Roche Moves Investigational Diabetes Drug, Taspoglutide, Into Phase III Clini...(s study Safety and Tolerability of Hi...),Health

Safety and Tolerability of High Doses of the Long-Acting, Human GLP-1 Analogue Taspoglutide in Diabetic Subjects Treated with Metformin: A Double-Blind, Placebo-Controlled Phase 2 Study(2)
-- Study evaluated safety and tolerability of escalating doses of

taspoglutide in patients with Type 2 diabetes mellitus

inadequately controlled with metformin

-- 133 patients were randomized of which 129 patients received either

placebo (PLO) or 20 mg taspoglutide weekly for 4 weeks, followed by

either maintenance at 20 mg (20/20), or a dose increase to 30 mg

(20/30) or 40 mg (20/40) weekly with matched PLO for additional 4

weeks. Patients were then followed up for 4 weeks after the last

administered dose

-- Significant improvements in glycemic control were observed in all

active arms. At the end of treatment, the percentage of patients

reaching HbA1c less than or equal to 7% was 72%, 53% and 70% with

20/20, 20/30 and 20/40 respectively versus 19% with PLO

-- As expected, the most common AE was nausea: transient,

mild-to-moderate, appearing early during therapy and resolving

spontaneously while continuing on therapy in most cases. No episodes of

pancreatitis were reported in this study

About Taspoglutide (R1583)

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. Ipsen is the originator of the concept of excipient free sustained release formulation applied to therapeutic peptides and proteins. Taspoglutide is being developed 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 pot
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