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

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: Diabetes Mellitus, Type 2
• Intervention / Treatment: Other: Experimental nutritional formula #M979; Other: Standard food

• Study Type: Interventional
• Enrollment (Actual): 168
• Phase: Phase 3

Contacts and Locations

Study Locations

• Russian Federation
  • Krasnodar, Russian Federation, 350043
    • Kuban State Medical University
  • Moscow, Russian Federation, 123182
    • City Clinical Hospital #52
  • Moscow, Russian Federation, 109263
    • City Clinical Hospital #68
  • Moscow, Russian Federation, 123423
    • City Hospital #67
  • Novosibirsk, Russian Federation, 630087
    • State Novosibirsk Regional Hospital
  • Novosibirsk, Russian Federation, 630047
    • Novosibirsk State Medical University
  • Samara, Russian Federation, 443046
    • Diabetes Centre, LLC
  • St. Petersburg, Russian Federation, 195257
    • City Clinical Hospital #3
  • St. Petersburgh, Russian Federation, 190068
    • Medical Centre Twenty First Century
  • Tyumen, Russian Federation, 625023
    • Tyumen State Medical Academy
  • Ufa, Russian Federation, 450071
    • Bashkir State Medical University

Participation Criteria

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:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary variable is glucose concentration	0 to 240 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
Additional measures of glucose concentration	0 to 240 mins

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Investigators: Study Chair: Anne Voss, PhD, Abbott Nutrition

Study record dates

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: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: BK79