ACZ885 in Type 1 Diabetes Mellitus

Diabetes Mellitus Clinical Trial

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)

Clinical Trial Details — Status: Withdrawn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• Status: Withdrawn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• Status: Withdrawn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. 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Type 1

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