IP Library Granted Patent US 11,833,166
Granted Patent B2
US 11,833,166 · App. 17/344,003 · Granted Dec 5, 2023

Pharmaceutical composition, methods for treating and uses thereof

Inventors: Uli Christian Broedl (Mainz am Rhein, DE); Sreeraj Macha (Basking Ridge, NJ); Maximilian von Eynatten (Wiesbaden, DE); Hans-Juergen Woerle (Grandvaux VD, CH)
Assignee: Boehringer Ingelheim International GmbH
A61K31/7048A61K9/2018A61K9/2866A61K31/7034
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Quick Facts
Patent No.
US 11,833,166
App. No.
17/344,003
Granted
Dec 5, 2023
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 (44)

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

a) assessing the renal function of the patient; and

b) administering empagliflozin to the patient if the eGFR of the patient is

≥45 ml/min/1.73 m 2 and <60 ml/min/1.73 m 2 ,

wherein empagliflozin is administered orally in a total daily amount of 10 mg or 25 mg, and

wherein the glycemic control in said patient is improved.

2. The method according to claim 1 , wherein empagliflozin is administered in a total daily amount of 10 mg.

3. The method according to claim 1 , wherein empagliflozin is administered in a total daily amount of 25 mg.

4. The method according to claim 1 , wherein empagliflozin is administered orally once daily as a pharmaceutical composition comprising 10 mg of empagliflozin.

5. The method according to claim 1 , wherein empagliflozin is administered orally once daily as a pharmaceutical composition comprising 25 mg of empagliflozin.

6. The method according to claim 1 , further comprising administering metformin to the patient.

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

a) assessing the renal function of a patient with type 2 diabetes mellitus; and

b) administering empagliflozin to the patient if the eGFR of the patient is

≥45 ml/min/1.73 m 2 and <60 ml/min/1.73 m 2 ,

wherein empagliflozin is administered orally in a total daily amount of 10 mg or 25 mg, and

wherein the glycemic control in said patient is improved.

8. The method according to claim 7 , wherein empagliflozin is administered in a total daily amount of 10 mg.

9. The method according to claim 7 , wherein empagliflozin is administered in a total daily amount of 25 mg.

10. The method according to claim 7 , wherein empagliflozin is administered orally once daily as a pharmaceutical composition comprising 10 mg of empagliflozin.

11. The method according to claim 7 , wherein empagliflozin is administered orally once daily as a pharmaceutical composition comprising 25 mg of empagliflozin.

12. The method according to claim 7 , further comprising administering metformin to the patient.

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

a) assessing the renal function of the patient; and

b) administering empagliflozin to the patient if the eGFR of the patient is

≥30 ml/min/1.73 m2 and <60 ml/min/1.73 m2,

wherein empagliflozin is administered orally in a total daily amount of 10 mg or 25 mg, and

wherein the glycemic control in said patient is improved.

14. The method according to claim 13 , wherein empagliflozin is administered in a total daily amount of 10 mg.

15. The method according to claim 13 , wherein empagliflozin is administered in a total daily amount of 25 mg.

16. The method according to claim 13 , wherein empagliflozin is administered orally once daily as a pharmaceutical composition comprising 10 mg of empagliflozin.

17. The method according to claim 13 , wherein empagliflozin is administered orally once daily as a pharmaceutical composition comprising 25 mg of empagliflozin.

18. The method according to claim 13 , further comprising administering metformin to the patient.

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

a) assessing the renal function of a patient with type 2 diabetes mellitus; 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 ,

wherein empagliflozin is administered orally in a total daily amount of 10 mg or 25 mg, and

wherein the glycemic control in said patient is improved.

20. The method according to claim 19 , wherein empagliflozin is administered in a total daily amount of 10 mg.

21. The method according to claim 19 , wherein empagliflozin is administered in a total daily amount of 25 mg.

22. The method according to claim 19 , wherein empagliflozin is administered orally once daily as a pharmaceutical composition comprising 10 mg of empagliflozin.

23. The method according to claim 19 , wherein empagliflozin is administered orally once daily as a pharmaceutical composition comprising 25 mg of empagliflozin.

24. The method according to claim 19 , further comprising administering metformin to the patient.

Continuity (7)
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 20210299153A1 · Sep 30, 2021
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