Methods for treating diabetes and reducing body weight

Abstract

Methods for reducing body weight, altering body composition, treating diabetes, reducing HbA1c and reducing average daily blood glucose by the use of exendins, exendin agonists or exendin analog agonists are provided.

1 . A method for treating type 2 diabetes in a human in need thereof, the method comprising administering to the human an effective amount of a sustained release pharmaceutical composition comprising 5% (w/w) exendin-4, 2% (w/w) sucrose, and 93% (w/w) poly(lactide-co-glycolide)copolymer to achieve a mean steady state plasma concentration of the exendin-4 of at least 200 pg/ml for at least one month in the human to treat type 2 diabetes. 
     
     
         2 . The method of  claim 1 , wherein the sustained release pharmaceutical composition is administered in a continuous mode. 
     
     
         3 . The method of  claim 2 , wherein the continuous mode results from administering the sustained release composition once weekly by subcutaneous injection. 
     
     
         4 . The method of  claim 1 , wherein the poly(lactide-co-glycolide) copolymer is purified 50:50 (lactide:glycolide) poly(D,L-lactide-co-glycolide). 
     
     
         5 . The method of  claim 1 , wherein the sustained minimum plasma concentration of the exendin-4 is between 200 pg/ml to 350 pg/ml. 
     
     
         6 . The method of  claim 1 , wherein the exendin-4 is co-administered with metformin, a sulphonylurea, a thiazolidinedione or any combination thereof. 
     
     
         7 . The method of  claim 3 , wherein 2 mg of the exendin-4 is administered once weekly. 
     
     
         8 . A method for reducing HbA1C, fasting plasma glucose, or body weight in a human in need thereof, the method comprising administering to the human in a continuous mode an effective amount of a sustained release pharmaceutical composition comprising 5% (w/w) exendin-4, 2% (w/w) sucrose, and 93% (w/w) poly(lactide-co-glycolide)copolymer in an amount to achieve a mean steady state concentration of exendin-4 of at least 200 pg/ml for at least one month to reduce HbA1C, fasting plasma glucose, or body weight. 
     
     
         9 . The method of  claim 8 , wherein the continuous mode is achieved by once weekly administration of a subcutaneous injection. 
     
     
         10 . The method of  claim 8 , wherein the method is for reducing HbA1C. 
     
     
         11 . The method of  claim 8 , wherein the method is for reducing fasting plasma glucose. 
     
     
         12 . The method of  claim 8 , wherein the method is for reducing body weight. 
     
     
         13 . The method of  claim 8 , wherein the sustained minimum plasma concentration of the exendin-4 is between 200 pg/ml to 350 pg/ml. 
     
     
         14 . The method of  claim 8 , wherein the exendin-4 is co-administered with metformin, a sulphonylurea, a thiazolidinedione or any combination thereof. 
     
     
         15 . A sustained release pharmaceutical composition, wherein the composition comprises an exendin analog, wherein the exendin analog is the amino acid sequence of any one of SEQ ID NOs: 2 and 9-142.