Methods for administering hypoglycemic agents

Abstract

The present invention relates to methods of administering hypoglycemic agents and/or GLP-1 agonists.

We claim: 
     
         1 . A method for treating a disease selected from the group consisting of Type 1 diabetes, Type II diabetes, obesity and hyperglycemia in a human in need thereof comprising administering a composition comprising at least one polypeptide having GLP-1 activity as a subcutaneous injection to said human 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. 
     
     
         2 . The method of  claim 1  wherein the disease is Type II diabetes. 
     
     
         3 . The method of  claim 1 , wherein the polypeptide having GLP-1 activity comprises at least one fragment or variant of human GLP-1 genetically fused with human serum albumin. 
     
     
         4 . The method of  claim 3  wherein the at least one fragment or variant of GLP-1 comprises GLP-1(7-36(A8G)). 
     
     
         5 . The method of  claim 4  wherein the at least one fragment or variant of GLP-1 is genetically fused to human serum albumin. 
     
     
         6 . The method of  claim 5  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. 
     
     
         7 . The method of  claim 6  wherein the at least two GLP-1(7-36(A8G)) are genetically fused at the N-terminus of the human serum albumin. 
     
     
         8 . The method of  claim 1  wherein at least one polypeptide having GLP-1 activity comprises the amino acid sequence of SEQ ID NO: 1. 
     
     
         9 . The method of  claim 8  wherein the polypeptide having the amino acid of SEQ ID NO:1 is administered at a dose of about 0.25 mg to about 32 mg weekly. 
     
     
         10 . The method of  claim 1 , wherein said composition comprising at least one polypeptide having GLP-1 activity comprises exendin-4. 
     
     
         11 . 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. 
     
     
         12 . The method of  claim 1 , wherein said composition comprising at least one polypeptide having GLP-1 activity further comprises trehalose dihydrate, mannitol, sodium phosphate, polysorbate 80, and water for injection. 
     
     
         13 . A method for treating Type II diabetes in a human comprising administering a composition comprising a polypeptide having the amino acid of SEQ ID NO:1 as a subcutaneous injection to said human via an injection device comprising a needle having a gauge of about 28 or greater once weekly, wherein the composition comprises about 0.01 mg to about 104 mg of said polypeptide having the amino acid of SEQ ID NO:1. 
     
     
         14 . The method of  claim 13 , further comprising the step of co-administering a compound selected from the group of: peroxisome proliferating activated receptor ligand, thiazolidinedione, metformin, insulin, and sulfonylurea. 
     
     
         15 . The method of  claim 13 , wherein said composition comprising at least one polypeptide having GLP-1 activity further comprises trehalose dihydrate, mannitol, sodium phosphate, polysorbate 80, and water for injection.