COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01188200
Recruitment Status : Completed
First Posted : August 25, 2010
Last Update Posted : August 25, 2010
Information provided by:
Abbott Nutrition

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

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 168 participants
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
Study Start Date : December 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01188200

Layout table for location information
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
Layout table for investigator information
Study Chair: Anne Voss, PhD Abbott Nutrition

Layout table for additonal information
Responsible Party: Bobbie Swearengin, Director Clinical Research, Abbott Nutrition Identifier: NCT01188200    
Other Study ID Numbers: BK79
First Posted: August 25, 2010    Key Record Dates
Last Update Posted: August 25, 2010
Last Verified: July 2010
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases