US2006252686A1PendingUtilityA1

Combinations of chromium or vanadium with antidiabetics for glucose metabolism disorders

Assignee: AKESIS PHARM INCPriority: Sep 17, 1998Filed: Mar 22, 2006Published: Nov 9, 2006
Est. expirySep 17, 2018(expired)· nominal 20-yr term from priority
A61K 31/155A61K 31/175A61P 3/08A61K 31/555A61K 45/06A61P 3/10A61K 31/426A61K 33/24
66
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Claims

Abstract

Compositions and methods of using the same for the treatment of diabetes and other disorders of glucose metabolism are provided. Compositions may include an anti-diabetic agent and one or more of a bioavailable source of chromium and vanadium.

Claims

exact text as granted — not AI-modified
1 - 96 . (canceled)  
   
   
       97 . A composition comprising synergistic effective amounts of an anti-diabetic agent other than insulin, a bioavailable source of chromium, and a bioavailable source of vanadium, wherein said anti-diabetic agent selected from the group consisting of glucagon-like peptide 1 (GLP-1), glucagon-like peptide 2 (GLP-2), analogues of GLP-1, analogues of GLP-2, agonists of the GLP-1 receptor, and agonists of the GLP-2 receptor, and wherein components of said composition synergistically reduce the HbA1c levels of a patient by at least about 10% after treatment for a period of at least about thirty days with said composition as compared to treatment with said anti-diabetic agent alone.  
   
   
       98 . The composition of  claim 97 , wherein said anti-diabetic agent is selected from the group consisting of glucagon-like peptide 1 (GLP-1), analogues of GLP-1, and agonists of the GLP-1 receptor.  
   
   
       99 . The composition of  claim 97 , wherein said reduction in said Hb1Ac level is at least about 50%.  
   
   
       100 . The composition of  claim 97 , wherein said bioavailable source of chromium comprises one or more of chromium picolinate or chromium polynicotinate.  
   
   
       101 . The composition according to  claim 100 , wherein the bioavailable source of chromium is chromium picolinate and wherein the amount of chromium picolinate is from about 30 μg up to about 1000 μg, per dose.  
   
   
       102 . The composition according to  claim 100 , wherein the bioavailable source of chromium is chromium polynicotinate and wherein the amount of chromium polynicotinate is from about 30 μg up to about 5000 μg, per dose.  
   
   
       103 . The composition of  claim 97 , wherein said bioavailable source of chromium comprises no less than about 200 micrograms of elemental chromium.  
   
   
       104 . The composition of  claim 97 , wherein said bioavailable source of chromium comprises no less than about 100 micrograms of elemental chromium.  
   
   
       105 . The composition of  claim 97 , wherein said bioavailable source of chromium comprises no less than about 5 micrograms of elemental chromium.  
   
   
       106 . The composition of  claim 97 , wherein said bioavailable source of vanadium is vanadyl sulfate.  
   
   
       107 . The composition of  claim 106 , wherein the amount of vanadyl sulfate is in the range of about 20 mg up to about 100 mg, per dose.  
   
   
       108 . The composition of  claim 97 , wherein said bioavailable source of vanadium comprises more than about 10 mg elemental vanadium.  
   
   
       109 . The composition of  claim 97 , wherein said amount of said bioavailable source of vanadium comprises no less than 5 mg of elemental vanadium.  
   
   
       110 . The composition according to  claim 97 , wherein said anti-diabetic agent is GLP-1.  
   
   
       111 . The composition according to  claim 97 , wherein said anti-diabetic agent is an analogue of GLP-1.  
   
   
       112 . The composition according to  claim 97 , wherein said anti-diabetic agent is an agonist of the GLP-1 receptor.  
   
   
       113 . The composition of  claim 100  wherein said anti-diabetic agent is selected from the group consisting of GLP-1, analogues of GLP-1, and agonists of the GLP-1 receptor.  
   
   
       114 . The composition according to  claim 100 , wherein said anti-diabetic agent is GLP-1.  
   
   
       115 . The composition according to  claim 100 , wherein said anti-diabetic agent is an analogue of GLP-1.  
   
   
       116 . The composition according to  claim 100 , wherein said anti-diabetic agent is an agonist of the GLP-1 receptor.  
   
   
       117 . The composition of  claim 106  wherein said anti-diabetic agent is selected from the group consisting of GLP-1, analogues of GLP-1, and agonists of the GLP-1 receptor.  
   
   
       118 . The composition according to  claim 106 , wherein said anti-diabetic agent is GLP-1.  
   
   
       119 . The composition according to  claim 106 , wherein said anti-diabetic agent is an analogue of GLP-1.  
   
   
       120 . The composition according to  claim 106 , wherein said anti-diabetic agent is an agonist of the GLP-1 receptor.  
   
   
       121 . A method for improving glucose metabolism, comprising treating a patient for at least about a thirty day period by administering a pharmaceutical composition comprising synergistic effective amounts of an anti-diabetic agent other than insulin, a bioavailable source of chromium, and a bioavailable source of vanadium, wherein said anti-diabetic agent is selected from the group consisting of glucagon-like peptide 1 (GLP-1), glucagon-like peptide 2 (GLP-2), analogues of GLP-1, analogues of GLP-2, agonists of the GLP-1 receptor, and agonists of the GLP-2 receptor, and wherein said components of said composition synergistically reduce the HbA1c level of said patient by at least about 10% after such treatment as compared to treatment with said anti-diabetic agent alone.  
   
   
       122 . The method of  claim 121 , wherein said anti-diabetic agent is selected from the group consisting of glucagon-like peptide 1 (GLP-1), analogues of GLP-1, and agonists of the GLP-1 receptor.  
   
   
       123 . The method of  claim 121 , wherein said bioavailable source of chromium comprises no less than about 200 micrograms elemental chromium when said composition is administered on a daily basis.  
   
   
       124 . The method of  claim 121 , wherein said bioavailable source of chromium comprises no less than about 5 micrograms of elemental chromium when said composition is administered on a daily basis.  
   
   
       125 . The method of  claim 121 , wherein said bioavailable source of chromium comprises one or more of chromium picolinate or chromium polynicotinate.  
   
   
       126 . The method of  claim 125 , wherein said anti-diabetic agent is selected from the group consisting of GLP-1, analogues of GLP-1, and agonists of the GLP-1 receptor.  
   
   
       127 . The method of  claim 125 , wherein said anti-diabetic agent is GLP-1.  
   
   
       128 . The method of  claim 125 , wherein said anti-diabetic agent is an analogue of GLP-1.  
   
   
       129 . The method of  claim 125 , wherein said anti-diabetic agent is an agonist of the GLP-1 receptor.  
   
   
       130 . The method of  claim 121 , wherein said bioavailable source of vanadium comprises at least about 10 mg elemental vanadium when said composition is administered on a daily basis.  
   
   
       131 . The method of  claim 121 , wherein said bioavailable source of vanadium comprises at least about 5 mg of elemental vanadium when said composition is administered on a daily basis.  
   
   
       132 . The method of  claim 121 , wherein said bioavailable source of vanadium is vanadyl sulfate.  
   
   
       133 . The method of  claim 132 , wherein said anti-diabetic agent is selected from the group consisting of GLP-1, analogues of GLP-1, and agonists of the GLP-1 receptor.  
   
   
       134 . The composition according to  claim 132 , wherein said anti-diabetic agent is GLP-1.  
   
   
       135 . The method of  claim 132 , wherein said anti-diabetic agent is an analogue of GLP-1.  
   
   
       136 . The method of  claim 132 , wherein said anti-diabetic agent is an agonist of the GLP-1 receptor.  
   
   
       137 . The method of  claim 121 , wherein said pharmaceutical composition further comprises a physiologically acceptable carrier.  
   
   
       138 . The method of  claim 121 , wherein said method further comprises monitoring said subject's HbA1c levels.  
   
   
       139 . The method of  claim 121 , wherein said reduction in said Hb1Ac level is at least about 50%.

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