Insulin glargine/lixisenatide fixed ratio formulation

Abstract

The present invention refers to a pharmaceutical composition comprising (a) lixisenatide or/and a pharmaceutically acceptable salt thereof, and (b) insulin glargine or/and a pharmaceutically acceptable salt thereof, wherein the compound (b) and compound (a) are present in a fixed ratio.

1 . A pharmaceutical composition comprising
 (a) lixisenatide or a pharmaceutically acceptable salt thereof, and   (b) insulin glargine or a pharmaceutically acceptable salt thereof,   wherein the compound (b) and compound (a) are present in a ratio of about 1.6 to about 2.4 U of compound (b) per μg of compound (a).   
     
     
         2 . The composition of  claim 1 , wherein the concentration of compound (a) is in the range of 40-60 μg/ml, and wherein the concentration of compound (b) is in the range of 64-144 U/ml. 
     
     
         3 . The composition of  claim 2 , wherein the concentration of compound (a) is not 55.56 μg/mL, 51.28 μg/mL, 47.62 μg/mL, 44.44 μg/mL, or 41.67 μg/mL. 
     
     
         4 . The pharmaceutical composition of  claim 1 , wherein the compound (b) and compound (a) are present in a ratio of about 2 U of compound (b) per μg of compound (a). 
     
     
         5 . The pharmaceutical composition of  claim 1 , wherein the pharmaceutical composition is administered at a dose of 0.25 to 1.5 U/kg body weight insulin glargine. 
     
     
         6 . The pharmaceutical composition of  claim 1 , wherein the pharmaceutical composition is administered at a dose of 0.05 to 0.5 μg/kg body weight lixisenatide. 
     
     
         7 . The pharmaceutical composition of  claim 1 , further comprising (c) metformin or pharmaceutically acceptable salt thereof. 
     
     
         8 . The pharmaceutical composition of  claim 1 , further comprising a pharmaceutically acceptable carrier.