Drug – bio-affecting and body treating compositions – Effervescent or pressurized fluid containing – Organic pressurized fluid
Reexamination Certificate
2002-04-04
2003-11-25
Hartley, Michael G. (Department: 1616)
Drug, bio-affecting and body treating compositions
Effervescent or pressurized fluid containing
Organic pressurized fluid
C424S046000, C424S464000, C424S400000, C128S200140, C514S866000, C514S002600
Reexamination Certificate
active
06652838
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to the treatment of diabetes. Particularly, the present invention relates to the treatment of diabetes without the use of insulin injections.
2. Description of the Prior Art
Diabetes mellitus is a chronic illness caused by a lack of an effective amount of insulin. It is manifested by the elevation of blood sugar. Diabetes mellitus is the fourth leading cause of death by disease in the United States and the leading cause of irreversible blindness and chronic renal failure. Treatment for diabetes is directed to lowering blood sugar, particularly after meals, and to preventing long term complications that include neuropathy, accelerated atherosclerosis, myocardial infarction, gangrene of the lower extremities, retinopathy and nephropathy. Diabetic individuals are typically required to comply with treatments over very long periods of time to avoid these complications.
The two pharmacological modalities presently used to lower blood sugar are oral hypoglycemic (anti-diabetic) agents and insulin. Insulin replacement is presently accomplished by injection and is based upon the lack of insulin or limitation of its action in diabetes mellitus. Oral anti-diabetic agents are not chemically akin to insulin and their sugar-lowering mechanism differs from the action of direct insulin replacement. Oral hypoglycemic agents and insulin are, at present, therapeutically utilized alone or in concert with each other, according to the needs of the diabetic individual. Some individuals are best treated with more than one oral agent, with, or without insulin.
Oral hypoglycemic agents presently include sulfonylureas, biguanides, alpha-glucosidase inhibitors, and thiazolidinediones. These agents are known to be used alone and in various combinations with each other to lower blood sugar. These oral hypoglycemic agents are considered to be long acting agents, acting over many hours. A side effect of agents acting over long periods is the risk of hypoglycemia if the user forgets or otherwise fails to eat hours after taking the medication. Each of these classes of compounds operates by a different mechanism. For example, sulfonylureas lower blood sugar by stimulating insulin release from pancreatic islet cells. Examples of sulfonylureas include so-called first-generation agents such as tolbutamide, acetohexamide, tolazamide, and chlorpropamide, and second-generation agents such as glyburide, glipizide, and glimeperide. First and second generation sulfonylureas differ in their potency, adverse effects and duration of action.
Metformin, which has an “insulin sparing” action, is an example of a biguanide. Acarabose, which has an action of reducing the rate of carbohydrate absorption, is an example of an alpha-glucosidase inhibitor. Troglitizone, which acts to potentiate the action of insulin (but has been found to cause idiosyncratic liver injury), is an example of the thiazolidinedione class. More recently, an additional class of hypoglycemic agent known as the meglitinides has become available for treatment in the United States. An example of a meglitinide is repaglinide, a carbamoylmethyl benzoic acid derivative.
Like the sulfonylureas, the meglitinides stimulate insulin secretion from pancreatic insulin-producing cells. However, they are chemically distinct and bind to a different receptor. They can be used alone as well as in concert with other oral agents. Repaglinide and nateglinide exhibit the fast-acting characteristics of the meglitinide class including rapid absorption, stimulation of insulin release within a few minutes, and rapid biliary excretion.
Recent clinical studies in diabetic individuals have disclosed that insulin can be administered topically to human membrane surfaces, especially nasal and pulmonary surfaces, and be absorbed. As with injected insulin, oral hypoglycemic medication may be utilized together with insulin administered by aerosol to lower blood sugar.
U.S. Pat. No. 6,187,291, issued Feb. 13, 2001, is an example of a device based on the use of aerosolizable insulin and at least one long-acting, oral, hypoglycemic agent. It teaches a dispensing container which incorporates an aerosolizable topical insulin preparation, at least one oral hypoglycemic agent, and indicia and instructions for their coordinated use as a single therapeutic regimen for treating diabetes mellitus in a human in order to make such regimens more convenient, encourage compliance and minimize error. The action of such topical insulin has been found to be limited compared to injected insulin.
Therefore, what is needed is a method for treating hyperglycemia, particularly postprandial hyperglycemia, in diabetes mellitus in a human. What is further needed is a method for treating postprandial hyperglycemia in diabetes mellitus in a human that does not require the user to eat in accordance with the timing and action of the treatment agents. What is still further needed is a method for treating postprandial hyperglycemia in diabetes mellitus in a human that minimizes the risk of lowering blood sugar to hypoglycemic levels.
SUMMARY OF THE INVENTION
It is an object of the present invention to provide a method for treating postprandial hyperglycemia in diabetes mellitus in a human without resorting to injections. It is another object of the present invention to provide a method for treating postprandial hyperglycemia in diabetes mellitus that does not require the user to eat in accordance with the timing and action of the treatment agents. It is still another object of the present invention to provide a method of treating postprandial hyperglycemia in diabetes mellitus that minimizes the risk of lowering blood sugar to hypoglycemic levels. It is yet another object of the present invention to facilitate treatment by combining topical aerosolized and oral medication together in a heretofore undisclosed manner for treating diabetes mellitus in a human.
The present invention achieves these and other objectives by providing a method for treating postprandial hyperglycemia in diabetes mellitus in a human that employs an aerosolizable topical insulin preparation and an oral hypoglycemic agent having a relatively short duration of action in combination as a regimen. The combining of short-acting topical insulin and short-acting oral hypoglycemic agents from the meglitinide class are particularly suitable for such regimens.
It is to be understood that oral hypoglycemic medications may be in the form of tablet, pill, capsule, caplet, packets or liquids, gels, or solids, some of which may require reconstituting, or any generally recognized oral form of medication. The topical insulin preparation is in a form such as a powder or liquid that is suitable for aerosolization.
REFERENCES:
patent: 6167880 (2001-01-01), Gonda et al.
patent: 6187291 (2001-02-01), Weinstein et al.
patent: 6447751 (2002-09-01), Weinstein et al.
Skyler, Jay S. et al., Efficacy of inhaled human insulin in Type 1 diabetes mellitus; a randomized proof-of-concept study, Lancet 201;357:331-335.
Gale, Edwin A. M., Commentary, Two cheers for inhaled insulin, Lancet 2001;357:324-325.
Cefalu, William T. et al., Inhaled human insulin treatment in patients with Type 2 diabetes mellitus, Annals of Internal Medicine 2001;134:203-207.
Landgraf, Rudiger, Meglitinide analogues in the treatment of Type 2 diabetes mellitus, Drugs and Aging 2000;17(5):411-425.
Moses, Robert G. et al., Flexible meal-related dosing with repaglinide facilitates glycemic control in therapy-naïve Type 2 diabetes, Diabetes Care 2001;24:11-15.
Kalbag, Jyoti B. et al., Mealtime glucose regulation with nateglinide in health volunteers, Diabetes Care 2001;24:73-77.
Lefebvre, Pierre J. et al., Glucose metabolism and the postprandial state, European Journal of Clinical Investigation 1999;29 (Suppl. 2), 1-6.
Kuusisto, J. et al., Prandial glucose regulation and cardiovascular disease in Type 2 diabetes, European Journal of Clinical Investigation 1999;29 (Suppl. 2), 7-11.
Heine, R. J., Current therapeutic opti
Weinstein Allan M.
Weinstein Robert E.
Deleault, Esq. Robert R.
Haghighatian Mina
Hartley Michael G.
Mesmer & Deleault, PLLC
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