Details for Patent: 9,078,866

Title:	Method for treating hyperglycemia with GLP-1
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:	Jan 08, 2010
Application Number:	13/257,284
Claims:	1. A method for treating hyperglycemia, comprising the step of administering to a human 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 a glucagon like peptide-1 (GLP-1) molecule and a diketopiperazine, wherein the GLP-1 molecule is a native GLP-1, a GLP-1 metabolite, a GLP-1 analog, a long acting GLP-1 analog, a GLP-1 mimetic, a GLP-1 peptide analog, a biosynthetic GLP-1 analog, or a combination thereof, wherein said GLP-1 has at least one biological activity of native GLP-1, and wherein said GLP-1 comprises GLP-1 in an amount from about 0.5 mg to about 3 mg of GLP-1 in the formulation and the formulation does not comprise a dipeptidyl-peptidase-IV (DPP-IV) inhibitor, and 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, and further wherein peak blood GLP-1 concentration is reached within about 20 minutes after administration. 2. The method of claim 1, wherein the patient is a mammal having Type 2 diabetes mellitus. 3. The method of claim 1 wherein the human subject has a fasting blood glucose concentration greater than about 9 mmol/L. 4. The method of claim 1 wherein X is fumaryl. 5. The method of claim 1, wherein the inhalable formulation is administered to said human subject prandially. 6. The method of claim 1 wherein the composition is administered pulmonarily. 7. A method for reducing glucose levels in a Type 2 diabetic patient, the method comprising the step of administering to said patient in need of treatment a dry powder inhalable formulation for pulmonary administration comprising microparticles comprising a therapeutically effective amount of a GLP-1, and a diketopiperazine or pharmaceutically acceptable salt thereof, wherein the Type 2 diabetic patient has a fasting blood glucose concentration greater than 8 mmol/L, wherein said GLP-1 comprises GLP-1 in an amount from about 0.5 mg to about 3 mg of GLP-1 in the formulation and the formulation does not comprise a DPP-IV inhibitor, and 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, and further wherein peak blood GLP-1 concentration is reached within about 20 minutes after administration. 8. The method of claim 7, 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. 9. The method of claim 7, wherein the inhalable formulation is administered to said Type 2 diabetic patient prandially, preprandially, post-prandially or in a fasting state. 10. The method of claim 9, wherein the inhalable formulation is administered to said Type 2 diabetic patient prandially. 11. The method of claim 7 wherein the patient has a fasting blood glucose concentration greater than about 9 mmol/L. 12. The method of claim 7 wherein X is fumaryl.