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ACZ885 in Type 1 Diabetes Mellitus

Primary Purpose

Diabetes Mellitus, Diabetes Type 1

Status
Withdrawn
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ACZ885
Placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring ACZ885, diabetes, type 1, C-peptide

Eligibility Criteria

6 Years - 35 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Aurora St Luke's Medical Center, Endocrine & Diabetes Center
  • LMC Endocrinology Centres (Barrie) Ltd
  • LMC Endocrinology Centres (Bayview) Ltd
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ACZ885

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 22, 2011
Last Updated
September 4, 2012
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01322321
Brief Title
ACZ885 in Type 1 Diabetes Mellitus
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Withdrawn
Study Start Date
March 2011 (undefined)
Primary Completion Date
June 2011 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Diabetes Type 1
Keywords
ACZ885, diabetes, type 1, C-peptide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ACZ885
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ACZ885
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Measure: Change from baseline of stimulated C-peptide after a mixed meal tolerance test at 13 months
Time Frame
at 13 months
Secondary Outcome Measure Information:
Title
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
Title
Measure: Change from baseline of fasted C-peptide at 4, 7, 10, 13, 18, 24, 30 and 36 months
Time Frame
36 months
Title
Measure: number of hypoglycemic events
Time Frame
36 months
Title
Measure: daily insulin dose
Time Frame
36 months
Title
Measure: anti-ACZ885 antibodies
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Aurora St Luke's Medical Center, Endocrine & Diabetes Center
City
Milwaukee
State/Province
Wisconsin
Country
United States
Facility Name
LMC Endocrinology Centres (Barrie) Ltd
City
Barrie
State/Province
Ontario
Country
Canada
Facility Name
LMC Endocrinology Centres (Bayview) Ltd
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Novartis Investigative Site
City
Dusseldorf
Country
Germany
Facility Name
Novartis Investigative Site
City
Hannover
Country
Germany
Facility Name
Novartis Investigative Site
City
Neuwied
Country
Germany
Facility Name
Novartis Investigative Site
City
Bristol
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Exeter
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Hull
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Liverpool
Country
United Kingdom

12. IPD Sharing Statement

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ACZ885 in Type 1 Diabetes Mellitus

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