Details for Patent: 9,801,925

Title:	Potentiation of glucose elimination
Abstract:	Methods related to the treatment of diabetes and improving the efficiency of insulin utilization are provided. The method enables effective control of prandial glucose levels while reducing the risk of postprandial hypoglycemia. In particular, methods of potentiating the activity of endogenous insulin in type 2 diabetics and exogenous long-acting insulin in diabetics requiring basal insulin replacement are provided.
Inventor(s):	Boss; Anders Hasager (Princeton, NJ), Steiner; Solomon S. (Mount Kisco, NY), Woods; Rodney J. (New Hampton, NY), Sulner; Joseph W. (Paramus, NJ)
Assignee:	MannKind Corporation (Westlake Village, CA)
Filing Date:	Mar 05, 2015
Application Number:	14/639,860
Claims:	1. A method of restoring normal insulin kinetics in a patient in need thereof comprising administering to a patient having an insulin-related disorder an inhaled insulin composition comprising a diketopiperazine such that said inhaled insulin composition produces in the patient a rapid increase in serum insulin concentration of between about 75 mU/L and about 375 mU/L within 20 minutes of administration, wherein said patient's glucose elimination rate returns to baseline by about 6 hours after administration. 2. The method of claim 1, wherein said rapid increase in serum insulin concentration is between about 100 mU/L and about 375 mU/L. 3. The method of claim 2, wherein said rapid increase in serum insulin concentration is between about 125 mU/L and about 375 mU/L. 4. The method of claim 1, wherein said rapid increase in serum insulin concentration is achieved within about 15 minutes after administration. 5. The method of claim 1, wherein said rapid increase in serum insulin concentration descends through half maximal within about 80 minutes after administration. 6. The method of claim 1, wherein said rapid increase in serum insulin concentration descends through half maximal within about 50 minutes after administration. 7. The method of claim 1, wherein said rapid increase in serum insulin concentration descends through half maximal within about 35 minutes after administration. 8. The method of claim 1, wherein said patient's glucose elimination rate reaches its maximum between about 30 and about 90 minutes after administration. 9. The method of claim 8, wherein said patient's glucose elimination rate reaches its maximum between about 45 and about 60 minutes after administration. 10. The method of claim 1, wherein said diketopiperazine is fumaryl diketopiperazine. 11. The method of claim 1, wherein said inhaled insulin composition is administered from approximately 10 minutes prior to a meal to approximately 30 minutes after a meal. 12. The method of claim 11 wherein about 74% of the glucose lowering activity of said inhaled insulin composition has been expended within about 180 minutes after administration. 13. The method of claim 12 wherein said patient's glucose elimination rate returns to baseline within about 270 minutes after administration. 14. A method of restoring normal insulin kinetics in a patient in need thereof wherein said comprising administering to a patient having an insulin-related disorder from approximately 10 minutes prior to a meal to approximately 30 minutes after a meal an inhaled insulin composition comprising fumaryl diketopiperazine; wherein said composition produces in the patient a a rapid increase in serum insulin levels of at least between about 75 mU/L and about 375 mU/L achieved within about 20 minutes after administration; and wherein about 74% of the glucose lowering activity of said inhaled insulin composition has been expended within about 180 minutes after administration, and said patient's glucose elimination rate returns to baseline within about 270 minutes after administration.