Insulin glargine/lixisenatide fixed ratio formulation

• US 9,950,039 B2
• Filed: 12/10/2015
• Issued: 04/24/2018
• Est. Priority Date: 12/12/2014
• Status: Active Grant

• Current Assignee: Saudi Arabian Oil Company (Government of Saudi Arabia), Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Souhami, Elisabeth, Silvestre, Louise
• Primary Examiner(s): Ha, Julie
• Assistant Examiner(s): Hellman, Kristina M
• Application Number:
  US14/965,586
• Publication Number:
  US 20160199452A1
• Time in Patent Office: 866 Days
• Field of Search: None
• 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 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 5/50 for increasing or potentiating the activity of insulin

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

1. A method of improving glycemic control in a patient with type 2 diabetes mellitus in need thereof, the method comprising administering to the patient a pharmaceutical composition comprising:

(a) lixisenatide or a pharmaceutically acceptable salt thereof at a concentration of 33 μ

g/mL, and

(b) insulin glargine or a pharmaceutically acceptable salt thereof at a concentration of 100 U/mL

wherein the patient'"'"'s type 2 diabetes mellitus is inadequately controlled by treatment with lixisenatide.

2. The method of claim 1, wherein the pharmaceutical composition is administered to the patient parenterally.

3. The method of claim 1, wherein the patient has a glycated hemoglobin (HbA1c) value between about 7% and about 10% when treated with lixisenatide.

4. The method of claim 1, wherein the patient'"'"'s type 2 diabetes mellitus is inadequately controlled when treated with lixisenatide at the onset of treatment with the pharmaceutical composition.

5. The method of claim 1, wherein the patient'"'"'s type 2 diabetes mellitus is inadequately controlled when treated with lixisenatide and metformin.

6. The method of claim 1, wherein the patient'"'"'s type 2 diabetes mellitus is inadequately controlled when treated with lixisenatide, metformin, and a second oral antidiabetic drug (OAD).

7. The method of claim 6, wherein the second OAD is a sulfonylurea, a dipeptidyl-peptidase 4 (DPP-4) inhibitor, a sodium glucose co-transporter 2 (SGLT-2) inhibitor, a glinide, or a combination thereof.