Claims for Patent: 9,821,032

Summary for Patent: 9,821,032

Title:	Pharmaceutical combination for improving glycemic control as add-on therapy to basal insulin
Abstract:	The present invention refers to a pharmaceutical combination for use in glycemic control in diabetes type 2 patients.
Inventor(s):	Niemoeller; Elisabeth (Frankfurt am Main, DE), Silvestre; Louise (Paris, FR), Boka; Gabor (Paris, FR), Miossec; Patrick (Paris, FR)
Assignee:	SANOFI-AVENTIS DEUTSCHLAND GMBH (Frankfurt am Main, DE)
Application Number:	13/467,707
Patent Claims:	1. A method for improving glycemic control in a patient with type 2 diabetes mellitus comprising administering to the patient in need thereof a therapeutically effective amount of a pharmaceutical combination comprising: (a) lixisenatide or a pharmaceutically acceptable salt thereof, and (b) insulin glargine or a pharmaceutically acceptable salt thereof, wherein the patient's type 2 diabetes mellitus is inadequately controlled after treatment with basal insulin at a dose of about 15 units to about 80 units per day for at least about 3 months. 2. The method of claim 1, wherein the patient is an adult. 3. The method of claim 1, wherein the patient has a glycosylated hemoglobin A.sub.1c(HbA.sub.1c) value of about 7% to about 10% after treatment with basal insulin. 4. The method of claim 1, wherein the basal insulin is insulin glargine. 5. The method of claim 1, wherein the pharmaceutical combination comprises a daily dose of about 15 units to about 80 units of insulin glargine. 6. The method of claim 1, wherein the pharmaceutical combination comprises a daily dose of about 10 .mu.g to about 20 .mu.g of lixisenatide. 7. A method for improving glycemic control in a patient with type 2 diabetes mellitus, the method comprising administering to the patient in need thereof a therapeutically effective amount of a pharmaceutical combination comprising: (a) lixisenatide or a pharmaceutically acceptable salt thereof, and (b) insulin glargine or a pharmaceutically acceptable salt thereof, wherein the patient's type 2 diabetes mellitus is inadequately controlled after treatment with basal insulin at a dose of about 15 units to about 80 units per day and metformin at a dose of at least about 1.0 g per day for at least about 3 months. 8. The method of claim 7, wherein the basal insulin is insulin glargine. 9. The method of claim 7, wherein the pharmaceutical combination comprises a daily dose of about 15 units to about 80 units of insulin glargine. 10. The method of claim 7, wherein the pharmaceutical combination comprises a daily dose of about 10 .mu.g to about 20 .mu.g of lixisenatide. 11. The method of claim 7, wherein the patient is an adult. 12. The method of claim 7, wherein the patient has an HbA.sub.1c value of about 7% to about 10% after treatment with basal insulin and metformin. 13. The method of claim 7, further comprising administering to the patient a therapeutically effective amount of metformin. 14. The method of claim 1 or 7, wherein the basal insulin is a long-acting basal insulin.