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Last Updated: October 18, 2019

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Claims for Patent: 9,950,039

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Summary for Patent: 9,950,039
Title:Insulin glargine/lixisenatide fixed ratio formulation
Abstract: The present invention refers to a pharmaceutical composition comprising (a) lixisenatide or/and a pharmaceutically acceptable salt thereof, and (b) insulin glargine or/and a pharmaceutically acceptable salt thereof, wherein the compound (b) and compound (a) are present in a fixed ratio.
Inventor(s): Souhami; Elisabeth (Paris, FR), Silvestre; Louise (Paris, FR)
Assignee: SANOFI-AVENTIS DEUTSCHLAND GMBH (Frankfurt am Main, DE)
Application Number:14/965,586
Patent Claims: 1. A method of improving glycemic control in a patient with type 2 diabetes mellitus in need thereof, the method comprising administering to the patient a pharmaceutical composition comprising: (a) lixisenatide or a pharmaceutically acceptable salt thereof at a concentration of 33 .mu.g/mL, and (b) insulin glargine or a pharmaceutically acceptable salt thereof at a concentration of 100 U/mL wherein the patient's type 2 diabetes mellitus is inadequately controlled by treatment with lixisenatide.

2. The method of claim 1, wherein the pharmaceutical composition is administered to the patient parenterally.

3. The method of claim 1, wherein the patient has a glycated hemoglobin (HbA1c) value between about 7% and about 10% when treated with lixisenatide.

4. The method of claim 1, wherein the patient's type 2 diabetes mellitus is inadequately controlled when treated with lixisenatide at the onset of treatment with the pharmaceutical composition.

5. The method of claim 1, wherein the patient's type 2 diabetes mellitus is inadequately controlled when treated with lixisenatide and metformin.

6. The method of claim 1, wherein the patient's type 2 diabetes mellitus is inadequately controlled when treated with lixisenatide, metformin, and a second oral antidiabetic drug (OAD).

7. The method of claim 6, wherein the second OAD is a sulfonylurea, a dipeptidyl-peptidase 4 (DPP-4) inhibitor, a sodium glucose co-transporter 2 (SGLT-2) inhibitor, a glinide, or a combination thereof.

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