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Clinical Trials/NCT01326299
NCT01326299
Completed
Phase 2

Post Prandial Glucose Control Proof-of-Principle

Abbott Nutrition1 site in 1 country50 target enrollmentStarted: August 2010Last updated:

Overview

Phase
Phase 2
Status
Completed
Enrollment
50
Locations
1
Primary Endpoint
Positive AUC from 0 to 240 minutes for plasma glucose.

Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
21 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • Subject uses exogenous insulin, exenatide, or sitagliptin phosphate
  • type 1 diabetes.
  • history of diabetic ketoacidosis.
  • current infection
  • active malignancy
  • has had a significant cardiovascular event or history of congestive heart failure.
  • end-stage organ failure or post organ transplant.
  • history of renal disease.
  • hepatic disease.
  • history of gastrointestinal disorders

Outcomes

Primary Outcomes

Positive AUC from 0 to 240 minutes for plasma glucose.

Time Frame: 0 to 240 minutes

Secondary Outcomes

  • Plasma glucose concentrations(0 to 240 minutes)

Investigators

Sponsor Class
Industry

Study Sites (1)

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