Late-stage program for taspoglutide will include eight trials and 6,000 patients.
Roche says data from the first five Phase III trials with its once-weekly type 2 diabetes candidate taspoglutide showed that the GLP-1 analogue met its primary endpoints of reducing blood glucose levels.
“These Phase III studies have shown that treatment with once weekly taspoglutide leads to significantly improved blood glucose control, consistent weight loss, a minimal risk of hypoglycemia, and a manageable safety profile,” comments Hal Barron, Roche’s global head of product development.
The Phase III development program for taspoglutide includes eight studies that will enroll some 6,000 patients. Four of the studies have active comparators including exenatide, sitagliptin, insulin glargine, and pioglitazone.
The company licensed taspoglutide from Ipsen in 2006. Under the terms of the deal, Roche has worldwide rights to develop and market taspoglutide, except in Japan, where rights are shared with Teijin, and in France, where Ipsen retains co-marketing rights.
Roche’s diabetes therapeutic pipeline includes a number of candidates in clinical development, including RG4929 and RG7234, both small molecule 11 beta HSD inhibitors in Phase I trials. RG7089 is a Y2R peptide agonist, also in Phase I trials for type 2 diabetes. RG7201 is a small molecule SGLT2 inhibitor, currently in Phase II development for type 2 diabetes. RG7201 is partnered with Chugai. Roche’s type 1 diabetes candidate, RG7426, is a small molecule undergoing Phase I testing.