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 method for improving glycemic control in a patient with type 2 diabetes mellitus comprising:
 administering to the patient in need thereof a therapeutically effective amount of a pharmaceutical combination comprising lixisenatide and insulin glargine;   wherein the patient's type 2 diabetes mellitus is not adequately controlled after a treatment comprising a dose of at least about 1.0 mg per day of metformin for at least about 3 months.   
     
     
         2 . The method of  claim 1 , wherein the patient's treatment comprises a dose of at least about 1.5 mg per day of metformin for at least about 3 months. 
     
     
         3 . The method of  claim 1 , wherein the pharmaceutical combination comprises insulin glargine at a dose of about 60 units or less per day. 
     
     
         4 . The method of  claim 1 , wherein the pharmaceutical combination comprises lixisenatide at a dose of about 20 μg or less per day. 
     
     
         5 . The method of  claim 1 , wherein the pharmaceutical combination comprises insulin glargine at a concentration of about 100 units per mL. 
     
     
         6 . The method of  claim 1 , wherein the patient's treatment comprises metformin and further comprises a second oral anti-diabetic (OAD) for at least about 3 months. 
     
     
         7 . The method of  claim 6 , wherein the second OAD comprises a sulfonylurea, a glinide, or a sodium-glucose co-transporter 2 (SGLT-2) inhibitor. 
     
     
         8 . The method of  claim 1 , wherein the patient has a HbA1c value of about 7% to about 10% at the onset of treatment with the pharmaceutical combination. 
     
     
         9 . The method of  claim 1 , wherein the pharmaceutical combination is administered parenterally. 
     
     
         10 . The method of  claim 1 , wherein the pharmaceutical combination is administered as an add-on to the patient's treatment with metformin. 
     
     
         11 . The method of  claim 1 , wherein the pharmaceutical combination further comprises metformin, and wherein the metformin is administered separately from the insulin glargine and the lixisenatide. 
     
     
         12 . The method of  claim 10 , wherein the metformin is administered orally. 
     
     
         13 . The method of  claim 11 , wherein the metformin is administered orally. 
     
     
         14 . A pharmaceutical combination comprising:
 (a) lixisenatide or a pharmaceutically acceptable salt thereof, and   (b) insulin glargine or a pharmaceutically acceptable salt thereof,   wherein the patient's type 2 diabetes mellitus is not adequately controlled after treatment with metformin at a dose of at least about 1.5 mg for at least about 3 months.   
     
     
         15 . The pharmaceutical combination of  claim 14 , wherein the pharmaceutical combination further comprises metformin.