Investigation of Otelixizumab in New-Onset, Autoimmune Type 1 Diabetes Mellitus Patients

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

March 12, 2014

Primary Completion Date

September 27, 2018

Study Completion Date

September 27, 2018

Conditions
Diabetes Mellitus, Type 1
Interventions
BIOLOGICAL

Otelixizumab

Otelixizumab is available at unit dose strength of 5 milligram/mL provided as 1 mL solution per vial to be diluted to 0.1 mg/mL in 0.9% sodium chloride. The 0.1 mg/mL solution is to be administered by intravenous infusion using a syringe pump and an in-line 0.2 micron filter by study personnel following specified regimens

BIOLOGICAL

Placebo

Placebo is available 0.9% w/v sodium chloride

Trial Locations (6)

1070

GSK Investigational Site, Brussels

1090

GSK Investigational Site, Brussels

2650

GSK Investigational Site, Edegem

3000

GSK Investigational Site, Leuven

4000

GSK Investigational Site, Liège

9000

GSK Investigational Site, Ghent

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Parexel

INDUSTRY

lead

GlaxoSmithKline

INDUSTRY