- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01188200
Four-Hour Evaluation of a Medical Food in Subjects With Type 2 Diabetes
August 24, 2010 updated by: Abbott Nutrition
The purpose of this study is to demonstrate the efficacy of a nutritional formula in patients with type 2 diabetes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
168
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Krasnodar, Russian Federation, 350043
- Kuban State Medical University
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Moscow, Russian Federation, 123182
- City Clinical Hospital #52
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Moscow, Russian Federation, 109263
- City Clinical Hospital #68
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Moscow, Russian Federation, 123423
- City Hospital #67
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Novosibirsk, Russian Federation, 630087
- State Novosibirsk Regional Hospital
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Novosibirsk, Russian Federation, 630047
- Novosibirsk State Medical University
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Samara, Russian Federation, 443046
- Diabetes Centre, LLC
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St. Petersburg, Russian Federation, 195257
- City Clinical Hospital #3
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St. Petersburgh, Russian Federation, 190068
- Medical Centre Twenty First Century
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Tyumen, Russian Federation, 625023
- Tyumen State Medical Academy
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Ufa, Russian Federation, 450071
- Bashkir State Medical University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subject has type 2 diabetes.
- Subject is over 18 years of age.
- Subject is a male, or a non-pregnant, non-lactating female.
- Subject's BMI is > 20 kg/m2 and < 40 kg/m2.
- Subject's HbA1c level is 6.5 - 11%.
- 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.
- Subject's weight is stable for the past two months prior to Screening Visit.
Exclusion Criteria:
- Subject uses exogenous insulin, Byetta or alpha-glucosidase inhibitor for glucose control.
- Subject has type 1 diabetes.
- Subject has history of diabetic ketoacidosis.
- 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.
- Subject has an active malignancy.
- Subject has had significant cardiovascular event <6 months prior to study entry or history of congestive heart failure.
- Subject has end stage organ failure.
- Subject has history of severe gastroparesis, renal or hepatic disease.
- Subject has an active metabolic, hepatic, or gastrointestinal disease or condition that may interfere with nutrient absorption, distribution, metabolism, or excretion, excluding diabetes.
- Subject has a chronic, contagious, infectious disease.
- Taking daily medications at doses that would interfere with nutrient absorption, metabolism, excretion, gastric motility, or blood glucose.
- Subject has fainted or experienced other adverse event in response to blood collection prior to enrollment into this study.
- Clotting or bleeding disorders.
- Allergic or intolerant to any ingredient found in the test meal.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Nutritional Formula #M979
nutritional formula
|
One two hundred and forty mL serving at test time, taken orally
|
Active Comparator: Regular standard meal
standard meal
|
Standard meal prior to test time
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary variable is glucose concentration
Time Frame: 0 to 240 minutes
|
0 to 240 minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Additional measures of glucose concentration
Time Frame: 0 to 240 mins
|
0 to 240 mins
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Anne Voss, PhD, Abbott Nutrition
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2009
Primary Completion (Actual)
June 1, 2010
Study Completion (Actual)
June 1, 2010
Study Registration Dates
First Submitted
August 24, 2010
First Submitted That Met QC Criteria
August 24, 2010
First Posted (Estimate)
August 25, 2010
Study Record Updates
Last Update Posted (Estimate)
August 25, 2010
Last Update Submitted That Met QC Criteria
August 24, 2010
Last Verified
July 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BK79
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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