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

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Other: Standard food; Other: Experimental nutritional formula #M979

• Registration Number: NCT01188200
• Lead Sponsor: Abbott Nutrition

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2010-07
• Study First Submitted: 2010-08-24
• Study First Submitted QC: 2010-08-24
• Last Update Submitted: 2010-08-24
• Study First Posted: 2010-08-25
• Last Update Posted: 2010-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Regular standard meal	Standard food	standard meal
Nutritional Formula #M979	Experimental nutritional formula #M979	nutritional formula

Primary Outcome Measures

Name	Time	Method
The primary variable is glucose concentration	0 to 240 minutes

Secondary Outcome Measures

Name	Time	Method
Additional measures of glucose concentration	0 to 240 mins

Trial Locations

Locations (11)

Bashkir State Medical University; 🇷🇺 Ufa, Russian Federation

Diabetes Centre, LLC; 🇷🇺 Samara, Russian Federation

Kuban State Medical University; 🇷🇺 Krasnodar, Russian Federation

City Clinical Hospital #68; 🇷🇺 Moscow, Russian Federation

State Novosibirsk Regional Hospital; 🇷🇺 Novosibirsk, Russian Federation

City Hospital #67; 🇷🇺 Moscow, Russian Federation

Medical Centre Twenty First Century; 🇷🇺 St. Petersburgh, Russian Federation

City Clinical Hospital #3; 🇷🇺 St. Petersburg, Russian Federation

Tyumen State Medical Academy; 🇷🇺 Tyumen, Russian Federation

City Clinical Hospital #52; 🇷🇺 Moscow, Russian Federation

Novosibirsk State Medical University; 🇷🇺 Novosibirsk, Russian Federation