This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by:
Abbott Nutrition Identifier:
First received: August 24, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
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
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Four-Hour Evaluation of a Medical Food in Subjects With Type 2 Diabetes

Further study details as provided by Abbott Nutrition:

Primary Outcome Measures:
  • The primary variable is glucose concentration [ Time Frame: 0 to 240 minutes ]

Secondary Outcome Measures:
  • Additional measures of glucose concentration [ Time Frame: 0 to 240 mins ]

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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01188200

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
Medical Centre Twenty First Century
St. Petersburgh, Russian Federation, 190068
City Clinical Hospital #3
St. Petersburg, Russian Federation, 195257
Tyumen State Medical Academy
Tyumen, Russian Federation, 625023
Bashkir State Medical University
Ufa, Russian Federation, 450071
Sponsors and Collaborators
Abbott Nutrition
Study Chair: Anne Voss, PhD Abbott Nutrition
  More Information

Responsible Party: Bobbie Swearengin, Director Clinical Research, Abbott Nutrition Identifier: NCT01188200     History of Changes
Other Study ID Numbers: BK79
Study First Received: August 24, 2010
Last Updated: August 24, 2010

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases processed this record on September 21, 2017