Claims for Patent: 11,090,323

Summary for Patent: 11,090,323

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):	Broedl; Uli Christian (Mainz am Rhein, DE), Macha; Sreeraj (Basking Ridge, NJ), von Eynatten; Maximilian (Wiesbaden, DE), Woerle; Hans-Juergen (Grandvaux VD, CH)
Assignee:	Boehringer Ingelheim International GmbH (Ingelheim am Rhein, DE)
Application Number:	16/288,192
Patent Claims:	1. A method for improving glycemic control in a patient with type 2 diabetes mellitus comprising administering empagliflozin to the patient if the eGFR of the patient is .gtoreq.45 ml/min/1.73 m.sup.2 and <60 ml/min/1.73 m.sup.2, wherein empagliflozin is administered orally in a total daily amount of 10 mg or 25 mg, wherein the glycemic control in said patient is improved, and discontinuing empagliflozin if the eGFR of the patient falls below 30 ml/min/1.73 m.sup.2. 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 for improving glycemic control in a patient with type 2 diabetes mellitus comprising: a) assessing the renal function of a patient; b) administering empagliflozin to the patient if the eGFR of the patient is .gtoreq.45 ml/min/1.73 m.sup.2 and <60 ml/min/1.73 m.sup.2, wherein empagliflozin is administered orally in a total daily amount of 10 mg or 25 mg, wherein the glycemic control in said patient is improved; c) discontinuing empagliflozin if the eGFR of the patient falls below 30 ml/min/1.73 m.sup.2. 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 of treating type 2 diabetes mellitus in a patient comprising administering empagliflozin to the patient if the eGFR of the patient is .gtoreq.45 ml/min/1.73 m.sup.2 and <60 ml/min/1.73 m.sup.2, wherein empagliflozin is administered orally in a total daily amount of 10 mg or 25 mg, wherein the glycemic control in said patient is improved, and discontinuing empagliflozin if the eGFR of the patient falls below 30 ml/min/1.73 m.sup.2. 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; b) administering empagliflozin to the patient if the eGFR of the patient is .gtoreq.45 ml/min/1.73 m.sup.2 and <60 ml/min/1.73 m.sup.2, wherein empagliflozin is administered orally in a total daily amount of 10 mg or 25 mg, wherein the glycemic control in said patient is improved; c) discontinuing empagliflozin if the eGFR of the patient falls below 30 ml/min/1.73 m.sup.2. 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. 25. A method for improving glycemic control in a patient with type 2 diabetes mellitus comprising administering empagliflozin to the patient if the eGFR of the patient is .gtoreq.30 ml/min/1.73 m.sup.2 and <60 ml/min/1.73 m.sup.2, wherein empagliflozin is administered orally in a total daily amount of 10 mg or 25 mg, wherein the glycemic control in said patient is improved, and discontinuing empagliflozin if the eGFR of the patient falls below 30 ml/min/1.73 m.sup.2. 26. The method according to claim 25, wherein empagliflozin is administered in a total daily amount of 10 mg. 27. The method according to claim 25, wherein empagliflozin is administered in a total daily amount of 25 mg. 28. The method according to claim 25, wherein empagliflozin is administered orally once daily as a pharmaceutical composition comprising 10 mg of empagliflozin. 29. The method according to claim 25, wherein empagliflozin is administered orally once daily as a pharmaceutical composition comprising 25 mg of empagliflozin. 30. A method for improving glycemic control in a patient with type 2 diabetes mellitus comprising: a) assessing the renal function of a patient; b) administering empagliflozin to the patient if the eGFR of the patient is .gtoreq.30 ml/min/1.73 m.sup.2 and <60 ml/min/1.73 m.sup.2, wherein empagliflozin is administered orally in a total daily amount of 10 mg or 25 mg, wherein the glycemic control in said patient is improved; c) discontinuing empagliflozin if the eGFR of the patient falls below 30 ml/min/1.73 m.sup.2. 31. The method according to claim 30, wherein empagliflozin is administered in a total daily amount of 10 mg. 32. The method according to claim 30, wherein empagliflozin is administered in a total daily amount of 25 mg. 33. The method according to claim 30, wherein empagliflozin is administered orally once daily as a pharmaceutical composition comprising 10 mg of empagliflozin. 34. The method according to claim 30, wherein empagliflozin is administered orally once daily as a pharmaceutical composition comprising 25 mg of empagliflozin. 35. A method of treating type 2 diabetes mellitus in a patient comprising administering empagliflozin to the patient if the eGFR of the patient is .gtoreq.30 ml/min/1.73 m.sup.2 and <60 ml/min/1.73 m.sup.2, wherein empagliflozin is administered orally in a total daily amount of 10 mg or 25 mg, wherein the glycemic control in said patient is improved, and discontinuing empagliflozin if the eGFR of the patient falls below 30 ml/min/1.73 m.sup.2. 36. The method according to claim 35, wherein empagliflozin is administered in a total daily amount of 10 mg. 37. The method according to claim 35, wherein empagliflozin is administered in a total daily amount of 25 mg. 38. The method according to claim 35, wherein empagliflozin is administered orally once daily as a pharmaceutical composition comprising 10 mg of empagliflozin. 39. The method according to claim 35, wherein empagliflozin is administered orally once daily as a pharmaceutical composition comprising 25 mg of empagliflozin. 40. A method of treating type 2 diabetes mellitus comprising: a) assessing the renal function of a patient with type 2 diabetes mellitus; b) administering empagliflozin to the patient if the eGFR of the patient is .gtoreq.30 ml/min/1.73 m.sup.2 and <60 ml/min/1.73 m.sup.2, wherein empagliflozin is administered orally in a total daily amount of 10 mg or 25 mg, wherein the glycemic control in said patient is improved; c) discontinuing empagliflozin if the eGFR of the patient falls below 30 ml/min/1.73 m.sup.2. 41. The method according to claim 40, wherein empagliflozin is administered in a total daily amount of 10 mg. 42. The method according to claim 40, wherein empagliflozin is administered in a total daily amount of 25 mg. 43. The method according to claim 40, wherein empagliflozin is administered orally once daily as a pharmaceutical composition comprising 10 mg of empagliflozin. 44. The method according to claim 40, wherein empagliflozin is administered orally once daily as a pharmaceutical composition comprising 25 mg of empagliflozin.