Lixisenatide significantly reduced A1C levels in both titration groups versus placebo (p less than 0.0001). There was a significantly higher number of patients achieving A1C levels less than or equal to 6.5 percent with lixisenatide (31.9% two-step, 25.4% one-step) and less than 7.0 percent (52.2% two-step, 46.5% one-step) versus placebo (p less than 0.01).

Lixisenatide significantly reduced the mean change from baseline two-hours postprandial glucose by respectively -4.51 and -5.47 mmol/L (p(less than)0.0001) in the one-step and two-step titration groups with mean decreases in body weight observed in all groups. In addition, lixisenatide once-daily reduced glucose excursion respectively by -3.77 and -4.36 mmol/L in the one-step and two-step titration groups with mean decreases in body weight observed in all groups.

Lixisenatide was well tolerated. Only one serious treatment-emergent adverse event (TEAE) occurred in the lixisenatide group (0.4%) versus five in the placebo group (4.1%). Nausea was the most frequent TEAE with lixisenatide (24.2% for lixisenatide 2-step, 20.2% for lixisenatide 1-step, 4.1% for placebo). The rate of symptomatic hypoglycemia was 1.7 percent and 1.6 percent in the lixisenatide and placebo groups, respectively.

Source: SANOFI-AVENTIS