Claims for Patent: 11,911,388

Summary for Patent: 11,911,388

Title:	Treatment for diabetes in patients with insufficient glycemic control despite therapy with an oral or non-oral antidiabetic drug
Abstract:	The present invention relates to the finding that certain DPP-4 inhibitors are particularly suitable for treating and/or preventing metabolic diseases, particularly diabetes, in patients with insufficient glycemic control despite a therapy with an oral and/or a non-oral antidiabetic drug.
Inventor(s):	Eva Ulrike Graefe-Mody, Thomas Klein, Michael Mark, Hans-Juergen Woerle
Assignee:	Boehringer Ingelheim International GmbH
Application Number:	US17/173,607
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,911,388
Patent Claims:	1. A method for treating metabolic diseases in type 2 diabetes patients with renal impairment and with insufficient glycemic control despite either metformin monotherapy or therapy with metformin in combination with an insulin or an insulin analogue, the method comprising administering a DPP-4 inhibitor which is 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine, or a pharmaceutically acceptable salt thereof, in an oral daily amount of 5 mg, wherein said 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine, or a pharmaceutically acceptable salt thereof, is used in combination with either metformin monotherapy or metformin in combination with an insulin or an insulin analogue. 2. The method according to claim 1, wherein the patients have insufficient glycemic control despite therapy with metformin monotherapy. 3. The method according to claim 1, for improving HbA1c, FPG or PPG, decreasing glucose excursion, or improving insulin secretion in said patients, or any combination of the foregoing conditions. 4. The method according to claim 1, wherein said patients are elderly patients. 5. The method according to claim 1, wherein said 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine is in free base form. 6. The method according to claim 1, wherein said patients are patients with insufficient glycemic control despite metformin monotherapy or despite therapy with metformin in combination with basal insulin. 7. The method according to claim 1, wherein said metabolic disease is type 2 diabetes and wherein said patients are patients with insufficient glycemic control despite metformin monotherapy, said method comprising administering 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine in an oral daily amount of 5 mg in combination with metformin to the patients. 8. The method according to claim 1, wherein said metabolic disease is type 2 diabetes and wherein said patients are patients with insufficient glycemic control despite therapy with metformin in combination with an insulin or an insulin analogue, said method comprising administering 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine in an oral daily amount of 5 mg in combination with metformin in combination with an insulin or an insulin analogue. 9. The method according to claim 1, for achieving a reduction in the dose of metformin, insulin and/or insulin analogue required for adequate therapeutic effect. 10. The method according to claim 1, wherein the 5 mg of 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine is administered once daily, with or without food. 11. The method according to claim 10, wherein steady state plasma levels of 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine are reached between second and fifth day of administration.