ACZ885 in Type 1 Diabetes Mellitus

NCT ID: NCT01322321

Last Updated: 2012-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus Diabetes Type 1

Keywords

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ACZ885 diabetes type 1 C-peptide

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ACZ885

Group Type EXPERIMENTAL

ACZ885

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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ACZ885

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Aurora St Luke's Medical Center, Endocrine & Diabetes Center

Milwaukee, Wisconsin, United States

Site Status

LMC Endocrinology Centres (Barrie) Ltd

Barrie, Ontario, Canada

Site Status

LMC Endocrinology Centres (Bayview) Ltd

Toronto, Ontario, Canada

Site Status

Novartis Investigative Site

Düsseldorf, , Germany

Site Status

Novartis Investigative Site

Hanover, , Germany

Site Status

Novartis Investigative Site

Neuwied, , Germany

Site Status

Novartis Investigative Site

Bristol, , United Kingdom

Site Status

Novartis Investigative Site

Exeter, , United Kingdom

Site Status

Novartis Investigative Site

Hull, , United Kingdom

Site Status

Novartis Investigative Site

Liverpool, , United Kingdom

Site Status

Countries

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United States Canada Germany United Kingdom

Other Identifiers

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2010-020166-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CACZ885I2208

Identifier Type: -

Identifier Source: org_study_id