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Date: 2009-12-17
Phase: III
Anouncement: Result
Biotech:
Pharma: Roche (Switzerland)
Product: taspoglutide (glucagon-like-peptide-1 (GLP-1) analogue) 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 retained co-marketing rights.
Disease: diabetes
Country:
Other: Ipsen announced that its partner Roche has disclosed headline results of the fourth and fifth of eight T-emerge phase III studies in patients with diabetes for taspoglutide originating from Ipsen’s research and developed by Roche.

T-emerge 5 is an open label and active controlled, 24 week core study to demonstrate noninferiority versus insulin glargine in 1,049 type 2 diabetic patients as add-on to metformin in patients failing on metformin and sulfonylurea.The patients were equally randomized into three arms (taspoglutide at doses of 10 mg and 20 mg once weekly, and insulin glargine once daily). The average final dose of Lantus® was 37 units. The results showed that taspoglutide demonstrated non-inferiority in HbA1c change versus insulin glargine. All patients are continuing into the long-term extension.

T-emerge 7 is a combination therapy study of taspoglutide as add-on to metformin in patients with high Body Mass Index. This is a double-blind, placebo-controlled, 24 week core study, to demonstrate superiority versus placebo, involving 305 patients equally randomized into two arms (taspoglutide at a dose of 20 mg once weekly and placebo). Taspoglutide demonstrated HbA1c superiority versus placebo in patients with high BMI. All patients are continuing into the long-term extension.

T-emerge 5 (subcutaneous weekly taspoglutide versus daily insulin glargine as add-on to metformin in patients failing on metformin and sulfonylurea) and T-emerge 7 (subcutaneous weekly taspoglutide versus placebo as add-on to metformin in patients with high BMI) both met their respective primary endpoints of change in HbA1c. In both studies taspoglutide was generally well tolerated. The most frequently reported adverse events among taspoglutide treated patients were nausea and vomiting.

The T-EMERGE Program comprise eight studies and over 6,000 patients will be enrolled. 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.