Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Evaluation of a Nutritional Product for People With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT01850810
First received: May 6, 2013
Last updated: March 2, 2015
Last verified: March 2015

May 6, 2013
March 2, 2015
May 2013
August 2013   (final data collection date for primary outcome measure)
Hunger [ Time Frame: Treatment Visit Week 1 and Treatment Visit Week 2 ] [ Designated as safety issue: No ]
An appetite questionnaire administered 0 to 300 minutes during each study visit.
Same as current
Complete list of historical versions of study NCT01850810 on ClinicalTrials.gov Archive Site
  • Fullness [ Time Frame: Treatment Visit Week 1 and Treatment Visit Week 2 ] [ Designated as safety issue: No ]
    An appetite questionnaire administered 0 to 300 minutes during each study visit.
  • Desire to Eat [ Time Frame: Treatment Visit Week 1 and Treatment Visit Week 2 ] [ Designated as safety issue: No ]
    An appetite questionnaire administered 0 to 300 minutes during each study visit.
  • Prospective Consumption [ Time Frame: Treatment Visit Week 1 and Treatment Visit Week 2 ] [ Designated as safety issue: No ]
    An appetite questionnaire administered 0 to 300 minutes during each study visit.
Same as current
Not Provided
Not Provided
 
Evaluation of a Nutritional Product for People With Type 2 Diabetes
Evaluation of a Nutritional Product for People With Type 2 Diabetes (T2DM)

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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Diabetes
  • Other: Experimental Study Product
    Other Name: Oral nutritional supplement for people with Diabetes.
  • Other: Control Study Product
    Other Name: Water beverage.
  • Experimental: Experimental Study Product
    1 serving of a nutritional product for people with diabetes.
    Intervention: Other: Experimental Study Product
  • Placebo Comparator: Control Study Product
    1 serving of control beverage.
    Intervention: Other: Control Study Product
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
August 2013
August 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects will be eligible for the study if they meet all of the following inclusion criteria:

    1. Diagnosis of Type 2 Diabetes.
    2. Age between 18 and 75 years.
    3. HbA1c > 6.0 but ≤ 8.5
    4. 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.
    5. BMI is > 18.5 kg/m2 and < 40.0 kg/m2.
    6. Chronic medication dosage must be stable for at least two months prior to Screening Visit.
    7. Subject states that they are a habitual consumer of a morning meal.

Exclusion Criteria:

  • Subjects will be excluded from the study if they meet any of the following criteria:

    1. Use of exogenous insulin or GLP-1 agonists for glucose control.
    2. Diagnosis of Type 1 diabetes.
    3. History of diabetic ketoacidosis.
    4. 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.
    5. Active malignancy.
    6. Significant cardiovascular event < 12 weeks prior to study entry.
    7. End stage organ failure or status post organ transplant.
    8. Active metabolic, hepatic, or gastrointestinal disease.
    9. Chronic, contagious, infectious disease.
    10. Currently taking herbals, dietary supplements, or medications (other than antihyperglycemic medications) that could profoundly affect blood glucose.
    11. History of fainting or other adverse reactions in response to blood collection.
    12. Clotting or bleeding disorders.
    13. Allergy or intolerance to study product ingredient.
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01850810
BL17
No
Abbott Nutrition
Abbott Nutrition
Not Provided
Study Chair: Amy Devitt-Maicher, PhD Abbott Nutrition
Abbott Nutrition
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP