Linagliptin: Phase III data

In a double-blind Phase III trial in 227 Type II diabetics for whom metformin therapy is inappropriate, once-daily 5 mg oral linagliptin as monotherapy met the primary endpoint of significantly reducing HbA1c from baseline to week 18 vs. placebo (0.57% placebo-adjusted mean reduction, p<0.0001). Additionally, a significantly greater proportion of patients receiving linagliptin achieved a reduction in HbA1c to <7%, and a reduction in HbA1c of >=0.5% at week 18 vs. placebo (27.9% and 36.1%, respectively, vs. 15.1% and 17.8%, p=0.0374 and p=0.0046). Linagliptin also significantly reduced mean FPG from baseline vs. placebo (p=0.0002). There were no significant differences between treatment groups in body weight or waist circumference. Rates of adverse events were 40.4% and 48.7% for linagliptin and placebo, respectively. Data were presented at the European Association for the Study of Diabetes meeting in Stockholm. A 34-week, double-blind extension study in which placebo was switched to glimepiride is ongoing. ...