DEFEND-1 Long Term Follow Up: Durable-Response Therapy Evaluation for Early or New Onset Type 1 Diabetes Extension Study - LTF

• Conditions: Otelixizumab is being developed for the treatment of patients with autoimmune T1DM with residual beta cell function (RBCF), for the purpose of preserving RBCF in this patient population. Currently there are no approved treatments for this indication. n the USA, the approved treatments for T1DM are insulin or insulin analogues.; MedDRA version: 12.1Level: LLTClassification code 10012608Term: Diabetes mellitus insulin-dependent

• Registration Number: EUCTR2010-021259-22-GB
• Lead Sponsor: TolerX, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-21
• Last Update Posted: 24 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 272

Inclusion Criteria

Subjects will be enrolled only if they meet all of the following criteria.

1.Previously enrolled in DEFEND-1.

2.Completed the Month 24 visit of DEFEND 1; or, if the Month 24 visit was skipped, at least 24 months have elapsed since the first dose of study drug in DEFEND 1.

3.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 interfere with the subject’s ability to provide assent or informed consent. Such conditions would include, but are not limited to, psychoses or mental retardation with an IQ below 65.

4.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.

5.No condition or situation that, in the investigator’s judgment, is likely to cause the subject to be unable or unwilling to participate in study procedures or to complete all scheduled assessments. In Germany, persons who are confined to an institution by official or judicial order are not eligible.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

See above.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified