Pharmaceutical combination for improving glycemic control as add-on therapy to basal insulin

Abstract

The present invention refers to a pharmaceutical combination for use in glycemic control in diabetes type 2 patients.

1 . A method for reducing fasting plasma glucose concentration (FPG) 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:
 (a) lixisenatide or a pharmaceutically acceptable salt thereof, and   (b) insulin glargine or a pharmaceutically acceptable salt thereof,   wherein prior to or at the onset of administration of the pharmaceutical combination the patient has a FPG of at least 8 mmol/L (144 mg/dL) after treatment with basal insulin; and   wherein the administration of the pharmaceutical combination reduces the FPG of the patient in need thereof.   
     
     
         2 . A method for reducing postprandial plasma glucose concentration (PPG) 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:
 (a) lixisenatide or a pharmaceutically acceptable salt thereof, and   (b) insulin glargine or a pharmaceutically acceptable salt thereof,   wherein prior to or at the onset of administration of the pharmaceutical combination the patient has a PPG of at least 14 mmol/L after treatment with basal insulin; and   wherein the administration of the pharmaceutical combination reduces the PPG of the patient in need thereof.   
     
     
         3 . A method for reducing glucose excursion 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:
 (a) lixisenatide or a pharmaceutically acceptable salt thereof, and   (b) insulin glargine or a pharmaceutically acceptable salt thereof,   wherein prior to or at the onset of administration of the pharmaceutical combination the patient has a glucose excursion of at least 5 mmol/L after treatment with basal insulin; and   wherein the administration of the pharmaceutical combination reduces the glucose excursion of the patient in need thereof.   
     
     
         4 . The method of any one of  claims 1 - 3 , wherein prior to or at the onset of administration of the pharmaceutical combination the patient's treatment with basal insulin also includes metformin treatment. 
     
     
         5 . The method of any one of  claims 1 - 3 , wherein the patient is an adult. 
     
     
         6 . The method of any one of  claims 1 - 3 , wherein the basal insulin is insulin glargine. 
     
     
         7 . The method of any one of  claims 1 - 3 , wherein the pharmaceutical combination is administered to the patient in need thereof at a starting dose of 15 units per day of insulin glargine. 
     
     
         8 . The method of any one of  claims 1 - 3 , wherein the pharmaceutical combination is administered to the patient in need thereof at a starting dose of 10 μg per day of lixisenatide. 
     
     
         9 . The method of any one of  claims 1 - 3 , wherein the pharmaceutical combination is administered to the patient in need thereof at a maximum daily dose of 20 μg per day of lixisenatide.