The Prot»g» Study
The Prot»g» Study
Contact form: http://www.protegediabetes.org/contact.aspx
1-888-218-8298
The Prot»g» study will further evaluate the safety of teplizumab and test whether it will reduce or prevent the autoimmune attack that damages beta cells. If it works, the person may need less injected insulin, and blood glucose levels may be easier to control if the remaining beta cells are preserved.
Your body uses a type of white blood cells, called T cells, to attack cells and germs that are foreign to your body. In type 1 diabetes, your body acts as if the insulin-producing beta cells in your pancreas are foreign and allows certain T cells to attack the beta cells.
To slow the effects of type 1 diabetes, you need a way to protect the beta cells from your body's attack. The Prot»g» study is testing an experimental drug called hOKT3γ1 (Ala-Ala) or teplizumab, a CD3 monoclonal antibody that may protect the beta cells. Teplizumab may protect beta cells by attaching to T cells before the T cells can attack your beta cells.
Who can join the Prot»g» study?
To be in the Prot»g» 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 Prot»g» 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 Prot»g» 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 Prot»g» 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 Prot»g» 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 Prot»g» study is carefully designed to accurately collect information and evaluate a potential new treatment for type 1 diabetes. After the Prot»g» study findings are analyzed, the researchers will share the results with study volunteers.
