Presymptomatic diabetes type 1 (stage 1)
Conditions
Brief summary
Cumulative diabetes incidence [only the progression to stage 3 considered as diabetes incidence]. (The analysis will cover the percentage of participants in each group who are in stage 2 type 1 diabetes mellitus, i.e., presence of autoantibodies, dysglycemia or stage 3 at year 1 and every year thereafter after the first dose of Tregs/placebo), Number of adverse events reported 1 year, 2 years after the first dose of Tregs and at the end of the trial comparing to control arms
Detailed description
Pace of diabetes development. Total number of days from the date of diagnosis of stage 2 to the date of onset of full-blown type 1 diabetes mellitus (stage 3 of type 1 diabetes mellitus) in each group (normalized to the number of person/days in each group), C-peptide levels [fasting/post MMTT stimulation (AUC)] 1 year, 2 years after the first dose of Tregs and then annually until the end of the trial comparing to control arms, Daily average dose of insulin per kg body weight (DDI) 1 year, 2 years after the first dose of Tregs, and annually thereafter until the end of the trial in each arm of the study, Number of participants per arm in remission 1 year, 2 years after the first dose of Tregs, and annually thereafter until the end of the trial, [remission defined as daily insulin dose is less than 0.5U/kg/day with an HbA1c level less than 6.5%], Assessment of the incidence and severity of adverse events associated with the administration of Treg preparation or anti-CD20 antibody, primarily the effects of immunosuppression: incidence of infections of any etiology and de novo tumors detected, Percentage of participants in each group who are still in stage 1 type 1 diabetes mellitus, i.e., presence of autoantibodies and normoglycemia
Interventions
Sponsors
Poltreg S.A.
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative diabetes incidence [only the progression to stage 3 considered as diabetes incidence]. (The analysis will cover the percentage of participants in each group who are in stage 2 type 1 diabetes mellitus, i.e., presence of autoantibodies, dysglycemia or stage 3 at year 1 and every year thereafter after the first dose of Tregs/placebo), Number of adverse events reported 1 year, 2 years after the first dose of Tregs and at the end of the trial comparing to control arms | — |
Secondary
| Measure | Time frame |
|---|---|
| Pace of diabetes development. Total number of days from the date of diagnosis of stage 2 to the date of onset of full-blown type 1 diabetes mellitus (stage 3 of type 1 diabetes mellitus) in each group (normalized to the number of person/days in each group), C-peptide levels [fasting/post MMTT stimulation (AUC)] 1 year, 2 years after the first dose of Tregs and then annually until the end of the trial comparing to control arms, Daily average dose of insulin per kg body weight (DDI) 1 year, 2 years after the first dose of Tregs, and annually thereafter until the end of the trial in each arm of the study, Number of participants per arm in remission 1 year, 2 years after the first dose of Tregs, and annually thereafter until the end of the trial, [remission defined as daily insulin dose is less than 0.5U/kg/day with an HbA1c level less than 6.5%], Assessment of the incidence and severity of adverse events associated with the administration of Treg preparation or anti-CD20 antibody, primar | — |
Countries
Poland
Outcome results
None listed