Methods for administering hypoglycemic agents
The present invention relates to methods of administering hypoglycemic agents and/or GLP-1 agonists.
1. A method of administering a GLP-1 agonist composition comprising at least one polypeptide to a patient in need thereof, comprising the step of injecting the GLP-1 agonist composition as a subcutaneous injection to said patient via an injection device comprising a tube having a gauge of about 28 or greater, wherein said polypeptide is administered as a subcutaneous injection once weekly and wherein said composition comprises about 0.01 mg to about 104 mg of said polypeptide.
2. The method of claim 1 , wherein said at least one polypeptide comprises GLP-1 or a fragment, variant, or conjugate thereof.
3. The method of claim 2 , wherein the GLP-1 or a fragment, variant, or conjugate thereof further comprises human serum albumin.
4. The method of claim 3 , wherein the human serum albumin is conjugated to the GLP-1 or fragment or variant thereof.
5. The method of claim 1 , wherein the GLP-1 agonist composition further comprises a compound selected from the group of: peroxisome proliferating activated receptor ligand, thiazolidinedione, metformin, insulin, and sulfonylurea.
6. The method of claim 1 , wherein the GLP-1 agonist composition is lyophilized.
7. The method of claim 6 , further comprising admixing said GLP-1 agonist composition with a liquid prior to administration of said GLP-1 agonist composition.
8. The method of claim 1 , wherein the GLP-1 agonist composition is in liquid form.
9. A method of administering a GLP-1 agonist composition comprising at least one polypeptide to a patient in need thereof, comprising the step of injecting the GLP-1 agonist composition as a subcutaneous injection to said patient via an injection device comprising a tube having a gauge of about 28 or greater, wherein said polypeptide is administered as a subcutaneous injection once monthly and wherein said composition comprises about 0.01 mg to about 104 mg of said polypeptide.
10. The method of claim 1 , wherein the patient has Type II diabetes.
11. The method of claim 1 , wherein the injection device is reusable.
12. The method of claim 1 , wherein the injection device is disposable.
13. The method of claim 1 , wherein the injection device comprises a needle.
14. The method of claim 1 , wherein the injection device comprises a catheter.
15. The method of claim 1 wherein said GLP-1 agonist composition is self-administered.
16. The method of claim 1 , further comprising the step of co-administering a compound selected from the group of: peroxisome proliferating activated receptor ligand, thiazolidinedione, metformin, insulin, and sulfonylurea.
17. A method for treating a disease selected from the group consisting of Type 1 diabetes, Type II diabetes, obesity and hyperglycemia in a mammal in need thereof comprising administering a composition comprising at least one polypeptide having GLP-1 activity as a subcutaneous injection to said mammal via an injection device comprising a tube having a gauge of about 28 or greater once weekly, wherein the composition comprises about 0.01 mg to about 104 mg of at least one polypeptide having GLP-1 activity.
18. The method of claim 17 wherein the disease is Type II diabetes.
19. The method of claim 17 , wherein the polypeptide having GLP-1 activity comprises at least one fragment or variant of human GLP-1 genetically fused with human serum albumin.
20. The method of claim 19 wherein the at least one fragment or variant of GLP-1 comprises GLP-1(7-36(A8G)).
21. The method of claim 20 wherein the at least one fragment or variant of GLP-1 is genetically fused to human serum albumin.
22. The method of claim 21 wherein at least one fragment or variant of GLP-1 comprises at least two GLP-1(7-36(A8G)) tandemly and genetically fused to the human serum albumin.
23. The method of claim 21 wherein the at least two GLP-1(7-36(A8G)) are genetically fused at the N-terminus of the human serum albumin.
24. The method of claim 17 wherein at least one polypeptide having GLP-1 activity comprises the amino acid sequence of SEQ ID NO: 1.
25. The method of claim 24 wherein at least one polypeptide having GLP-1 activity is administered at a dose of about 0.25 mg to about 32 mg weekly.
26. The method of claim 1 , wherein said GLP-1 agonist composition comprises said polypeptide in an amount of about 2 mg.
27. The method of claim 26 , wherein said GLP-1 agonist composition comprises exendin-4.
28. The method of claim 1 , wherein said GLP-1 agonist composition comprises the amino acid sequence of SEQ ID NO:1.
29. The method of claim 28 , wherein said amino acid sequence of SEQ ID NO:1 is present in said injection in an amount of about 0.25 mg to about 32 mg.