METHOD OF PRESERVING THE FUNCTION OF INSULIN-PRODUCING CELLS
Methods and compositions for preserving the function of insulin-producing cells and to furthering the lifespan of insulin-producing cells in non-insulin dependent patients with insulin-related disorders are provided.
1 . A method of preserving the function of insulin-producing cells in a non-insulin dependent patient having an insulin-related disorder, comprising:
providing said non-insulin dependent patient having an insulin-related disorder, with an insulin dose;
administering said insulin dose to said patient;
wherein said insulin dose mimics a physiological meal-related early phase insulin response and preserves the function of said insulin-producing cells in said patient.
2 . The method of claim 1 , wherein said insulin dose is administered orally.
3 . The method of claim 1 , wherein said insulin dose is inhaled.
4 . The method of claim 3 , wherein said insulin dose comprises a dry powder formulation.
5 . The method of claim 1 , wherein said insulin dose is administered with any meal containing more than 15 g of carbohydrate.
6 . The method of claim 1 , wherein said insulin dose comprises a dose sufficient to reduce serum levels of proinsulin.
7 . The method of claim 1 wherein said insulin dose comprises a dose sufficient to control glucose excursions.
8 . The method of either of claims 6 or 7 , wherein said insulin dose is sufficient to control blood glucose levels.
9 . The method of either of claims 6 or 7 , wherein the insulin dose is sufficient to reduce glucose release from the liver.
10 . The method of claim 1 , wherein said insulin reaches peak serum levels within about 15 minutes of administration.
11 . The method of claim 10 wherein said peak serum insulin level is at least 60 mU/L.
12 . The method of claim 1 , wherein said insulin dose comprises a fumaryl diketopiperazine (FDKP) associated with insulin.
13 . The method of claim 12 , wherein said insulin dose is within the range equivalent to about 15 IU to about 90 IU of FDKP insulin.
14 . The method of claim 1 wherein said patient is further treated with an insulin sensitizer or an insulin secretagogue.
15 . A method of lessening post-prandial pancreatic stress in a non-insulin dependent patient having an insulin-related disorder comprising:
providing said non-insulin dependent patient having an insulin-related disorder to be treated,
administering an insulin dose to said patient sufficient to control blood glucose levels and reduce serum levels of proinsulin; and
wherein said insulin dose mimics the physiologic meal-related early phase insulin response and pancreatic stress is attenuated.
16 . A method of increasing longevity of an insulin-producing cell transplant in a patient, comprising
providing an insulin-producing cell transplant recipient to be treated,
administering an insulin dose to said patient sufficient to control blood glucose levels and reduce serum levels of proinsulin; and
wherein said insulin dose mimics the physiologic meal-related early phase insulin response and pancreatic stress is attenuated and longevity of said insulin-producing cells is achieved.
17 . A method of preserving the function of insulin-producing cells in a patient, comprising;
providing a non-insulin dependent patient having an insulin-related disorder, an insulin dose and an immunosuppressive medication;
administering said insulin dose to said patient wherein said insulin dose mimics the physiologic meal-related early phase insulin response; and
administering said immunosuppressive medication to said patient to in conjunction with said insulin dose to slow an auto-immune response.
18 . A composition useful for the preservation of insulin-producing cells in a non-insulin dependent patient having an insulin-related disorder comprising a controlled-release insulin formulation.
19 . A composition useful for the preservation of insulin-producing cells in a non-insulin dependent patient having an insulin-related disorder comprising a delayed onset preparation including an insulin formulation.
20 . A method of preserving the function of insulin-producing cells in a non-insulin dependent patient having an insulin-related disorder, comprising;
providing a non-insulin dependent patient having an insulin-related disorder, wherein said patient is selected from the group consisting of type 1 diabetics in the honeymoon phase, insulin-producing cell transplant recipients and pre-diabetics, and an insulin dose;
administering said insulin dose to said patient; and
wherein said insulin dose mimics a physiological meal-related early phase insulin response and preserves the function of said insulin-producing cells in said patient.
21 . A method of preserving the function of insulin-producing cells in a patient having an insulin-related disorder, comprising:
providing a patient having an insulin-related disorder, wherein said patient has not been treated with an insulin composition other than basal insulin, with an insulin dose;
administering said insulin dose to said patient at a mealtime; and
wherein said insulin dose mimics a physiological meal-related early phase insulin response and preserves the function of said insulin-producing cells in said patient.
22 . A method of preserving the function of insulin-producing cells in a patient having an insulin-related disorder, comprising:
providing a patient having an insulin-related disorder, wherein said patient has lost early phase insulin release and has a level of serum glycated hemoglobin (HbA1c) less than 8%, with an insulin dose;
administering said insulin dose to said patient at a mealtime; and
wherein said insulin dose mimics a physiological meal-related early phase insulin response and preserves the function of said insulin-producing cells in said patient.
23 . The method of claim 22 , wherein said insulin dose is administered with any meal containing more than 15 g of carbohydrate.
24 . The method of claim 22 , wherein said patient is not on a prandial insulin regimen.
25 . The method of claim 22 , wherein said patient has elevated serum proinsulin levels.
26 . The method of claim 22 , wherein said patient has elevated mean amplitude of glucose excursions.
27 . The method of claim 22 , wherein said patient has evidence of elevated oxidative stress.
28 . The method of claim 22 , wherein said level of serum HbA1c is less than 7%.
29 . The method of claim 28 , wherein said level of serum HbA1c is less than 6.5%