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Details for Patent: 8,377,869

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Details for Patent: 8,377,869

Title:Method of preventing adverse effects by GLP-1
Abstract: A method for preventing or reducing adverse effects such as profuse sweating, nausea and vomiting, which normally are associated with subcutaneous and intravenous administration of glucagon-like peptide 1 (GLP-1) therapy is provided. In particular, the method comprises the rapid administration of a GLP-1 formulation into the pulmonary circulation such as by inhalation, directly into pulmonary alveolar capillaries using a dry powder drug delivery system.
Inventor(s): Richardson; Peter (Ringoes, NJ), Baughman; Robert A. (Ridgefield, CT), Costello; Donald (Bridgewater, NJ)
Assignee: MannKind Corporation (Valencia, CA)
Filing Date:Oct 24, 2008
Application Number:12/258,340
Claims:1. A method for the treatment of hyperglycemia or diabetes in a patient, comprising the step of administering prandially to a patient in need of treatment an inhalable rapid-acting dry powder GLP-1 formulation, the dry powder formulation comprising microparticles comprising a therapeutically effective amount of a GLP-1 molecule in an amount of at least about 0.5% by weight and a diketopiperazine, wherein the weight ratio of diketopiperazine to GLP-1 is at least about 17:3, and a dipeptidyl peptidase-IV (DPP-IV) inhibitor, and wherein the GLP-1 formulation comprises about 0.5 mg to about 3 mg of GLP-1 dose.

2. The method of claim 1, wherein the patient is a mammal suffering with Type 2 diabetes mellitus.

3. The method of claim 1, wherein the diketopiperazine is 2,5-diketo-3,6-di(4-X-aminobutyl)piperazine; wherein X is selected from the group consisting of succinyl, glutaryl, maleyl, and fumaryl; or a pharmaceutically acceptable salt thereof.

4. The method of claim 1, wherein the GLP-1 molecule is selected from the group consisting of a native GLP-1, a GLP-1 analog, a GLP-1 derivative, a long acting GLP-1 analog, a GLP-1 mimetic, and combinations thereof.

5. The method of claim 1, further comprising administering to a patient a therapeutically amount of an insulin molecule.

6. The method of claim 5, wherein the inhalable dry powder formulation comprises the GLP-1 molecule co-formulated with the insulin molecule.

7. The method of claim 5, wherein the insulin molecule is administered separately as an inhalable dry powder formulation.

8. The method of claim 1, wherein the inhalable dry powder formulation lacks inhibition of gastric emptying.

9. A method for reducing glucose levels in a Type 2 diabetic patient suffering from hyperglycemia, the method comprising the step of administering to said patient in need of treatment an inhalable rapid-acting dry powder GLP-1 formulation for pulmonary administration, said dry powder inhalable formulation comprising microparticles comprising a therapeutically effective amount of GLP-1 in an amount of at least about 0.5% by weight and a diketopiperazine or pharmaceutically acceptable salt thereof, wherein the weight ratio of diketopiperazine to GLP-1 is at least about 17:3, and a DPP-IV inhibitor, and wherein the GLP-1 formulation comprises about 0.02 mg to about 2 mg of GLP-1 dose.

10. The method of claim 9, 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 patient.

11. The method of claim 9, wherein the inhalable formulation is administered to said Type 2 diabetic patient prandially, preprandially, prandially, post-prandially or in a fasting state.

12. The method of claim 9, wherein the diketopiperazine is 2,5-diketo-3,6-di(4-X-aminobutyl)piperazine; wherein X is selected from the group consisting of succinyl, glutaryl, maleyl, and fumaryl; or a pharmaceutically acceptable salt thereof.

13. The method of claim 9, wherein the inhalable dry powder formulation comprises the GLP-1 molecule co-formulated with an insulin molecule.

14. The method of claim 9, wherein the method further comprises administering insulin as an inhalable dry powder formulation.

15. The method of claim 14, wherein the insulin is a rapid acting or a long acting insulin.

16. The method of claim 9, further comprising administering a formulation comprising a long acting GLP-1 analog.

17. The method of claim 9, wherein the inhalable dry powder formulation lacks inhibition of gastric emptying.

18. A method for the treatment of hyperglycemia or diabetes in a patient, comprising the step of administering prandially to a patient in need thereof an inhalable rapid-acting dry powder GLP-1 formulation, the dry powder formulation comprising microparticles comprising a therapeutically effective amount of a GLP-1 molecule and a diketopiperazine, and a DPP-IV inhibitor; wherein the weight ratio of diketopiperazine to GLP-1 is at least about 17:3, wherein said GLP-1 reaches a peak plasma concentration greater than 100 pMol/L by 6 minutes after administration, and wherein the GLP-1 formulation comprises about 0.5 mg to about 3 mg of GLP-1 dose.

19. The method of claim 18, wherein the GLP-1 and the DPP-IV inhibitor are administered in separate compositions.

20. The method of claim 18, wherein the GLP-1 and the DPP-IV inhibitor are administered in a single composition.
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