SUNRISE- Tolerion

Diabetes Autoimmunity Withdrawn In New Onset and In Established Patients (SUNRISE)- Tolerion

The SUNRISE study is a prospective, multi-center, double-blind, randomized, placebo-controlled trial of TOL-3021 (a plasmid expression vector containing the coding sequences for the human proinsulin (hINS) gene) in subjects aged 14.0 to <41.0 years diagnosed with Type 1 diabetes with a duration of diabetes less than 5 years.  The primary outcome for the study is preservation of endogenous insulin production as measured by C-peptide during a 4 our mixed meal tolerance test (MMTT).

Screening assessments will include a physical examination, retinal photograph, chemistry and hematology safety labs, urinalysis, HbA1c, presence of T1D antibodies, and an MMTT demonstrating endogenous insulin production. Qualified subjects who meet all selection criteria will be randomized in

a 2:1 (active:placebo) ratio to treatment with TOL-3021 or placebo and treated with weekly IM injection, mostly at home, for 52 weeks with 2 more years of follow-up. Subjects will agree to diabetes management including wearing a study provided G6 Dexcom sensor during the study with the goal of maintaining HbA1c levels of approximately 7.0% without frequent episodes of hypoglycemia.

More details at

https://clinicaltrials.gov/ct2/show/NCT03895437

• 1. Diagnosis of Type 1 Diabetes Mellitus based on American Diabetes Association (ADA) criteria and within 5.0 years from diagnosis, defined as the first day of insulin administration.
• 2. Age at randomization of 14.0 - <41.0 years of age .
• 3. Adequate glycemic control as defined by HbA1c <7.6% based on point-of-care or local lab measurement and time in glycemic range (70-180 mg/dL) >55% by CGM recording over 3 or more days within 5 days of baseline mixed meal tolerance test (MMTT)
• 4. On insulin therapy (total insulin dose >0.125 U/kg BW)
• 5. Presence of antibodies to at least one of the following antigens: GAD-65, IA-2, ZnT8, or insulin, or documentation of positive antibodies.
• 6. Peak C-peptide during screening 4-hour mixed meal tolerance test (MMTT) ≥ 0.2pmol/mL.
• 7. Willingness to wear the Dexcom G6 continuous glucose monitoring (CGM) device and use according to instructions most of each day from screening to end of treatment period.
• 8. Written informed consent, including authorization to release health information.
• 9. Willingness and ability of subject to comply with all study procedures of the study protocol, includingattending all clinic visits.
• 10. Willing to avoid pregnancy

• 1.       Body Mass Index (BMI) >32 kg/m2
• 2.       Previous immunotherapy for diabetes
• 3.       Diagnosis of significant other diseases
• 4.       The use of selected other medications
• 5.       Pregnancy or breast feeding

If you're interested in learning more about this study, please reach out to the research coordinator listed on the right. You may also download the consent form, assent form, and any other documents linked on the right.