PARIS Swiss drug maker Roche has started a risk-mitigation plan in the late-stage clinical trial of an investigational diabetes drug due to some patients having bad reactions to it, the company’s development partner said Friday.
Ipsen announced the plan for the phase 3 trial of taspoglutide, a once-weekly treatment for Type 2 diabetes that belongs to class known as glucagon-like peptide-1 analogues. Other GLP-1 analogues include Novo Nordisk’s Victoza (liraglutide) and Byetta (exenatide), by Eli Lilly, Amylin Pharmaceuticals and Alkermes.
Among the more than 6,000 patients enrolled in phase 3 studies of taspoglutide, hypersensitivity reactions have remained uncommon, but are higher than expected, Ipsen said. Reactions have included skin and gastrointestinal symptoms, though patients have recovered without complications. Nevertheless, in light of the reactions, Roche has consulted with the Food and Drug Administration and decided to implement a risk-mitigation plan to identify patients at potential risk of the reactions.