ACZ885 in Type 1 Diabetes Mellitus

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the safety and efficacy of ACZ885 on stimulated C-peptide during a mixed meal test in patients with newly-diagnosed type 1 diabetes mellitus.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

Inclusion Criteria:

• diagnosis of type 1 diabetes within 3 months of visit 1 and on a stable insulin regimen

• presence of at least one diabetes-related autoantibody

• qualifying C-peptide value in a mixed meal test at visit 1

• willing to not have vaccination with a live vaccine for 18 months, from 3 months before visit 1 until 3 months after the last dose of study drug

• body weight of at least 30 kg

Exclusion Criteria:

• women of child-bearing potential unless a highly effective method of birth control is used (such as combined oral contraceptives, intrauterine devices, etc)

• immunodeficiency

• active infections or febrile illness within 3 days before visit 1

• major dental work within 8 days before visit 1

• positive test for tuberculosis at visit 1

• use of medications other than insulin for the treatment of diabetes Other protocol-defined inclusion/exclusion criteria may apply