# US 10,117,909 B2 · Combination of an insulin and a GLP-1 agonist

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- Number: US 10,117,909 B2
- Document ID: US10117909B2
- Status: Granted
- Kind: B2
- Application number: 15/340,969
- Filed: 2016-11-01
- Published: 2017-10-05
- Granted: 2018-11-06
- Earliest claimed: 2008-10-17
- Assignees: Sanofi-Aventis Deutschland GmbH
- Applicants: Sanofi-Aventis Deutschland GmbH
- Inventors: Ulrich Werner; Barbel Rotthauser
- Web page: https://patentgrep.com/patent/US10117909B2

## CPC

- A61K 38/28: Insulins
- A61K 38/26: Glucagons
- A61P 1/18: for pancreatic disorders, e.g. pancreatic enzymes
- A61P 3/04: Anorexiants; Antiobesity agents
- A61P 3/08: for glucose homeostasis (pancreatic hormones A61P5/48)
- A61P 3/10: for hyperglycaemia, e.g. antidiabetics
- A61P 5/00: Drugs for disorders of the endocrine system
- A61P 5/48: of the pancreatic hormones
- A61P 5/50: for increasing or potentiating the activity of insulin
- 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 invention relates to a drug comprising at least one insulin and at least one GLP-1 receptor agonist.

## Claims

### Claim 1

A prefilled syringe comprising a pharmaceutical formulation, wherein the pharmaceutical formulation comprises a combination of:
(a) insulin glargine or a pharmaceutically acceptable salt thereof, and
(b) desPro36exendin-4(1-39)-Lys6-NH2 (AVE0010) or a pharmaceutically acceptable salt thereof;
wherein the pharmaceutical formulation has a concentration of insulin glargine that is about 100 units/mL and a concentration of AVE0010 that is about 33 μg/mL; and
wherein the prefilled syringe is configured to administer the pharmaceutical formulation at a dosage of insulin glargine between about 15 units and about 80 units and a dosage of AVE0010 between about 5 μg and about 2 mg.

### Claim 2 (depends on 1)

The prefilled syringe of claim 1,
wherein the prefilled syringe is configured to administer the pharmaceutical formulation at a dosage of insulin glargine between about 15 units and about 60 units and a dosage of AVE0010 between about 5 μg and about 20 μg.

### Claim 3 (depends on 1)

The prefilled syringe of claim 1,
wherein the prefilled syringe is configured to administer the pharmaceutical formulation at a dosage of insulin glargine between about 15 units and about 80 units and a dosage of AVE0010 between about 5 μg and about 20 μg.

### Claim 4

A prefilled syringe comprising a pharmaceutical formulation, wherein the pharmaceutical formulation comprises a combination of:
(a) insulin glargine or a pharmaceutically acceptable salt thereof, and
(b) desPro36exendin-4(1-39)-Lys6-NH2 (AVE0010) or a pharmaceutically acceptable salt thereof;
wherein the pharmaceutical formulation has a concentration of insulin glargine that is about 100 units/mL and a concentration of AVE0010 that is about 20 m/ml to about 150 μg/ml.

### Claim 5 (depends on 4)

The prefilled syringe of claim 4,
wherein the pharmaceutical formulation has a concentration of insulin glargine that is about 100 units/mL and a concentration of AVE0010 that is about 25, 33, 40, 66, or 75m/mL.

### Claim 6 (depends on 4)

The prefilled syringe of claim 4,
wherein the pharmaceutical formulation has a concentration of insulin glargine that is about 100 units/mL and a concentration of AVE0010 that is about 33 μg/mL.

### Claim 7

A prefilled syringe comprising a pharmaceutical formulation, wherein the pharmaceutical formulation comprises a combination of:
(a) insulin glargine or a pharmaceutically acceptable salt thereof, and
(b) desPro36exendin-4(1-39)-Lys6-NH2 (AVE0010) or a pharmaceutically acceptable salt thereof;
wherein the pharmaceutical formulation has a concentration of insulin glargine that is about 100 units/mL, and
wherein the ratio of insulin glargine and AVE0010 in the pharmaceutical formulation is about 1.5 units to about 4 units of insulin glargine to 1 μg of AVE0010.

### Claim 8 (depends on 7)

The prefilled syringe of claim 7,
wherein the ratio of insulin glargine and AVE0010 in the pharmaceutical formulation is about 3 units of insulin glargine to 1 μg of AVE0010.