PHARMACEUTICAL COMPOSITION, METHODS FOR TREATING AND USES THEREOF

• US 20160038524A1
• Filed: 10/21/2015
• Published: 02/11/2016
• Est. Priority Date: 04/05/2013
• Status: Active Grant

• Current Assignee: Boehringer Ingelheim International GmbH (C.H. Boehringer Sohn AG & Co. KG)
• Original Assignee: Boehringer Ingelheim International GmbH (C.H. Boehringer Sohn AG & Co. KG)
• Inventors: BROEDL, Uli Christian, MACHA, Sreeraj, von EYNATTEN, Maximilian, WOERLE, Hans-Juergen
• Granted Patent: US 9,949,998 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61K 31/7034 attached to a carbocyclic compound, e.g. phloridzin
• CPC Class Codes: A61K 31/7048 having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin , digitoxin or digoxin
• CPC Class Codes: A61K 9/2018 Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
• CPC Class Codes: A61K 9/2866 Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
• CPC Class Codes: A61P 13/12 of the kidneys
• CPC Class Codes: A61P 3/08 for glucose homeostasis pancreatic hormones A61P5/48
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics

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

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 m².

14. The method according to claim 13, wherein empagliflozin is administered if the eGFR of the patient is between ≧

30 ml/min/1.73 m² and <

60 ml/min/1.73 m².

15. The method according to claim 13, wherein empagliflozin is administered if the eGFR of the patient is ≧

45 mV/min/1.73 m².

16. The method according to claim 13, wherein empagliflozin is administered if the eGFR of the patient is between ≧

45 mV/min/1.73 m² and <

60 ml/min/1.73 m².

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 m²;

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 mV/min/1.73 m² and <

60 mV/min/1.73 m²

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 mV/min/1.73 m² and <

60 mV/min/1.73 m²

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.