ACZ885 in Type 1 Diabetes Mellitus

A Randomized, Double-blind, Multiple-dose, Placebo-controlled, Parallel Group Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of ACZ885 in Patients With Newly Diagnosed Type-1 Diabetes Mellitus (T1DM)

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01322321

Enrollment

Registered

2011-03-24

Start date

2011-03-31

Completion date

Unknown

Last updated

2012-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Diabetes Type 1

Keywords

ACZ885, diabetes, type 1, C-peptide

Brief 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.

Interventions

DRUGACZ885

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

6 Years to 35 Years

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/

Design outcomes

Primary

Measure	Time frame
Measure: Change from baseline of stimulated C-peptide after a mixed meal tolerance test at 13 months	at 13 months

Secondary

Measure	Time frame
Measure: Change from baseline of stimulated C-peptide after a mixed meal tolerance test at 4, 7, 10, 18, 24, 30 and 36 months	36 months
Measure: Change from baseline of fasted C-peptide at 4, 7, 10, 13, 18, 24, 30 and 36 months	36 months
Measure: number of hypoglycemic events	36 months
Measure: daily insulin dose	36 months
Measure: anti-ACZ885 antibodies	36 months

Countries

Canada, Germany, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026