IP Library › Granted Patent US 12,433,906
Granted Patent B2
US 12,433,906 · App. 18/492,972 · Granted Oct 7, 2025

Pharmaceutical composition, methods for treating and uses thereof

Inventors: Uli Christian Broedl (Mainz, DE); Sreeraj Macha (Basking Ridge, NJ); Maximilian von Eynatten (Erding, DE); Hans-Juergen Woerle (Cully, CH)
Assignee: Boehringer Ingelheim International GmbH
A61K31/7048A61K9/2018A61K9/2866A61K31/7034
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Quick Facts
Patent No.
US 12,433,906
App. No.
18/492,972
Granted
Oct 7, 2025
Kind
B2
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 (54)

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 type 2 diabetes; and

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 type 2 diabetes mellitus comprising:

a) determining that the eGFR of a patient in need of treatment for type 2 diabetes is ≥30 ml/min/1.73 m 2 ; and

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 type 2 diabetes is between ≥30 ml/min/1.73 m 2 and <60 ml/min/1.73 m 2 .

22. The method according to claim 20 , wherein empagliflozin is administered as a pharmaceutical composition.

23. The method according to claim 22 , wherein said pharmaceutical composition comprises 10 mg or 25 mg of empagliflozin.

24. The method according to claim 20 , wherein empagliflozin is administered once daily.

25. The method according to claim 20 , wherein empagliflozin is administered orally in a total daily amount of 10 mg or 25 mg.

26. A method of treating type 2 diabetes mellitus comprising:

a) determining that the eGFR of a patient in need of treatment for type 2 diabetes is ≥45 ml/min/1.73 m 2 ; and

b) administering empagliflozin to the patient.

27. The method according to claim 26 comprising determining that the eGFR of a patient in need of treatment for type 2 diabetes is between ≥45 ml/min/1.73 m 2 and <60 ml/min/1.73 m 2 .

28. The method according to claim 26 , wherein empagliflozin is administered as a pharmaceutical composition.

29. The method according to claim 28 , wherein said pharmaceutical composition comprises 10 mg or 25 mg of empagliflozin.

30. The method according to claim 26 , wherein empagliflozin is administered once daily.

31. A method of treating type 2 diabetes comprising:

a) determining the glomerular filtration rate (eGFR) of a patient in need of treatment for type 2 diabetes; and

b) administering empagliflozin to the patient, if the eGFR of the patient is ≥30 ml/min/1.73 m 2 and <60 ml/min/1.73 m 2 .

32. The method according to claim 31 , wherein empagliflozin is administered as a pharmaceutical composition.

33. The method according to claim 32 , wherein said pharmaceutical composition comprises 10 mg or 25 mg of empagliflozin.

34. The method according to claim 31 , wherein empagliflozin is administered once daily.

35. The method according to claim 31 , wherein empagliflozin is administered orally in a total daily amount of 10 mg or 25 mg.

36. A method of treating type 2 diabetes mellitus comprising:

a) determining that the eGFR of a patient in need of treatment for type 2 diabetes is ≥30 ml/min/1.73 m 2 and <60 ml/min/1.73 m 2 ; and

b) administering empagliflozin to the patient.

37. The method according to claim 36 , wherein empagliflozin is administered as a pharmaceutical composition.

38. The method according to claim 37 , wherein said pharmaceutical composition comprises 10 mg or 25 mg of empagliflozin.

39. The method according to claim 36 , wherein empagliflozin is administered once daily.

40. The method according to claim 36 , wherein empagliflozin is administered orally in a total daily amount of 10 mg or 25 mg.

41. A method for improving glycemic control in a patient with type 2 diabetes comprising:

a) determining that the patient has an eGFR ≥30 ml/min/1.73 m 2 ;

b) administering 10 mg of empagliflozin daily to the patient; and

c) increasing the dose of empagliflozin administered to the patient to 25 mg daily if the patient requires additional glycemic control and the patient has an GFR ≥30 ml/min/1.73 m 2 .

Continuity (8)
Continuation 17344003 · Jun 10, 2021
Continuation 16288192 · Feb 28, 2019
Continuation 15918401 · Mar 12, 2018
Continuation 14918727 · Oct 21, 2015
Continuation 14244208 · Apr 3, 2014
Provisional Application 61908991 · Nov 26, 2013
Provisional Application 61808804 · Apr 5, 2013
Related Publication 20240066046A1 · Feb 29, 2024
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