Night-time oral insulin therapy
First Claim
Patent Images
1. A method of treating a mammal which has impaired glucose tolerance or early stage diabetes mellitus, comprising administering an orally effective dose of a pharmaceutical formulation comprising insulin at or shortly before bedtime.
3 Assignments
0 Petitions
Accused Products
Abstract
A method for protection of a mammal that has impaired glucose tolerance or early stage diabetes mellitus from developing overt or insulin dependent diabetes comprises administering an orally effective dose of a pharmaceutical formulation comprising insulin at nighttime, e.g., at or shortly before bedtime.
14 Citations
39 Claims
- 1. A method of treating a mammal which has impaired glucose tolerance or early stage diabetes mellitus, comprising administering an orally effective dose of a pharmaceutical formulation comprising insulin at or shortly before bedtime.
-
16. A method of treating mammals having impaired glucose tolerance or early stage diabetes mellitus, comprising,
orally administering insulin at or shortly before bedtime to mammals having impaired glucose tolerance or early stage diabetes mellitus such that a statistically significant decrease in C-peptide levels from a mean baseline level is achieved in said mammals when said C-peptide level is measured about 8 hours after said oral administration of insulin.
- 27. A method of prolonging the effect of an oral administration of an unmodified insulin in order to treat mammals who have impaired glucose tolerance, comprising orally administering at bedtime a dosage form comprising a orally therapeutically effective amount of unmodified insulin to a diabetic patient which provides an insulin tmax at a time point from about 0.1 to about 1.5 hours after said oral administration, such that a statistically significant decrease in C-peptide levels from baseline is achieved in said patients when said C-peptide level is measured about 8 hours after said oral administration of insulin.
-
30. A method of prolonging the effect of an administration of oral insulin for a time period longer than the time period that the insulin can be measured in the blood stream, comprising orally administering at or shortly before bedtime a dosage form comprising an orally therapeutically effective amount of insulin to a diabetic patient, such that:
-
(i) the blood glucose level of the patient when measured about 8 hours after said oral administration is not statistically significantly changed from baseline levels;
or(ii) endogenous insulin production of the patient is lowered by a statistically significant degree as compared to baseline insulin levels when measured about 8 hours after said oral administration, as evidenced by reduced C-peptide levels;
or(iii) plasma insulin levels of the patient are lowered by a statistically significant degree as compared to baseline plasma insulin levels when measured about 8 hours after said oral administration;
or(iv) any combination of (i)-(iii) above. - View Dependent Claims (31, 32, 33, 34, 35, 36, 37)
-
Specification