Study Name: TOPPLE Study
Principal Investigator: Carla Greenbaum, MD
What is the TOPPLE Study
Patients ages 18 – 45 with type 1 diabetes diagnosed in the past four years have an opportunity to participate in a TrialNet study that is testing the safety of a new treatment, NNC0361-0041. The treatment is a plasmid vector designed to transfer DNA into cells, where it can communicate with the immune system.
Earlier studies in the lab show this treatment might retrain the immune system to stop attacking insulin-producing beta cells.
While plasmids are small circular pieces of DNA, they do not change your DNA. They are currently being studied in many clinical trials for other conditions.
As with any medical intervention, there are risks and benefits to participating in this study. Before you decide to participate, a member of our research team will explain all potential risks and benefits and answer any questions you may have.
Who Can Participate?
You may be eligible to participate if you:
- have been diagnosed with type 1 diabetes within the past 48 months (four years),
- are 18 - 45 years of age
What Will Study Participants Be Asked to Do?
All study visits take place at Benaroya Research Institute’s clinical research center in Seattle.
The study has two phases: treatment and follow up.
In the treatment phase, participants will visit our clinical research center once a week for 12 weeks. At each visit, they will receive an injection (treatment or placebo). For the first visit, they will stay at the clinical research center as an inpatient for 48 hours of observation. The remaining treatment visits will last 3-7 hours, depending on observation and testing.
In the follow up phase, participants will have a study visit at months 3, 4, 6 and 12. These visits will last 1-4 hours, depending on which tests are needed.
If you would like to participate, please contact us as soon as possible at 800-888-4187 or email Diabetes@BenaroyaResearch.org.