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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01188200
• Other study ID #: BK79
• Status: Completed
• Phase: Phase 3
• First received: August 24, 2010
• Last updated: August 24, 2010
• Start date: December 2009
• Est. completion date: June 2010

Study information

• Verified date: July 2010
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Other:
• Experimental nutritional formula #M979
One two hundred and forty mL serving at test time, taken orally
• Standard food
Standard meal prior to test time

Locations

Country	Name	City	State
Russian Federation	Kuban State Medical University	Krasnodar
Russian Federation	City Clinical Hospital #52	Moscow
Russian Federation	City Clinical Hospital #68	Moscow
Russian Federation	City Hospital #67	Moscow
Russian Federation	Novosibirsk State Medical University	Novosibirsk
Russian Federation	State Novosibirsk Regional Hospital	Novosibirsk
Russian Federation	Diabetes Centre, LLC	Samara
Russian Federation	City Clinical Hospital #3	St. Petersburg
Russian Federation	Medical Centre Twenty First Century	St. Petersburgh
Russian Federation	Tyumen State Medical Academy	Tyumen
Russian Federation	Bashkir State Medical University	Ufa

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary variable is glucose concentration		0 to 240 minutes	No
Secondary	Additional measures of glucose concentration		0 to 240 mins	No