Claims for Patent: 12,433,906

Summary for Patent: 12,433,906

Title:	Pharmaceutical composition, methods for treating and uses thereof
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).
Inventor(s):	Uli Christian BROEDL, Sreeraj MACHA, Maximilian von EYNATTEN, Hans-Juergen Woerle
Assignee:	Boehringer Ingelheim International GmbH
Application Number:	US18/492,972
Patent 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 type 2 diabetes; and 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 ml/min/1.73 m2. 16. The method according to claim 13, wherein empagliflozin is administered if the eGFR of the patient is between ≥45 ml/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 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 m2; 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 m2 and <60 ml/min/1.73 m2. 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 m2; 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 m2 and <60 ml/min/1.73 m2. 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 m2 and <60 ml/min/1.73 m2. 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 m2 and <60 ml/min/1.73 m2; 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 m2; 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 m2.