People with stage 1 or stage 2 T1D between the ages of 7 and 45
Conditions
Brief summary
Beta-cell function - measured by disposition index during OGTT - after 48 weeks of treatment.
Detailed description
Proinsulin-to-C-peptide ratio during OGTT at baseline, 24 and 48 weeks, Chromogranin A/GLP-1/GIP during OGTT at baseline, 24 and 48 weeks, Changes in disposition index components: insulin sensitivity and insulin secretion measured by metabolic modelling during 24-week and 48 weeks OGTT., CD4+/CD8+ T-cell responses of peripheral blood monocytes to type 1 diabetes-associated antigens at baseline and 48 weeks, Percentage change in time spent in glucose ranges (70-140 mg/dL, 70-180 mg/dL) and glucose variability (SD, CV, CONGA1, 2 and 4) during sensor sessions (CGM) at 10 days, 24 and 48 weeks after treatment initiation
Interventions
DRUGPlacebo of Verapamil LP 120mg
Sponsors
Assistance Publique Hopitaux De Paris
Eligibility
Sex/Gender
All
Age
0 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Beta-cell function - measured by disposition index during OGTT - after 48 weeks of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Proinsulin-to-C-peptide ratio during OGTT at baseline, 24 and 48 weeks, Chromogranin A/GLP-1/GIP during OGTT at baseline, 24 and 48 weeks, Changes in disposition index components: insulin sensitivity and insulin secretion measured by metabolic modelling during 24-week and 48 weeks OGTT., CD4+/CD8+ T-cell responses of peripheral blood monocytes to type 1 diabetes-associated antigens at baseline and 48 weeks, Percentage change in time spent in glucose ranges (70-140 mg/dL, 70-180 mg/dL) and glucose variability (SD, CV, CONGA1, 2 and 4) during sensor sessions (CGM) at 10 days, 24 and 48 weeks after treatment initiation | — |
Outcome results
None listed