Claims for Patent: 12,115,179

Summary for Patent: 12,115,179

Title:	Pharmaceutical composition, methods for treating and uses thereof
Abstract:	The invention relates to a pharmaceutical composition comprising an SGLT2 inhibitor, a DPPIV inhibitor and a third antidiabetic agent which is suitable in the treatment or prevention of one or more conditions selected from type 1 diabetes mellitus, type 2 diabetes mellitus, impaired glucose tolerance and hyperglycemia. In addition the present invention relates to methods for preventing or treating of metabolic disorders and related conditions.
Inventor(s):	Peter Eickelmann, Michael Mark, Leo John Seman, Leo Thomas, Uli Christian BROEDL, Rolf GREMPLER
Assignee:	Boehringer Ingelheim International GmbH
Application Number:	US18/320,462
Patent Claims:	1. A method for slowing the progression of, delaying or treating a metabolic disorder selected from the group consisting of type 2 diabetes mellitus, impaired glucose tolerance, impaired fasting blood glucose, hyperglycemia, postprandial hyperglycemia, overweight, obesity, metabolic syndrome, gestational diabetes, new onset diabetes after transplantation (NODAT) and complications associated therewith, and post-transplant metabolic syndrome (PTMS) and complications associated therewith in a patient in need thereof, the method comprising administering to the patient an SGLT2 inhibitor, a DPP IV inhibitor and a third antidiabetic agent in combination or alternation to the patient, wherein the SGLT2 inhibitor is 1-chloro-4-(β-D-glucopyranos-1-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy)-benzyl]-benzene, the DPPIV inhibitor is linagliptin or a pharmaceutically acceptable salt thereof, and the third antidiabetic agent is metformin or a pharmaceutically acceptable salt thereof, wherein the SGLT2 inhibitor is administered to the patient in a dosage of 1 mg to 50 mg per day, the DPPIV inhibitor is administered to the patient in a dosage of 1 mg to 5 mg per day, and the third antidiabetic agent administered to the patient in a dosage of 500 mg to 2000 mg per day. 2. The method according to claim 1, wherein the SGLT2 inhibitor and the DPP IV inhibitor are present in a single dosage form and the third antidiabetic agent is present in a separate dosage form. 3. The method according to claim 1, wherein the SGLT2 inhibitor and the third antidiabetic agent are present in a single dosage form and the DPPIV inhibitor is present in a separate dosage form. 4. The method according to claim 1, wherein the DPPIV inhibitor and the third antidiabetic agent are present in a single dosage form and the SGLT2 inhibitor is present in a separate dosage form. 5. The method according to claim 1, wherein the SGLT2 inhibitor, the DPP IV inhibitor and the third antidiabetic agent are present each in a separate dosage form. 6. The method according to claim 1, wherein the dosage of the SGLT2 inhibitor is 10 mg or 25 mg per day. 7. The method according to claim 1, wherein the dosage of the DPPIV inhibitor is 5 mg per day. 8. The method according to claim 1, wherein the dosage of the third antidiabetic agent is 500 mg, 750 mg, 850 mg or 1000 mg per day. 9. The method according to claim 1, wherein the SGLT2 inhibitor is administered to the patient once daily. 10. The method according to claim 1, wherein the DPP IV inhibitor is administered to the patient once daily. 11. The method according to claim 1, wherein the third antidiabetic agent is administered to the patient once or twice daily. 12. The method according to claim 1, wherein the method is for treating type 2 diabetes mellitus. 13. A method for improving glycemic control and/or for reducing of fasting plasma glucose, of postprandial plasma glucose and/or of glycosylated hemoglobin HbA1c in a patient in need thereof, the method comprising administering to the patient an SGLT2 inhibitor, a DPP IV inhibitor and a third antidiabetic agent in combination or alternation to the patient, wherein the SGLT2 inhibitor is 1-chloro-4-(β-D-glucopyranos-1-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy)-benzyl]-benzene, the DPPIV inhibitor is linagliptin or a pharmaceutically acceptable salt thereof, and the third antidiabetic agent is metformin or a pharmaceutically acceptable salt thereof, wherein the SGLT2 inhibitor is administered to the patient in a dosage of 1 mg to 50 mg per day the DPPIV inhibitor is administered to the patient in a dosage of 1 mg to 5 mg per day, and the third antidiabetic agent administered to the patient in a dosage of 500 mg to 2000 mg per day. 14. The method according to claim 13, wherein the SGLT2 inhibitor and the DPP IV inhibitor are present in a single dosage form and the third antidiabetic agent is present in a separate dosage form. 15. The method according to claim 13, wherein the SGLT2 inhibitor and the third antidiabetic agent are present in a single dosage form and the DPPIV inhibitor is present in a separate dosage form. 16. The method according to claim 13, wherein the DPPIV inhibitor and the third antidiabetic agent are present in a single dosage form and the SGLT2 inhibitor is present in a separate dosage form. 17. The method according to claim 13, wherein the SGLT2 inhibitor, the DPP IV inhibitor and the third antidiabetic agent are present each in a separate dosage form. 18. The method according to claim 13, wherein the dosage of the SGLT2 inhibitor is 10 mg or 25 mg per day. 19. The method according to claim 13, wherein the dosage of the DPPIV inhibitor is 5 mg per day. 20. The method according to claim 13, wherein the dosage of the third antidiabetic agent is 500 mg, 750 mg, 850 mg or 1000 mg per day. 21. The method according to claim 13, wherein the SGLT2 inhibitor is administered to the patient once daily. 22. The method according to claim 13, wherein the DPP IV inhibitor is administered to the patient once daily. 23. The method according to claim 13, wherein the third antidiabetic agent is administered to the patient once or twice daily. 24. The method according to claim 13, wherein the method is for improving glycemic control in a patient with type 2 diabetes mellitus.