Treatment Type 2 Diabetes Mellitus Patients

Abstract

A pharmaceutical combination for use in glycemic control in a type 2 diabetes mellitus patient, said combination comprising (i) lixisenatide or/and a pharmaceutically acceptable salt thereof, (ii) insulin glargine or/and a pharmaceutically acceptable salt thereof, and (iii) optionally metformin or/and a pharmaceutically acceptable salt thereof.

1 . A pharmaceutical combination for use in glycemic control in a type 2 diabetes mellitus patient, said combination comprising
 (a) lixisenatide or/and a pharmaceutically acceptable salt thereof,   (b) insulin glargine or/and a pharmaceutically acceptable salt thereof, and   (c) optionally metformin or/and a pharmaceutically acceptable salt thereof.   
     
     
         2 . The pharmaceutical combination for use according to  claim 1 , wherein the type 2 diabetes mellitus to be treated is not adequately controlled with compound (b) and optionally compound (c) alone. 
     
     
         3 . The pharmaceutical combination for use according to  claim 1 , wherein the patient to be treated is obese. 
     
     
         4 . The pharmaceutical combination for use according to  claim 1 , wherein the patient to be treated has an age of at least 65 years. 
     
     
         5 . The pharmaceutical combination for use according to  claim 1 , wherein prior to the onset of therapy with the combination according to  claim 1 , the patient has a fasting plasma glucose of at least 9 mmol/L when treated with a basal insulin monotherapy or a basal insulin and one to three oral anti-diabetics alone selected from the group consisting of metformin, a sulfonylurea, a DPP-4 inhibitor or a glinide alone. 
     
     
         6 . The pharmaceutical combination for use according to  claim 1 , wherein prior to the onset of therapy with the combination according to  claim 1 , the patient has a fasting plasma glucose concentration in the range of 5.6 to 6.9 mmol/L or a fasting plasma glucose concentration of at least 6.6 mmol/L when treated with compound (b) and optionally compound (c) alone. 
     
     
         7 . The pharmaceutical combination for use according to  claim 1 , wherein prior to the onset of therapy with the combination according to  claim 1 , the patient has a HbA1c of at least 8.5% when treated with a basal insulin monotherapy or a basal insulin and one to three oral anti-diabetics alone selected from the group consisting of metformin, a sulfonylurea, a DPP-4 inhibitor or a glinide alone. 
     
     
         8 . The pharmaceutical combination for use according to  claim 1 , wherein prior to the onset of therapy with the combination according to  claim 1 , the patient has a HbAlc of at least 7.5% when treated with compound (b) and optionally compound (c) alone. 
     
     
         9 . The pharmaceutical combination for use according to  claim 5 , wherein the basal insulin is selected from insulin glargine, insulin detemir and isophane insulin (NPH insulin). 
     
     
         10 . The pharmaceutical combination for use according to  claim 1 , wherein the patient does not receive concomitant treatment with at least one of a sulfonylurea, a DPP-4 inhibitor and a glinide. 
     
     
         11 . The pharmaceutical combination for use according to  claim 1 , wherein in the type 2 diabetes mellitus patient to be treated has been diagnosed for at least 1 year or at least 2 years prior to the onset of a therapy with compounds (a), (b) and optionally (c). 
     
     
         12 . The pharmaceutical combination for use according to  claim 1 , wherein the administration of the combination comprises the steps:
 (i) administration of compounds (b) and (c) for at least 4 weeks, and   (ii) continuing treatment by administration of compounds (a), (b) and (c),   wherein the amount of compound (b) to be administered in step (i) is adjusted so that a predetermined fasting plasma glucose level or/and a predetermined self-monitored plasma glucose level is reached or at least approximated.   
     
     
         13 . The pharmaceutical combination for use according to  claim 12 , wherein the amount of compound (b) to be administered in step (i) is adjusted so that
 (I) a fasting plasma glucose level or/and a fasting self-monitored plasma glucose level of about 4.4 mmol/l to about 5.6 mmol/l, or/and   (II) a self-monitored plasma glucose level (SMPG) of about 7.8 mmol/1 (or about 140 mg/dl) or less   is reached or at least approximated.   
     
     
         14 . The pharmaceutical combination for use according to  claim 13 , wherein the self-monitored plasma glucose level in (II) is a 4-point self-monitored plasma glucose level or a 7-point self-monitored plasma glucose level. 
     
     
         15 . The pharmaceutical combination for use according to  claim 1 , wherein
 (a) lixisenatide or/and the pharmaceutically acceptable salt thereof is prepared for parenteral administration,   (b) insulin glargine or/and or/and the pharmaceutically acceptable salt thereof is prepared for parenteral administration, or/and   (c) metformin or/and the pharmaceutically acceptable salt thereof is prepared for oral administration.