Methods and Devices for Delivering GLP-1 and Uses Thereof

Abstract

The invention provides various devices for delivering Glucagon-Like Peptide-1 (7-36), in various infusion patterns and rates, to optimally stimulate carbohydrate metabolism, to inhibit gastropancreatic secretion and gastric motility, and to treat various disease conditions (including diabete) as described in the instant specification. The devices and methods of the invention provide various ways to deliver doses (escalating, constant, on demand, etc.) of GLP-1 in response to different patient need.

1 . A system for delivering an effective amount of a GLP-1 compound to a patient in need of GLP-1 receptor stimulation, the system comprising:
 (1) a pump-driven fluid delivery device;   (2) a liquid form of said GLP-1 compound stored in said pump-driven fluid delivery device.   
     
     
         2 . The system of  claim 1 , wherein said pump-driven fluid delivery device comprises:
 (1) a pump chamber, and a fluid storage chamber having an orifice and being functionally connected to said pump chamber by a moveable barrier;   (2) a hydraulic fluid reservoir for storing a high viscosity fluid, said reservoir being connected to said pump chamber via a restrictor capable of controlling the rate of flow of the high viscosity fluid, and,   (3) an actuator functionally connected to said hydraulic fluid reservoir to cause said hydraulic fluid to flow into said pump chamber through said restrictor, thereby expanding the volume of said pump chamber, displacing said moveable barrier and causing a quantity of said liquid component stored in said fluid storage chamber to be delivered at a sustained rate.   
     
     
         3 . A method of stimulating a GLP-1 receptor in a subject in need of such stimulation, said method comprising the step of administering to a patient an effective amount of a GLP-1 compound using a pump-driven fluid delivery device with a liquid form of said GLP-1 compound stored therein. 
     
     
         4 . The method of  claim 3 , wherein said GLP-1 compound is GLP-1. 
     
     
         5 . The method of  claim 3 , wherein said GLP-1 compound is a GLP-1 analog with substantially the same or better potency than that of GLP-1. 
     
     
         6 . The method of  claim 3 , wherein said GLP-1 compound is a derivative of GLP-1 or GLP-1 analog, with substantially the same or better potency than that of GLP-1. 
     
     
         7 . The method of  claim 3 , wherein said GLP-1 compound is delivered continuously. 
     
     
         8 . The method of  claim 7 , wherein the rate of delivery is equivalent to about 0.25 to 6 pmol/kg body weight/min., preferably from about 0.5 to about 1.2 pmol/kg/min., or from about 0.6 to about 2.4 pmol/kg/min. of GLP-1. 
     
     
         9 . The method of  claim 3 , wherein said GLP-1 compound is delivered intermittently. 
     
     
         10 . The method of  claim 9 , wherein the rate of delivery, as averaged over the entire delivery period, is equivalent to about 0.25 to 6 pmol/kg body weight/min., preferably from about 0.5 to about 1.2 pmol/kg/min., or from about 0.6 to about 2.4 pmol/kg/min. of GLP-1. 
     
     
         11 . The method of  claim 7 , wherein the entire delivery period for said GLP-1 compound is about 6 hrs, about 12 hrs, about 1 day, about 3 days, about 5 days, about 2 weeks, about 1 month, about 3 months, about 6 months, about 1 year or more. 
     
     
         12 . The method of  claim 9 , wherein the entire delivery period for said GLP-1 compound is about 6 hrs, about 12 hrs, about 1 day, about 3 days, about 5 days, about 2 weeks, about 1 month, about 3 months, about 6 months, about 1 year or more.