DiabeteS AUtoimmuNity WithdRawn In New OnSEt and In Established Patients (SUNRISE) A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety of TOL-3021 in Patients with New Onset or Established Type 1 Diabetes Mellitus
Do you have Type 1 Diabetes (T1D)?
- Was your T1D diagnosed within the last 5 years?
- Are you between 18 and 40 years old?
- Is your HbA1c about 7.6% or lower
- Are you on insulin therapy?
If you have answered yes to all of these questions, you may be eligible to participate in a clinical trial to evaluate the safety of an investigational drug called TOL-3021 and whether TOL-3021 can stop the immune system from attacking beta cells in the pancreas of individuals with T1D and thus help the pancreas make insulin.
What else should I know?
- 1-year study with 2-year follow-up
- Randomized placebo-controlled with 2 in 3 chances to get TOL-3021 and 1 in 3 chances to get placebo (inactive ingredient)
- Weekly injections for 52 weeks (self-administered at home starting with week 5)
- 18 visits (mostly monthly) during first year; 4 visits during 2-year follow-up
- Dexcom G6 CGM and all supplies provided at no cost for required glucose monitoring through 52 weeks
- Study visits and tests provided at no cost
- Gift card for each scheduled and completed visit
How do I get more information?
- Call (352) 273-5580
- Email firstname.lastname@example.org
Can be done from home
KeywordsDiabetes diet - type 1, Type 1 diabetes
Principal InvestigatorLaura Jacobsen, MD
Begin a new search for other research studies
Studies listed on this site have been approved by a UF Institutional Review Board (IRB), which works to ensure the welfare and rights of research participants as required by federal regulations. Study listings are provided by the UF Clinical and Translational Science Institute in collaboration with UF research teams and the UF IRBs.