22-Oct-2010
The protocol amendment designed to reflect the real-world population; by permitting insulin use (with or without metformin) at baseline was approved in August by the Committee for Medicinal Products for Human Use (CHMP). The number of patients required to be taking pioglitazone at baseline has also been reduced from 2000 to 1000. This amendment is currently being submitted in all countries for ethical and regulatory approval. The first post-amendment patient on baseline insulin has been randomized in the US.
TECOS rejuvenation meetings are currently being undertaken in all regions to highlight the clinical and academic importance of the trial and launch the protocol amendment. The first of these was held for the EU region, which took place in Stockholm and attracted a large proportion of the EU TECOS investigators and study coordinators.
The third TECOS Data Safety and Monitoring Board meeting took place in October to review the study data. The Committee recommended that the trial continue as planned.