Treatment of type 2 diabetes mellitus patients

• US 10,159,713 B2
• Filed: 03/17/2016
• Issued: 12/25/2018
• Est. Priority Date: 03/18/2015
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Belder, Rene, Johnston, Peter, Lawson, Francesca, Ping, Lin, Wei, Xiaodan
• Primary Examiner(s): Ha, Julie
• Assistant Examiner(s): Hellman, Kristina M
• Application Number:
  US15/073,364
• Publication Number:
  US 20160296601A1
• Time in Patent Office: 1,013 Days
• Field of Search: None
• CPC Class Codes: A61K 38/26 Glucagons
• CPC Class Codes: A61K 47/20 containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61P 13/02 of urine or of the urinary tract, e.g. urine acidifiers
• CPC Class Codes: A61P 13/12 of the kidneys
• 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 5/50 for increasing or potentiating the activity of insulin
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system
• CPC Class Codes: A61P 9/04 Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
• CPC Class Codes: A61P 9/06 Antiarrhythmics
• CPC Class Codes: A61P 9/10 for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

Abstract

The present invention refers to lixisenatide for use in the reduction of progression of urinary albumin excretion in a type 2 diabetes mellitus patient.

Claims

1. A method of reducing urinary albumin excretion in a type 2 diabetes mellitus patient with albumunuria, said method comprising

selecting a type 2 diabetes mellitus patient with albuminuria, and administering lixisenatide or a pharmaceutically acceptable salt thereof to the patient in need thereof, thereby reducing albumin excretion in the patient.

2. The method of claim 1, wherein the patient has microalbuminuria.

3. The method of claim 1, wherein the patient has a urinary albumin to creatinine ratio (UACR) of ≥

30 mg/g to <

300 mg/g.

4. The method of claim 1, wherein the patient has a urinary albumin to creatinine ratio (UACR) of ≥

300 mg/g.

5. The method of claim 1, wherein the patient has a glomerular filtration rate (GFR) of ≥

60 mL/min/1.73 m² to <

90 mL/min/1.73 m².

6. The method of claim 1, wherein the patient has a glomerular filtration rate (GFR) of ≥

30 mL/min/1.73 m² to <

60 mL/min/1.73 m².

7. The method of claim 1, wherein the patient has a glomerular filtration rate (GFR) of ≥

15 mL/min/1.73 m² to <

30 mL/min/1.73 m².

8. The method of claim 1, wherein the patient receives lixisenatide in combination with

an insulin or a pharmaceutically acceptable salt thereof.

9. The method of claim 1, wherein prior to the onset of treatment with lixisenatide, the patient has a HbA1c value of 7% to 10%.

10. The method of claim 1, wherein the patient has macroalbuminuria.

11. The method of claim 1, wherein prior to the onset of treatment with lixisenatide, the patient'"'"'s type 2 diabetes mellitus is not adequately controlled.

12. The method of claim 1, wherein the lixisenatide is administered subcutaneously.

13. The method of claim 1, wherein the lixisenatide is administered in a daily dose of 5 μ

g to 20 μ

g.

14. The method of claim 11, wherein the patient'"'"'s type 2 diabetes mellitus is not adequately controlled on insulin or a pharmaceutically acceptable salt thereof.

15. The method of claim 1, wherein the patient receives lixisenatide in combination with metformin or a pharmaceutically acceptable salt thereof.

16. The method of claim 1, wherein the patient receives lixisenatide in combination with a glinide or a pharmaceutically acceptable salt thereof.

17. The method of claim 1, wherein the patient receives lixisenatide in combination with a sulfonylurea or a pharmaceutically acceptable salt thereof.