ACZ885 in Type 1 Diabetes Mellitus

Phase 2

Withdrawn

• Conditions: Diabetes Mellitus; Diabetes Type 1
• Interventions: Drug: ACZ885; Drug: Placebo

• Registration Number: NCT01322321
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-22
• Study First Submitted QC: 2011-03-23
• Study First Posted: 2011-03-24
• Primary Completion: 2011-06
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-04
• Last Update Posted: 2012-09-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACZ885	ACZ885	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Measure: Change from baseline of stimulated C-peptide after a mixed meal tolerance test at 13 months	at 13 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

LMC Endocrinology Centres (Barrie) Ltd; 🇨🇦 Barrie, Ontario, Canada

Novartis Investigative Site; 🇬🇧 Liverpool, United Kingdom

LMC Endocrinology Centres (Bayview) Ltd; 🇨🇦 Toronto, Ontario, Canada

Aurora St Luke's Medical Center, Endocrine & Diabetes Center; 🇺🇸 Milwaukee, Wisconsin, United States