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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01322321
Other study ID # CACZ885I2208
Secondary ID 2010-020166-20
Status Withdrawn
Phase Phase 2
First received March 22, 2011
Last updated September 4, 2012
Start date March 2011

Study information

Verified date September 2012
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationCanada: Health CanadaGermany: Paul-Ehrlich-InstitutUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender Both
Age group 6 Years to 35 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Drug:
ACZ885

Placebo


Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada,  Germany,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Measure: Change from baseline of stimulated C-peptide after a mixed meal tolerance test at 13 months at 13 months No
Secondary 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 No
Secondary Measure: Change from baseline of fasted C-peptide at 4, 7, 10, 13, 18, 24, 30 and 36 months 36 months No
Secondary Measure: number of hypoglycemic events 36 months Yes
Secondary Measure: daily insulin dose 36 months No
Secondary Measure: anti-ACZ885 antibodies 36 months No
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