ORAL INSULIN THERAPIES & PROTOCOL
First Claim
1. A method of treating a human diabetic patient, comprising:
- orally administering to said diabetic patient, at a time from about 30 minutes prior to ingestion of a meal to concurrently with ingestion of a meal, a dose of a therapeutically effective amount of insulin with from about 20 to about 600 mg of a pharmaceutically acceptable delivery agent that facilitates absorption of said insulin from the gastrointestinal tract, said delivery agent of the formula or a pharmaceutically acceptable salt thereof,
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Accused Products
Abstract
Methods for treating impaired glucose tolerance and early and late stage diabetes in mammals, for prophylactically sparing β-cell function, aiding in preventing β-cell death, preventing the onset of overt diabetes in a mammal with type 2 diabetes, treating the current level of glycemic control dysfunction of a mammal with impaired glucose tolerance or diabetes, comprising orally administering insulin and a delivery agent that facilitates insulin absorption from the gastrointestinal tract at the time of or shortly before mealtime, e.g., within about 10 minutes prior to ingestion of a meal, on a chronic basis. The methods also comprise, in addition to administering a rapid-acting insulin to provide a first insulin peak, administering a slow acting insulin to provide a second insulin peak occurring at a later time but of a longer duration. These methods achieve improved glycemic control without the risks of hypoglycemia, hyperinsulinemia and weight gain and the need for frequent blood glucose monitoring that are normally associated with insulin therapy.
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Citations
65 Claims
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1. A method of treating a human diabetic patient, comprising:
orally administering to said diabetic patient, at a time from about 30 minutes prior to ingestion of a meal to concurrently with ingestion of a meal, a dose of a therapeutically effective amount of insulin with from about 20 to about 600 mg of a pharmaceutically acceptable delivery agent that facilitates absorption of said insulin from the gastrointestinal tract, said delivery agent of the formula or a pharmaceutically acceptable salt thereof, - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 35, 36, 45, 46, 47, 48, 49, 50, 51, 52)
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10. A method of treating pre-diabetic patients, early stage type 2 patients and/or late stage type 2 diabetic patients comprising:
orally administering to a mammal on a chronic basis a pharmaceutical formulation comprising a therapeutically effective dose of insulin and a delivery agent that facilitates absorption of insulin from the gastrointestinal tract, said delivery agent of the formula or a pharmaceutically acceptable salt thereof, - View Dependent Claims (11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 37, 38, 39, 40, 41, 42, 43, 44, 53)
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54. A method for treating a human diabetic patient in accordance with the patient'"'"'s stage of development of diabetes mellitus, comprising:
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(a) identifying a patient'"'"'s stage of diabetes along a continuum of development of diabetes as one of prediabetic stage, early stage type 2 diabetes, late stage type 2 diabetes and type 1 diabetes; and (b) recommending a treatment to said patient that includes an oral insulin treatment appropriate to said patient'"'"'s stage along the continuum of development of diabetes. - View Dependent Claims (55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65)
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Specification