A 12-month, randomized, single-blind, placebo-controlled exposure-response study of TCD601 (siplizumab) in new onset type 1 diabetes patients (STRIDE)

Conditions

New onset type I diabetes

Brief summary

Change from baseline in mean 4 hour stimulated C-Peptide AUC following a MMTT, compared to placebo at week 52.

Detailed description

Reported AEs/SAEs and AESIs (e.g., local, and systemic infections) graded per CTCAE criteria., • Change from baseline in: hemoglobin A1c (HbA1c); exogenous insulin usage •Incidence and severity of hypoglycemic episodes over time •Partial remission as measured by insulin dose adjusted HbA1c •Change in fasting and postprandial blood glucose concentrations by treatment arm •Incidence and severity of ketoacidosis. •CGM derived Ambulatory Glucose Profiles (AGPs) •4h MMTT C-peptide AUC and 2h MMTT C-peptide AUC •4h MMTT C-peptide peak concentration and percent of subjects with ≥0.2 pmol/mL, Incidence, Frequency, and severity of infection AEs/SAEs graded by CTCAE criteria, • Serial measurement of serum siplizumab concentrations. • Serial measurement of total lymphocyte counts, T-cells subsets over time, and siplizumab dose and serum concentrations.

Related papers

No related papers found yet.

Interventions

DRUGCetirizin Mylan 10 mg film-coated tablets

DRUGParacetamol 500 mg Film Coated Tablets

DRUG0

DRUG9% normal saline

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Change from baseline in mean 4 hour stimulated C-Peptide AUC following a MMTT, compared to placebo at week 52.	—

Secondary

Measure	Time frame
Reported AEs/SAEs and AESIs (e.g., local, and systemic infections) graded per CTCAE criteria., • Change from baseline in: hemoglobin A1c (HbA1c); exogenous insulin usage •Incidence and severity of hypoglycemic episodes over time •Partial remission as measured by insulin dose adjusted HbA1c •Change in fasting and postprandial blood glucose concentrations by treatment arm •Incidence and severity of ketoacidosis. •CGM derived Ambulatory Glucose Profiles (AGPs) •4h MMTT C-peptide AUC and 2h MMTT C-peptide AUC •4h MMTT C-peptide peak concentration and percent of subjects with ≥0.2 pmol/mL, Incidence, Frequency, and severity of infection AEs/SAEs graded by CTCAE criteria, • Serial measurement of serum siplizumab concentrations. • Serial measurement of total lymphocyte counts, T-cells subsets over time, and siplizumab dose and serum concentrations.	—

Measure

Time frame

Reported AEs/SAEs and AESIs (e.g., local, and systemic infections) graded per CTCAE criteria., • Change from baseline in: hemoglobin A1c (HbA1c); exogenous insulin usage •Incidence and severity of hypoglycemic episodes over time •Partial remission as measured by insulin dose adjusted HbA1c •Change in fasting and postprandial blood glucose concentrations by treatment arm •Incidence and severity of ketoacidosis. •CGM derived Ambulatory Glucose Profiles (AGPs) •4h MMTT C-peptide AUC and 2h MMTT C-peptide AUC •4h MMTT C-peptide peak concentration and percent of subjects with ≥0.2 pmol/mL, Incidence, Frequency, and severity of infection AEs/SAEs graded by CTCAE criteria, • Serial measurement of serum siplizumab concentrations. • Serial measurement of total lymphocyte counts, T-cells subsets over time, and siplizumab dose and serum concentrations.

—

Countries

Belgium, Italy, Spain, Sweden

Outcome results

None listed