Diabetes Mellitus, Type 1
Conditions
Keywords
Diabetes Mellitus, type 1, ChAgly CD3
Brief summary
Compared to placebo, treatment with ChAgly CD3 has a beneficial effect on preservation of beta cell function and metabolic outcome in type 1 diabetic patients with recent clinical onset of disease that persists until 48 months after administration. The investigators also hypothesize that in type 1 diabetic patients with recent clinical onset of disease compared to placebo, ChAgly CD3 will be safe and well tolerated between 18 and 48 months after administration, based on assessment of clinical and laboratory adverse events.
Interventions
DRUGChAgly CD3
6 days treatment 8mg/d intravenous
DRUGPlacebo
6 days
Sponsors
KU Leuven
Universiteit Antwerpen
Erasme University Hospital
AZ-VUB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Subjects with Type 1 diabetes mellitus included in the phase II therapeutic trial with a humanized non-mitogenic CD3 monoclonal antibody (ChAgly CD3) at time of clinical diagnosis and who agree and are likely to comply with the investigator's instructions
Exclusion criteria
* Any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risks to the patient * Use of illicit drugs or over consumption of alcohol (\> 3 beers/day) * Being legally incapacitated, having significant emotional problems at the time of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference in change in daily insulin need between baseline and month 48, between placebo and ChAgly CD3 treated patients | 48 months |
Countries
Belgium, Germany
Outcome results
None listed