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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2010-06-30

Brief Summary

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

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nutritional Formula #M979

nutritional formula

Group Type EXPERIMENTAL

Experimental nutritional formula #M979

Intervention Type OTHER

One two hundred and forty mL serving at test time, taken orally

Regular standard meal

standard meal

Group Type ACTIVE_COMPARATOR

Standard food

Intervention Type OTHER

Standard meal prior to test time

Interventions

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Experimental nutritional formula #M979

One two hundred and forty mL serving at test time, taken orally

Intervention Type OTHER

Standard food

Standard meal prior to test time

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No