Details for Patent: 8,623,817

Title:	Method of treating diabetes type 2 by administering ultrarapid acting insulin
Abstract:	Disclosed herein are improved methods of treating hyperglycemia with a combination of an ultrarapid acting insulin and insulin glargine comprising prandial administration of the ultrarapid insulin, and administration of a first dose of insulin glargine within 6 hours of waking for a day.
Inventor(s):	Richardson; Peter (Ringoes, NJ), Baughman; Robert A. (Ridgefield, CT), Potocka; Elizabeth (Bethel, CT), Boss; Anders Hasager (Princeton, NJ), Petrucci; Richard (New Canaan, CT)
Assignee:	Mannkind Corporation (Valencia, CA)
Filing Date:	Jan 17, 2012
Application Number:	13/351,855
Claims:	1. A method of treating diabetes type 2, comprising: selecting a patient with diabetes type 2 currently being treated with a suppressor of hepatic glucose output and an insulin secretagogue; discontinuing treatment with the insulin secretagogue; and routinely administering an ultrarapid acting insulin preparation with at least one established meal. 2. The method of claim 1 wherein treatment with the suppressor of hepatic glucose output is also discontinued. 3. The method of claim 2 wherein the patient is further selected for having an insulin resistance at the lower portion of the insulin resistance spectrum. 4. The method of claim 1 wherein the patient is further selected for needing to reduce or avoid weight gain. 5. The method of claim 1 wherein the administering step does not comprise an injection. 6. The method of claim 5 wherein patient is further a candidate for treatment with insulin and is further selected on the basis of being needle-phobic or desiring to avoid frequent injections. 7. The method of claim 1 wherein the suppressor of hepatic glucose output is metformin. 8. The method of claim 1 wherein the insulin secretagogue is a sulfonylurea. 9. The method of claim 1 wherein the patient is further selected for having well or moderately controlled fasting blood glucose. 10. The method of claim 1 wherein the ultrarapid acting insulin preparation is administered by inhalation. 11. The method of claim 10 wherein the ultrarapid acting insulin preparation is a dry powder. 12. The method of claim 11 wherein ultrarapid acting insulin preparation comprises a fumaryl diketopiperazine (FDKP) associated with insulin. 13. The method of claim 11 wherein ultrarapid acting insulin preparation comprises insulin-FDKP. 14. The method of claim 1 wherein the patient is further selected for having an HbA1c level .gtoreq.8. 15. The method of claim 1 wherein the patient is further selected for having an elevated mean amplitude of glucose excursions. 16. The method of claim 1 wherein said ultrarapid acting insulin preparation is administered with each meal containing more than 15 g of carbohydrate. 17. The method of claim 1 wherein said ultrarapid acting insulin preparation is administered at a dosage sufficient to maximally reduce hepatic glucose output within 60 minutes of administration. 18. The method of claim 1 wherein said ultrarapid acting insulin preparation is administered at a dosage within the range of 1 to 32 subcutaneous equivalent units. 19. The method of claim 1 wherein the ultrarapid acting insulin preparation comprises an insulin analog. 20. The method of claim 19 wherein the insulin analog is insulin aspart, insulin glulisine, or insulin lispro.