PHARMACEUTICAL COMPOSITION, METHODS FOR TREATING AND USES THEREOF
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).
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.