ACZ885 in newly diagnosed type 1 diabetes mellitus CACZ885I2208

• Research type

  Research Study

• Full title

  A randomized, double-blind, multiple-dose, placebocontrolled, parallel group study to evaluate the safety, tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics of ACZ885 in patients with newly diagnosed type-1 diabetes mellitus (T1DM)

• IRAS ID

  61944

• Contact name

  Danny McBryan

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2010-020166-20

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This study is designed to look at the effect of ACZ885 in newly diagnosed type 1 diabetic patients and measure their clinical response to treatment over a year compared to placebo. We are looking at the effects of IL-1Ç? blockade on the preservation of stimulated C-peptide after a mixed meal test in addition to standard of care. The study is also looking at gene expression, antibody responses and HbA1c effects. A total of 48 patients aged 6 to 35 years will be enrolled globally whom have been diagnosed with type 1 diabetes in the previous 3 months.

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  10/H0502/90

• Date of REC Opinion

  4 Jan 2011

• REC opinion

  Favourable Opinion