ARTICLE | Clinical News

Linagliptin: Phase III data

September 27, 2010 7:00 AM UTC

In a double-blind Phase III trial in 245 patients with inadequately controlled Type II diabetes, once-daily 5 mg oral linagliptin as an add-on to sulfonylurea met the primary endpoint of significantly reducing HbA1c from baseline to week 18 vs. placebo (0.47% 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 (15.2% and 57.6%, respectively, vs. 3.7% and 22.2%, p=0.0065 and p<0.0001). There were no significant differences between treatment groups in body weight or waist circumference. Rates of adverse events were 42.2% and 42.9% for linagliptin and placebo, respectively. Data were presented at the European Association for the Study of Diabetes meeting in Stockholm. ...