DiabeteS AUtoimmuNity WithdRawn In New OnSEt and In Established Patients (SUNRISE) A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety of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

Purpose

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? 

Age

18 to 65

Gender

Male
Female

Monetary compensation

Yes

Can be done from home

No

Keywords

Diabetes diet - type 1, Type 1 diabetes

Principal Investigator

Laura Jacobsen, MD

Department

Pediatric Endocrinology

Contact Information

cintrm@peds.ufl.edu

(352) 273-5580


Be an Informed Participant

Before deciding to participate in a research study, take time to learn about clinical research, how it's conducted and your rights as a research participant. Following are some helpful resources from independent sources. Always remember that a clinical research study is research, not treatment.

Know Who to Contact

  • Eligibility: For questions about a specific study and who is eligible to participate, call or email the contact person listed for that study.
  • Your Rights: For questions about your rights as a research participant, contact the UF Institutional Review Boards at 352-273-9600.
  • Feedback: For general questions or feedback about study listings, email the UF Clinical and Translational Science Institute at CTSI-Studies-L@lists.ufl.edu.

Other Resources

  • HealthStreet: Health-focused services, classes and events, and opportunities to participate in research.
  • ResearchMatch.org: Join a national registry of volunteers willing to be contacted about research studies.

For Research Teams