Investigating Re-Dosing With Otelixizumab in Adults With Newly-Diagnosed Type 1 Diabetes Mellitus

Summary

The purpose of this study to assess the safety and tolerability of re-dosing at 6 months with otelixizumab (given as an 8-day series of intravenous infusions) in adult subjects with newly diagnosed type 1 diabetes mellitus

Timeline

Start

2010-11-22

Primary completion

2011-05-19

Completion

2011-05-19

Outcome

Outcome not reported

Stopped: “A Phase 3 study recently reported and demonstrated that the dose of otelixizumab in OTX113390 is not effective.”

Publications

• Background GSK has concluded that it is not feasible to publish this study in a peer-reviewed scientific journal because the nature of the study is unlikely to be of interest to a journal. GSK is providing the attached study results summary with a conclusion.

Drugs

Indications