Insulin Resistance Improver

• US 20090233851A1
• Filed: 05/26/2006
• Published: 09/17/2009
• Est. Priority Date: 05/27/2005
• Status: Abandoned Application

• Current Assignee: Asubio Pharma Co., Ltd. (Daiichi Sankyo Company Limited)
• Original Assignee: Asubio Pharma Co., Ltd. (Daiichi Sankyo Company Limited)
• Inventors: Masuda, Yutaka, Harada, Yuriko, Wakabayashi, Naomi
• Application Number:
  US11/921,027
• Publication Number:
  US 20090233851A1
• Time in Patent Office: Days
• US Class Current: 514/1.100
• CPC Class Codes: A61K 38/26 Glucagons
• 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: A61K 9/0043 Nose
• CPC Class Codes: A61K 9/0073 Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy; nasal sprays A61K9/0043; inhalation of vapours of volatile or heated drugs, e.g. essential oils or nicotine, A61K9/007; devices A61M
• CPC Class Codes: A61P 3/04 Anorexiants; Antiobesity agents
• CPC Class Codes: A61P 3/06 Antihyperlipidemics
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system
• 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
• CPC Class Codes: A61P 9/12 Antihypertensives

Abstract

A novel dosage regimen of GLP-1 receptor agonists causes little or no side effects or drug interactions and is suitable for improving insulin resistance. Also provided is an insulin resistance improver for use in the dosage regimen. The dosage regimen comprises repeatedly administering, preferably in a non-invasive manner, a GLP-1 receptor agonist at least before eating for a predetermined period of time to create a condition similar to what is observed with postprandial temporary secretion of the endogenous GLP-1 receptor agonist, rather than administering it continuously. This creates a similar or enhanced variation in the plasma levels of GLP-1 receptor agonist as compared to the circadian variation of the endogenous GLP-1 receptor agonist in a healthy individual. A pharmaceutical composition for use in the dosage regimen containing GLP-1 receptor agonist as an active ingredient is also provided.

Claims

1. :

A pharmaceutical composition for improving insulin resistance, or for preventing or treating disorders associated with insulin resistance, the composition containing as an active ingredient a GLP-1 receptor agonist or a pharmaceutically acceptable salt thereof and intended for use on a continuous schedule involving administering the GLP-1 receptor agonist or a pharmaceutically acceptable salt thereof to an individual which exhibits insulin resistance in a single dose of 0.5 to 5000 μ

g at least once daily before eating for at least 2 weeks.

2. :

The pharmaceutical composition according to claim 1, wherein the composition is also administered after eating.

3. :

The pharmaceutical composition according to claim 1, wherein the GLP-1 receptor agonist is GLP-1(7-36) amide.

4. :

The pharmaceutical composition according to claim 1, wherein the composition is administered either subcutaneously, nasally or pulmonarily.

5. :

The pharmaceutical composition according to claim 1, wherein the disorder associated with insulin resistance is hyperinsulinemia, diabetes, obesity, hyperlipidemia, arteriosclerosis, hypertension or a cardiovascular disease.

6. :

The pharmaceutical composition according to claim 1, wherein the disorder associated with insulin resistance is diabetes.

7. :

The pharmaceutical composition according to claim 1, intended for nasally administering GLP-1(7-36) amide before eating.

8. :

A method for improving insulin resistance, or for preventing or treating disorders associated with insulin resistance, the method comprising a continuous schedule involving administering a GLP-1 receptor agonist or a pharmaceutically acceptable salt thereof to an individual which exhibit insulin resistance in a single dose of 0.5 to 5000 μ

g at least once daily before eating for at least 2 weeks.

9. :

The method according to claim 8, wherein the GLP-1 receptor agonist is also administered after eating.

10. :

The method according to claim 8, wherein the GLP-1 receptor agonist is GLP-1(7-36) amide.

11. :

The method according to claim 8, wherein the GLP-1 receptor agonist is administered either subcutaneously, nasally or pulmonarily.

12. :

The method according to claim 8, wherein the disorder associated with insulin resistance is hyperinsulinemia, diabetes, obesity, hyperlipidemia, arteriosclerosis, hypertension or a cardiovascular disease.

13. :

The method according to claim 12, wherein the disorder associated with insulin resistance is diabetes.

14. :

The method according to claim 8 for nasally administering GLP-1(7-36) amide before eating.

15. :

A use of GLP-1 receptor agonist in the production of a pharmaceutical composition for improving insulin resistance, or for preventing or treating disorders associated with insulin resistance, the composition containing as an active ingredient a GLP-1 receptor agonist or a pharmaceutically acceptable salt thereof and intended for use on a continuous schedule involving administering the GLP-1 receptor agonist or a pharmaceutically acceptable salt thereof to an individual which exhibit insulin resistance in a single dose of 0.5 to 5000 μ

g at least once daily before eating for at least 2 weeks.

16. :

The use according to claim 15, wherein the composition is also administered after eating.

17. :

The use according to claim 15, wherein the GLP-1 receptor agonist is GLP-1(7-36) amide.

18. :

The use according to claim 15, wherein the GLP-1 receptor agonist is administered either subcutaneously, nasally or pulmonarily.

19. :

The use according to claim 15, wherein the disorder associated with insulin resistance is hyperinsulinemia, diabetes, obesity, hyperlipidemia, arteriosclerosis, hypertension or a cardiovascular disease.

20. :

The use according to claim 19, wherein the disorder associated with insulin resistance is diabetes.

21. :

The use according to claim 15 for nasally administering GLP-1(7-36) amide before eating.