IP Library › Granted Patent US 12,186,374
Granted Patent B2
US 12,186,374 · App. 17/731,371 · Granted Jan 7, 2025

Insulin glargine/lixisenatide fixed ratio formulation

Inventors: Elisabeth Souhami (Paris, FR); Louise Silvestre (Paris, FR)
Assignee: Sanofi-Aventis Deutschland GmbH
A61K38/26A61K38/28
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Quick Facts
Patent No.
US 12,186,374
App. No.
17/731,371
Granted
Jan 7, 2025
Kind
B2
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.

Claims (15)

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.

2. The method of claim 1 , further comprising (3) titrating the dose upwards or downwards by 2-4 units of insulin glargine every week to reach and maintain a target fasting plasma glucose level in the patient of 80 to 100 mg/dL (4.4 to 5.6 mmol/L).

3. The method of claim 1 , wherein the patient has a HbA1c level between 7.5% and 10% and a fasting plasma glucose (FPG) concentration less than or equal to 180 mg/dL (10.0 mmol/L) prior to administration of the pharmaceutical composition.

4. The method of claim 1 , wherein the patient has a body mass index (BMI) between 20 kg/m 2 to 40 kg/m 2 .

5. The method of claim 1 , wherein the patient has been treated with basal insulin for at least 6 months.

6. The method of claim 5 , wherein the patient has been treated with a stable dose of basal insulin for at least 3 months.

7. The method of claim 1 , wherein the patient has been treated with basal insulin and 1 or 2 oral anti-diabetic drugs (OADs), wherein the OADs are selected from the group consisting of metformin, a sulfonylurea, a glinide, a sodium glucose co-transporter 2 (SGLT-2) inhibitor, and a dipeptidyl-peptidase 4 (DPP-4) inhibitor.

8. The method of claim 7 , wherein the patient has been treated with the stable dose of basal insulin and 1 or 2 OADs for at least 3 months.

9. The method of claim 7 , wherein the patient has been treated with metformin at a dose of at least 1.0 grams per day.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 19, 2024
From: SOUHAMI, ELISABETH; SILVESTRE, LOUISE
To: SANOFI-AVENTIS DEUTSCHLAND GMBH
Reel/Frame 068331/0214 →
Priority Claims (2)
EP 14197685 · Dec 12, 2014 · regional
EP 15193940 · Nov 10, 2015 · regional
Continuity (5)
Continuation 16995466 · Aug 17, 2020
Continuation 16387178 · Apr 17, 2019
Division 15914197 · Aug 10, 2018
Division 14965586 · Dec 10, 2015
Related Publication 20230037934A1 · Feb 9, 2023
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