	US 12,186,374 B2
	Insulin glargine/lixisenatide fixed ratio formulation
Elisabeth Souhami, Paris (FR); and Louise Silvestre, Paris (FR)
Assigned to Sanofi-Aventis Deutschland GmbH, Frankfurt (DE)
Filed by Sanofi-Aventis Deutschland GmbH, Frankfurt (DE)
Filed on Apr. 28, 2022, as Appl. No. 17/731,371.
Application 16/387,178 is a division of application No. 15/914,197, filed on Aug. 10, 2018, abandoned.
Application 15/914,197 is a division of application No. 14/965,586, filed on Dec. 10, 2015, granted, now 9,950,039, issued on Apr. 24, 2018.
Application 17/731,371 is a continuation of application No. 16/995,466, filed on Aug. 17, 2020, abandoned.
Application 16/995,466 is a continuation of application No. 16/387,178, filed on Apr. 17, 2019, abandoned.
Claims priority of application No. 14197685 (EP), filed on Dec. 12, 2014; and application No. 15193940 (EP), filed on Nov. 10, 2015.
Prior Publication US 2023/0037934 A1, Feb. 9, 2023
Int. Cl. A61K 38/26 (2006.01); A61K 38/28 (2006.01)

CPC A61K 38/26 (2013.01) [A61K 38/28 (2013.01)]

9 Claims

1. A method of improving glycemic control in a patient with type 2 diabetes mellitus inadequately controlled on 15 to 40 units of basal insulin, the method comprising:

(1) discontinuing the patient's current therapy with basal insulin; and

(2) administering to the patient a dose of a pharmaceutical composition comprising:

(a) lixisenatide at a concentration of 33 μg/mL, and

(b) insulin glargine at a concentration of 100 units/mL;

wherein a starting dose of the pharmaceutical composition is at a fixed-dose ratio of 30 units insulin glargine and 10 μg lixisenatide subcutaneously once daily, and

wherein the patient is a patient in need thereof.