Taspoglutide: Additional Phase III data

Additional data from the open-label, international Phase III T-emerge 2 trial in 1,189 Type II diabetics inadequately controlled with metformin with or without thiazolidinedione showed that 10 and 20 mg subcutaneous weekly taspoglutide significantly reduced HbA1c by 1.24% and 1.31%, respectively, from baseline to week 24 vs. 0.98% for twice-daily subcutaneous Byetta exenatide (p<0.001 for both). Additionally, a greater proportion of patients receiving low- and high-dose taspoglutide achieved a reduction in HbA1c to <7% at week 24 vs. Byetta (62% and 63%, respectively, vs. 46%).

Low- and high-dose taspoglutide also reduced body weight from baseline to week 24 by 1.6 and 2.3 kg, respectively, vs. 2.3 kg for Byetta. Injection site reactions were reported in 24.7% and 31.7% of patients receiving 10 and 20 mg taspoglutide, respectively, vs. 1.4% for Byetta. Additionally, taspoglutide-treated patients experienced higher rates of nausea and vomiting that were of mild-to-moderate intensity vs. Byetta. Furthermore, rates of discontinuation due to gastrointestinal adverse events were 4.1% and 7.6% for low- and high-dose taspoglutide, respectively, vs. 6.5% for Byetta. Patients received weekly 10 mg taspoglutide, weekly 10 mg taspoglutide for 4 weeks followed by weekly 20 mg taspoglutide, or twice-daily 10 µg Byetta for a total of 24 weeks. Data were presented at the American Diabetes Association meeting in Orlando. ...