ACZ885 in Type 1 Diabetes Mellitus

Novartis

Status and phase

Withdrawn

Phase 2

Conditions

Diabetes Mellitus

Diabetes Type 1

Treatments

Drug: ACZ885

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01322321

CACZ885I2208

2010-020166-20 (EudraCT Number)

Details and patient eligibility

About

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.

Sex

All

Ages

6 to 35 years old

Volunteers

No Healthy Volunteers

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