Treatment of Type 2 Diabetes Mellitus Patients

Abstract

The present invention refers to lixisenatide for use in the reduction of progression of urinary albumin excretion in a type 2 diabetes mellitus patient.

1 . A method of improving glycemic control in a patient with type 2 diabetes mellitus and impaired renal function, the method comprising:
 administering to the patient in need thereof a starting dose of lixisenatide or a pharmaceutically acceptable salt thereof (lixisenatide) for two weeks, wherein the starting dose is 10 μg once daily;   administering to the patient in need thereof a maintenance dose of lixisenatide, wherein the maintenance dose is 20 μg once daily;   monitoring the renal function of the patient, and   titrating down the maintenance dose of lixisenatide if the patient becomes intolerant to the maintenance dose of lixisenatide.   
     
     
         2 . The method of  claim 1 , wherein the maintenance dose of lixisenatide is titrated down to 15 μg or 10 μg once daily. 
     
     
         3 . The method of  claim 1 , wherein the patient becomes intolerant to the maintenance dose of lixisenatide due to experiencing an adverse gastrointestinal reaction. 
     
     
         4 . The method of  claim 3 , wherein the adverse gastrointestinal reaction comprises nausea or vomiting. 
     
     
         5 . The method of  claim 1 , wherein the renal function of the patient is monitored by measuring the glomerular filtration rate (GFR) or the urinary albumin to creatinine ratio (UACR) of the patient. 
     
     
         6 . The method of  claim 1 , wherein the patient becomes intolerant to the maintenance dose of lixisenatide due to a decrease in renal function. 
     
     
         7 . The method of  claim 6 , wherein the decrease in renal function of the patient comprises a decrease in the glomerular filtration rate (GFR) of the patient. 
     
     
         8 . The method of  claim 7 , wherein the decrease in renal function of the patient comprises a decrease in the GFR of the patient to <30 mL/min/1.73 m 2 . 
     
     
         9 . The method of  claim 7 , wherein the decrease in renal function of the patient comprises an increase in the urinary albumin to creatinine ratio (UACR) of the patient. 
     
     
         10 . The method of  claim 9 , wherein the decrease in renal function of the patient comprises an increase in the UACR in the patient to ≥30 mg/g.