Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai
Reexamination Certificate
2000-02-22
2002-08-27
Carlson, Karen Cochrane (Department: 1653)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Peptide containing doai
C514S003100, C514S002600, C514S560000, C514S549000, C514S558000, C426S630000, C426S002000, C426S807000
Reexamination Certificate
active
06440931
ABSTRACT:
FIELD OF THE INVENTION
This invention provides a method for treatment and prophylaxis of diabetes comprising administering conjugated linoleic acid to subjects suspected of suffering from or at risk of developing diabetes.
BACKGROUND
Diabetes mellitus is a chronic metabolic disorder characterized by a high concentration of glucose in blood (hyperglycemia) which is a result of insulin deficiency and/or insulin resistance. Diabetes is a common disease in humans, with more than 50 million cases worldwide. There are two main forms of diabetes, insulin-dependent diabetes mellitus (e.g., Type I diabetes) and non-insulin dependent diabetes mellitus (e.g., Type II diabetes).
Insulin is the main form of treatment of Type I diabetes and has to be administrated parenterally (e.g., by injection). Today, most of the insulin in clinical use is produced recombinantly. Type II diabetes can be treated with various oral anti-hyperglycemic agents like biguanidines (e.g., metformin), sulphonylurea compounds such as tolbutamide, chlorpropamide, glipizid and glibenclamide, and acarbose (i.e., an alpha-glucosidase inhibitor). Very mild forms of diabetes mellitus (Type II) can often be kept under control by the patient without use of drugs by selection of correct diet (e.g., intake of limited amounts of carbohydrates), bodyweight reduction for obese patients, increased exercise and reduction of stress.
Anti-diabetic drugs only provide symptomatic relief and do not cure the disease. Thus, affected patients usually undergo treatment for the rest of their lives. Anti-diabetic drugs have several unwanted effects such as stimulation of appetite resulting in gain of body weight, hypoglycemia, gastrointestinal upsets, allergic skin reactions, bone marrow damage and cardiovascular effects. (See, e.g., Godman and Gilman's “The Pharmacologocal Basis of Therapeutics”, 9
th
edition and “H. P. Rand et al., Pharmacology 1995”, Churchill Livingstone).
Research continues in the development of improved drugs and treatment regimens. Of particular interest is the development of drugs with increased safety and efficacy. Ongoing concerns include the detrimental interactions of current anti-diabetic drugs with other medications in common use (e.g., anti-inflammatory agents), development of drug resistance and/or tolerance, and patient compliance with prescribed treatment regimes.
What is needed are safe and effective compounds for treating diabetes that lack significant side effects and can be consumed as part of the normal diet.
SUMMARY OF THE INVENTION
An important challenge in modern medicine is to devise safe and effective methods of treating diabetes. It is therefore an object of the present invention to provide a safe method of treating Type I and Type II diabetes through the use of a naturally occurring substance, conjugated linoleic acid (CLA). Accordingly, the present invention provides methods for the use of CLA in treatment and prophylaxis of diabetes.
In one embodiment of the present invention, methods are provided for treating diabetes in human patients suffering from diabetes that comprises administering a safe and therapeutically effective amount of conjugated linoleic acid. In some embodiments, the patients suffer from Type I diabetes, while in other embodiments, patients suffer from Type II diabetes. In some preferred embodiments, a safe and effective amount is sufficient to reduce the percentage of glycoslylated hemoglobin (HbA
IC
) in the patient's blood. In some embodiments, the method of treatment comprises: a) providing i) a safe and therapeutically effective amount of conjugated linoleic acid; and ii) a patient suffering from diabetes; and b) administering said safe and therapeutically effective amount of conjugated linoleic acid to said diabetic patient. In other embodiments, the method of treatment comprises providing: i) a patient at risk for diabetes, and ii) a therapeutic composition comprising a safe and effective amount of conjugated linoleic acid; and b) prophylactically administering the therapeutic composition to said patient.
In some embodiments of the invention, the conjugated linoleic acid administered to patients is a mixture of octadecadienoic acid isomers selected from the group of cis-9, trans-11; cis-9, cis-11; trans-9, cis-11; trans-9, trans-11; cis-10, cis-10, trans-12; trans-10, cis-12; trans-10, trans-12 octadecadienoic acid. In other embodiments, the conjugated linoleic acid administered to patients contains less than 5% of minor isomers of conjugated linoleic acid. In still other embodiments, the minor isomer is c11,t13; t11,c13; t11,t13; or c11,c13 octadecadienoic acid. In a particularly preferred embodiment, the conjugated linoleic acid contains less than 1% of minor isomers of conjugated linoleic acid. In other embodiments, the conjugated linoleic acid further comprises an ester or triglyceride. In still other embodiments, the conjugated linoleic acid further comprises greater than about 55% t10,c12 octadecadienoic acid.
In other embodiments of the present invention, the conjugated linoleic acid comprises a daily dosage of about 0.05 to 40 grams. In some particularly preferred embodiments, the conjugated linoleic acid comprises a daily dosage of about 1 to 5 grams. In some embodiments, the conjugated linoleic acid is administered orally in a gel capsule. In other embodiments, the conjugated linoleic acid is provided as a supplement to a low carbohydrate diet. In still other embodiments, the conjugated linoleic acid is provided in a food product (e.g., prepared food or drink).
In some embodiments, the conjugated linoleic acid is co-administered with an anti-hyperglycemia agent. In other embodiments, the anti-hyperglycemia agent is selected from the group consisting of insulin, metformin, chorplopamide, glipizid, glibenclamide and acarbose.
DEFINITIONS
The following definitions are provided to make the invention be more easily understood:
As used herein, “diabetes” refers to any disease characterized by a high concentration of glucose in blood (hyperglycemia) and includes, but is not limited to, both Type I diabetes mellitus and Type II diabetes mellitus.
As used herein, “Type I diabetes” refers to any insulin dependent diabetes disease.
As used herein, “Type II diabetes” refers to any non-insulin diabetes disease.
As used herein, “patient at risk for diabetes” refers to any person having risk factors known in the art for Type I diabetes (e.g., family history, descent (African or hispanic), etc.) or Type II diabetes (e.g., family history, age (over 45), obesity, previous diagnosis of impaired glucose tolerance, physical inactivity, etc.).
As used herein, “conjugated linoleic acid” or “CLA” refers to any conjugated linoleic acid or octadecadienoic acid. It is intended that this term encompass and indicate all positional and geometric isomers of linoleic acid with two conjugated carbon-carbon double bonds any place in the molecule. CLA differs from ordinary linoleic acid in that ordinary linoleic acid has double bonds at carbon atoms 9 and 12. Examples of CLA include cis- and trans isomers (“E/Z isomers”) of the following positional isomers: 2,4-octadecadienoic acid, 4,6-octadecadienoic acid, 6,8 -octadecadienoic acid, 7,9 - octadecadienoic acid, 8,10- octadecadienoic acid, 9,11-octadecadienoic acid and 10,12 octadecadienoic acid, 11, 13 octadecadienoic acid. As used herein, CLA encompasses a single isomer, a selected mixture of two or more isomers, and a non-selected mixture of isomers obtained from natural sources, as well as synthetic and semisynthetic CLA. As used herein, CLA further encompasses free fatty acid(s) of CLA, physiologically acceptable salts of CLA, and esters with physiologically acceptable, preferably naturally occurring, alcohols ( e.g., ethanol and glycerol).
As used herein, it is intended that “triglycerides” of CLA contain an isomer of CLA at any or all of three positions on the triglyceride backbone. Methods for the synthesis of triglycerides containing CLA are taught in PCT Application US99/05806, incorporated herein by reference.
As used h
Klaveness Jo
Remmereit Jan
Wadstein Jan
Carlson Karen Cochrane
Medlen & Carroll LLP
Natural Corporation
Robinson Hope A.
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