ACZ885 in Type 1 Diabetes Mellitus

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01322321
First received: March 22, 2011
Last updated: September 4, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus
Diabetes Type 1
Drug: ACZ885
Drug: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Measure: Change from baseline of stimulated C-peptide after a mixed meal tolerance test at 13 months [ Time Frame: at 13 months ] [ Designated as safety issue: No ]

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 [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Measure: Change from baseline of fasted C-peptide at 4, 7, 10, 13, 18, 24, 30 and 36 months [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Measure: number of hypoglycemic events [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • Measure: daily insulin dose [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Measure: anti-ACZ885 antibodies [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: March 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ACZ885 Drug: ACZ885
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Ages Eligible for Study:   6 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01322321

Locations
United States, Wisconsin
Aurora St Luke's Medical Center, Endocrine & Diabetes Center
Milwaukee, Wisconsin, United States
Canada, Ontario
LMC Endocrinology Centres (Barrie) Ltd
Barrie, Ontario, Canada
LMC Endocrinology Centres (Bayview) Ltd
Toronto, Ontario, Canada
Germany
Novartis Investigative Site
Dusseldorf, Germany
Novartis Investigative Site
Hannover, Germany
Novartis Investigative Site
Neuwied, Germany
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 Kingdom
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01322321     History of Changes
Other Study ID Numbers: CACZ885I2208, 2010-020166-20
Study First Received: March 22, 2011
Last Updated: September 4, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Germany: Paul-Ehrlich-Institut
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:
ACZ885
diabetes
type 1
C-peptide

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 24, 2014