PIONEER TEENS Study

Study Type

Pediatrics

Study Purpose

The purpose of the PIONEER TEENS research study is to test the efficacy of a study drug versus a placebo on controlling blood sugars in children and adolescents with Type 2 diabetes.

About the Study

Eligible participants will be randomized to either the study drug or placebo treatment for 52 weeks. For the duration of the study, participants should be on stable background treatment with either metformin, basal insulin, or a combination of both, all in addition to diet and exercise.

After the 52-week treatment period, all participants will continue in a 12-week follow-up period with visits at week 57 and week 64.

Study Design

Number of Visits:

  • 1 screening visit
  • 12 study visits
  • 8 phone call visits

Procedures:

  • Medical history
  • Height and weight
  • Vital signs (pulse and blood pressure, etc.)
  • Physical exam and ECG
  • Eye exam
  • X-Rays
  • Pregnancy tests
  • Oral glucose tolerance test
  • Questionnaires
  • Diet and activity counseling
  • Glucose diary instructions

Study Qualifications

To qualify for this research study, participants should:

  • Be between the ages of 10 – 17 years old
  • Have a diagnosis of Type 2 diabetes
  • Be willing to self-measure their blood sugar at home on a regular basis

Study Duration

Participation in the study will last approximately 64 weeks with 12 clinic study visits.

Compensation

Compensation of up to $620 is offered for the completion of this study.

Study Contact

If you are interested in volunteering for this research study, click here to screen online. Interested volunteers may also call 225-763-3000 or email clinicaltrials@pbrc.edu.

If you think you may be eligible, please click the button below to screen online.

GET STARTED

Please do not fill out this questionnaire for anyone other than yourself unless you are their legal guardian.
If you know someone who may be interested please direct them to the site or have them call us directly at 225-763-3000.

CALCULATE YOUR BMI

English Calculation
Enter Your Weight: 
 lbs.
Enter Your Height: 
 ft.  in.
Your BMI: