Frexalimab Trial for Type 1 Diabetes
Phase 2
192
about 6.9 years
12–35
14 sites in CA, CO, FL +9
About this study
This trial is testing Frexalimab, a drug given by injection, compared to placebo in adults and adolescents with type 1 diabetes who are already on insulin. The goal is to see if Frexalimab helps preserve the body's natural ability to produce insulin.
Based on ClinicalTrials.gov records.
What participants do
- 1.Receive Insulin
- 2.Take Frexalimab
- 3.Take Placebo
Participation effort
Estimated from trial records. Details can vary by site.
Logistics difficulty varies by site location and availability.
Trial highlights
Treatment details
Auto-extracted from trial records to preview treatments and outcomes.
monoclonal antibody, insulin (human)
injection
Primary: Change from baseline to W52 in mean 2h mixed meal tolerance test (MMTT) stimulated C-peptide concentration
Secondary: Change from baseline to W104 in mean 2h mixed meal tolerance test (MMTT) stimulated C-peptide concentration, calculated from AUC, Change from baseline to W52 and W104 in DTSQs Total and item scores (caregivers of all participants 12-17 y.o.), Change from baseline to W52 and W104 in Diabetes Treatment Satisfaction Questionnaires (DTSQs) total and item scores (all participants), Change from baseline to W52 and W104 in PAID immediate and theoretical domain scores (caregivers of all participants 12-17 y.o.), Change from baseline to W52 and W104 in Pediatric Quality of Life (PedsQL) Diabetes Management domain score (all participants), Change from baseline to W52 and W104 in PedsQL Diabetes Symptoms domain score (all participants), Change from baseline to W52 and W104 in Problem Areas In Diabetes (PAID) total score (all participants), Change from baseline to W52 and W104 in insulin dose [IU/kg/day]
Endocrinology