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 uncontrolled on treatment with basal insulin and 1 or 2 oral anti-diabetic drugs (OADs), the method comprising administering to the patient in need thereof a pharmaceutical composition comprising a fixed ratio combination of:
 (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 units/mL;   wherein the fixed ratio combination is administered as a single daily injection;   wherein the patient has been treated with basal insulin at a stable dose of between 15 units and 40 units per day;   wherein the 1 or 2 OADs comprise metformin, a sulfonylurea, a glinide, a sodium glucose co-transporter 2 (SGLT-2) inhibitor, or a dipeptidyl-peptidase 4 (DPP-4) inhibitor, and   wherein the patient has a HbA1c level between 7.5% and 10% and a fasting plasma glucose (FPG) concentration less than or equal to 200 mg/dL.   
     
     
         2 . The method of  claim 1 , wherein the patient has been treated with the stable dose of basal insulin and 1 or 2 OADs for at least 3 months. 
     
     
         3 . The method of  claim 2 , wherein the patient has been diagnosed with T2DM for at least 1 year. 
     
     
         4 . The method of  claim 3 , wherein treatment with a sulfonylurea, a glinide, a sodium glucose co-transporter 2 (SGLT-2) inhibitor, or a dipeptidyl-peptidase 4 (DPP-4) inhibitor is discontinued prior to administering the pharmaceutical composition. 
     
     
         5 . The method of  claim 3 , wherein treatment with metformin is continued in combination with treatment using the pharmaceutical composition. 
     
     
         6 . A method of improving glycemic control in a patient with type 2 diabetes mellitus uncontrolled on 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 patient has been treated with metformin and the second OAD for at least 3 months;   wherein the second OAD is a sulfonylurea, a glinide, a sodium glucose co-transporter 2 (SGLT-2) inhibitor, or a dipeptidyl-peptidase 4 (DPP-4) inhibitor; and   wherein the patient has a HbA1c level between 7% and 9%.   
     
     
         7 . The method of  claim 6 , wherein the patient has been diagnosed with T2DM for at least 1 year. 
     
     
         8 . The method of  claim 7 , wherein the patient has a body mass index (BMI) between 20 kg/m 2  to 40 kg/m 2 . 
     
     
         9 . The method of  claim 8 , wherein treatment with the second OAD is discontinued prior to administering the pharmaceutical composition. 
     
     
         10 . A method of improving glycemic control in a patient with type 2 diabetes mellitus uncontrolled on basal insulin alone, the method comprising administering to the patient in need thereof a pharmaceutical composition comprising a fixed ratio combination of:
 (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 units/mL;   wherein the fixed ratio combination is administered as a single daily injection;   wherein the patient has been treated with basal insulin at a stable dose of between 15 units and 40 units per day, and   wherein the patient has a HbA1c level between 7.5% and 10% and a fasting plasma glucose (FPG) concentration less than or equal to 180 mg/dL.   
     
     
         11 . The method of  claim 10 , wherein the patient has been treated with basal insulin for at least 6 months. 
     
     
         12 . The method of  claim 11 , wherein the patient has been treated with the stable dose of basal insulin for at least 2 months. 
     
     
         13 . The method of  claim 12 , wherein the patient has a body mass index (BMI) between 20 kg/m 2  to 40 kg/m 2 .