# US 11,026,999 B2 · Insulin glargine/lixisenatide fixed ratio formulation

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- Number: US 11,026,999 B2
- Document ID: US11026999B2
- Status: Granted
- Kind: B2
- Application number: 16/374,536
- Filed: 2019-04-03
- Published: 2020-02-06
- Granted: 2021-06-08
- Earliest claimed: 2013-06-17
- Assignees: Sanofi-Aventis Deutschland GmbH
- Applicants: Sanofi-Aventis Deutschland GmbH
- Inventors: Elisabeth Souhami; Louise Silvestre
- Web page: https://patentgrep.com/patent/US11026999B2

## CPC

- A61K 38/28: Insulins
- A61K 38/26: Glucagons
- A61P 3/00: Drugs for disorders of the metabolism (of the blood or the extracellular fluid A61P7/00)
- A61P 3/04: Anorexiants; Antiobesity agents
- A61P 3/10: for hyperglycaemia, e.g. antidiabetics
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## 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

### Claim 1

A method for improving glycemic control in a patient with type 2 diabetes mellitus inadequately controlled by treatment with insulin glargine and metformin, the method comprising administering to the patient in need thereof a therapeutically effective amount of a fixed ratio combination of:
(a) lixisenatide or a pharmaceutically acceptable salt thereof, and
(b) insulin glargine or a pharmaceutically acceptable salt thereof,
wherein the fixed ratio combination is administered as a single daily injection;
wherein the patient has been treated with metformin at a stable dose of at least 1.5 g per day for at least 3 months and has a HbA1c level between 7% and 10%;
such that the administration of the fixed ratio combination improves glycemic control in the patient over treatment with insulin glargine and metformin.

### Claim 2 (depends on 1)

The method of claim 1, wherein the improvement in glycemic control is a reduction of HbA1c levels in the patient.

### Claim 3 (depends on 1)

The method of claim 1, wherein the improvement in glycemic control is a reduction of post-prandial glucose (PPG) levels in the patient.