Medical treatment

Abstract

A compound of formula I or a pharmaceutically acceptable salt thereof in which R 1 and R 2 are independently H or methyl (for example N,N-dimethyl-1-[1-(4-chlorophenyl)cyclobutyl]-3-methylbutyl amine hydrochloride optionally in the form of its monohydrate) is used for reducing insulin resistance in humans in whom Impaired Glucose Tolerance and Non-Insulin Dependent Diabetes Mellitus have not presented.

1 . A method of reducing insulin resistance in humans in whom Impaired Glucose Tolerance or Non-Insulin Dependent Diabetes Mellitus have not presented but in whom there is an increased risk of developing such conditions, said method comprising administering to a human in need thereof a therapeutically effective amount of a compound of formula I  
       
         
           
           
               
               
           
         
       
       including enantiomers and pharmaceutically acceptable salts thereof in which R 1  and R 2  are independently H or methyl, in conjunction with a pharmaceutically acceptable diluent or carrier.  
     
     
         2 . A method as claimed in  claim 1  in which the human is not obese.  
     
     
         3 . A method as claimed in  claim 1  in which the human is obese.  
     
     
         4 . A method as claimed in any preceding claim wherein the compound of formula I is N,N-dimethyl-1-[1-(4-chlorophenyl)cyclobutyl]-3-methylbutylamine hydrochloride.  
     
     
         5 . A method as claimed in any preceding claim wherein the compound of formula I is N,N-dimethyl-1-[1-(4-chlorophenyl)cyclobutyl]-3-methylbutylamine hydrochloride in the form of its monohydrate.  
     
     
         6 . Use of a compound of formula I  
       
         
           
           
               
               
           
         
       
       including enantiomers and pharmaceutically acceptable salts thereof in which R 1  and R 2  are independently H or methyl, in the manufacture of a medicament for reducing insulin resistance in humans in whom Impaired Glucose Tolerance and Non-Insulin Dependent Diabetes Mellitus have not presented but in whom there is an increased risk of developing such conditions.  
     
     
         7 . The use as claimed in  claim 6  in which the human is not obese.  
     
     
         8 . The use as claimed in  claim 6  in which the human is obese.  
     
     
         9 . The use as claimed in  claim 6 ,  7  or  8  in which the compound of formula I is N,N-dimethyl-1-[1-(4-chorophenyl)cyclobutyl]-3-methylbutylamine hydrochloride.  
     
     
         10 . The use as claimed in  claim 6 ,  7  or  8  in which the compound of formula I is N,N-dimethyl-1-[1-(4-chlorophenyl)cyclobutyl]-3-methylbutylamine hydrochloride mono-hydrate.  
     
     
         11 . A pharmaceutical composition for reducing insulin resistance in humans in whom Impaired Glucose Tolerance and Non-Insulin Dependent Diabetes Mellitus have not presented but in whom there is an increased risk of developing such conditions, comprising a therapeutically effective amount of a compound of formula I  
       
         
           
           
               
               
           
         
       
       including enantiomers and pharmaceutically acceptable salts thereof in which R 1  and R 2  are independently H or methyl, in conjunction with a pharmaceutically acceptable diluent or carrier.  
     
     
         12 . A pharmaceutical composition as claimed in  claim 11  in which the compound of formula I is N,N-dimethyl-1-[1-(4-chlorophenyl)cyclobutyl]-3-methylbutylamine hydrochloride.  
     
     
         13 . A pharmaceutical composition as claimed in  claim 11  in which the compound of formula I is N,N-dimethyl-1-[1-(4-chlorophenyl)cyclobutyl]-3-methylbutylamine hydrochlorid monohydrate.  
     
     
         14 . Use of a compound of formula I in the manufacture of a medicament which is an insulin sensitiser.  
     
     
         15 . Use of a compound of formula I in the manufacture of a medicament for reducing the amount of insulin required daily by a human having Insulin Dependent Diabetes Mellitus or NIDDM.  
     
     
         16 . Use of a compound of formula I in the manufacture of a medicament for the prophylaxis of long-term detrimental effects caused by prolonged high doses of insulin in humans having Insulin Dependent Diabetes Mellitus or NIDDM.  
     
     
         17 . Use of a compound of formula I in the manufacture of a medicament for the prophylaxis of Impaired Glucose Tolerance and Non-Insulin Dependent Diabetes Mellitus in humans having a high risk of developing the same.  
     
     
         18 . Use as claimed in  claim 17  in which the human is not obese.  
     
     
         19 . Use of a compound for formula I in the manufacture of a medicament for reducing insulin resistance in humans having acanthosis nigricans, leprechaunism, lipoatrophy or polycystic ovary syndrome or other conditions in which insulin resistance is present.  
     
     
         20 . Use of a compound of formula I in the manufacture of a medicament for combination therapy of NIDDM patients to improve their weight and diabetic control, comprising a compound of formula I and an oral insulin secretagogue or insulin sensitising agent.  
     
     
         21 . A method of improving the weight and diabetic control of NIDDM patients comprising the administration of a compound of formula I in combination with an oral insulin secretagogue or insulin sensitising agent in conjunction with a pharmaceutically acceptable diluent or carrier to a human in need thereof.  
     
     
         22 . A product containing a compound of formula I and an oral insulin secretagogue or insulin sensitising agent as a combined preparation for simultaneous, separate or sequential use for the improvement of weight and diabetic control in NIDDM patients.  
     
     
         23 . A product comprising a pharmaceutical composition which comprises a compound of formula I and an oral insulin secretagogue or insulin sensitising agent together with a pharmaceutically acceptable diluent or carrier.  
     
     
         24 . A product as claimed in  claim 22  or  23  in which the oral insulin secretagogue is 1,1-dimethyl-2-(2-morpholinophenyl)guanidine fumarate (BTS67582) or a sulfonylurea selected from tolbutamide, tolazamide, chlorpropamide, glibenclamide, glimepiride, glipizide and gliclazide.  
     
     
         25 . A product as claimed in  claim 22  or  23  in which the insulin sensitising agent is selected from metformin, ciglitazone, troglitazone and pioglitazone.  
     
     
         26 . A method for reducing the amount of insulin required daily by a human having Insulin Dependent Diabetes Mellitus or NIDDM comprising the administration of a compound of formula I in conjunction with a pharmaceutically acceptable diluent or carrier to a human in need thereof.  
     
     
         27 . A method for the prophylaxis of long-term detrimental effects caused by prolonged high doses of insulin in humans having Insulin Dependent Diabetes Mellitus or NIDDM comprising the administration of a compound of formula I in conjunction with a pharmaceutically acceptable diluent or carrier to a human in need thereof.  
     
     
         28 . A method for the prophylaxis of Impaired Glucose Tolerance and Non-Insulin Dependent Diabetes Mellitus in humans having a high risk of developing the same comprising the administration of a compound of formula I in conjunction with a pharmaceutically acceptable diluent or carrier to a human in need thereof.  
     
     
         29 . A method as claimed in  claim 27  in which the human is not obese.  
     
     
         30 . A method of reducing insulin resistance in humans having acanthosis nigricans, leprechaunism, lipoatrophy or polycystic ovary syndrome or other conditions in which insulin resistance is present comprising the administration of a compound of formula I in conjunction with a pharmaceutically acceptable diluent or carrier to a human in need thereof.