The Phase II study evaluated the efficacy, safety and tolerability of taspoglutide in patients with type 2 diabetes mellitus inadequately controlled with metformin. In the study, 306 patients were randomized to eight weeks of treatment with placebo (PLO) or taspoglutide, either 5, 10, or 20mg weekly (QW), or 10 and 20mg once every two weeks (Q2W) and followed up for four additional weeks after the last administered dose.
Significant reductions in HbA1c were seen after eight weeks of treatment compared to PLO. The percentage of patients who achieved target HbA1c less than or equal to 7% at the end of the study was 59%, 79%, 81% in the 5mg, 10mg, 20mg weekly arms and 44% and 63% in the 10mg and 20mg every two weeks, respectively, versus 17% with PLO. Body weight decreased progressively and dose-dependently, with significant reductions from baseline in the 10mg and 20mg QW and 20mg Q2W arms.
The Phase II studies showed that the safety profile of taspoglutide supports the move to Phase III with the most common adverse event reported being mild-to-moderate nausea. These events were dose-dependent, and in most cases, resolved spontaneously while continuing on therapy. Based on these promising Phase II results Roche has made the decision to move taspoglutide into Phase III clinical trials with the program anticipated to start in the second half of 2008.
William Burns, CEO of the pharmaceuticals division of Roche, and Jean-Luc Belingard, chairman and CEO of the Ipsen Group, said: “Glucagon-like peptide-1 (GLP-1) analogs, which stimulate insulin secretion and suppress glucagon secretion, are true innovations in the diabetes field. These data reinforce the role of GLP-1 in type 2 diabetes and Roche and Ipsen believe taspoglutide has the potential to be a best-in-class treatment.”