We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01188200
First Posted: August 25, 2010
Last Update Posted: August 25, 2010
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.
Information provided by:
Abbott Nutrition
  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
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

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 ]

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

  Eligibility

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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
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
Investigators
Study Chair: Anne Voss, PhD Abbott Nutrition
  More Information

Responsible Party: Bobbie Swearengin, Director Clinical Research, Abbott Nutrition
ClinicalTrials.gov Identifier: NCT01188200     History of Changes
Other Study ID Numbers: BK79
First Submitted: August 24, 2010
First Posted: August 25, 2010
Last Update Posted: August 25, 2010
Last Verified: July 2010

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