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 of improving glycemic control in a patient with type 2 diabetes mellitus inadequately controlled by treatment with metformin, the method comprising administering to the patient in need thereof a pharmaceutical composition comprising:
 (a) lixisenatide or a pharmaceutically acceptable salt thereof at a concentration of 33 μg/mL, and   (b) insulin glargine or a pharmaceutically acceptable salt thereof at a concentration of 100 U/mL;   wherein the glycemic control of the patient with type 2 diabetes mellitus inadequately controlled by treatment with metformin is improved.   
     
     
         2 . The method of  claim 1 , wherein the patient has a HbA1c level between about 7% and about 10% when treated with metformin. 
     
     
         3 . The method of  claim 1 , wherein the patient has a fasting plasma glucose (FPG) concentration in the normoglycemic range when treated with metformin. 
     
     
         3 . The method of  claim 1 , wherein the patient has a fasting plasma glucose (FPG) concentration in the normoglycemic range when treated with metformin. 
     
     
         4 . The method of  claim 1 , wherein the patient has a FPG concentration of less than or equal to 200 mg/dL when treated with metformin. 
     
     
         5 . The method of  claim 1 , wherein the patient has a FPG concentration of less than or equal to 180 mg/dL when treated with metformin. 
     
     
         6 . The method of  claim 1 , wherein the patient has a FPG concentration of less than or equal to 140 mg/dL when treated with metformin. 
     
     
         7 . The method of  claim 1 , wherein the patient's type 2 diabetes mellitus is inadequately controlled when treated with metformin at a dose of at least about 1.0 grams per day. 
     
     
         8 . A method of improving glycemic control in a patient with type 2 diabetes mellitus inadequately controlled by treatment with metformin and a second oral anti-diabetic drug (OAD), the method comprising administering to the patient in need thereof a pharmaceutical composition comprising:
 (a) lixisenatide or a pharmaceutically acceptable salt thereof at a concentration of 33 μg/mL, and   (b) insulin glargine or a pharmaceutically acceptable salt thereof at a concentration of 100 U/mL;   wherein the glycemic control of the patient with type 2 diabetes mellitus inadequately controlled by treatment with metformin and a second OAD is improved.   
     
     
         9 . The method of  claim 8 , wherein the second OAD is a sulfonylurea, a dipeptidyl-peptidase 4 (DPP-4) inhibitor, a sodium glucose co-transporter 2 (SGLT-2) inhibitor, a glinide, or a combination thereof.