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Status:

WITHDRAWN

Evaluation of a Nutritional Supplement for People With Type 2 Diabetes.

Lead Sponsor:

Abbott Nutrition

Conditions:

Diabetes

Eligibility:

All Genders

18-75 years

Phase:

NA

Brief Summary

The objective of this trial is to evaluate a nutritional supplement for people with Diabetes.

Eligibility Criteria

Inclusion

  • Subjects will be eligible for the study if they meet all of the following inclusion criteria:
  • Diagnosis of Type 2 Diabetes.
  • Age between 18 and 75 years.
  • HbA1c \> 6.0 but ≤ 8.5
  • If female and of childbearing potential , subject is non-pregnant, non- lactating, at least 6 weeks postpartum and agrees to practice birth control throughout study duration.
  • BMI \> 18.5 kg/m2 and \< 40.0 kg/m2.
  • Chronic medication dosage must be stable for at least two months prior to Screening Visit.
  • Subject states that they are a habitual consumer of a morning meal.

Exclusion

  • Subjects will be excluded from the study if they meet any of the following criteria:
  • Use of exogenous insulin or GLP-1 agonists for glucose control.
  • Diagnosis of Type 1 diabetes.
  • History of diabetic ketoacidosis.
  • Current infection (requiring medication or hospitalization), has received corticosteroid treatment in the last 3 months, or has had surgery or received antibiotics in the last 3 weeks.
  • Active malignancy.
  • Significant cardiovascular event \< 12 weeks prior to study entry.
  • End stage organ failure or status post organ transplant.
  • Active metabolic, hepatic, or gastrointestinal disease.
  • Chronic, contagious, infectious disease.
  • Currently taking herbals, dietary supplements, or medications (other than antihyperglycemic medications) that could profoundly affect blood glucose.
  • History of fainting or other adverse reactions in response to blood collection.
  • Clotting or bleeding disorders.
  • Allergy or intolerance to study product ingredient.

Key Trial Info

Start Date :

June 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2013

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT01850134

Start Date

June 1 2013

End Date

July 1 2013

Last Update

July 13 2016

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Biofortis Clinical Research

Addison, Illinois, United States, 60101

2

Radiant Research

Cincinnati, Ohio, United States, 45249