| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01123083 | Trial of Otelixizumab for Adolescents and Adults With Newly Diagnosed Type 1 Diabetes Mellitus (Autoimmune): DEFEND-2 | PHASE3 | COMPLETED | 179 | — | — | May 17, 2010 | Mar 9, 2012 | Sep 15, 2017 | 1 | Italy |
| NCT02000817 | Investigation of Otelixizumab in New-Onset, Autoimmune Type 1 Diabetes Mellitus Patients | PHASE1 | COMPLETED | 30 | — | — | Mar 12, 2014 | Sep 27, 2018 | Jun 24, 2019 | 6 | Belgium |
| NCT00946257 | Subcutaneous Administration of Otelixizumab to T1DM Patients | PHASE1 | COMPLETED | 33 | — | — | Jul 8, 2009 | Jun 25, 2013 | Jun 1, 2017 | 6 | Belgium |
C-peptide is a protein that shows how much insulin the body is producing. For 3 days before the mixed meal tolerance test participants were asked to eat a balanced diet. The test was performed only when the finger-stick blood glucose level was above 70 mg per deciliter (mg/dL) and no higher than 200 mg/dL. Mixed meal-stimulated C-peptide AUC was the area under the C-peptide/time curve from time 0 to 120-minutes, calculated using the trapezoidal rule. This AUC was normalized for time interval by dividing it by 120-minutes (the number of minutes over which it was determined), and was adjusted by inclusion of Baseline C-peptide AUC as a covariate in the analysis. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the value at Month 12 from the Baseline value.
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. On treatment AEs have been reported. Safety Population comprised of all participants who received at least one dose of study treatment.
Blood samples were collected for analysis of EBV viral load and detection was done by polymerase chain reaction (PCR).
Blood samples were collected to analyze the laboratory parameters which included alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), bilirubin, calcium, chloride, creatinine, direct bilirubin, glucose, potassium, protein, sodium, urate, urea nitrogen, basophil, eosinophil, mean corpuscular haemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), mean corpuscular volume (MCV), erythrocytes, haematocrit, haemoglobin, leukocytes, lymphocytes, monocytes, neutrophils, platelets and reticulocytes.
12-lead electrocardiograms (ECGs) were obtained in semi-supine position after 5 minutes rest for the participants at indicated time points to measure QTc.
Vital signs were measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Vital signs included systolic, diastolic blood pressure, pulse rate and respiratory rate
| Arm | Type | Description |
|---|---|---|
| otelixizumab | EXPERIMENTAL | otelixizumab |
| placebo | PLACEBO_COMPARATOR | placebo |
| Otelixizumab 9 mg | EXPERIMENTAL | Each subject will receive otelixizumab 1.5 mg diluted with 0.9% weight /volume sodium chloride intravenously daily for 6 consecutive days (cumulative dose-9 mg) |
| Otelixizumab 18 mg | EXPERIMENTAL | Each subject will receive otelixizumab 3 mg diluted with 0.9% weight /volume sodium chloride intravenously daily for 6 consecutive days (cumulative dose-18 mg) |
| Otelixizumab 27 mg | EXPERIMENTAL | Each subject will receive otelixizumab 4.5 mg diluted with 0.9% weight /volume sodium chloride intravenously daily for 6 consecutive days (cumulative dose-27 mg) |
| Otelixizumab 36 mg | EXPERIMENTAL | Each subject will receive otelixizumab 1.5 mg diluted with 0.9% weight /volume sodium chloride intravenously daily for 6 consecutive days (cumulative dose-36 mg) |
| Cohort 1 | EXPERIMENTAL | 0.3 mg dose |
| Cohort 2 | EXPERIMENTAL | 0.6 mg dose |
| Cohort 3 | EXPERIMENTAL | 1.2 mg dose |
| Cohort 4 | EXPERIMENTAL | 1.8 mg dose |
| Cohort 5 | EXPERIMENTAL | 2.4 mg dose |
| Cohort 6 | EXPERIMENTAL | 3.0 mg dose |
| Name | Type | Description |
|---|---|---|
| Otelixizumab | BIOLOGICAL | infusion |
| Placebo | BIOLOGICAL | Infusion |
Inclusion Criteria: * Ages 12-17 * Diagnosis of diabetes mellitus, consistent with ADA criteria * No more than 90 days between diagnosis and administration of study compounds * Requires insulin for type 1 diabetes mellitus, or has required insulin at some time between diagnosis and administration o...