USE OF GLP-1 COMPOUND FOR TREATMENT OF CRITICALLY ILL PATIENTS

• US 20100311651A1
• Filed: 07/02/2009
• Published: 12/09/2010
• Est. Priority Date: 02/07/2002
• Status: Active Grant

• Current Assignee: Novo Nordisk A/S
• Original Assignee: Novo Nordisk A/S
• Inventors: Hansen, Kristian Tage, Selmer, Johan, Knudsen, Lotte Bjerre
• Granted Patent: US 8,088,731 B2
• Time in Patent Office: Days
• US Class Current: 514/6.5
• CPC Class Codes: A61K 38/26 Glucagons
• CPC Class Codes: A61P 17/02 for treating wounds, ulcers, burns, scars, keloids, or the like
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• 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 7/12 Antidiuretics, e.g. drugs for diabetes insipidus ADH A61P5/10

Abstract

Use of medicament for life saving treatment of critically ill patients and method of treatment. The medicament comprises a GLP-1 compound which effectively controls the blood glucose level.

Claims

1. A method for treating a critically ill patient and/or a patient having critical illness polyneuropathy (CIPNP) and/or a patient having systemic inflammatory response syndrome (SIRS), said method comprising administering to said patient a therapeutically effective amount of a GLP-1 compound.

2. The method according to claim 1, wherein the GLP-1 compound is GLP-1(7-36)-amide, GLP-1(7-37), or an analogue thereof or a derivative thereof.

3. The method according to claim 2, wherein the GLP-1 compound is a derivative of GLP-1(7-36)-amide or GLP-1(7-37) which comprises a lipophilic substituent.

4. The method according to claim 3, wherein the GLP-1 compound is Arg³⁴, Lys²⁶(N^ε

-(γ

-Glu(N^α

-hexadecanoyl)))-GLP-1(7-37).

5. The method according to claim 2, wherein the GLP-1 compound is selected from the group consisting of Gly⁸-GLP-1(7-36)-amide, Gly⁸-GLP-1(7-37), Val⁸-GLP-1(7-36)-amide, Val⁸-GLP-1(7-37), Val⁸Asp²²-GLP-1(7-36)-amide, Val⁸Asp²²-GLP-1(7-37), Val⁸Glu²²-GLP-1(7-36)-amide, Val⁸Glu²²-GLP-1(7-37), Val⁸Lys²²-GLP-1(7-36)-amide, Val⁸Lys²²-GLP-1(7-37), Val⁸Arg²²-GLP-1(7-36)-amide, Val⁸Arg²²-GLP-1(7-37), Val⁸His²²-GLP-1(7-36)-amide, Val⁸His²²-GLP-1(7-37), and analogues and derivatives thereof.

6. The method according to claim 1, wherein the GLP-1 compound is a stable GLP-1 analog/derivative.

7. The method according to claim 1, wherein the GLP-1 compound is exendin-4 or an analogue thereof or a derivative thereof.

8. The method according to claim 1, wherein the GLP-1 compound is a stable exendin-4 analog/derivative.

9. The method according to claim 1, wherein the GLP-1 compound is administered parenterally.

10. The method according to claim 1, wherein the GLP-1 compound is administered by injection.

11. The method according to claim 1, wherein the GLP-1 compound is administered by infusion or drip.

12. The method according to claim 1, wherein the GLP-1 compound is administered at a dosage of from about 0.5 μ

g/kg/day to about 20 μ

g/kg/day.

13. The method according to claim 1, wherein the GLP-1 compound is administered at a dosage of from about 0.1 μ

g/kg/day to about 2 μ

g/kg/day.

14. The method according to claim 1, wherein said administration of the GLP-1 compound results in said patient'"'"'s blood glucose level being kept below an upper limit of about 110 mg/dL.

15. The method according to claim 1, wherein said administration of the GLP-1 compound results in said patient'"'"'s blood glucose level being kept below an upper limit which is about 120 mg/dL.

16. The method according to claim 1, wherein said administration of the GLP-1 compound results in said patient'"'"'s blood glucose level being kept below an upper limit which is about 130 mg/dL.

17. The method according to claim 1, wherein said administration of the GLP-1 compound results in said patient'"'"'s blood glucose level being kept within a range between about 60 mg/dL and about 130 mg/dL.

18. The method according to claim 1, wherein said administration of the GLP-1 compound results in said patient'"'"'s blood glucose level being kept within a range between about 70 mg/dL and about 120 mg/dL.

19. The method according to claim 1, wherein said administration of the GLP-1 compound results in said patient'"'"'s blood glucose level being kept within a range between about 80 mg/dL and about 110 mg/dL.

20. The method according to claim 1, wherein said patient is further administered a blood glucose regulator.

21. The method according to claim 20, wherein the blood glucose regulator is selected from the group consisting of insulin, insulin analogs, insulin derivatives, insulin secretagogues, insulin compounds that stimulate signal transduction mediated by an insulin receptor type tyrosine kinase in a cell, protein-tyrosine phosphatases and Type II antidiabetic compounds.

22. The method according to claim 20, wherein the blood glucose regulator is selected from the group consisting of insulin, an insulin analog, an insulin derivative, a second GLP-1 compound and an orally administered blood glucose regulator.

23. The method according to claim 1, wherein the patient is a non-diabetic.

24. The method according to claim 1, wherein the patient is a human.

25. The method according to claim 1, wherein the patient is in need of a surgery selected from the group consisting of cardiac surgery, cerebral surgery, thoracic surgery, abdominal surgery, vascular surgery, and transplantation.

26. The method according to claim 1, wherein the patient is suffering from a condition selected from the group consisting of neurological diseases, cerebral trauma, respiratory insufficiency, abdominal peritonitis, multiple trauma, and severe burns.

27. The method according to claim 1, wherein the patient is fed parenterally.

28. The method according to claim 1, wherein at least about one third of said patient'"'"'s caloric intake is through the normal enteric route.

29. The method according to claim 1, wherein at least about half of said patient'"'"'s caloric intake is through the normal enteric route.

30. The method according to claim 1, wherein at least about two third of said patient'"'"'s caloric intake is through the normal enteric route.

31. The method according to claim 17, wherein said patient'"'"'s blood glucose level is kept within the specified range for a period of more than about 8 hours.

32. The method according to claim 17, wherein said patient'"'"'s blood glucose level is kept within the specified range for a period of more than about 24 hours.

33. The method according to claim 17, wherein said patient'"'"'s blood glucose level is kept within the specified range for a period of more than about 2 days.

34. The method according to claim 17, wherein said patient'"'"'s blood glucose level is kept within the specified range for a period of more than about 4 days.

35. The method according to claim 17, wherein said patient'"'"'s blood glucose level is kept within the specified range for a period of more than about about 7 days.