Use of AVE0010 for the Treatment of Diabetes Mellitus Type 2

Abstract

The present invention refers to the use of Lixisenatide or/and a pharmaceutically acceptable salt thereof, for the manufacture of a medicament for the treatment of diabetes mellitus type 2, for inducing weight loss in diabetes type 2 patients or/and for preventing weight gain in diabetes type 2 patients.

1 . A method of improving glycemic control in a patient with untreated type 2 diabetes mellitus comprising:
 administering once daily to the patient a therapeutically effective amount of desPro 36 Exendin-4(1-39)-Lys 6 -NH 2  (“lixisenatide”) and/or a pharmaceutically acceptable salt thereof;   wherein the improvement of glycemic control in the patient leads to a significant reduction of fasting plasma glucose (FPG) (mmol/L).   
     
     
         2 . The method of  claim 1 , wherein the patient is an adult. 
     
     
         3 . The method of  claim 1 , wherein the patient has not previously received glucose-lowering therapy. 
     
     
         4 . The method of  claim 1 , wherein the therapeutically effective amount of lixisenatide and/or a pharmaceutically acceptable salt thereof is administered as a daily dose in the range between 10 μg to 20 μg per dose. 
     
     
         5 . The method of  claim 1 , wherein the therapeutically effective amount of lixisenatide and/or a pharmaceutically acceptable salt thereof is administered as a daily dose of either 10 μg or 20 μg per dose. 
     
     
         6 . The method of  claim 1 , wherein the FPG is reduced by about 0.68 mmol/L. 
     
     
         7 . The method of  claim 1 , wherein the FPG is reduced by about 0.433 mmol/L to about 0.927 mmol/L. 
     
     
         8 . The method of  claim 1 , wherein the FPG is reduced by about 0.89 mmol/L. 
     
     
         9 . The method of  claim 1 , wherein the FPG is reduced by about 0.636 mmol/L to about 1.144 mmol/L. 
     
     
         10 . The method of  claim 1 , wherein the FPG is reduced by at least about 0.4 mmol/L.