Compositions and methods for glycemic control of subjects with impaired fasting glucose

• US 9,132,117 B2
• Filed: 06/17/2013
• Issued: 09/15/2015
• Est. Priority Date: 06/17/2013
• Status: Active Grant

• Current Assignee: 1242753 Ontario Incorporated
• Original Assignee: KGK Synergize Incorporated
• Inventors: Guthrie, Najla
• Primary Examiner(s): SHIAO, REI TSANG
• Application Number:
  US13/919,589
• Publication Number:
  US 20140371303A1
• Time in Patent Office: 820 Days
• Field of Search: 514/458, 514/456, 514/473
• US Class Current: 1/1
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/155 Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
• CPC Class Codes: A61K 31/352 condensed with carbocyclic rings, e.g. methantheline cannabinoids A61K31/658
• CPC Class Codes: A61K 31/353 3,4-Dihydrobenzopyrans, e.g. chroman, catechin
• CPC Class Codes: A61K 31/355 Tocopherols, e.g. vitamin E
• CPC Class Codes: A61K 31/366 having six-membered rings, e.g. delta-lactones
• CPC Class Codes: A61K 38/168 from plants
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics

Abstract

Compositions and methods for providing anti-diabetic and anti-hyperlipidemia benefits to diabetic subjects currently on medication but not meeting recommended targets for blood glucose, HbA1c, blood pressure and total cholesterol.

Claims

1. A method comprising administering an effective amount of a composition to a subject diagnosed with diabetes, wherein the subject is currently taking one or more prescribed medications selected from the group consisting of metformin, acarbose, fibrates, thiazolidienodiones and Sulphonylureas, for control of diabetes, wherein the subject does not have the following:

HbA1c≦

7%;

LDL-C≦

100 mg/dL;

total cholesterol ≦

200 mg/dL; and

systolic blood pressure ≦

130 mmHg, wherein after a predetermined period of supplementation with the composition, the subject has at least one of the following;

HbA1c≦

7%;

LDL-C≦

100 mg/dL;

total cholesterol ≦

200 mg/dL; and

systolic blood pressure ≦

130 mmHg; and

wherein the composition comprises at least one limonoid, at least one flavonoid and at least one tocotrienol.

2. The method of claim 1, wherein the composition comprises at least one polymethoxyflavone.

3. The method of claim 1, wherein the one or more prescribed medications are metformin.

4. The method of claim 1, wherein the subject is a human.

5. The method of claim 1, wherein the predetermined period of supplementation is at least 12 weeks.

6. The method of claim 5, wherein the predetermined period of supplementation is at least 24 weeks.

7. The method of claim 1, wherein the composition further comprises soy protein.

8. The method of claim 1, wherein the composition is administered orally, transdermally, rectally, intravenously, intramuscularly, intraperitoneally, subcutaneously, topically, or by inhalation.

9. The method of claim 1, wherein the medication is administered orally.