Clinical trial NCT01322321: 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
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Diabetes Mellitus
Diabetes Type 1
Keywords: ACZ885
diabetes
type 1
C-peptide
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-03-24
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Measure: Change from baseline of stimulated C-peptide after a mixed meal tolerance test at 13 months
timeFrame: at 13 months
Secondary outcomes:
measure: Measure: Change from baseline of stimulated C-peptide after a mixed meal tolerance test at 4, 7, 10, 18, 24, 30 and 36 months
timeFrame: 36 months
measure: Measure: Change from baseline of fasted C-peptide at 4, 7, 10, 13, 18, 24, 30 and 36 months
timeFrame: 36 months
measure: Measure: number of hypoglycemic events
timeFrame: 36 months
measure: Measure: daily insulin dose
timeFrame: 36 months
measure: Measure: anti-ACZ885 antibodies
timeFrame: 36 months
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Aurora St Luke's Medical Center, Endocrine & Diabetes Center
state: Wisconsin
city: Barrie
country: Canada
facility: LMC Endocrinology Centres (Barrie) Ltd
state: Ontario
city: Toronto
country: Canada
facility: LMC Endocrinology Centres (Bayview) Ltd
state: Ontario
city: Dusseldorf
country: Germany
facility: Novartis Investigative Site
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Neuwied
country: Germany
facility: Novartis Investigative Site
city: Bristol
country: United Kingdom
facility: Novartis Investigative Site
city: Exeter
country: United Kingdom
facility: Novartis Investigative Site
city: Hull
country: United Kingdom
facility: Novartis Investigative Site
city: Liverpool
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: