US2005282794A1PendingUtilityA1

Combinations of chromium or vanadium with antidiabetics for glucose metabolism disorders

56
Individually held — no corporate assignee on recordPriority: Sep 17, 1998Filed: May 31, 2005Published: Dec 22, 2005
Est. expirySep 17, 2018(expired)· nominal 20-yr term from priority
Inventors:Stuart FineKevin Kinsella
A61P 3/08A61K 31/155A61K 31/426A61K 31/175A61K 31/555A61K 45/06A61P 3/10A61K 33/24
56
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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 . A composition comprising an anti-diabetic agent and a bioavailable source of chromium.  
   
   
       2 . A composition comprising an anti-diabetic agent and a bioavailable source of chromium, whereby said composition reduces initial Hb1Ac levels observed in a patient by at least a 10% change from the baseline after treatment.  
   
   
       3 . A composition comprising an anti-diabetic agent and a bioavailable source of chromium, whereby said composition reduces initial Hb1Ac levels observed in a patient by at least a 50% change from the baseline after treatment.  
   
   
       4 . The composition of  claim 1 , wherein said bioavailable source of chromium comprises one or more of chromium picolinate or chromium polynicotinate.  
   
   
       5 . The composition of  claim 1 , wherein said anti-diabetic agent comprises a type of anti-diabetic agent selected from the group consisting of insulin, thiazolidinediones, sulfonylureas, benzoic acid derivatives, and alpha-glucosidase inhibitors.  
   
   
       6 . The composition of  claim 1 , wherein said anti-diabetic agent is metformin.  
   
   
       7 . The composition of  claim 6 , wherein metformin is in the range of about 100 mg up to about 2550 mg per dose.  
   
   
       8 . The composition of  claim 1 , wherein said anti-diabetic agent is a sulfonylurea.  
   
   
       9 . A composition according to  claim 8 , wherein said sulfonylurea is acetohexamide, chlorpropamide, tolazimide, tolbutamide, glycazide, glipizide, glyburide, or glimeperide.  
   
   
       10 . A composition according to  claim 1 , wherein said anti-diabetic agent is a thiazolidinedione.  
   
   
       11 . A composition according to  claim 10 , wherein said thiazolidinedione is troglitazone, rosiglitazone, or pioglitazone.  
   
   
       12 . A composition according to  claim 1 , wherein said anti-diabetic agent is an alpha-glucosidase inhibitor.  
   
   
       13 . A composition according to  claim 12 , wherein said alpha-glucosidase inhibitor is acarbose or miglitol.  
   
   
       14 . A composition according to  claim 1 , wherein said anti-diabetic agent is a benzoic acid derivative.  
   
   
       15 . A composition according to  claim 14 , wherein said benzoic acid derivative is repaglinide.  
   
   
       16 . The composition of  claim 1 , wherein said bioavailable source of chromium comprises more than 300 mcg elemental chromium.  
   
   
       17 . The composition of  claim 1 , further comprising an effective amount of a bioavailable source of vanadium.  
   
   
       18 . The composition of  claim 17 , wherein said bioavailable source of vanadium is vanadyl sulfate.  
   
   
       19 . The composition of  claim 1 , further comprising an effective amount of a bioavailable source of one or more of the following: chromium, magnesium, and aspirin.  
   
   
       20 . A composition comprising an anti-diabetic agent and a bioavailable source of vanadium.  
   
   
       21 . A composition comprising an anti-diabetic agent and a bioavailable source of vanadium, %% hereby said composition reduces initial Hb1Ac levels observed in a patient by at least a 10% change from the baseline after treatment.  
   
   
       22 . A composition comprising an anti-diabetic agent and a bioavailable source of vanadium, whereby said composition reduces initial Hb1Ac levels observed in a patient by at least a 50% change from the baseline after treatment.  
   
   
       23 . The composition of  claim 20 , wherein said anti-diabetic agent comprises a type of anti-diabetic agent selected from the group consisting of insulin, thiazolidinediones, sulfonylureas, benzoic acid derivatives, and alpha-glucosidase inhibitors.  
   
   
       24 . The composition of  claim 20 , wherein said anti-diabetic agent is metformin.  
   
   
       25 . The composition of  claim 24 , wherein metformin is in the range of about 100 mg up to about 2550 mg per dose.  
   
   
       26 . The composition of  claim 20 , wherein said anti-diabetic agent is a sulfonylurea.  
   
   
       27 . A composition according to  claim 26 , wherein said sulfonylurea is acetohexamide, chlorpropamide, tolazimide, tolbutamide, glycazide, glipizide, glyburide, or glimeperide.  
   
   
       28 . A composition according to  claim 20 , wherein said anti-diabetic agent is a thiazolidinedione.  
   
   
       29 . A composition according to  claim 28 , wherein said thiazolidinedione is troglitazone, rosiglitazone or pioglitazone.  
   
   
       30 . A composition according to  claim 20 , wherein said anti-diabetic agent is an alpha-glucosidase inhibitor.  
   
   
       31 . A composition according to  claim 30 , wherein said alpha-glucosidase inhibitor is acarbose or miglitol.  
   
   
       32 . A composition according to  claim 20 , wherein said anti-diabetic agent is a benzoic acid derivative.  
   
   
       33 . A composition according to  claim 32 , wherein said benzoic acid derivative is repaglinide.  
   
   
       34 . The composition of  claim 20 , wherein said bioavailable source of vanadium is vanadyl sulfate.  
   
   
       35 . The composition of  claim 20 , wherein said bioavailable source of vanadium comprises more than 10 mg elemental vanadium.  
   
   
       36 . The composition of  claim 20 , further comprising an effective amount of a bioavailable source of chromium, wherein said bioavailable source of chromium is chromium polynicotinate.  
   
   
       37 . The composition of  claim 20 , further comprising an effective amount of a bioavailable source of one or more of the following: chromium, magnesium, and aspirin.  
   
   
       38 . A method for improving glucose metabolism, comprising administering to a patient an anti-diabetic agent and bioavailable source of chromium.  
   
   
       39 . The method of  claim 38 , wherein said bioavailable source of chromium comprises one or more of chromium picolinate or chromium polynicotinate.  
   
   
       40 . The method of  claim 38 , wherein said anti-diabetic agent comprises a type of anti-diabetic agent selected from the group consisting of insulin, thiazolidinediones, sulfonylureas, benzoic acid derivatives, and alpha-glucosidase inhibitors.  
   
   
       41 . The method of  claim 38 , wherein said anti-diabetic agent is metformin.  
   
   
       42 . The method of  claim 38 , wherein said bioavailable source of chromium comprises more than 300 mcg elemental chromium.  
   
   
       43 . The method of  claim 38 , further comprising administering an effective amount of a bioavailable source of vanadium.  
   
   
       44 . The method of  claim 38 , wherein said bioavailable source of vanadium is vanadyl sulfate.  
   
   
       45 . The method of  claim 38 , further comprising an effective amount of a bioavailable source of one or more of the following: vanadium, magnesium, and aspirin.  
   
   
       46 . A method for improving glucose metabolism, comprising administering to a patient an anti-diabetic agent and bioavailable source of vanadium.  
   
   
       47 . The method of  claim 46 , wherein said bioavailable source of vanadium comprises vanadyl sulfate.  
   
   
       48 . The method of  claim 46 , wherein said anti-diabetic agent comprises a type of anti-diabetic agent selected from the group consisting of insulin, thiazolidinediones, sulfonylureas, benzoic acid derivatives, and alpha-glucosidase inhibitors.  
   
   
       49 . The method of  claim 46  wherein said anti-diabetic agent is metformin.  
   
   
       50 . The method of  claim 46 , wherein said anti-diabetic agent is a thiazolidinedione.  
   
   
       51 . The method of  claim 50 , wherein said thiazolidinedione is troglitazone, rosiglitazone, or pioglitazone.  
   
   
       52 . The method of  claim 46 , further comprising an effective amount of a bioavailable source of one or more of the following: vanadium, magnesium, and aspirin.  
   
   
       53 . An ingestible formulation for improving glucose metabolism in a subject with abnormal glucose metabolism, comprising: 
 (a) a bioavailable source of chromium in a complex and amount that delivers an effective amount of chromium for improving glucose metabolism; and    (b) an anti-diabetic agent.    
   
   
       54 . The ingestible formulation of  claim 53 , wherein said amount of said bioavailable source of chromium is no less than 200 mcg of elemental chromium.  
   
   
       55 . The ingestible formulation of  claim 53 , further comprising an effective amount of one or more of the following: aspirin, Vitamin E, and magnesium.  
   
   
       56 . The ingestible formulation of  claim 53 , wherein said anti-diabetic agent comprises a type of anti-diabetic agent selected from the group consisting of insulin, thiazolidinediones, sulfonylureas, benzoic acid derivatives, and alpha-glucosidase inhibitors.  
   
   
       57 . The ingestible formulation of  claim 53 , wherein said anti-diabetic agent is metformin.  
   
   
       58 . An ingestible formulation for improving glucose metabolism in a subject with abnormal glucose metabolism, comprising: 
 (a) a bioavailable source of vanadium in a complex and amount that delivers an effective amount of vanadium for improving glucose metabolism; and    (b) an anti-diabetic agent.    
   
   
       59 . The ingestible formulation of  claim 58 , wherein said amount of said bioavailable source of vanadium is no less than 5 mg of elemental vanadium.  
   
   
       60 . The ingestible formulation of  claim 58 , further comprising an effective amount of one or more of the following: aspirin, Vitamin E, and magnesium.  
   
   
       61 . The ingestible formulation of  claim 58 , wherein said anti-diabetic agent comprises a type of anti-diabetic agent selected from the group consisting of insulin, thiazolidinediones, sulfonylureas, benzoic acid derivatives, and alpha-glucosidase inhibitors.  
   
   
       62 . The ingestible formulation of  claim 58 , wherein said anti-diabetic agent is metformin.  
   
   
       63 . The use of an ingestible formulation which improves glucose metabolism in a subject for the manufacture of a medicament for the treatment of glucose metabolism disorders, wherein said ingestible formulation comprises a bioavailable source of chromium in a complex and amount that delivers an effective amount of chromium for improving glucose metabolism, and an anti-diabetic agent.  
   
   
       64 . The use of an ingestible formulation which improves glucose metabolism in a subject for the manufacture of a medicament for the treatment of glucose metabolism disorders, wherein said ingestible formulation comprises a bioavailable source of vanadium in a complex and amount that delivers an effective amount of vanadium for improving glucose metabolism, and an anti-diabetic agent.  
   
   
       65 . The use of  claim 63  or  64 , wherein said anti-diabetic agent is selected from the group consisting of insulin, thiazolininediones, sulfonylurease, benzoic acid derivatives, and alpha-glucosidase inhibitors.  
   
   
       66 . The use of an ingestible formulation which improves glucose metabolism in a subject for the development of a regimen for the treatment of glucose metabolism disorders, wherein said ingestible formulation comprises a bioavailable source of chromium in a complex and amount that delivers an effective amount of chromium for improving glucose metabolism, and an anti-diabetic agent.  
   
   
       67 . The use of an ingestible formulation which improves glucose metabolism in a subject for the development of a regimen for the treatment of glucose metabolism disorders, wherein said ingestible formulation comprises a bioavailable source of vanadium in a complex and amount that delivers an effective amount of vanadium for improving glucose metabolism, and an anti-diabetic agent.  
   
   
       68 . The use of  claim 66  or  67 , wherein said anti-diabetic agent is selected from the group consisting of insulin, thiazolininediones, sulfonylurease, benzoic acid derivatives, and alpha-glucosidase inhibitors.  
   
   
       69 . A pill for improving glucose metabolism in a subject with abnormal glucose metabolism, comprising: 
 (a) a bioavailable source of chromium in a complex and amount that delivers an effective amount of chromium for improving glucose metabolism; and    (b) an anti-diabetic agent.    
   
   
       70 . The pill of  claim 69 , wherein said amount of said bioavailable source of chromium is no less than 5 mg of elemental chromium.  
   
   
       71 . The pill of  claim 69 , further comprising an effective amount of one or more of the following: aspirin, Vitamin E, and magnesium.  
   
   
       72 . The pill of  claim 69 , wherein said anti-diabetic agent comprises a type of anti-diabetic agent selected from the group consisting of insulin, thiazolidinediones, sulfonylureas, benzoic acid derivatives, and alpha-glucosidase inhibitors.  
   
   
       73 . The pill of  claim 69 , wherein said anti-diabetic agent is metformin.  
   
   
       74 . A pill for improving glucose metabolism in a subject with abnormal glucose metabolism, comprising: 
 (a) a bioavailable source of vanadium in a complex and amount that delivers an effective amount of vanadium for improving glucose metabolism; and    (b) an anti-diabetic agent.    
   
   
       75 . The pill of  claim 74 , wherein said amount of said bioavailable source of vanadium is no less than 5 mg of elemental vanadium.  
   
   
       76 . The pill of  claim 74 , further comprising an effective amount of one or more of the following: aspirin, Vitamin E, and magnesium.  
   
   
       77 . The pill of  claim 74 , wherein said anti-diabetic agent comprises a type of anti-diabetic agent selected from the group consisting of insulin, thiazolidinediones, sulfonylureas, benzoic acid derivatives, and alpha-glucosidase inhibitors.  
   
   
       78 . The pill of  claim 74 , wherein said anti-diabetic agent is metformin.  
   
   
       79 . The use of a pill which improves glucose metabolism in a subject for the manufacture of a medicament for the treatment of glucose metabolism disorders, wherein said ingestible formulation comprises a bioavailable source of chromium in a complex and amount that delivers an effective amount of chromium for improving glucose metabolism, and an anti-diabetic agent.  
   
   
       80 . The use of a pill which improves glucose metabolism in a subject for the manufacture of a medicament for the treatment of glucose metabolism disorders, wherein said ingestible formulation comprises a bioavailable source of vanadium in a complex and amount that delivers an effective amount of vanadium for improving glucose metabolism, and an anti-diabetic agent.  
   
   
       81 . The use of  claim 79  or  80 , wherein said anti-diabetic agent is selected from the group consisting of insulin, thiazolininediones, sulfonylurease, benzoic acid derivatives, and alpha-glucosidase inhibitors.  
   
   
       82 . The use of a pill which improves glucose metabolism in a subject for the development of a regimen for the treatment of glucose metabolism disorders, wherein said ingestible formulation comprises a bioavailable source of chromium in a complex and amount that delivers an effective amount of chromium for improving glucose metabolism, and an anti-diabetic agent.  
   
   
       83 . The use of a pill which improves glucose metabolism in a subject for the development of a regimen for the treatment of glucose metabolism disorders, wherein said ingestible formulation comprises a bioavailable source of vanadium in a complex and amount that delivers an effective amount of vanadium for improving glucose metabolism, and an anti-diabetic agent.  
   
   
       84 . The use of  claim 82  or  83 , wherein said anti-diabetic agent is selected from the group consisting of insulin, thiazolininediones, sulfonylurease, benzoic acid derivatives, and alpha-glucosidase inhibitors.  
   
   
       85 . A kit for improving glucose metabolism in a subject comprising: 
 (a) an ingestible formulation for improving glucose metabolism in a subject comprising a bioavailable source of chromium in a complex and amount that delivers an effective amount of chromium for improving glucose metabolism, and an anti-diabetic agent; and    (b) instructions for the administration of said ingestible formulation.    
   
   
       86 . The kit of  claim 85 , wherein said instructions provide for the simultaneous administration of chromium and anti-diabetic agent, and provide the daily dosage regiment and duration of treatment.  
   
   
       87 . A kit for improving glucose metabolism in a subject comprising: 
 (c) an ingestible formulation for improving glucose metabolism in a subject comprising a bioavailable source of vanadium in a complex and amount that delivers an effective amount of vanadium for improving glucose metabolism, and an anti-diabetic agent; and    (d) instructions for the administration of said ingestible formulation.    
   
   
       88 . The kit of  claim 87 , wherein said instructions provide for the simultaneous administration of vanadium and anti-diabetic agent, and provide the daily dosage regiment and duration of treatment.  
   
   
       89 . A kit for improving glucose metabolism in a subject comprising: 
 (a) a pill comprising an effective amount of a bioavailable source of chromium a complex and amount that delivers an effective amount of chromium for improving glucose metabolism, and an anti-diabetic agent; and    (b) instructions for the administration of said pill.    
   
   
       90 . The kit of  claim 89 , wherein said instructions provide the daily dosage regimen and the duration of treatment.  
   
   
       91 . A kit for improving glucose metabolism in a subject comprising: 
 (a) a pill comprising an effective amount of a bioavailable source of vanadium in a complex and amount that delivers an effective amount of vanadium for improving glucose metabolism, and an anti-diabetic agent; and    (b) instructions for the administration of said pill.    
   
   
       92 . The kit of  claim 91 , wherein said instructions provide the daily dosage regimen and the duration of treatment.  
   
   
       93 . A kit for improving glucose metabolism in a subject comprising: 
 (a) a bioavailable source of chromium in a complex and amount that delivers an effective amount of chromium for improving glucose metabolism; and    (b) instructions for the administration of said bioavailable source of chromium.    
   
   
       94 . The kit of  claim 93 , wherein said instructions provide for the daily dosage regimen and duration of treatment.  
   
   
       95 . A kit for improving glucose metabolism in a subject comprising: 
 (a) a bioavailable source of vanadium in a complex and amount that delivers an effective amount of vanadium for improving glucose metabolism; and    (b) instructions for the administration of said bioavailable source of vanadium.    
   
   
       96 . The kit of  claim 95 , wherein said instructions provide for the daily dosage regimen and duration of treatment.

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