In this Phase III study, statistically significant differences in HbA1c between linagliptin and placebo could be seen at week six, and at week 18 the placebo adjusted mean difference was “0.57 percent (p<0.0001). Among patients who began the trial with an HbA1c of greater than or equal to 7.0 percent, 23.5 percent taking linagliptin achieved HbA1c <7.0 percent, compared to 11.8 percent taking placebo. Linagliptin-treated patients also saw statistically significant reductions in fasting plasma glucose (FPG) levels compared to placebo (adjusted mean difference from baseline “20.5 mg/dl).

Linagliptin as add-on therapy to an SU in inadequately controlled T2D patients

In another Phase III study presented at EASD, treatment with linagliptin resulted in significant reductions in HbA1c from baseline (mean placebo adjusted HbA1c reduction “0.47 percent; p<0.0001). The most commonly reported AEs in the linagliptin arm were metabolism and nutrition disorders (4.3 percent in linagliptin group, 8.3 percent in placebo group), nervous system disorders (1.9 percent) and general disorders and administration site conditions (1.2 percent).

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.