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Last Updated: December 16, 2025

Claims for Patent: 10,159,713

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Summary for Patent: 10,159,713

Title:	Treatment of type 2 diabetes mellitus patients
Abstract:	The present invention refers to lixisenatide for use in the reduction of progression of urinary albumin excretion in a type 2 diabetes mellitus patient.
Inventor(s):	Belder; Rene (Bridgewater, NJ), Johnston; Peter (Barryville, NY), Lawson; Francesca (Bridgewater, NJ), Ping; Lin (Bridgewater, NJ), Wei; Xiaodan (Bridgewater, NJ)
Assignee:	Sanofi-Aventis Deutschland GmbH (DE)
Application Number:	15/073,364
Patent Claims:	1. A method of reducing urinary albumin excretion in a type 2 diabetes mellitus patient with albumunuria, said method comprising selecting a type 2 diabetes mellitus patient with albuminuria, and administering lixisenatide or a pharmaceutically acceptable salt thereof to the patient in need thereof, thereby reducing albumin excretion in the patient. 2. The method of claim 1, wherein the patient has microalbuminuria. 3. The method of claim 1, wherein the patient has a urinary albumin to creatinine ratio (UACR) of .gtoreq.30 mg/g to <300 mg/g. 4. The method of claim 1, wherein the patient has a urinary albumin to creatinine ratio (UACR) of .gtoreq.300 mg/g. 5. The method of claim 1, wherein the patient has a glomerular filtration rate (GFR) of .gtoreq.60 mL/min/1.73 m.sup.2 to <90 mL/min/1.73 m.sup.2. 6. The method of claim 1, wherein the patient has a glomerular filtration rate (GFR) of .gtoreq.30 mL/min/1.73 m.sup.2 to <60 mL/min/1.73 m.sup.2. 7. The method of claim 1, wherein the patient has a glomerular filtration rate (GFR) of .gtoreq.15 mL/min/1.73 m.sup.2 to <30 mL/min/1.73 m.sup.2. 8. The method of claim 1, wherein the patient receives lixisenatide in combination with an insulin or a pharmaceutically acceptable salt thereof. 9. The method of claim 1, wherein prior to the onset of treatment with lixisenatide, the patient has a HbA1c value of 7% to 10%. 10. The method of claim 1, wherein the patient has macroalbuminuria. 11. The method of claim 1, wherein prior to the onset of treatment with lixisenatide, the patient's type 2 diabetes mellitus is not adequately controlled. 12. The method of claim 1, wherein the lixisenatide is administered subcutaneously. 13. The method of claim 1, wherein the lixisenatide is administered in a daily dose of 5 .mu.g to 20 .mu.g. 14. The method of claim 11, wherein the patient's type 2 diabetes mellitus is not adequately controlled on insulin or a pharmaceutically acceptable salt thereof. 15. The method of claim 1, wherein the patient receives lixisenatide in combination with metformin or a pharmaceutically acceptable salt thereof. 16. The method of claim 1, wherein the patient receives lixisenatide in combination with a glinide or a pharmaceutically acceptable salt thereof. 17. The method of claim 1, wherein the patient receives lixisenatide in combination with a sulfonylurea or a pharmaceutically acceptable salt thereof.

Details for Patent 10,159,713

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Sanofi-aventis U.s. Llc	ADLYXIN	lixisenatide	Injection	208471	July 27, 2016	10,159,713	2036-03-17
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

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