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Details for Patent: 7,144,900

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Details for Patent: 7,144,900

Title:Pharmaceutical composition
Abstract: Pharmaceutical composition which comprises an insulin sensitivity enhancer in combination with other antidiabetics differing from the enhancer in the mechanism of action, which shows a potent depressive effect on diabetic hyperglycemia and is useful for prophylaxis and treatment of diabetes.
Inventor(s): Ikeda; Hitoshi (Higashiosaka, JP), Sohda; Takashi (Takatsuki, JP), Odaka; Hiroyuki (Hyogo, JP)
Assignee: Takeda Pharmaceutical Company Limited (Osaka, JP)
Filing Date:Sep 10, 2004
Application Number:10/937,494
Claims:1. A pharmaceutical composition comprising an insulin sensitivity enhancer in combination with a statin compound, wherein the insulin sensitivity enhancer is a compound represented by the formula: ##STR00008## wherein R represents an optionally substituted hydrocarbon or 5- to 7-membered heterocyclic group; Y represents a group represented by --CO--, --CH(OH)-- or --NR.sup.3-- wherein R.sup.3 represents an optionally substituted alkyl group; m is 0 or 1; n is 0, 1 or 2; X represents CH or N; A represents a bond or a C.sub.1-7 divalent aliphatic hydrocarbon group; Q represents oxygen atom or sulfur atom; R.sup.1 represents hydrogen atom or an alkyl group; ring E may optionally have further 1 to 4 substituents, and the substituents may optionally be combined with R.sup.1 to form a ring; L and M respectively represent hydrogen atom, or L and M may optionally be combined with each other to form a bond; or a pharmacologically acceptable salt thereof.

2. The pharmaceutical composition of claim 1, wherein R is pyridyl, oxazolyl or thiazolyl group optionally having 1 to 3 substituents selected from the group consisting of C.sub.1-3 alkyl, furyl, thienyl, phenyl and naphthyl; m is 0; n is 0 or 1; X is CH; A is a bond or --(CH.sub.2).sub.2--; R.sup.1 is hydrogen atom; the partial formula: ##STR00009## wherein R.sup.2 is hydrogen atom or C.sub.1-4 alkoxy group; and L and M are both hydrogen atom.

3. The pharmaceutical composition of claim 1, wherein the insulin sensitivity enhancer is pioglitazone or its hydrochloride.

4. The pharmaceutical composition of claim 1, wherein the insulin sensitivity enhancer is 5-[[4-[2-(methyl-2-pyridylamino)ethoxy]phenyl]methyl]-2,4-thiazolidinedio- ne or its pharmacologically acceptable salt.

5. The pharmaceutical composition of claim 1, wherein the statin compound is selected from the group consisting of pravastatin or its sodium salt, simvastatin, lovastatin, atorvastatin and fluvastatin.

6. The pharmaceutical composition of claim 1, wherein the statin compound is pravastatin or its sodium salt.

7. The pharmaceutical composition of claim 1, wherein the statin compound is simvastatin.

8. The pharmaceutical composition of claim 1, wherein the statin compound is lovastatin.

9. The pharmaceutical composition of claim 1, wherein the statin compound is atorvastatin.

10. The pharmaceutical composition of claim 1, wherein the statin compound is fluvastatin.

11. A method for treating diabetes in a mammal in need thereof, comprising administering to the mammal an insulin sensitivity enhancer in combination with a statin compound, wherein the insulin sensitivity enhancer is a compound represented by the formula: ##STR00010## wherein R represents an optionally substituted hydrocarbon or 5-to 7-membered heterocyclic group; Y represents a group represented by --CO--, --CH(OH)-- or --NR.sup.3-- wherein R.sup.3 represents an optionally substituted alkyl group; m is 0 or 1; n is 0, 1 or 2; X represents CH or N; A represents a bond or a C.sub.1-7 divalent aliphatic hydrocarbon group; Q represents oxygen atom or sulfur atom; R.sup.1 represents hydrogen atom or an alkyl group; ring E may optionally have further 1 to 4 substituents, and the substituents may optionally be combined with R.sup.1 to form a ring; and L and M respectively represent hydrogen atom, or L and M may optionally be combined with each other to form a bond; or a pharmacologically acceptable salt thereof.

12. The method of claim 11, wherein R is pyridyl, oxazolyl or thiazolyl group optionally having 1 to 3 substituents selected from the group consisting of C.sub.1-3 alkyl, furyl, thienyl, phenyl and naphthyl; m is 0; n is 0 or 1; X is CH; A is a bond or --(CH.sub.2).sub.2--; R.sup.1 is hydrogen atom; the partial formula: ##STR00011## wherein R.sup.2 is hydrogen atom or C.sub.1-4 alkoxy group; and L and M are both hydrogen atom.

13. The method of claim 11, wherein the insulin sensitivity enhancer is pioglitazone or its hydrochloride.

14. The method of claim 11, wherein the insulin sensitivity enhancer is 5 -[[4-[2-(methyl-2-pyridylamino)ethoxy]phenyl]methyl]-2,4-thiazolidinedion- e or its pharmacologically acceptable salt.

15. The method of claim 11, wherein the statin compound is selected from the group consisting of pravastatin or its sodium salt, simvastatin, lovastatin, atorvastatin and fluvastatin.

16. The method of claim 11, wherein the statin compound is pravastatin or its sodium salt.

17. The method of claim 11, wherein the statin compound is simvastatin.

18. The method of claim 11, wherein the statin compound is lovastatin.

19. The method of claim 11, wherein the statin compound is atorvastatin.

20. The method of claim 11, wherein the statin compound is fluvastatin.

21. The method of claim 11, wherein the insulin sensitivity enhancer and the statin compound are mixed together to form an admixture and the admixture is administered to the mammal.

22. The method of claim 11, wherein the insulin sensitivity enhancer and the statin compound are administered independently to the mammal.
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