Joining the Protégé Encore study — who, what, why & how?
Who can join the Protégé Encore study?
To be in the Protégé Encore study, you (or your child) must meet a set of criteria including:
- 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 entering the study
- Weigh at least 36 kg (79 lbs)
- Not have had a vaccination with a live virus within 8 weeks before entering the study
For a more complete list of eligibility criteria, please visit: www.clinicaltrials.gov.
The Protégé Encore study will enroll approximately 400 people in over 100 medical facilities worldwide. Each volunteer’s participation will last 2 years.
What will I (or my child) be asked to do if I (or my child) am in the Protégé Encore study?
MacroGenics, the manufacturer of the study drug, is trying to determine the safest and most effective dose in people with newly diagnosed type 1 diabetes.
You (or your child) will be asked to follow study procedures including:
- 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 intravenous (through a vein) infusions of the investigational study drug or a placebo for 14 consecutive days. This will happen twice: at the very beginning of the study and then again 6 months later
- Attend follow-up visits in person and by telephone during the 2-year study commitment
Why should I (or my child) consider joining the Protégé Encore study?
People with type 1 diabetes are prone to a number of complications from the disease. These include heart disease, kidney disease, and blindness. Study volunteers 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 taking the investigational study drug or placebo against the possible benefits of participating in the study. The study doctor will explain the risks and benefits to you.
Those who join this clinical research study will receive, at no cost, all study-related care and exams, including:
- Close monitoring of their disease
- Direct access to doctors or nurses to answer questions and concerns
- Physical exams
- Blood work
- Investigational study drug or placebo
- Glucose monitor and supplies
Rights and responsibilities of Protégé Encore study volunteers
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 (or your child) 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 taking any investigational study drug or joining another clinical research study
- Be informed about all risks and benefits of the study
- Have access to study staff to answer all questions
- Be informed about new information that pertains to your safety or that may affect your willingness to continue participation in the 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 and receiving the investigational study drug or a placebo
- Answering study questions honestly
How can I (or my child) join the Protégé Encore study?
Step 1: Click here to fill out a questionnaire to determine if you meet some of the study requirements such as age, weight and how recently you were diagnosed with type 1 diabetes. If you feel more comfortable speaking to a person about these requirements, call the Encore contact center at 1-866-874-2527.
Step 2: If you meet all of the criteria in the questionnaire, you might be eligible for the study. You will be shown a list of study doctors within 300 miles of your ZIP code to choose from. Your information will automatically be sent to the study doctor you choose. His/her office will call you to tell you more about the study, answer any questions you have, and schedule an appointment for testing to see if you meet the rest of the requirements to participate in the study.
