US20040142879A1 - Use of the acetyl l-carnitine in association with the biotin for the treatment of patients with type 2 insulin-resistant diabetes mellitus - Google Patents

Use of the acetyl l-carnitine in association with the biotin for the treatment of patients with type 2 insulin-resistant diabetes mellitus Download PDF

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Publication number
US20040142879A1
US20040142879A1 US10/478,372 US47837203A US2004142879A1 US 20040142879 A1 US20040142879 A1 US 20040142879A1 US 47837203 A US47837203 A US 47837203A US 2004142879 A1 US2004142879 A1 US 2004142879A1
Authority
US
United States
Prior art keywords
carnitine
acid
acetyl
biotin
day
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
Application number
US10/478,372
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English (en)
Inventor
Menotti Calvani
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Individual
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Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of US20040142879A1 publication Critical patent/US20040142879A1/en
Priority to US12/216,279 priority Critical patent/US8053472B2/en
Abandoned legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/21Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/22Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
    • A61K31/221Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin with compounds having an amino group, e.g. acetylcholine, acetylcarnitine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4151,2-Diazoles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/41641,3-Diazoles
    • A61K31/41881,3-Diazoles condensed with other heterocyclic ring systems, e.g. biotin, sorbinil
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/48Drugs for disorders of the endocrine system of the pancreatic hormones

Definitions

  • the present invention relates to the use of acetyl L-carnitine in association with biotin for the treatment of patients suffering from Type 2 insulin-resistant diabetes mellitus
  • the diabetes is divided into two main categories:
  • Type 1 diabetes Insulin-dependent diabetes mellitus (also known as Type 1 diabetes) which concerns patients suffering from this type of diabetes who literally depend on exogenous insulin to prevent ketoacidosis and death. As far as the endogenous insulin secretion is concerned, patients suffering from Type 1 diabetes mellitus exhibit insulinopenia.
  • Noninsulin-dependent diabetes mellitus also known as Type 2 diabetes
  • patients with this type of diabetes do not need insulin to live: they can decide whether to use it or not to control the symptoms of the diabetes.
  • patients with Type 2 diabetes can be further classified into two groups. In the first group, insulin levels are either normal or lower than normal; in the second group, insulin values are higher than normal and patients exhibit insulin resistance.
  • WO 98/01128 discloses the use of the acetyl L-carnitine, isovaleryl L-carnitine, propionil L-carnitine to increase the levels of IGF-1.
  • the diabetes is also included in the long list of curable pathologies stated in WO 98/01128.
  • WO 98/41113 describes a therapeutic nutritive composition for patients with diabetes mellitus consisting of gamma-linolenic acid, acetyl L-carnitine, mineral salts and vitamins.
  • U.S. Pat. No. 4,362,719 describes the use of the L-carnitine and the acyl L-carnitine in treating the juvenile onset diabetes mellitus.
  • acetyl L-carnitine a product available on the market, can be prepared by following the method described by R. Krinmberg, and W. Wittandt, in Biochem., Z. 251, 229 (1932).
  • an object of the invention is the use of the acetyl L-carnitine, or a pharmaceutically acceptable salt thereof, in association with the biotin for the preparation of a medicament for the treatment of Type 2 insulin-resistant diabetes.
  • salt of the acetyl L-carnitine is meant any salt of this with an acid that does not give rise to undesirable toxic or side effects. These acids are will known to pharmacologists and to experts in pharmacy.
  • Non-limiting examples of these salts are the following: chloride, bromide, orotate, acid aspartate, acid citrate, citrate magnesium, acid phosphate, fumarate and acid fumarate, fumarate magnesium, lactate, maleate and acid maleate, mucate, acid oxalate, pamoate, acid pamoate, acid sulphate, phosphate glucose, tartrate, acid tartrate, tartrate magnesium, 2-amine ethanesulphonate, magnesium 2-amine ethanesulphonate, tartrate coline and trichloroacetate.
  • this association shows an unexpected synergic effect, unpredictable on the basis of the knowledge of the use of both compounds, either alone or in association, and can be used as a suitable medicament for the treatment of the Type 2 insulin-resistant diabetes.
  • the daily dose to be administered whether one single or multiple, is left to the doctor's judgment according to the weight, age and general condition of the patient, it has been found that the quantity of acetyl L-carnitine to be administered is 0,1 to 2 g/day, while the dose of biotin is 1 to 8 mg/day.
  • a preferred amount of the acetyl L-carnitine is 0,2 to 1 g/day, while of the biotin is 3 to 5 mg/day.

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Emergency Medicine (AREA)
  • Diabetes (AREA)
  • Endocrinology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Heterocyclic Carbon Compounds Containing A Hetero Ring Having Oxygen Or Sulfur (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
US10/478,372 2001-05-29 2002-05-24 Use of the acetyl l-carnitine in association with the biotin for the treatment of patients with type 2 insulin-resistant diabetes mellitus Abandoned US20040142879A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
US12/216,279 US8053472B2 (en) 2001-05-29 2008-07-02 Use of the acetyl L-carnitine in association with the biotin for the treatment of patients with type 2 insulin-resistant diabetes mellitus

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IT2001RM000294A ITRM20010294A1 (it) 2001-05-29 2001-05-29 Uso della acetil l-carnetina in associazione con la biotina per il trattamento di pazienti affetti da diabete mellito di tipo ii insulino re
ITRM2001A000294 2001-05-29
PCT/IT2002/000338 WO2002096410A1 (en) 2001-05-29 2002-05-24 Use of the acetyl l-carnitine in association with the biotin for the treatment of patients with type 2 insulin-resistant diabetes mellitus

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US12/216,279 Continuation US8053472B2 (en) 2001-05-29 2008-07-02 Use of the acetyl L-carnitine in association with the biotin for the treatment of patients with type 2 insulin-resistant diabetes mellitus

Publications (1)

Publication Number Publication Date
US20040142879A1 true US20040142879A1 (en) 2004-07-22

Family

ID=11455558

Family Applications (2)

Application Number Title Priority Date Filing Date
US10/478,372 Abandoned US20040142879A1 (en) 2001-05-29 2002-05-24 Use of the acetyl l-carnitine in association with the biotin for the treatment of patients with type 2 insulin-resistant diabetes mellitus
US12/216,279 Expired - Fee Related US8053472B2 (en) 2001-05-29 2008-07-02 Use of the acetyl L-carnitine in association with the biotin for the treatment of patients with type 2 insulin-resistant diabetes mellitus

Family Applications After (1)

Application Number Title Priority Date Filing Date
US12/216,279 Expired - Fee Related US8053472B2 (en) 2001-05-29 2008-07-02 Use of the acetyl L-carnitine in association with the biotin for the treatment of patients with type 2 insulin-resistant diabetes mellitus

Country Status (18)

Country Link
US (2) US20040142879A1 (el)
EP (1) EP1399142B1 (el)
JP (1) JP4381685B2 (el)
KR (1) KR20040010666A (el)
AT (1) ATE333274T1 (el)
CA (1) CA2448244C (el)
CY (1) CY1105403T1 (el)
CZ (1) CZ297743B6 (el)
DE (1) DE60213237T2 (el)
DK (1) DK1399142T3 (el)
ES (1) ES2268053T3 (el)
HU (1) HUP0400060A2 (el)
IT (1) ITRM20010294A1 (el)
MX (1) MXPA03010921A (el)
PL (1) PL207522B1 (el)
PT (1) PT1399142E (el)
SK (1) SK287832B6 (el)
WO (1) WO2002096410A1 (el)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040120967A1 (en) * 2000-12-15 2004-06-24 Menotti Calvani Use of l-carnitine as stabilizing agent of proteins
US20060004095A1 (en) * 2004-07-01 2006-01-05 Menotti Calvani Use of acetyl L-carnitine for the preparation of a medicine for the treatment of neuropathic pain in diabetic patients
US20060241058A1 (en) * 2005-04-26 2006-10-26 Sigma-Tau Industrie Farmaceutiche Riunite S.P.A. Acetyl L-carnitine for prevention of painful peripheral neuropathy in patients with type 2 diabetes
US20090286726A1 (en) * 2006-03-10 2009-11-19 Tecnogen S.P.A. Use of the long pentraxin ptx3 for the prevention or treatment of viral diseases

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2136798B1 (en) * 2007-03-21 2015-07-29 SIGMA-TAU Industrie Farmaceutiche Riunite S.p.A. Composition useful for the prevention of type 2 diabetes and its complications in pre-diabetic patients with insulin resistance
GB201304112D0 (en) * 2013-03-07 2013-04-24 Univ Nottingham Modulation of energy expenditure

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4751242A (en) * 1986-08-04 1988-06-14 Sigma-Tau Industrie Farmaceutiche Riunite S.P.A. Use of acetyl L-carnitine in the therapeutical treatment of peripheral neuropathies
US5929066A (en) * 1997-08-08 1999-07-27 Nutrition 21 Chromium/biotin treatment of Type II diabetes
US6020139A (en) * 1995-04-25 2000-02-01 Oridigm Corporation S-adenosyl methionine regulation of metabolic pathways and its use in diagnosis and therapy

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IT1263004B (it) * 1992-10-08 1996-07-23 Sigma Tau Ind Farmaceuti Impiego della l-carnitina e acil l-carnitine nel trattamento a lungo termine di pazienti diabetici non insulino-dipendenti.

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4751242A (en) * 1986-08-04 1988-06-14 Sigma-Tau Industrie Farmaceutiche Riunite S.P.A. Use of acetyl L-carnitine in the therapeutical treatment of peripheral neuropathies
US6020139A (en) * 1995-04-25 2000-02-01 Oridigm Corporation S-adenosyl methionine regulation of metabolic pathways and its use in diagnosis and therapy
US5929066A (en) * 1997-08-08 1999-07-27 Nutrition 21 Chromium/biotin treatment of Type II diabetes

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040120967A1 (en) * 2000-12-15 2004-06-24 Menotti Calvani Use of l-carnitine as stabilizing agent of proteins
US7833977B2 (en) 2000-12-15 2010-11-16 Sigma-Tau Industrie Farmaceutiche Riunite S.P.A. Use of L-Carnitine as stabilizing agent of proteins
US20060004095A1 (en) * 2004-07-01 2006-01-05 Menotti Calvani Use of acetyl L-carnitine for the preparation of a medicine for the treatment of neuropathic pain in diabetic patients
US20060241058A1 (en) * 2005-04-26 2006-10-26 Sigma-Tau Industrie Farmaceutiche Riunite S.P.A. Acetyl L-carnitine for prevention of painful peripheral neuropathy in patients with type 2 diabetes
US8569366B2 (en) * 2005-04-26 2013-10-29 Sigma-Tau Industrie Farmaceutiche Riunite S.P.A. Acetyl L-carnitine for prevention of painful peripheral neuropathy in patients with type 2 diabetes
US8952059B2 (en) 2005-04-26 2015-02-10 Sigma-Tau Industrie Faramceutiche Riunite S.p.A. Acetyl L-carnitine for the preparation of a medicament for the prevention of painful peripheral neuropathy in patients with type 2 diabetes
US20090286726A1 (en) * 2006-03-10 2009-11-19 Tecnogen S.P.A. Use of the long pentraxin ptx3 for the prevention or treatment of viral diseases
US7910092B2 (en) 2006-03-10 2011-03-22 Tecnogen S.P.A. Use of the long pentraxin PTX3 for the prevention or treatment of viral diseases
US20110224132A1 (en) * 2006-03-10 2011-09-15 Tecnogen S.P.A Use of the long pentraxin ptx3 for the prevention or treatment of viral diseases
US8268304B2 (en) 2006-03-10 2012-09-18 Sigma-Tau Industrie Farmaceutiche Riunite Spa Use of the long pentraxin PTX3 for the prevention or treatment of viral diseases

Also Published As

Publication number Publication date
ES2268053T3 (es) 2007-03-16
PT1399142E (pt) 2006-10-31
KR20040010666A (ko) 2004-01-31
SK15852003A3 (sk) 2004-04-06
PL367630A1 (en) 2005-03-07
HUP0400060A2 (hu) 2004-04-28
JP4381685B2 (ja) 2009-12-09
DK1399142T3 (da) 2006-10-30
SK287832B6 (sk) 2011-11-04
DE60213237T2 (de) 2007-08-02
CZ297743B6 (cs) 2007-03-21
CZ20033221A3 (cs) 2004-06-16
JP2004532866A (ja) 2004-10-28
US20080269307A1 (en) 2008-10-30
ATE333274T1 (de) 2006-08-15
CA2448244A1 (en) 2002-12-05
CA2448244C (en) 2010-11-02
PL207522B1 (pl) 2010-12-31
CY1105403T1 (el) 2010-04-28
WO2002096410A1 (en) 2002-12-05
US8053472B2 (en) 2011-11-08
EP1399142B1 (en) 2006-07-19
ITRM20010294A1 (it) 2002-11-29
DE60213237D1 (de) 2006-08-31
MXPA03010921A (es) 2004-02-27
EP1399142A1 (en) 2004-03-24
ITRM20010294A0 (it) 2001-05-29

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