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Details for Patent: 8,921,311

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Details for Patent: 8,921,311

Title:Method for treating hyperglycemia
Abstract: A method for treating hyperglycemia and/or diabetes in a subject is provided. In particular, the method is directed for the treatment of patients with type 2 diabetes mellitus who have a fasting blood glucose concentration greater than about 8 mM, wherein the patient is administered a formulation comprising a GLP-1 molecule and a diketopiperazine by pulmonary inhalation with a dry powder inhalation system.
Inventor(s): Costello; Donald (Bridgewater, NJ), Richardson; Peter (Ringoes, NJ), Baughman; Robert A. (Ridgefield, CT), Marino; Mark T. (Long Valley, NJ)
Assignee: MannKind Corporation (Valencia, CA)
Filing Date:Sep 16, 2011
Application Number:13/235,208
Claims:1. A method for treating hyperglycemia, comprising the step of administering to a subject having a fasting blood glucose concentration greater than about 7 mmol/L an inhalable dry powder formulation comprising microparticles comprising a therapeutically effective amount of at least one peptide selected from oxyntomodulin and peptide YY(3-36) (PYY), and a crystalline diketopiperazine, wherein the diketopiperazine is 2,5-diketo-3,6-di(4-X-aminobutyl)piperazine and wherein X is selected from the group consisting of succinyl, glutaryl, maleyl, and fumaryl.

2. The method of claim 1, wherein the subject is a mammal having Type 2 diabetes mellitus.

3. The method of claim 1, wherein said X comprises fumaryl.

4. The method of claim 1, wherein the inhalable dry powder formulation further comprises a dipeptidyl peptidase (DPP-IV) inhibitor.

5. The method of claim 1, wherein the peptide comprises oxyntomodulin and PYY.

6. The method of claim 1 wherein the peptide comprises oxyntomodulin.

7. The method of claim 6 wherein the oxyntomodulin is in an amount from about 0.1 mg to about 3.0 mg in the formulation.

8. The method of claim 6 wherein the oxyntomodulin is in an amount from about 50 pmol to about 700 pmol in the formulation.

9. The method of claim 1 wherein the peptide comprises PYY.

10. The method of claim 9 wherein the PYY is in an amount from about 0.01 mg to about 30.0 mg in the formulation.

11. The method of claim 10 wherein the PYY is in an amount from about 0.1 mg to about 3.0 mg in the formulation.

12. The method of claim 9 wherein the PYY is in an amount from about 5 mg to about 25 mg in the formulation.

13. A method for reducing glucose levels in a Type 2 diabetic patient, the method comprising the step of administering to said patient in need thereof a dry powder inhalable formulation for pulmonary administration comprising microparticles comprising a therapeutically effective amount of at least one peptide selected from an exendin, oxyntomodulin, and PYY, and a crystalline diketopiperazine, wherein the diketopiperazine is 2,5-diketo-3,6-di(4-X-aminobutyl)piperazine and wherein X is selected from the group consisting of succinyl, glutaryl, maleyl, and fumaryl; and wherein the Type 2 diabetic patient has a fasting blood glucose concentration greater than 8 mmol/L.

14. The method of claim 13, wherein the glucose levels are reduced by about 0.1 mmol/L to about 3 mmol/L for a period of approximately four hours after administration of said inhalable formulation to said Type 2 diabetic patient.

15. The method of claim 13, wherein the inhalable formulation is administered to said Type 2 diabetic patient prandially, preprandially, post-prandially or in a fasting state.

16. The method of claim 13, wherein the inhalable dry powder formulation further comprises a DPP-IV inhibitor.

17. The method of claim 13 wherein the at least one peptide comprises an exendin.

18. The method of claim 13 wherein the at least one peptide comprises oxyntomodulin.

19. The method of claim 18 wherein the oxyntomodulin is in an amount from about 0.1 mg to about 3.0 mg in the formulation.

20. The method of claim 13 wherein the at least one peptide comprises PYY.

21. The method of claim 20 wherein the PYY is in an amount from about 5 mg to about 25 mg in the formulation.

22. A method for treating hyperglycemia, comprising the step of administering to a subject having a fasting blood glucose concentration greater than about 7 mmol/L an inhalable dry powder formulation comprising microparticles comprising a therapeutically effective amount of oxyntomodulin or PYY, and a crystalline diketopiperazine, wherein the diketopiperazine is 2,5-diketo-3,6-di(4-X-aminobutyl)piperazine and wherein X is selected from the group consisting of succinyl, glutaryl, maleyl, and fumaryl.

23. The method of claim 22 wherein the peptide comprises PYY.

24. The method of claim 23 wherein the PYY is in an amount from about 5 mg to about 25 mg in the formulation.

25. The method of claim 23 wherein the PYY is in an amount from about 0.1 mg to about 3.0 mg in the formulation.

26. The method of claim 22 wherein the peptide comprises oxyntomodulin.

27. The method of claim 26 wherein the oxyntomodulin is in an amount from about 0.1 mg to about 3.0 mg in the formulation.

28. The method of claim 26 wherein the oxyntomodulin is in an amount from about 50 pmol to about 700 pmol in the formulation.
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