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CompletedNCT01326299Updated Mar 30, 2011

Post Prandial Glucose Control Proof-of-Principle

A Phase 2/3 interventional study of Carbohydrate placebo and Nutritional ingredient in Diabetes Mellitus, Type 2, sponsored by Abbott Nutrition. Completed at 1 site in United States. Open to participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2011-03-30.

Sponsored by Abbott Nutrition · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
21 Years to 75 Years
Sex
All
01

Study summary

The purpose of this study is to compare the postprandial glycemic response of subjects with type 2 diabetes when consuming a meal along with beverages containing various combinations of nutritional ingredients and fibers versus control beverage.

02

Conditions studied

  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 50 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Abbott Nutrition is the lead sponsor of 153 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. type 2 diabetes
  2. between 21 and 75 years of age
  3. male or a non-pregnant, non-lactating female, at least 6 weeks postpartum or postmenopausal or surgically sterile
  4. BMI is > 18.5 kg/m2 and \<35 kg/m2
  5. HbA1c \< 9.0%

Exclusion criteria

Exclusion Criteria:

  1. Subject uses exogenous insulin, exenatide, or sitagliptin phosphate
  2. type 1 diabetes.
  3. history of diabetic ketoacidosis.
  4. current infection
  5. active malignancy
  6. has had a significant cardiovascular event or history of congestive heart failure.
  7. end-stage organ failure or post organ transplant.
  8. history of renal disease.
  9. hepatic disease.
  10. history of gastrointestinal disorders
  11. chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
  12. taking any herbals, dietary supplements, or medications, other than oral hypoglycemic medications
  13. clotting or bleeding disorders.
  14. allergic or intolerant to any ingredient found in the study products.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • Active comparator
    Nutritional ingredient

    Dissolve in water and consume with meal

    Other: Nutritional ingredient

  • Placebo comparator
    Carbohydrate

    dissolve in water and consume with meal

    Other: Carbohydrate placebo

  • Experimental
    #1 Nutrtitional ingredient + Fiber

    Dissolve in water and consume with meal

    Other: #1 Nutritional ingredient +Fiber

  • Experimental
    #2 Nutritional ingredient + Fiber

    Dissolve in water and consume with meal

    Other: #2 Nutritional ingredient + Fiber

  • Experimental
    #3 Nutritional ingredient + Fiber

    Dissolve in water and consume with meal

    Other: #3 Nutritional ingredient + Fiber

Interventions

  • OtherCarbohydrate placebo

    dissolve in water and consume with meal

  • OtherNutritional ingredient

    Dissolve in water and consume with meals

  • Other#1 Nutritional ingredient +Fiber

    Dissolve in water and consume with meal

  • Other#2 Nutritional ingredient + Fiber

    Dissolve in water and consume with meal

  • Other#3 Nutritional ingredient + Fiber

    Dissolve in water and consume with meal

06

What researchers measure

Primary outcomes

  1. Positive AUC from 0 to 240 minutes for plasma glucose.

    Time frame: 0 to 240 minutes

Secondary outcomes

  1. Plasma glucose concentrations

    Time frame: 0 to 240 minutes

07

Study locations

1 site
  • Radiant Research
    Cincinnati, Ohio 45249, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01326299
Lead sponsor
Abbott Nutrition
First posted
Mar 30, 2011
Start date
Aug 2010
Primary completion
Sep 2010
Completion
Sep 2010
Last update
Mar 30, 2011

Study contacts

Amy Devitt-Maicher, PhD
study chair · Abbott Nutrition

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2011. You cannot join it, but the record below documents what was studied.

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