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Claims for Patent: 6,329,404

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Claims for Patent: 6,329,404

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 (Kobe, JP)
Assignee: Takeda Chemical Industries, Ltd. (Osaka, JP)
Application Number:09/453,521
Patent Claims: 1. A pharmaceutical composition comprising an insulin sensitivity enhancer in combination with an insulin secretion enhancer, wherein the insulin sensitivity enhancer is selected from the group consisting of:

(1) 5-(4-(2-(3-ethyl-2-pyridyl)ethoxy)benzyl)-2,4-thiazolidinedione or its pharmacologically acceptable salt,

(2) 5-(4-(2-(4-ethyl-2-pyridyl)ethoxy)benzyl)-2,4-thiazolidinedione or its pharmacologically acceptable salt,

(3) 5-(4-(2-(5-ethyl-2-pyridyl)ethoxy)benzyl)-2,4-thiazolidinedione or its pharmacologically acceptable salt, and

(4) 5-(4-(2-(6-ethyl-2-pyridyl)ethoxy)benzyl)-2,4-thiazolidinedione or its pharmacologically acceptable salt.

2. The pharmaceutical composition according to claim 1, wherein the insulin sensitivity enhancer is pioglitazone or its hydrochloride.

3. The pharmaceutical composition according to claim 1, wherein the insulin secretion enhancer is a sulfonylurea.

4. The pharmaceutical composition according to claim 3, wherein the sulfonylurea is selected from tolbutamide, chlorpropamide, tolazamide, acetohexamide, 4-chloro-N-[(1-pyrolidinylamino)carbonyl]-benzenesulfonamide or its ammonium salt, glibenclamide, gliclazide, 1-butyl-3-metanilylurea, carbutamide, glibonuride, glipizide, gliquidone, glisoxepid, glybuthiazole, glibuzole, glyhexamide, glymidine, glypinamide, phenbutamide and tolcyclamide.

5. The pharmaceutical composition according to claim 1, wherein the insulin secretion enhancer is glibenclamide.

6. The pharmaceutical composition according to claim 1, wherein the insulin sensitivity enhancer is pioglitazone or its hydrochloride and the insulin secretion enhancer is glibenclamide.

7. The pharmaceutical composition according to claim 1, which is for the treatment of diabetes.

8. The pharmaceutical composition according to claim 1, wherein the amount of the insulin secretion enhancer is about 0.002 to 5 weight parts relative to one weight part of the insulin sensitivity enhancer.

9. The pharmaceutical composition according to claim 1, wherein the amount of the insulin secretion enhancer is about 0.025 to 0.5 weight parts relative to one weight part of the insulin sensitivity enhancer.

10. The pharmaceutical composition according to claim 1, which has a synergistic effect for the treatment of diabetes in humans.

11. The pharmaceutical composition according to claim 8, which has a synergistic effect for the treatment of diabetes in humans.

12. The pharmaceutical composition according to claim 9, which has a synergistic effect for the treatment of diabetes in humans.

13. A method for treating diabetes in a mammal in need thereof, which comprises administering to such mammal a therapeutically effective amount of an insulin sensitivity enhancer in combination with an insulin secretion enhancer, wherein the insulin sensitivity enhancer is selected from the group consisting of:

(1) 5-(4-(2-(3-ethyl-2-pyridyl)ethoxy)benzyl)-2,4-thiazolidinedione or its pharmacologically acceptable salt,

(2) 5-(4-(2-(4-ethyl-2-pyridyl)ethoxy)benzyl)-2,4-thiazolidinedione or its pharmacologically acceptable salt,

(3) 5-(4-(2-(5-ethyl-2-pyridyl)ethoxy)benzyl)-2,4-thiazolidinedione or its pharmacologically acceptable salt,

(4) 5-(4-(2-(6-ethyl-2-pyridyl)ethoxy)benzyl)-2,4-thiazolidinedione or its pharmacologically acceptable salt.

14. The method according to claim 13, wherein the insulin sensitivity enhancer is pioglitazone or its hydrochloride.

15. The method according to claim 13, wherein the insulin secretion enhancer is a sulfonylurea.

16. The method according to claim 15, wherein the sulfonylurea is selected from tolbutamide, chlorpropamide, tolazamide, acetohexamide, 4-chloro-N-[(1-pyrolidinylamino)carbonyl]-benzenesulfonamide or its ammonium salt, glibenclamide, gliclazide, 1-butyl-3-metanilylurea, carbutamide, glibonuride, glipizide, gliquidone, glisoxepid, glybuthiazole, glibuzole, glyhexamide, glymidine, glypinamide, phenbutamide and tolcyclamide.

17. The method according to claim 13, wherein the insulin secretion enhancer is glibenclamide.

18. The method according to claim 13, wherein the insulin sensitivity enhancer is pioglitazone or its hydrochloride and the insulin secretion enhancer is glibenclamide.

19. The method according to claim 13, wherein the amount of the insulin secretion enhancer is about 0.002 to 5 weight parts relative to one weight part of the insulin sensitivity enhancer.

20. The method according to claim 13, wherein the amount of the insulin secretion enhancer is about 0.025 to 0.5 weight parts relative to one weight part of the insulin sensitivity enhancer.

21. The method according to claim 13, which provides a synergistic effect for the treatment of diabetes in humans.

22. The method according to claim 19, which provides a synergistic effect for the treatment of diabetes in humans.

23. The method according to claim 20, which provides a synergistic effect for the treatment of diabetes in humans.

24. The method according to claim 13, wherein the insulin sensitivity enhancer and the insulin secretion enhancer are mixed together to form an admixture and the admixture is administered to the mammal.

25. The method according to claim 13, wherein the insulin sensitivity enhancer and the insulin secretion enhancer are not mixed together to form an admixture but are administered independently to the mammal.
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