Last updated on August 2019

Diabetes Autoimmunity Withdrawn In New Onset and In Established Patients

Brief description of study

TThe study is a prospective, randomized, 52-week double-blind, placebo-controlled, multicenter trial in subjects with T1D followed by a 2-year safety follow-up.

Detailed Study Description

The SUNRISE study is a prospective, multi-center, double-blind, randomized, placebo-controlled trial in subjects aged 18.0 to <41.0 years diagnosed with T1D, as defined by American Diabetes Association (ADA) criteria, and within 5 years of diagnosis. Time of diagnosis is defined as the first day of insulin administration. Subjects will be stratified by duration (zero up to 1 year and 1 year up to five years) to ensure balance of disease duration across treatment and placebo groups in each strata. Subjects should be randomized no sooner than 6 weeks after diagnosis, unless blood glucose is adequately controlled for >14 days, defined as 3 consecutive fasting glucose levels by SMBG or lab testing <130 mg/dL. Screening assessments will include a physical examination, an ophthalmic examination, chemistry and hematology safety labs, urinalysis, 24-hour urine protein and creatinine, HbA1c, presence of T1D antibodies, and an MMTT. Approximately 51 qualified subjects who meet all selection criteria will be randomized in a 2:1 ratio to treatment with TOL-3021 or placebo and treated for 52 weeks. Subjects will agree to diabetes management during the study with the goal of maintaining HbA1c levels of approximately 7.0% without frequent episodes of hypoglycemia.

Clinical Study Identifier: NCT03895437

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