Clinical Trial Details

Overview

Research Study Summary

Does type 2 diabetes run in your family? Then sit up and take notice

Purpose

If your child has type 2 diabetes that is difficult to control or if type 2 diabetes runs in your family, you may want to learn more about the SITup research studies.

What is the purpose of the SITup studies?

The purpose of the SITup studies is to find out whether an investigational medication, called sitagliptin, can safely and effectively help control blood sugar levels in children and adolescents.

There are two kinds of studies in the SITup program:

  • One kind is for children and adolescents who have not taken oral diabetes medication or insulin in the past 12 weeks
  • One kind is for children and adolescents currently taking metformin therapy but whose diabetes is still not under control

What is the investigational medication?

Sitagliptin is approved by regulatory agencies around the world to treat type 2 diabetes in adults. It is considered investigational in this study because it has not been previously studied in children and adolescents.

To find out if your child may be eligible to participate, visit www.diabetesresearchinfo.com

To Learn more

CW ID: 205543
Date Last Changed: February 11, 2015

Clinical Trial Snapshot

Gender
Both Male and Female
Age
10 to 17 Years
Overall Status
Recruiting
Facility Type
N/A

Eligibility

Who can participate?

Your child may be able to participate in one type of study in the SITup program if he or she:

  • Is 10 to 17 years of age
  • Has an A1C level between 6.5% and 10%
  • Has not taken oral diabetes medication in the past 12 weeks
  • Has not taken insulin in the past 12 weeks

Your child may be able to participate in another type of study in the SITup program if he or she:

  • Is 10 to 17 years of age
  • Has an A1C level between 6.5% and 10%
  • Has been on metformin for at least 12 weeks
  • Has not taken insulin in the past 12 weeks

If your child has not been tested for type 2 diabetes or you are unsure of his or her A1C level, contact your doctor.

More Info

What will my child be asked to do?

If you and your child decide to participate in the SITup program, your child will enter a one-week screening period to determine if he or she is eligible to participate. If he or she is eligible, your child will have study-related tests and procedures at study visits. Depending on the type of SITup study for which your child qualifies, participation in the SITup program may last between 5 and 14 months and include anywhere from 6 to 10 study visits.

What are the potential risks and benefits?

Everyone who participates in a research study must first complete a screening visit. During the screening visit, the study doctor will explain to you the study details and the potential risks and benefits of participation in the study.

The information learned from the study and your participation may help improve future treatment options for children and adolescents with type 2 diabetes.

Study participation is voluntary. If you choose to participate, you may leave the study at any time for any reason. The study doctor and staff will be available to help you throughout the study and to address any questions you may have.

Contact

To find out if your child may be eligible to participate, visit www.diabetesresearchinfo.com

Research Site
Located in:
Birmingham, AL 35233

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