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 basal insulin, 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 units/mL;   wherein the patient has been treated with a stable dose of between 15 units and 40 units basal insulin 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 (10.0 mmol/L).   
     
     
         2 : The method of  claim 1 , wherein the patient has a HbA1c level between 7.5% and 10% and a fasting plasma glucose (FPG) concentration less than or equal to 140 mg/dL (7.8 mmol/L). 
     
     
         3 : The method of  claim 1 , wherein the patient has a body mass index (BMI) between 20 kg/m 2  to 40 kg/m 2 . 
     
     
         4 : The method of  claim 1 , wherein the patient has been treated with basal insulin for at least 6 months. 
     
     
         5 : The method of  claim 4 , wherein the patient has been treated with the stable dose of basal insulin for at least 2 months. 
     
     
         6 : The method of  claim 1 , wherein the patient has been treated basal insulin and 1 or 2 oral anti-diabetic drugs (OADs), wherein the OADs comprise metformin, a sulfonylurea, a glinide, a sodium glucose co-transporter 2 (SGLT-2) inhibitor, or a dipeptidyl-peptidase 4 (DPP-4) inhibitor. 
     
     
         7 : The method of  claim 6 , wherein the patient has been treated with the stable dose of basal insulin and 1 or 2 OADs for at least 3 months. 
     
     
         8 : The method of  claim 6 , wherein the patient has been treated with metformin at a dose of at least 1.0 grams per day. 
     
     
         9 : A method of improving glycemic control in a patient with type 2 diabetes mellitus uncontrolled on treatment with metformin alone, 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 alone at a dose of at least 1.0 grams per day for at least 3 months; and   wherein the patient has a HbA1c level between 7.5% and 10%.   
     
     
         10 : The method of  claim 9 , wherein the patient has a body mass index (BMI) between 20 kg/m 2  to 40 kg/m 2 . 
     
     
         11 : 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%.   
     
     
         12 : The method of  claim 11 , wherein the patient has a body mass index (BMI) between 20 kg/m 2  to 40 kg/m 2 .