott Nutrition
ClinicalTrials.gov Identifier: NCT01188200     History of Changes
Other Study ID Numbers: BK79
Study First Received: August 24, 2010
Last Updated: August 24, 2010
Health Authority: Russia: Ethics Committee

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 14, 2014