Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai
Reexamination Certificate
2001-10-25
2004-11-09
Weddington, Kevin E. (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Carbohydrate doai
C514S060000
Reexamination Certificate
active
06815433
ABSTRACT:
The present invention concerns a method for long term prevention and/or treatment of dysglucaemia and/or for improved glycaemic control, for example the long term prevention of nocturnal and morning hypoglycaemia in diabetic patients, a composition for this purpose and a method for its production.
BACKGROUND OF THE INVENTION
Dysglucaemia is an overall definition, which in the present description and claims is meant to comprise all irregularities in blood glucose level in humans, both healthy persons and persons with a diagnosed disease, irrespective of these irregularities being chronic or temporary, caused by a metabolic disorder, a disease or by physical exercise, bad nutritional habits, medical treatment such as surgery, and desired or undesired pharmaceutical or chemical influences, such as pharmaceutical treatments or substance abuse.
Diabetes mellitus is a complex disorder of the carbohydrate, fat, and protein metabolism that is primarily a result of a relative or complete lack of insulin secretion by the beta cells of the pancreas or of defects of the insulin receptors. The various forms of diabetes are divided in several categories, the two most frequent being juvenile-onset diabetes or Type I insulin-dependent diabetes mellitus (IDDM) and adult-onset diabetes or Type II non-insulin-dependent diabetes mellitus (NIDDM). Both diseases, even when correctly diagnosed and medicated, require life-long medication, good patient compliance, a careful diet and frequent medical observation to avoid potentially serious sequelae.
One problem, frequently encountered by patients suffering from diabetes, is the nocturnal drop in blood glucose levels, hypoglycaemia, in mild cases resulting in morning dizziness and/or nausea. Occasionally the blood glucose level sinks so low during the night, or early in the morning, that the state of hypoglycaemia becomes severe, leading to unconsciousness or convulsions. Importantly, severe hypoglycaemia is more likely to occur at night, when the patient is asleep, rather than during the day, when the patient can feel the onset of hypoglycaemia and prevent it by eating carbohydrates, e.g. a lump of sugar or specific glucose tablets, energy gels or bars, marketed for diabetic patients.
Moreover, both mild (a blood glucose level about 2.4-4.0 mmol/l) and severe (less than 2.4 mmol/l) hypoglucaemia predisposes the patient to a condition known as hypoglycaemic unawareness, which in turn means that hypoglucaemia can occur more frequently and at any time of the day, due to attenuation of the typical warning symptoms of a declining blood glucose level, e.g. hunger, perspiration etc.
Notably, the incidence of hypoglycaemia is rapidly increasing as diabetic patients seek better control of their blood glucose levels, in order to avoid hyperglycaemia. An active life, involving exercise as prescribed for diabetics, also adds to the risk of hypoglycaemia unless the patient carefully controls his/her carbohydrate intake, insulin dosage and regularly monitors their blood glucose level.
There is presently no satisfactory therapeutic regime for the prevention of nocturnal and morning hypoglycaemia. Patients suffering from diabetes are often recommended to eat a light meal before bedtime, e.g. potato chips or cereals. This results in an almost instant peak in blood glucose, followed by a more or less rapid decline during the night. In order to guarantee a sufficient blood glucose level throughout the night, the initial level must be very high, bordering to the unhealthy. When attempting this kind of crude self-medication, the patients have difficulty finding the optimal dose and mix of carbohydrates, and over-eating tends to be the result. There is currently no medication available with an appropriate kinetic profile to counteract the effect of the night-time intermediate-acting insulin.
PRIOR ART
A method of treating diabetic hypoglycaemia by administration of uncooked cornstarch is described in W095/24906. According to this application, published in September 1995, the patient is given about 0.1 to 1.0 g starch per kg body weight, preferably about 0.25 to 0.5 g per kg body weight. Different dosage formulations are suggested, including a suspension of starch in milk, sustained release tablets and a snack bar, containing a total of 30 g carbohydrates, but having about ½ to ¼ of the carbohydrate in the form of uncooked cornstarch. Although containing “slow” carbohydrates in the form of cornstarch, this product contains considerable amounts of free sugar and fats, resulting both in an initially very high blood glucose peak, and in the intake of unnecessary calories in the form of fats and surplus carbohydrates. Further information concerning the sustained release tablets is not given, apart from a reference to well known techniques of tablet formulation.
U.S. Pat. No. 5,605,893 (Kaufman, F.) discloses a specific method of treating a diabetic patient and preventing hypoglycaemic episodes, said method consisting of administration to the patient of a therapeutic food composition comprising per serving or unit about 20-50 grams of nutrients, including
about 5-15 g of slowly absorbed complex carbohydrate, preferably cornstarch;
about 7-19 g of rapidly absorbed complex carbohydrate;
about 5-20 g of protein; and
about 3-7 g of fat,
said composition being substantially free from simple sugars.
U.S. Pat. No. 5,843,921 (Kaufman, F.) discloses a therapeutic food composition for treatment of diabetic patients and preventing hypoglycaemic episodes, comprising per serving or unit about 20-50 grams of nutrients, including
about 5-15 g of slowly absorbed complex carbohydrate, preferably cornstarch;
about 7-19 g of rapidly absorbed complex carbohydrate;
about 5-20 g of protein; and
about 3-7 g of fat;
wherein the amount of simple sugars other than fructose in said composition is less than about 3 g per unit.
U.S. Pat. No. 5,866,555 (Bell, S. J. et al.) discloses a diabetic supplement bar for the treatment or prevention of night time hypoglycaemia in a diabetic patient, made by blending simple carbohydrates, proteins, lipids, complex carbohydrates, and any additional additives, and homogenising the mixture into a food bar. Sucrose is presented as the preferred source of simple carbohydrates, whereas uncooked cornstarch is the preferred source of complex carbohydrates. The final fat concentration of the product is high, from 2 to 40% by weight. The remaining ingredients are:
about 10-60% by weight sucrose;
about 1-25% by weight protein;
about 1-60% by weight complex carbohydrate.
The high fat content of the above products accounts—together with the naturally slow degradation of uncooked cornstarch—for the delayed glucose release, as fat delays gastric emptying, thereby slowing the rate at which nutrients enter the intestines and become digested.
Another product, available on the market under the trade mark NiteBite® (Optim Nutrition Inc.) contains three sources of glucose: sucrose, protein and uncooked cornstarch. These components are digested more or less consecutively and are claimed to deliver glucose into the blood during a period of 6 hours or more.
U.S. Pat. No. 5,545,410 discloses the coating of a core of a carbohydrate in a food or pharmaceutical grade coating such as stearic acid, hydrogenated or partially hydrogenated oils, calcium stearate, stearyl alcohol, wax etc. The claims of U.S. Pat. No. 5,545,410 mention sucrose, glucose, lactose, dextrins, monosaccharides, disaccharides, oligosaccharides, and polysaccharides, as well as pregelatinized starches, raw starches, and modified starches. A limitation is however that the coated core has a particle size from 30-1000 &mgr;m. The resulting product consists of individually coated particles or granulates thereof, the properties of the coating regulating the release of the core compound.
The related patent U.S. Pat. No. 5,360,614 discloses the above coated carbohydrated cores, further defining their size to the interval of 75-500 &mgr;m, and the coating as providing for the release of substantially all said metabolizabl
Hansson Henri
Hansson Kerstin
Lake Mats
Metcon Medicin AB
Weddington Kevin E.
Young & Thompson
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