Roche announced that results from the first five phase-III clinical trials show that taspoglutide has met the primary end-points of reduction in blood glucose (blood sugar) in these studies. Roche’s taspoglutide, the first weekly human GLP-1 analogue in late stage development may improve treatment options for patients with type-2 diabetes.

Taspoglutide is similar to the naturally occurring human hormone GLP-1 which plays a key role in blood glucose metabolism through a range of mechanisms, including improvement of insulin secretion, suppression of abnormal glucose production by the liver, slowing food absorption through the gut and suppressing appetite in animal studies resulting in glycaemic control and weight loss with a low risk of hypoglycaemia. Roche’s phase-III clinical trials programme – called T-emerge - includes placebo-controlled and active-comparator controlled studies with current standards of care* in patients treated with metformin or other therapies as well as evaluating the effect of this innovative option in patients who are not controlled on diet and exercise alone.

“Taspoglutide’s consistent robust efficacy data across studies in terms of glucose control, when compared head-to-head with other widely prescribed diabetes treatments, are encouraging. This weekly GLP-1 receptor agonist has the potential to become a valuable new treatment option for patients with type 2 diabetes,” said one of the lead investigators, Julio Rosenstock, director of Dallas Diabetes and Endocrine Center at Medical City and also Clinical Professor of Medicine University of Texas Southwestern Medical School.

In all five studies taspoglutide was generally well tolerated; the most frequently reported adverse events among taspoglutide treated patients were nausea and vomiting which is an expected occurrence in all medications in this class.

“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 hypoglycaemia, and manageable safety profile. We believe taspoglutide has the potential to become an important therapy for diabetic patients,” said Hal Barron, Global head of Product Development at Roche.

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 may elect to retain co-marketing rights.

The T-emerge phase-III clinical trial programme is designed as multicentre, multi-country, randomized, controlled (active or placebo), double-blind and open studies.