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news.Roche has disclosed results of the Phase III T-emerge 3 study in patients with diabetes with Taspoglutide, the first once weekly glucagon-like peptide-1 (GLP-1) analogue based on a human sequence. Taspoglutide originating from Ipsen’s research is developed by Roche.
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Roche’s T-emerge Phase III clinical trials are designed as multicenter, multi-country, randomized, controlled (active or placebo), double-blind and open studies.
Over 6,000 patients will be enrolled in the eight studies that comprise the T-emerge program.
Studies include two parallel taspoglutide arms including 10 mg once weekly and 10 mg once weekly titrated up to 20 mg once weekly after 4 weeks. Four of the eight studies have active comparators, including exenatide, sitagliptin, insulin glargine and pioglitazone.
Taspoglutide was selected from a family of human once-weekly long-acting glucagon-like peptide-1 (GLP-1) analogues with structural modifications which confer intrinsic controlled release properties.
Taspoglutide is being developed, by Roche, as a novel and innovative treatment for patients with type 2 diabetes mellitus, the fourth leading cause of death in most developed countries. The structure of the molecule is similar to that of the natural human hormone GLP-1, and has the potential for intervals of up to two weeks in between administration without the use of a matrix.
Roche exercised its licensing option for Taspoglutide from Ipsen in 2006 and acquired exclusive worldwide rights to develop and market Taspoglutide, except in Japan where these rights are shared with Teijin and in France where Ipsen has elected to retain co-marketing rights.
The results of T-emerge 3 showed that Taspoglutide demonstrated superiority in HbA1c change versus placebo following 24 weeks of treatment. The study analysis included 326 patients, randomised into three arms (Taspoglutide 10mg once weekly, Taspoglutide 20mg once weekly and placebo).
Roche said that in addition to the already released T-emerge 1, T-emerge 2, T-emerge 4, T-emerge 5 and T-emerge 7 studies, data from T-emerge 3 will be submitted for presentation at upcoming international scientific meetings. A further two T-emerge Phase III trials exploring Taspoglutide in patients with diabetes are ongoing.