The clinical trial was designed to compare a new solid oral dose formulation of LX4211 to the liquid dose formulation.
The study results showed that 300mg solid oral tablet dose of LX4211, administered as two 150 mg tablets, significantly increased total Glucagon-like peptide(GLP) -1, active GLP-1 and Peptide YY, important mediators of glycemic and appetite control as well as other metabolic parameters.
Lexicon Pharma said that the single doses of LX4211 resulted in rapid and significant improvement in post-prandial glucose (PPG) and fasting plasma glucose (FPG).
Pharmacokinetic and pharmacodynamic data from the study revealed that solid oral formulation was as effective as or better than the liquid formulation on key parameters of hormonal release, PPG and FPG.
The trial used a randomised, triple-cross over design in which 12 patients with type II diabetes were treated with 300mg of LX4211 in different dose forms.
LX4211 is an orally-delivered small molecule, which works by inhibiting both sodium-glucose co-transporter type 1 (SGLT1) and sodium-glucose co-transporter type 2 (SGLT2), for the treatment of diabetes.