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Claims for Patent: 8,815,889

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Claims for Patent: 8,815,889

Title:Compositions and methods for increasing insulin sensitivity
Abstract: Methods and compositions for treating a blood glucose condition involve identifying a suitable subject and administering an effective amount of a composition that contains one or more of an opioid antagonist, an anticonvulsant, and a psychotherapeutic agent. The compositions can include insulin. In some embodiments, such methods and compositions can be used to modulate a blood glucose level. In preferred embodiments, such methods and compositions are useful for increasing a subject's sensitivity to insulin.
Inventor(s): Cowley; Michael A. (Portland, OR), McKinney; Anthony A. (San Diego, CA), Tollefson; Gary (Indianapolis, IN)
Assignee: Orexigen Therapeutics, Inc. (San Diego, CA)
Application Number:11/602,571
Patent Claims: 1. A method of treating insulin resistance, comprising: identifying a subject having a blood-glucose condition characterized by insulin resistance in need of treatment; and administering to the subject an amount of a composition that is effective to treat the insulin resistance, wherein the composition comprises naltrexone or a pharmaceutically acceptable salt thereof and bupropion or a pharmaceutically acceptable salt thereof, wherein the amount of the naltrexone or pharmaceutically acceptable salt thereof is about 25 mg per day to about 50 mg per day, and wherein the amount of the bupropion or pharmaceutically acceptable salt thereof is about 200 mg per day to about 400 mg per day.

2. The method of claim 1, wherein the condition is Type 2 diabetes.

3. The method of claim 1, wherein the naltrexone or pharmaceutically acceptable salt thereof is administered to the subject separately from the bupropion or pharmaceutically acceptable salt thereof.

4. The method of claim 1, wherein the composition further comprises insulin.

5. The method of claim 1, further comprising obtaining a measurement of the subject's blood glucose level.

6. The method of claim 5, further comprising adjusting a dosage of the composition after obtaining the measurement of the subject's blood glucose level.

7. The method of claim 1, further comprising providing dietary instructions to the subject.

8. The method of claim 1, wherein at least one of the naltrexone or pharmaceutically acceptable salt thereof and the bupropion or pharmaceutically acceptable salt thereof is in a sustained release formulation.

9. The method of claim 1, wherein each of the naltrexone or pharmaceutically acceptable salt thereof and the bupropion or pharmaceutically acceptable salt thereof is in a sustained release formulation.

10. The method of claim 1, wherein the naltrexone or pharmaceutically acceptable salt thereof and the bupropion or pharmaceutically acceptable salt thereof are in a single oral dosage form.

11. The method of claim 10, wherein the single oral dosage form is in the form of a tablet, pill, or capsule.

12. A method of treating insulin resistance, comprising: identifying a subject having a blood-glucose condition characterized by insulin resistance in need of treatment; and administering to the subject an amount of a composition that is effective to treat the insulin resistance, wherein the composition comprises a sustained-release naltrexone formulation and a sustained-release bupropion formulation or pharmaceutically acceptable salts thereof, wherein the amount of the naltrexone or pharmaceutically acceptable salt thereof is about 25 mg per day to about 50 mg per day, and wherein the amount of the bupropion or pharmaceutically acceptable salt thereof is about 200 mg per day to about 400 mg per day, and wherein the composition is in a single oral dosage form.

13. The method of claim 12, wherein the condition is Type 2 diabetes.

14. The method of claim 12, wherein the composition further comprises insulin.

15. The method of claim 12, wherein the single oral dosage form is in the form of a tablet, pill, or capsule.

16. The method of claim 1, wherein the amount of the naltrexone or pharmaceutically acceptable salt thereof is about 25 mg per day to about 38 mg per day, and wherein the amount of the bupropion or pharmaceutically acceptable salt thereof is about 300 mg per day to about 400 mg per day.

17. The method of claim 16, wherein the subject is obese.

18. The method of claim 1, wherein the subject is obese.

19. The method of claim 12, wherein the amount of the naltrexone or pharmaceutically acceptable salt thereof is about 25 mg per day to about 38 mg per day, and wherein the amount of the bupropion or pharmaceutically acceptable salt thereof is about 300 mg per day to about 400 mg per day.

20. The method of claim 19, wherein the subject is obese.

21. The method of claim 12, wherein the subject is obese.

22. The method of claim 1, wherein the condition is pre-diabetes.

23. The method of claim 22, wherein the subject is obese.

24. The method of claim 12, wherein the condition is pre-diabetes.

25. The method of claim 24, wherein the subject is obese.

26. The method of claim 16, wherein the condition is pre-diabetes.

27. The method of claim 26, wherein the subject is obese.

28. The method of claim 19, wherein the condition is pre-diabetes.

29. The method of claim 28, wherein the subject is obese.

30. The method of claim 2, wherein the subject is obese.

31. The method of claim 13, wherein the subject is obese.
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