About Clinical Research

Clinical research studies are done to test investigational medications for diseases and conditions. Studies help determine if investigational medications are safe to use and work to improve the health of people. Before any medication, therapy, or medical device can be approved and made available to the general public, it has to go through several phases of clinical research.

Conducting research in children is important, as children are not just small adults. It is important to assess the safety and effectiveness of all new investigational medicines in children and adolescents.

Why do people participate in studies?

Clinical study participation is completely voluntary. People participate in clinical research studies for a variety of reasons. Some volunteers may participate in studies because they want to learn more about their disease. Others volunteer to participate because they want to help researchers learn more about a disease so that it may help others in the future.

Participating in clinical research can be challenging. Speak with the study doctor about any questions you may have and let the study doctor know if you expect any challenges to participating in the study.

What requirements are in place to help protect clinical trial participants?

Regulations and policies have been developed to help protect the rights, safety, and well-being of people who take part in clinical research studies and to help ensure that these studies are conducted according to strict scientific and ethical principles.

Before a clinical research study can begin, a review board must review and approve the study. This group is called an IRB or institutional review board, and is comprised of doctors, scientists, and members of the community.

What is the informed consent process?

Since many clinical trials involve new investigational medications or test medications in new ways, there are risks associated with participation. It is important that as a parent you understand these risks before agreeing that your child can participate. The possible benefits and risks of participation should be discussed with the study doctor. You are encouraged to bring up any concerns you may have and to ask any questions you may have.

Once you have had an opportunity to ask questions, and before your child can participate in a study, you must read and sign an informed consent document indicating you understand the risks and benefits of study participation for your child, as well as your responsibilities as the parent of a study participant. You will receive a copy of the informed consent form to take with you. Depending on his or her age, your child may be asked to read and sign an informed assent document indicating that he or she understands what it means to participate

What if I have questions during the study?

You and your child can ask questions of the study team at any point before, during, and after the study. Before agreeing to participate, please make sure that you and your child understand the possible risks and benefits of participating, as well as the responsibilities of study participants. If you have any concerns about your child participating in the study, you should feel comfortable discussing them with a member of the study team at any time.

Can my child leave the study once it has started?

Study participation is completely voluntary, and you can end your child’s participation at any time, for any reason. If you think you would like your child to stop participating in the study, talk to the study doctor about how to leave the study safely. If you decide your child should leave the study early, the study doctor may ask that he or she return to the study site for a final visit. If you decide your child should stop taking the investigational medication, you will be asked to allow the site to contact you at intervals to follow-up on your child’s health.

Can my child see other doctors during the study?

During the study, your child can still see his or her regular doctor for non-study-related care. You should tell the study doctor if your child starts taking any other medications. While your child is participating in the study, he or she should not have any diabetes-related testing done outside of the study.

About the Studies

The SITup studies are evaluating an investigational medication for type 2 diabetes to learn if it can safely and effectively help control blood sugar levels in children and adolescents. Blood sugar is tested using an A1C test, which tells you the average level of blood sugar in the body. What we learn in these studies may help us develop new future options for managing type 2 diabetes in children and adolescents.

There are two types of studies in the SITup program:

  • One type for those who have not taken oral diabetes medication or insulin in the past 12 weeks (SITup 083)
  • One type for those currently taking metformin therapy but whose diabetes is still not under control (SITup 170 and 289)

SITup 083

Who Can Participate

Your child may be able to join the SITup 083 study if he or she:

  • Is aged 10 to 17
  • Has type 2 diabetes
  • Has an A1C level of 6.5% to 10%
  • Has not taken an oral medication for type 2 diabetes in the past 12 weeks
  • Has not received insulin in the past 12 weeks

There are other eligibility criteria that your child must meet. The study staff can discuss these criteria with you in greater detail.

If you do not know if your child has type 2 diabetes, or if you do not know his or her A1C level, testing is available for your child at no cost.

How long will the study last?

If your child is eligible for the SITup 083 study, his or her participation will last approximately 14 months, including 10 visits to the study clinic and 1 phone call.

SITup 170 and SITup 289

Who can participate?

Your child may be able to join the SITup 170 study or the SITup 289 study if he or she:

  • Is aged 10 to 17
  • Has type 2 diabetes
  • Has an A1C level of 6.5% to 10%
  • Has been taking the same dose of metformin for at least 12 weeks
  • Has not received insulin in the past 12 weeks

There are other eligibility criteria that your child must meet. The study staff can discuss these criteria with you in greater detail.

If you do not know your child’s A1C level, testing is available for your child at no cost.

How long will the study last?

If your child is eligible for the SITup 170 study, his or her participation will last approximately 5.5 months, including 6 visits to the study clinic and 3 phone calls. An extension study for SITup 170 may be available to participants who completed the SITup 170 study, also referred to as the SITup 170 “base” study. The SITup 170 extension study will last up to an additional 8 months.

If your child is eligible for the SITup 289 study, his or her participation will last approximately 14 months, including 9 visits to the study clinic and at least 4 phone calls.

What is the investigational medication?

The investigational medication in all three studies is called sitagliptin. Sitagliptin is approved by regulatory agencies around the world to treat type 2 diabetes in adults. It is considered investigational in these studies because it has not been previously studied in or approved for use in children and adolescents.

In SITup 083, sitagliptin will be compared to placebo. Placebo looks like the investigational medication but has no active ingredients.

In SITup 170 and 289, sitagliptin will be given as a fixed-dose medication (with immediate-release metformin in SITup 170 and extended-release metformin in SITup 289). Metformin is approved in the United States and other countries to treat type 2 diabetes in adults and children. In these studies, the addition of sitagliptin to either immediate-release or extended-release metformin will be compared to the addition of placebo to metformin.

What will happen during the study?

If your child is eligible and agrees to participate in any of the SITup studies and you provide consent, he or she will:

  • Visit the study clinic as directed; at these visits, study staff will provide study-related care and may perform tests and procedures
  • Avoid eating anything for at least 10 hours prior to some visits
  • Take the investigational medication as directed by the study staff
  • Have urine tests at home
  • Use blood sugar monitors to test his or her blood sugar at home
  • Write down information about his or her blood sugar and complete a log if they have a low blood sugar reaction

There are additional requirements that the study doctor will explain to you.

About Type 2 Diabetes

What is type 2 diabetes?

People with diabetes have too much sugar in their blood. Sugar comes from all kinds of foods like pasta, cereal, and bread, not just from sweets and candy. Insulin helps sugar go from the blood to the cells so that it can be used for energy. Insulin is a hormone that is made in the pancreas.

Type 2 diabetes is different from type 1 diabetes because people with type 2 diabetes can make insulin, while those with type 1 diabetes cannot. But sometimes the cells in the body cannot use the insulin very well; that’s when type 2 diabetes develops.

Type 2 diabetes is more common in adults than in children, but more children and teenagers are being diagnosed. Type 2 diabetes is also more common in some ethnic groups, especially African Americans, Latinos, Native Americans, Asian Americans, and Pacific Islanders.

A family history of type 2 diabetes makes it more likely that your child will develop the disease. Not getting enough exercise, not eating healthy, and being overweight can also increase your child’s risk of getting type 2 diabetes. In adults type 2 diabetes that is not treated or is poorly controlled may cause health problems, such as blindness, loss of toes or feet, and kidney failure.

How is type 2 diabetes treated?

Eating healthy and being active can help your child manage his or her type 2 diabetes. However, for some people, a healthy diet and exercise aren’t enough. Some people need to be treated with medication to reduce their high blood sugar.