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

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    Recruiting
Updated on 23 November 2020

Summary

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

Description

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.

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.

Details
Clinical Study IdentifierTX139441
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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How to participate?

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What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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