"The HbA1c reduction combined with urinary glucose data presented at the AHA conference provide further evidence of the clinically meaningful and differentiating effects of SGLT1 inhibition achieved by LX4211," said Dr. Brian Zambrowicz, Lexicon's chief scientific officer. "The achievement of SGLT1-mediated improvements in glycemic control that do not rely on urinary glucose excretion has the potential to further differentiate LX4211 from SGLT2-selective drugs based on genitourinary safety, as well as offering opportunities in the treatment of patients whose impaired renal function compromises their ability to benefit from the SGLT2 mechanism. Importantly, the substantially greater reduction in HbA1c seen in the 400 mg QD group compared to the 200 mg group was not associated with an increased rate of gastrointestinal adverse events, an area of special interest for SGLT1 inhibition."Consistent with previous reports, the primary efficacy endpoint of change from baseline to Week 12 in HbA1c was achieved; dose dependent changes from placebo were observed with statistically significant differences observed at each dose level and most notably at the higher doses with p-values < 0.001. Lexicon has also previously demonstrated that SGLT1 inhibition by LX4211 increases levels of GLP-1 and PYY, GI hormones associated with glycemic control and appetite. Lexicon is currently conducting clinical studies of LX4211 in type 2 diabetes patients with renal impairment and in patients with type 1 diabetes, and is making preparations for the planned commencement of Phase 3 clinical trials in type 2 diabetes in the first half of 2013.
LX4211 Phase 2b Results Presented At American Heart Association Annual Conference
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