US2014303098A1PendingUtilityA1

Pharmaceutical composition, methods for treating and uses thereof

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Assignee: BROEDL ULI CHRISTIANPriority: Apr 5, 2013Filed: Apr 3, 2014Published: Oct 9, 2014
Est. expiryApr 5, 2033(~6.7 yrs left)· nominal 20-yr term from priority
Inventors:Uli Christian BroedlSreeraj MachaMaximilian Von EynattenHans-Juergen Woerle
A61P 3/10A61P 3/08A61P 13/12A61K 9/2866A61K 31/7034A61K 31/7048A61K 9/2018
60
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Claims

Abstract

The present invention relates to certain SGLT-2 inhibitors for treating and/or preventing metabolic disorders, such as type 1 or type 2 diabetes mellitus or pre-diabetes, in patients with renal impairment or chronic kidney disease (CKD).

Claims

exact text as granted — not AI-modified
1 . A method of treating prediabetes, type 1 or type 2 diabetes mellitus in patient comprising administering empagliflozin to the patient, wherein the patient has moderate renal impairment or stage 3 chronic kidney disease (CKD). 
     
     
         2 . The method according to  claim 1 , wherein the patient has moderate A renal impairment or stage 3A chronic kidney disease (CKD). 
     
     
         3 . The method according to  claim 1 , wherein the patient has moderate B renal impairment or stage 3B chronic kidney disease (CKD). 
     
     
         4 . The method according to  claim 1 , wherein empagliflozin is administered as a pharmaceutical composition. 
     
     
         5 . The method according to  claim 4 , wherein said pharmaceutical composition comprises 10 mg or 25 mg of empagliflozin. 
     
     
         6 . The method according to  claim 1 , wherein empagliflozin is administered once daily. 
     
     
         7 . A method for improving glycemic control in a patient with type 2 diabetes comprising administering empagliflozin to the patient, wherein the patient has moderate renal impairment or stage 3 chronic kidney disease (CKD). 
     
     
         8 . The method according to  claim 7 , wherein the patient has moderate A renal impairment or stage 3A chronic kidney disease (CKD). 
     
     
         9 . The method according to  claim 7 , wherein the patient has moderate B renal impairment or stage 3B chronic kidney disease (CKD). 
     
     
         10 . The method according to  claim 7 , wherein empagliflozin is administered as a pharmaceutical composition. 
     
     
         11 . The method according to  claim 10 , wherein said pharmaceutical composition comprises 10 mg or 25 mg of empagliflozin. 
     
     
         12 . The method according to  claim 7 , wherein empagliflozin is administered once daily. 
     
     
         13 . A method of treating prediabetes, type 1 or type 2 diabetes comprising:
 a) determining the glomerular filtration rate (eGFR) of a patient in need of treatment for prediabetes, type 1 or type 2 diabetes;   b) administering empagliflozin to the patient, if the eGFR of the patient is ≧30 ml/min/1.73 m 2 .   
     
     
         14 . The method according to  claim 13 , wherein empagliflozin is administered if the eGFR of the patient is between ≧30 ml/min/1.73 m 2  and <60 ml/min/1.73 m 2 . 
     
     
         15 . The method according to  claim 13 , wherein empagliflozin is administered if the eGFR of the patient is ≧45 ml/min/1.73 m 2 . 
     
     
         16 . The method according to  claim 13 , wherein empagliflozin is administered if the eGFR of the patient is between ≧45 ml/min/1.73 m 2  and <60 ml/min/1.73 m 2 . 
     
     
         17 . The method according to  claim 13 , wherein empagliflozin is administered as a pharmaceutical composition. 
     
     
         18 . The method according to  claim 17 , wherein said pharmaceutical composition comprises 10 mg or 25 mg of empagliflozin. 
     
     
         19 . The method according to  claim 13 , wherein empagliflozin is administered once daily. 
     
     
         20 . A method of treating prediabetes, type 1 or type 2 diabetes mellitus comprising:
 a) determining that the eGFR of a patient in need of treatment for prediabetes, type 1 or type 2 diabetes is between ≧30 ml/min/1.73 m 2 ;   b) administering empagliflozin to the patient.   
     
     
         21 . The method according to  claim 20  comprising determining that the eGFR of a patient in need of treatment for prediabetes, type 1 or type 2 diabetes is between ≧30 ml/min/1.73 m 2  and <60 ml/min/1.73 m 2    
     
     
         22 . A method of treating prediabetes, type 1 or type 2 diabetes mellitus comprising:
 a) determining that the eGFR of a patient in need of treatment for prediabetes, type 1 or type 2 diabetes is between ≧45 ml/min/1.73 m2;   b) administering empagliflozin to the patient.   
     
     
         23 . The method according to  claim 22  comprising determining that the eGFR of a patient in need of treatment for prediabetes, type 1 or type 2 diabetes is between ≧45 ml/min/1.73 m 2  and <60 ml/min/1.73 m 2    
     
     
         24 . The method according to  claim 22 , wherein empagliflozin is administered as a pharmaceutical composition. 
     
     
         25 . The method according to  claim 24 , wherein said pharmaceutical composition comprises 10 mg or 25 mg of empagliflozin. 
     
     
         26 . The method according to  claim 22 , wherein empagliflozin is administered once daily.

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