ORAL INSULIN THERAPIES AND PROTOCOL
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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.
13 Citations
89 Claims
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1-57. -57. (canceled)
- 58. An oral solid dosage form comprising a dose of insulin and an effective amount of the delivery agent 4-CNAB in an amount that facilitates the absorption of the insulin from the gastrointestinal tract, one or more of said dosage forms upon oral administration to a diabetic patient at a time from about 30 minutes prior to ingestion of a meal to concurrently with ingestion of a meal providing a therapeutically effective reduction in blood glucose after oral administration and a maximum plasma concentration of insulin at a time point from about 10 to about 20 minutes after oral administration, said total dose being sufficient to replace an endogenous first phase insulin response to an ingested meal in a non-diabetic subject.
- 60. A substantially homogeneous oral tablet comprising a therapeutically effective dose of insulin, the delivery agent 4-CNAB in an amount that facilitates absorption of insulin from the gastrointestinal tract and an excipient suitable for tableting, said tablet upon oral administration to a diabetic patient at a time from about 30 minutes prior to ingestion of a meal to concurrently with ingestion of a meal providing a therapeutically effective reduction in blood glucose after oral administration.
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80-87. -87. (canceled)
Specification