ClinicalTrials.gov Identifier: NCT02846545.
The purpose of the T1GER clinical research study is to determine the safety and efficacy of an investigational medication in children and young adults with newly diagnosed type 1 diabetes. The investigational medication is being tested to find out if it can maintain beta cell (insulin-producing) function in the pancreas of those newly diagnosed with type 1 diabetes.
Who may qualify.
The T1GER study may be appropriate for:
- Children and young adults ages 6–21
- Those who have been newly diagnosed (within the past three months) with type 1 diabetes
This study will be conducted in the United States only and will last a little more than two years. During the first year, patients will visit the study clinic a minimum of 11 times, not including the screening visit.
At these visits, patients will receive the investigational medication or a placebo. During the second year of the study, patients will enter the follow-up period and visit the study clinic twice so study site staff can see how patients are doing.
At study visits, the study staff will collect lab samples and ask questions to evaluate and monitor each patient’s health and well-being throughout the study.
More about the T1GER study
This study will last about two years and is divided into three parts.
Screening – no more than 28 days.
At screening, you will read and sign the informed consent form if you agree to participate, or to let your child participate, in the study. You or your child will then be evaluated to determine eligibility.
Double-blinded treatment period – one year;
at least 11 visits.
If you or your child is eligible, the double-blinded treatment period will begin. Participants will be assigned in a 2:1 ratio to receive the investigational medication or the placebo. (A placebo contains no active medication.) During this time, a minimum of 11 study visits will occur for at-home dosing. The injections are done once every two weeks. Patients will need to visit the office once every two weeks if they choose to receive the injection at the study site.
Follow-up period – one year; two visits.
Once the treatment period has ended, the follow-up period will begin. The study team will check to see how you or your child is doing. Two clinic visits will occur after the last dose of the investigational medication, and you will be required to maintain an electronic diary. The first visit is at 26 weeks (about six months), and the second is at 52 weeks (one year).