Medical use of pharmaceutical combination or composition

Abstract

The present invention relates to a certain DPP-4 inhibitor for use in combination with metformin in CKD patients.

1 . A method of using linagliptin, or a pharmaceutically acceptable salt thereof, in combination with metformin, and optionally one or more further active agents selected from the group consisting of insulin and a sulfonylurea to treat a type 2 diabetes patient having estimated glomerular filtration rate (eGFR; mL/minute/1.73 m 2 ) levels down to 45 or down to 30. 
     
     
         2 . The method of  claim 1 , wherein the type 2 diabetes patient has an estimated glomerular filtration rate (eGFR; mL/minute/1.73m 2 ) level down to 45. 
     
     
         3 . The method of  claim 1 , wherein the type 2 diabetes patient has an estimated glomerular filtration rate (eGFR; mL/minute/1.73 m 2 ) level down to 30. 
     
     
         4 . The method of  claim 2 , wherein linagliptin and metformin are administered in a single pharmaceutical composition, such as e.g. in form of a single oral dosage form (e.g. tablet). 
     
     
         5 . The method of  claim 4 , wherein the linagliptin is present in the composition in a dosage strength of 2.5 mg; or of 5 mg. 
     
     
         6 . The method of  claim 5 , wherein the metformin is present in the composition in a dosage strength of 500 mg, 850 mg or 1000 mg in form of immediate release metformin; or 500 mg, 750 mg, 1000 mg, 1500 mg or 2000 mg in form of extended release metformin. 
     
     
         7 . The method of  claim 4 , wherein the pharmaceutical composition comprises 2.5 mg linagliptin and 500 mg, 850 mg or 1000 mg metformin in immediate release form, and optionally one or more pharmaceutically auxiliaries 
     
     
         8 . The method of  claim 4 , wherein
 the pharmaceutical composition comprises 5 mg linagliptin and 1000 mg metformin in extended release form, and optionally one or more pharmaceutically auxiliaries, or   wherein   the pharmaceutical composition comprises 2.5 mg linagliptin and 750 mg or 1000 mg metformin in extended release form, and optionally one or more pharmaceutically auxiliaries.   
     
     
         9 . The method of  claim 1 , wherein linagliptin is administered in a total oral daily dose of 5 mg. 
     
     
         10 . The method of  claim 2 , wherein linagliptin is administered in a total oral daily dose of 5 mg, wherein the 5 mg daily dose is administered as 2.5 mg linagliptin twice daily or 5 mg linagliptin once daily. 
     
     
         11 . A method of using linagliptin, or a pharmaceutically acceptable salt thereof, in combination with metformin, to treat a type 2 diabetes patient having eGFR level 30-44,
 wherein the maximum daily dose of metformin hydrochloride is 1000 mg,   wherein linagliptin and metformin are administered in a single oral dosage form comprising 2.5 mg linagliptin and 500 mg metformin, and optionally one or more pharmaceutically auxiliaries, and   wherein the single oral dosage form is administered orally twice daily to the patient.