DEFEND 2: durable-Response Therapy Evaluation For Early- or New-Onset Type 1 Diabetes - DEFEND-2

INTERVENTION: Product Name: Otelixizumab Product Code: TRX4 Pharmaceutical Form: Solution for infusion CAS Number: 881191‐44‐2 Current Sponsor code: TRX4 Other descriptive name: Otelixizumab Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 0.2‐ Route of administration of the placebo: Intravenous use CONDITION: Type 1 Diabetes Mellitus ; MedDRA version: 13.1 Level: LLT Classification code 10012608 Term: Diabetes mellitus insulin‐dependent System Organ Class: 10027433 ‐ Metabolism and nutrition disorders PRIMARY OUTCOME: Main Objective: The primary objective is to demonstrate that subjects who receive an 8 day series of otelixizumab infusions have greater improvement than subjects who receive placebo in endogenous insulin secretion, as assessed by area under the concentration‐time curve (AUC) for mixed meal‐stimulated C peptide, at 12 months after study drug administration. Primary end point(s): The primary efficacy endpoint is change from baseline in 2 hour mixed meal‐stimulated C peptide AUC at Month 12. Secondary Objective: Secondary objectives are:; 1. To assess exogenous insulin use for the otelixizumab and placebo groups and for selected subpopulations;; 2. To assess glycemic control, as measured by HbA1c, subject‐reported hypoglycemic events, and hypoglycemic and hyperglycemic excursions, for the otelixizumab and placebo groups and for selected subpopulations;; 3. To assess the safety of an 8 day series of otelixizumab infusions, especially with regards to adverse events (AEs) and Epstein‐Barr virus monitoring; and; 4. To assess the pharmacodynamic (PD) effects of an 8 day series of otelixizumab infusions, especially with regards to absolute counts and percentages of lymphocyte subsets and CD3/T cell receptor (TCR) modulation.; INCLUSION CRITERIA: 1. No condition that, in the investigator’s judgment, is likely to cause the subject to be unable to understand the information in the assent form or Informed Consent Document (ICD) or provide informed consent. Such conditions would include, but are not limited to, psychoses or mental retardation with an IQ below 65. 2. Informed Consent Document signed by the subject if the subject is legally an adult. If the subject is legally a minor, ICD signed by the subject’s parent, both parents, or guardian and assent form signed by the subject, in accordance with the regulatory and legal requirements of the participating country. 3. Male or female, aged 12 to 45 years, inclusive, at the time of anticipated first dose of study drug. In Denmark, subjects must be aged 18 to 45 years. Subjects aged 12 to 17 years must be Tanner Stage >= 2. All subjects must weigh at least 31 kg. 4. a. Diagnosis of diabetes mellitus according to ADA criteria (Appendix 1), with an int