Christiana Care News
Trials for New Type 1 Diabetes Patients
To find out about participating in either study, please call 302-623-3838.
Just diagnosed with type 1 diabetes? Take action.
Individuals who have recently had their first symptoms of type 1 diabetes are being invited to participate in Protégé Encore, a clinical research study to evaluate an investigational study drug that may help to slow or stop the progression of type 1 diabetes.
Why is the study being conducted?
The Protégé Encore study will test whether the investigational study drug, called teplizumab, may slow or stop the progression of the autoimmune disease that damages the insulin-producing beta cells of the pancreas.
The Protégé Encore study is the second Phase 3 clinical trial testing the safety and effectiveness of this investigational study drug. The first clinical trial, called Protégé, has completed enrollment.
What will volunteers be asked to do?
Study volunteers will be asked to:
- Receive daily intravenous infusions of the investigational study drug or placebo for 14 consecutive days. This will occur twice: once at the beginning of the study and then again 6 months later.
- Attend follow-up study visits in person or by telephone during the 2-year commitment.
Who can participate in the study?
To be in the Protégé Encore study, volunteers must:
- Have had their first visit to a doctor for symptoms of type 1 diabetes and received that diagnosis within 12 weeks of starting the study treatment.
- Be 8 to 35 years of age.
- Weigh at least 36 kg (79 lbs).
- Not have had certain vaccinations within four weeks of study entry.
Volunteers will receive, at no cost, study-related:
- Diabetes monitoring.
- Direct access to study doctors or nurses to answer questions and concerns.
- Physical exams.
- Blood work.
- Investigational study drug or placebo.
- Glucose monitor and supplies.
For more information about Protégé Encore, please visit www.ProtegeDiabetes.org
Has a friend or family member recently been diagnosed with type 1 diabetes?
The DiaPrevent research study is now available.
About type 1 diabetes
Type 1 diabetes is a lifelong disease that occurs when your body's insulin producing cells do not make enough insulin to properly control blood-sugar levels. The disease can occur at any age; however, it is most often diagnosed in younger people. Without enough insulin, sugar (glucose) builds up in the bloodstream and the body is unable to use this glucose for energy. Therefore people with type 1 diabetes need to take insulin shots every day.
There may, however, still be some cells left that produce insulin in the body. If the insulin-producing cells that are left could be saved, it would be easier to keep a good blood-sugar level.
Studies have shown that people with type 1 diabetes who continue to produce their own insulin have less trouble with low blood sugar and fewer health complications.
About the DiaPrevent research study
The DiaPrevent research study aims to find out if the investigational study vaccine, named Diamyd, may preserve the body's ability to produce insulin in children and young adults with type 1 diabetes. As in other research studies, the study vaccine will be compared to a placebo (shots without the active drug). Two out of three participants will receive active study vaccine and one out of three will receive placebo. There is a 66% percent chance you will receive the investigational study vaccine Diamyd if you choose to participate in the study.
If you qualify for this study, you will receive one shot at 4 different occasions and your diabetes will be monitored for a period of 2.5 years. All study-related procedures, laboratory tests, examinations and study drug will be provided at no cost. The DiaPrevent research study will include 320 participants at 30 to 50 sites across the United States. We hope that the DiaPrevent study will lead to advancements in the treatment of type 1 diabetes.
Participating In DiaPrevent research study
Participation is strictly voluntary. Prior to your participation in the DiaPrevent research study, the study staff will take the time to answer any questions you may have. An informed consent form will be provided for your review and signature prior to a medical evaluation to determine if you qualify to participate. The informed consent will present the specifics of the DiaPrevent research study and allow the opportunity for you and your doctor to discuss if the DiaPrevent research study is right for you or your child.
The DiaPrevent study may be an option for someone who:
- Is between 10 and 20 years of age.
- Has been diagnosed with Type 1 Diabetes within the past 3 months.
- Meets other study entry criteria.
Visit www.DiaPrevent.com for more information about the study.
To find out about participating in the study, please call 302-623-3838.
For media inquiries, call Kate Klemas at 302-327-3327, Jay Moorhead at 302-327-3394 or Bill Schmitt at 302-327-3318.
