ACZ885 in Type 1 Diabetes Mellitus

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Diabetes Mellitus, Diabetes Type 1

In brief

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.

Key facts

Study ID

NCT01322321

Run by

Novartis Pharmaceuticals

People needed

0

Starts

2011-03-01

Last updated by the study team

2012-09-05

Who can join

Age: 6 and older, up to 35. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Aurora St Luke's Medical Center, Endocrine & Diabetes Center — Milwaukee, Wisconsin, United States
• LMC Endocrinology Centres (Barrie) Ltd — Barrie, Ontario, Canada
• LMC Endocrinology Centres (Bayview) Ltd — Toronto, Ontario, Canada
• Novartis Investigative Site — Düsseldorf, Germany
• Novartis Investigative Site — Hanover, Germany
• Novartis Investigative Site — Neuwied, Germany
• Novartis Investigative Site — Bristol, United Kingdom
• Novartis Investigative Site — Exeter, United Kingdom
• Novartis Investigative Site — Hull, United Kingdom
• Novartis Investigative Site — Liverpool, United Kingdom

Full record on ClinicalTrials.gov

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