Durable-Response Therapy Evaluation For Early -or New-Onset Type 1 Diabetes.

Phase 3

Withdrawn

Conditions: Type-1 Diabetes
10003816

Registration Number: NL-OMON34462

Lead Sponsor: Tolerx Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 25

Inclusion Criteria

4a. Diagnosis of diabetes mellitus according to ADA criteria, with an interval of <= 90 days between initial diagnosis and first dose of study drug.
4b. History and clinical course consistent with Type 1A DM.
5. Currently requires insulin for T1DM treatment, or has required insulin for DM at some time between the date of diagnosis and the first dose of study drug.
9. Positive for one or more of the following autoantibodies typically associated with T1DM: antibody to glutamic acid decarboxylase; antibody to protein tyrosine phosphatase-like protein; zinc transporter autoantibodies; insulin autoantibodies. A subject who is positive for IAA and negative for the other autoantibodies will not be eligible if the subject has used insulin for a total of 7 days or more.
10. Evidence of residual functioning β cells as measured by a stimulated C-peptide level over 0.20 nmo/L during an MMTT that was initiated when blood glucose level was > 70 mg/dL and <= 200 mg/dL.
11. Maximum stimulated C-peptide level <= 3.50 nmol/L.
12. Body Mass Index < 32.

Exclusion Criteria

15. Significant systemic infection during the 6 weeks before the first dose of study drug.
16. Current of prior malignancy, other than non-melanoma skin cancer.
17. History of current or past active tuberculosis infection and no latent tuberculosis infection.
22. EBV viral load of > 10,000 copies per 10.000.000 peripheral blood mononuclear cells as determined by qPCR.
25. Have used any potent immunosuppressive agent within the 30 days before the first dose of study drug, and expected to require such treatment within 3 months after the last dose of study drug.
27. Have received a vaccine within the 30 days before the first dose of study drug, and expected to require a vaccine during the dosing period or the 14 days after the last dose of study drug.
29. Have previously received any anti-lymphocyte monoclonal antibody and planning to use any such antibody for the planned duration of study participation.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary efficacy endpoint is change from baseline in 2-hour mixed<br /><br>meal-stimulated C-peptide AUC at Month 12. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Efficacy endpoints:<br /><br>* Responder status at 'key visits' (Week 12 and Months 6, 12, 18 and 24). A<br /><br>subject is considered a responder if, at the given time point, the subject has:<br /><br>a) HbA1c <= 6.5% and<br /><br>b) Mean daily insulin use < 0.5 IU/kg/day over 7 consecutive days during the 2<br /><br>weeks preceding the visit.<br /><br><br /><br>* Mean daily insulin use over 7 consecutive days during the 2 weeks preceding<br /><br>each key visit.<br /><br><br /><br>* HbA1c level at key visit.</p><br>