Methods and compositions for the treatment and prevention of hypoglycemia and related disorders

Abstract

A composition comprising chromium and insulin and/or a chromium-insulin complex, its method of preparation, and its use in the prevention and treatment of hypoglycemia and hypoglycemia-related conditions. This composition can be administered in numerous ways, including parenterally, intranasally, and orally. The composition stabilizes serum glucose levels and has a synergistic effect compared to chromium and insulin administered separately.

What is claimed is: 
     
         1 . A sterile injectable formulation comprising:
 an amount of a chromium-insulin complex, the chromium-insulin complex having between 4 and 6 chromium ions per insulin hexamer; and   at least one excipient.   
     
     
         2 . The formulation of  claim 1 , wherein the amount of the chromium-insulin complex is an amount sufficient to stabilize serum glucose levels in a patient in need thereof 
     
     
         3 . The formulation of  claim 1 , wherein the sterile injectable pharmaceutical formulation provides greater therapeutic effect than an equivalent amount of injected insulin. 
     
     
         4 . The formulation of  claim 1 , wherein the sterile injectable pharmaceutical formulation provides greater therapeutic effect than an equivalent amount of injected zinc-insulin. 
     
     
         5 . The formulation of  claim 1 , wherein the chromium-insulin complex is dissolved in a solution. 
     
     
         6 . The formulation of  claim 1 , wherein the chromium-insulin complex is suspended in a solution. 
     
     
         7 . The formulation of  claim 1 , wherein the chromium-insulin complex has a molecular weight that is between about 30 kDa and 40 kDa. 
     
     
         8 . A method for reducing serum glucose levels in a subject in need thereof comprising:
 providing an injectable chromium-insulin formulation; and   administering the composition to the subject, wherein the administration reduces serum glucose levels in the subject to a great extent after one hour than an equivalent amount of an injectable insulin formulation or injectable zinc-insulin formulation.   
     
     
         9 . The method of  claim 8 , further comprising identifying the patient in need of reduced serum glucose levels. 
     
     
         10 . The method of  claim 8 , wherein the injectable chromium-insulin formulation includes chromium-insulin complexes, the chromium-insulin complexes having between 4 and 6 chromium ions per insulin hexamer. 
     
     
         11 . A method for reducing serum glucose levels in a subject having diabetes comprising:
 providing an injectable chromium-insulin formulation; and   administering the composition to the subject having diabetes, wherein the administration reduces serum glucose levels in the subject to a great extent after three hours than an equivalent amount of an injectable insulin formulation or injectable zinc-insulin formulation.   
     
     
         12 . The method of  claim 11 , further comprising identifying the subject having diabetes. 
     
     
         13 . The method of  claim 11 , wherein the injectable chromium-insulin formulation includes chromium-insulin complexes, the chromium-insulin complexes having between 4 and 6 chromium ions per insulin hexamer. 
     
     
         14 . A method for increasing serum insulin levels in a subject in need thereof comprising:
 providing an injectable chromium-insulin formulation; and   administering the composition to a subject, wherein the administration increases serum insulin levels in the subject to a great extent after thirty minutes than an equivalent amount of an injectable insulin formulation or injectable zinc-insulin formulation.   
     
     
         15 . The method of  claim 14 , further comprising identifying a patient in need of increased serum insulin levels. 
     
     
         16 . The method of  claim 14 , wherein the injectable chromium-insulin formulation includes chromium-insulin complexes, the chromium-insulin complexes having between 4 and 6 chromium ions per insulin hexamer. 
     
     
         17 . A method for increasing serum insulin levels in a subject having diabetes comprising:
 providing an injectable chromium-insulin formulation; and   administering the composition to the subject having diabetes, wherein the administration increases serum levels in the subject to a great extent after one hour than an equivalent amount of an injectable insulin formulation or injectable zinc-insulin formulation.   
     
     
         18 . The method of  claim 17 , further comprising identifying the patient having diabetes. 
     
     
         19 . The method of  claim 17 , wherein the injectable chromium-insulin formulation includes chromium-insulin complexes, the chromium-insulin complexes having between 4 and 6 chromium ions per insulin hexamer.