Pharmaceutical compositions

Abstract

The present invention provides pharmaceutical compositions comprising at least one polypeptide having GLP-1 activity wherein an effective dose of said pharmaceutical composition comprises 15 mg, 30 mg, 50 mg or 100 mg of said polypeptide having GLP-1 activity. Also provided are methods of administering the pharmaceutical compositions of the invention.

1 . A method of treating diabetes in a human comprising administering to said human a an initial dose of a pharmaceutical composition comprising about 30 mg of a polypeptide comprising the amino acid sequence set forth in SEQ ID NO:1. 
     
     
         2 . The method of  claim 1 , wherein said pharmaceutical composition is administered subcutaneously. 
     
     
         3 . The method of  claim 1 , wherein said pharmaceutical composition is administered as a subcutaneous injection selected from the group of at least one 0.32 mL injection, at least one 0.65 mL injection, and at least one 1.0 mL injection. 
     
     
         4 . The method of  claim 1 , wherein said pharmaceutical composition reduces serum glucose in said human. 
     
     
         5 . The method of  claim 1 , wherein said human has type II diabetes mellitus. 
     
     
         6 . The method of  claim 1  wherein administration of said pharmaceutical composition causes weight loss in said human. 
     
     
         7 . The method of  claim 1 , wherein said pharmaceutical composition is administered subcutaneously in the leg, arm, or abdomen of said human. 
     
     
         8 . The method of  claim 1  wherein said human has received metformin previous to receiving said pharmaceutical composition. 
     
     
         9 . The method of  claim 1  wherein said pharmaceutical composition is administered as monotherapy. 
     
     
         10 . The method of  claim 1  wherein said pharmaceutical composition is co-administered with at least one second hypoglycaemic agent. 
     
     
         11 . The method of  claim 10  wherein said at least one second hypoglycaemic agent is selected from: a second GLP-1 agonist, exendin, sulfonylurea, meglitinide, acetohexamide, chlorpropamide, tolazamide, glipizide, gliclazide, glibenclamide (glyburide), gliquidone, glimepiride, DPP-IV inhibitor, glitazone, thiazolidinedione, rosiglitazone, pioglitazone, pPAR agonist, metformin, α-glucosidase inhibitor, insulin glargine and insulin. 
     
     
         12 . The method of  claim 1  wherein said pharmaceutical composition is administered to said human at an initial dose of 30 mg/week of a polypeptide comprising the amino acid sequence set forth in SEQ ID NO:1 and subsequently titrated up to a dose comprising 50 mg/week of a polypeptide comprising the amino acid sequence set forth in SEQ ID NO:1.