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)
2 other identifiers
interventional
N/A
4 countries
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 22, 2011
CompletedFirst Posted
Study publicly available on registry
March 24, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedSeptember 5, 2012
September 1, 2012
3 months
March 22, 2011
September 4, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measure: Change from baseline of stimulated C-peptide after a mixed meal tolerance test at 13 months
at 13 months
Secondary Outcomes (5)
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
Study Arms (2)
ACZ885
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Aurora St Luke's Medical Center, Endocrine & Diabetes Center
Milwaukee, Wisconsin, United States
LMC Endocrinology Centres (Barrie) Ltd
Barrie, Ontario, Canada
LMC Endocrinology Centres (Bayview) Ltd
Toronto, Ontario, Canada
Novartis Investigative Site
Düsseldorf, Germany
Novartis Investigative Site
Hanover, Germany
Novartis Investigative Site
Neuwied, Germany
Novartis Investigative Site
Bristol, United Kingdom
Novartis Investigative Site
Exeter, United Kingdom
Novartis Investigative Site
Hull, United Kingdom
Novartis Investigative Site
Liverpool, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2011
First Posted
March 24, 2011
Study Start
March 1, 2011
Primary Completion
June 1, 2011
Last Updated
September 5, 2012
Record last verified: 2012-09