ACZ885 in Type 1 Diabetes Mellitus

September 4, 2012 updated by: Novartis Pharmaceuticals

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)

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Barrie, Ontario, Canada
        • LMC Endocrinology Centres (Barrie) Ltd
      • Toronto, Ontario, Canada
        • LMC Endocrinology Centres (Bayview) Ltd
  • Germany
      • Dusseldorf, Germany
        • Novartis Investigative Site
      • Hannover, Germany
        • Novartis Investigative Site
      • Neuwied, Germany
        • Novartis Investigative Site
  • United Kingdom
      • Bristol, United Kingdom
        • Novartis Investigative Site
      • Exeter, United Kingdom
        • Novartis Investigative Site
      • Hull, United Kingdom
        • Novartis Investigative Site
      • Liverpool, United Kingdom
        • Novartis Investigative Site
  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States
        • Aurora St Luke's Medical Center, Endocrine & Diabetes Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 35 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Experimental: ACZ885
Drug: ACZ885

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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
Time Frame: 36 months
36 months
Measure: Change from baseline of fasted C-peptide at 4, 7, 10, 13, 18, 24, 30 and 36 months
Time Frame: 36 months
36 months
Measure: number of hypoglycemic events
Time Frame: 36 months
36 months
Measure: daily insulin dose
Time Frame: 36 months
36 months
Measure: anti-ACZ885 antibodies
Time Frame: 36 months
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Anticipated)

June 1, 2011

Study Registration Dates

First Submitted

March 22, 2011

First Submitted That Met QC Criteria

March 23, 2011

First Posted (Estimate)

March 24, 2011

Study Record Updates

Last Update Posted (Estimate)

September 5, 2012

Last Update Submitted That Met QC Criteria

September 4, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CACZ885I2208
  • 2010-020166-20 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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