Combination of an insulin and a GLP-1-agonist

• US 9,526,764 B2
• Filed: 10/09/2009
• Issued: 12/27/2016
• Est. Priority Date: 10/17/2008
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Werner, Ulrich, Rotthauser, Barbel
• Primary Examiner(s): Shafer, Shulamith H
• Application Number:
  US13/123,835
• Publication Number:
  US 20120021978A1
• Time in Patent Office: 2,636 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 38/26 Glucagons
• CPC Class Codes: A61K 38/28 Insulins
• CPC Class Codes: A61P 1/18 for pancreatic disorders, e.g. pancreatic enzymes
• CPC Class Codes: A61P 3/04 Anorexiants; Antiobesity agents
• CPC Class Codes: A61P 3/08 for glucose homeostasis pancreatic hormones A61P5/48
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 5/00 Drugs for disorders of the endocrine system
• CPC Class Codes: A61P 5/48 of the pancreatic hormones
• CPC Class Codes: A61P 5/50 for increasing or potentiating the activity of insulin

Abstract

The invention relates to a drug comprising at least one insulin and at least one GLP-1 receptor agonist.

Claims

1. A pharmaceutical formulation comprising 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 concentration of insulin glargine is about 100 units/mL, and the concentration of AVE0010 is about 20 μ

g/ml to about 150 μ

g/ml.

2. The pharmaceutical formulation of claim 1,

wherein the concentration of insulin glargine is about 100 units/mL, and the concentration of AVE0010 is about 25, 33, 40, 66, or 75 μ

g/mL.

3. The pharmaceutical formulation of claim 2,

wherein the concentration of insulin glargine is about 100 units/mL, and the concentration of AVE0010 is about 25 μ

g/mL.

4. The pharmaceutical formulation of claim 2,

wherein the concentration of insulin glargine is about 100 units/mL, and the concentration of AVE0010 is about 33 μ

g/mL.

5. The pharmaceutical formulation of claim 2,

wherein the concentration of insulin glargine is about 100 units/mL, and the concentration of AVE0010 is about 40 μ

g/mL.

6. The pharmaceutical formulation of claim 2,

wherein the concentration of insulin glargine is about 100 units/mL, and the concentration of AVE0010 is about 66 μ

g/mL.

7. The pharmaceutical formulation of claim 2,

wherein the concentration of insulin glargine is about 100 units/mL, and the concentration of AVE0010 is about 75 μ

g/mL.

14. The pharmaceutical formulation of claim 1, 8, or 11, wherein the pharmaceutical formulation is a liquid formulation suitable for parenteral administration.

15. The pharmaceutical formulation of claim 1, 8, or 11, wherein the pharmaceutical formulation is suitable for administration once daily.

8. A pharmaceutical formulation comprising a combination of:

(a) insulin glargine or a pharmaceutically acceptable salt thereof, and

(b) AVE0010 or a pharmaceutically acceptable salt thereof;

wherein the concentration of insulin glargine is about 100 units/mL, and

wherein insulin glargine and AVE0010 are present in a ratio of about 1.5 units to about 4 units of insulin glargine to 1 μ

g of AVE0010.

9. The pharmaceutical formulation of claim 8,

wherein insulin glargine and AVE0010 are present in a ratio of about 3 units of insulin glargine to 1 μ

g of AVE0010.

10. The pharmaceutical formulation of claim 8,

wherein insulin glargine and AVE0010 are present in a ratio of about 2 units of insulin glargine to 1 μ

g of AVE0010.

11. A pharmaceutical formulation comprising 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 dosage of insulin glargine is between about 5 units and about 100 units, and the dosage of AVE0010 is between about 5 μ

g and about 2 mg.

12. The pharmaceutical formulation of claim 11,

wherein the dosage of insulin glargine is between about 15 units and about 80 units, and the dosage of AVE0010 is between about 10 μ

g and about 30 μ

g.

13. The pharmaceutical formulation of claim 11,

wherein the dosage of insulin glargine is between about 15 units and about 80 units, and the dosage of AVE0010 is between about 10 μ

g and about 20 μ

g.