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Who can join the Protégé study?
To be in the Protégé study, you must:
- Be 8 to 35 years of age
- Have had your first visit to a doctor for symptoms of type 1 diabetes and received that diagnosis within 12 weeks of starting treatment on this study
- Weigh at least 36 kg (79 lbs)
- Not be using any other experimental treatment during the time you are in the study
- Not have received treatment with a monoclonal antibody within 1 year before joining the study
- Not currently be using or planning to use inhaled insulin
- Not have received a vaccination with a live virus within 12 weeks before joining the study
The Protégé study will enroll up to 530 people at approximately 85 medical facilities and 10 countries. Each person's participation will last two years.
What will I need to do if I am in the Protégé study?
MacroGenics, the manufacturer of teplizumab, is trying to determine the safest and most effective dose of teplizumab that may protect beta cells in people with newly diagnosed type 1 diabetes.
You (or your child) will be asked to:
- Confirm that you have had your first visit to a doctor for symptoms of type 1 diabetes and received that diagnosis within 12 weeks of starting treatment on this study
- Give consent for the study
- Have urine and blood tests to see if you qualify for this study
- Receive daily IV infusions of the study drug for 14 consecutive days. This will happen twice: at the very beginning of the study and then again 6 months later.
- Attend 14 additional study visits during the two-year study commitment
Why should I (or my child) join the Protégé study?
People with type 1 diabetes are prone to a number of complications from the disease. These include heart disease, kidney disease, high blood pressure, and blindness. You or your child may or may not directly benefit from this study. What we learn from this study will be added to the research knowledge base and may help others at risk for type 1 diabetes. You will need to weigh the possible risks of the study medication against the possible benefits of participating in the study.
Those who join the study will receive, at no cost:
- Close monitoring of their disease
- Direct access to doctors or nurses to answer questions and concerns
- Physical exams
- Blood work
- Study medication
Rights and responsibilities of Protégé study participation
Those who join a clinical study have certain rights and responsibilities. A doctor or nurse who is running the study will explain to study volunteers their rights and responsibilities.
For example, as a volunteer you have the right to:
- Talk to the study doctor about other kinds of treatment, which may include having usual diabetes treatment under the guidance of your own doctor without any experimental study drug or joining another clinical study
- Be informed about all risks and benefits of the study
- Have access to study staff to answer all questions
- Have new information that pertains to your safety or that may affect your willingness to continue participation in this study
- Have your health carefully and frequently monitored
- Be able to leave the study if you no longer wish to participate
Study volunteers will also be asked to make a commitment to the study. Responsibilities include:
- Following the study requirements, which include keeping study appointments, receiving study medication, and completing a diary card
- Answering study questions honestly
The Protégé study is carefully designed to accurately collect information and evaluate a potential new treatment for type 1 diabetes. After the Protégé study findings are analyzed, the researchers will share the results with study volunteers.
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