Use of AVE0010 for the treatment of diabetes mellitus type 2

• US 9,981,013 B2
• Filed: 08/15/2016
• Issued: 05/29/2018
• Est. Priority Date: 08/30/2010
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Boka, Gabor, Miossec, Patrick, Silvestre, Louise
• Primary Examiner(s): Ha, Julie
• Assistant Examiner(s): Hellman, Kristina M
• Application Number:
  US15/237,285
• Publication Number:
  US 20170119852A1
• Time in Patent Office: 652 Days
• Field of Search: None
• CPC Class Codes: A61K 38/22 Hormones derived from pro-opiomelanocortin, pro-enkephalin or pro-dynorphin A61K38/33, e.g. corticotropin A61K38/35
• CPC Class Codes: A61K 38/26 Glucagons
• CPC Class Codes: A61P 3/00 Drugs for disorders of the metabolism of the blood or the extracellular fluid A61P7/00
• 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: C07K 14/463 from amphibians

Abstract

The present invention refers to the use of Lixisenatide or/and a pharmaceutically acceptable salt thereof, for the manufacture of a medicament for the treatment of diabetes mellitus type 2, for inducing weight loss in diabetes type 2 patients or/and for preventing weight gain in diabetes type 2 patients.

Claims

1. A method of improving glycemic control in a patient with type 2 diabetes mellitus comprising:

administering a dose of 10 μ

g lixisenatide to the patient once daily for 14 days, and

administering a dose of 20 μ

g lixisenatide to the patient once daily starting on day 15 of lixisenatide treatment.

2. The method of claim 1, wherein the patient is an adult.

3. The method of claim 1, wherein the patient has an HbA1c value of about 7% to about 10%.

4. The method of claim 1, wherein the patient is not currently receiving treatment with antidiabetic agents.

5. The method of claim 1, wherein the patient is inadequately controlled on the patient'"'"'s current antidiabetic treatment.

6. The method of claim 5, wherein the patient'"'"'s current antidiabetic treatment does not include an antidiabetic agent.

7. The method of claim 1, wherein the lixisenatide is administered as a pharmaceutical composition comprising lixisenatide, methionine, a suitable preservative, and a tonicity agent.

8. The method of claim 1, wherein the lixisenatide is administered as a pharmaceutical composition comprising lixisenatide, methionine, m-cresol, and glycerol.