Roche reports results of 5 taspoglutide Phase III studies for type 2 diabetes at 70th ADA

“Effect of Taspoglutide, a Human GLP-1 Analog, on Insulin Secretion in Patients with Type 2 Diabetes (T2D)”

Ipsen (Paris:IPN) (Euronext: IPN; ADR: IPSEY) a global biopharmaceutical group, today announced that its partner Roche disclosed results of five Phase III 24-week studies for taspoglutide for type 2 diabetes at the American Diabetes Association's (ADA) 70th Annual Scientific Sessions. Taspoglutide, the first once weekly glucagon-like peptide-1 (GLP-1) analogue based on a human sequence, originating from Ipsen's research is developed by Roche. This compound is similar to the natural hormone GLP-1 which has a key role in blood sugar regulation.

Three head-to-head comparisons against exenatide, sitagliptin and insulin glargine found that treatment with taspoglutide showed comparable or greater reductions in HbA1c levels with a low risk of hypoglycemia, resulted in more patients reaching the ADA target for HbA1c of <7.0%, and produced clinically meaningful weight loss.

Two additional Phase III studies showed that taspoglutide, when used alone or added to metformin (the most common first-line treatment for type 2 diabetes), significantly reduced HbA1c and body weight with low risk of hypoglycemia. Further studies suggest that taspoglutide may help restore a normal insulin response as well as potentially preserving insulin-producing beta cells and subsequently protect them from cell death.

In the studies, taspoglutide was administered once a week with a pre-filled, disposable syringe with a small-gauge needle.

The most common adverse events seen with taspoglutide based on the 24-week data are related to gastrointestinal tolerability and injection site reactions. Nausea and vomiting were of mild to moderate intensity, generally occurred early in treatment on the day of injection and predominantly as a single episode. Roche also recently announced the implementation of a risk mitigation plan in the Phase III programme designed to identify patients at potential risk of hypersensitivity reactions. While the occurrence of hypersensitivity reactions reported as related to taspoglutide is higher than expected for the study population in the Phase III trials, the incidence remains uncommon (< 1%).

Jean-Luc Bélingard, Chairman and Chief Executive Officer of the Ipsen Group, stated: "These 5 phase III clinical trials have clearly demonstrated the marked and reproducible efficacy profile of taspoglutide in blood glucose control and body weight loss. The T-emerge programme provides the medical community with extensive data on the competitive positioning of this promising compound in the treatment of type 2 diabetes. We are confident that the ongoing clinical programme will further establish taspoglutide as a potential best-in-class with the added convenience of a once-a-week injection."



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