Roche Moves Investigational Diabetes Drug, Taspoglutide, Into Phase III Clini...(tions said lead author Professor Michae...),Health

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.

About the Studies

Eight Weeks of Treatment with the Long-Acting, Human GLP-1 Analogue Taspoglutide Improves Glycemic Control and Lowers Body Weight in Subjects with Type 2 Diabetes Mellitus (T2DM) Treated with Metformin: A Double-Blind Placebo-Controlled Phase 2 Study(1)
-- Study evaluated the efficacy, safety and tolerability of taspoglutide

in patients with Type 2 diabetes mellitus inadequately controlled with

metformin

-- 306 patients were randomized to 8 weeks of treatment with placebo (PLO)

or taspoglutide, either 5, 10, or 20 mg weekly (QW), or 10 and 20 mg

once every two weeks (Q2W) and followed-up for 4 additional weeks after

the last administered dose

-- Significant reductions in HbA1c were seen after 8 weeks of treatment

compared to PLO. The percentage of patients who achieved target HbA1c

less than or equal to 7% at end-of-study was 59%, 79%, 81% in the

5 mg, 10 mg, 20 mg weekly arms and 44% and 63% in the 10 and 20 mg

every two weeks respectively versus 17% with PLO

-- Body weight decreased progressively and dose-dependently, with

significant reductions from baseline in the 10 and 20 mg QW and 20 mg

Q2W arms

-- The most common adverse event (AE) was dose-dependent, transient,

mild-to-moderate nausea. No episodes of pancreatitis were reported in

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