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WO2014008374A3 - Combination therapies comprising metformin salts and antihyperglycemia agents or antihyperlipidemia agents - Google Patents

Combination therapies comprising metformin salts and antihyperglycemia agents or antihyperlipidemia agents Download PDF

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Publication number
WO2014008374A3
WO2014008374A3 PCT/US2013/049285 US2013049285W WO2014008374A3 WO 2014008374 A3 WO2014008374 A3 WO 2014008374A3 US 2013049285 W US2013049285 W US 2013049285W WO 2014008374 A3 WO2014008374 A3 WO 2014008374A3
Authority
WO
WIPO (PCT)
Prior art keywords
agents
antihyperglycemia
metformin
antihyperlipidemia
combination therapies
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.)
Ceased
Application number
PCT/US2013/049285
Other languages
French (fr)
Other versions
WO2014008374A2 (en
Inventor
Banavara L. Mylari
Frank C. SCIAVOLINO
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Thetis Pharmaceuticals LLC
Original Assignee
Thetis Pharmaceuticals LLC
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 Thetis Pharmaceuticals LLC filed Critical Thetis Pharmaceuticals LLC
Publication of WO2014008374A2 publication Critical patent/WO2014008374A2/en
Publication of WO2014008374A3 publication Critical patent/WO2014008374A3/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/13—Amines
    • A61K31/155—Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/20—Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids
    • A61K31/202—Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids having three or more double bonds, e.g. linolenic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • A61K31/4439—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/04—Anorexiants; Antiobesity agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/06—Antihyperlipidemics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/06—Antiarrhythmics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Biophysics (AREA)
  • Endocrinology (AREA)
  • Emergency Medicine (AREA)
  • Urology & Nephrology (AREA)
  • Child & Adolescent Psychology (AREA)
  • Vascular Medicine (AREA)
  • Molecular Biology (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

The present invention is directed to a combination therapy comprising metformin eicosapentaenoate or metformin docosahexaenoate, or a mixture thereof, and an antihyperglycemic agent or an antihyperlipidemic agent, or a pharmaceutically-acceptable salt or prodrug thereof, or a pharmaceutically-acceptable salt of said prodrug. The invention further relates to methods of treating a metabolic disorder selected from the group consisting of type 2 diabetes (T2D), pre-diabetes, obesity, metabolic syndrome, hypertrilipidemia and T2D complications such as neuropathy, nephropathy, retinopathy, cataracts and cardiovascular complications, including cardiac arrhythmia, myocardial infarction, stroke, and cardiomyopathy in diabetic patients.
PCT/US2013/049285 2012-07-06 2013-07-03 Combination therapies comprising metformin salts and antihyperglycemia agents or antihyperlipidemia agents Ceased WO2014008374A2 (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201261668496P 2012-07-06 2012-07-06
US201261668495P 2012-07-06 2012-07-06
US61/668,496 2012-07-06
US61/668,495 2012-07-06

Publications (2)

Publication Number Publication Date
WO2014008374A2 WO2014008374A2 (en) 2014-01-09
WO2014008374A3 true WO2014008374A3 (en) 2014-02-27

Family

ID=49882604

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2013/049285 Ceased WO2014008374A2 (en) 2012-07-06 2013-07-03 Combination therapies comprising metformin salts and antihyperglycemia agents or antihyperlipidemia agents

Country Status (1)

Country Link
WO (1) WO2014008374A2 (en)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016075539A1 (en) * 2014-11-10 2016-05-19 Промомед Холдинге Лимитед Composition for use in the treatment of disorders associated with overweight or obesity
BR112021002387A2 (en) * 2018-08-09 2021-05-11 Dalcor Pharma Uk Ltd., Leatherhead, Zug Branch methods for delaying the occurrence of new-onset type 2 diabetes and for reducing the progression and treatment of type 2 diabetes
CN119997931A (en) * 2021-12-30 2025-05-13 纽阿姆斯特丹制药公司 Obicetrapib and SGLT2 inhibitor combination
CN115192625A (en) * 2022-06-30 2022-10-18 山东海赜生物科技有限公司 an oral composition
EP4642454A1 (en) * 2022-12-30 2025-11-05 Shenzhen Hightide Biopharmaceutical Ltd. Pharmaceutical combinations and compositions, and methods of use thereof
WO2024226537A1 (en) * 2023-04-24 2024-10-31 Newamsterdam Pharma B.V. Amorphous obicetrapib and sglt2 inhibitor combination

Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6031004A (en) * 1997-12-08 2000-02-29 Bristol-Myers Squibb Company Salts of metformin and method
WO2003097039A1 (en) * 2002-05-21 2003-11-27 Bernard Charles Sherman Stable dosage forms comprising atorvastatin calcium
US20030220301A1 (en) * 2002-02-14 2003-11-27 Sonus Pharmaceuticals, Inc. Metformin salts of lipophilic acids
US20050272814A1 (en) * 2004-06-04 2005-12-08 Keisuke Inoue Medicine for prevention or treatment of diabetes
WO2008053340A1 (en) * 2006-11-03 2008-05-08 Pronova Biopharma Norge As A combination product comprising at least one lipid substituted in the alpha position and at least one hypoglycemic agent
US20110098240A1 (en) * 2007-08-16 2011-04-28 Boehringer Ingelheim International Gmbh Pharmaceutical composition comprising a sglt2 inhibitor in combination with a dpp-iv inhibitor
US20110218142A1 (en) * 2004-02-23 2011-09-08 Trustees Of Tufts College Inhibitors of Dipeptidylpeptidase IV
US20110301182A1 (en) * 2009-01-07 2011-12-08 Boehringer Ingelheim International Gmbh Treatment for diabetes in patients with inadequate glycemic control despite metformin therapy comprising a DPP-IV inhibitor
US8088743B2 (en) * 2007-03-22 2012-01-03 Bristol-Myers Squibb Company Methods for treating obesity employing an SGLT2 inhibitor
US20120041069A1 (en) * 2008-10-17 2012-02-16 Nectid Inc. Sglt2 inhibitor dosage forms

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6031004A (en) * 1997-12-08 2000-02-29 Bristol-Myers Squibb Company Salts of metformin and method
US20030220301A1 (en) * 2002-02-14 2003-11-27 Sonus Pharmaceuticals, Inc. Metformin salts of lipophilic acids
WO2003097039A1 (en) * 2002-05-21 2003-11-27 Bernard Charles Sherman Stable dosage forms comprising atorvastatin calcium
US20110218142A1 (en) * 2004-02-23 2011-09-08 Trustees Of Tufts College Inhibitors of Dipeptidylpeptidase IV
US20050272814A1 (en) * 2004-06-04 2005-12-08 Keisuke Inoue Medicine for prevention or treatment of diabetes
WO2008053340A1 (en) * 2006-11-03 2008-05-08 Pronova Biopharma Norge As A combination product comprising at least one lipid substituted in the alpha position and at least one hypoglycemic agent
US8088743B2 (en) * 2007-03-22 2012-01-03 Bristol-Myers Squibb Company Methods for treating obesity employing an SGLT2 inhibitor
US20110098240A1 (en) * 2007-08-16 2011-04-28 Boehringer Ingelheim International Gmbh Pharmaceutical composition comprising a sglt2 inhibitor in combination with a dpp-iv inhibitor
US20120041069A1 (en) * 2008-10-17 2012-02-16 Nectid Inc. Sglt2 inhibitor dosage forms
US20110301182A1 (en) * 2009-01-07 2011-12-08 Boehringer Ingelheim International Gmbh Treatment for diabetes in patients with inadequate glycemic control despite metformin therapy comprising a DPP-IV inhibitor

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
ALEXANDROV, A.A.: "Metformin - «miledi» sakharnogo diabeta.", RUSSKY MEDITSINSKY ZHOURNAL, no. 14, 18 June 2012 (2012-06-18), pages 666 - 671, Retrieved from the Internet <URL:http://www.rmj.ru/numbers_584.htm> [retrieved on 20130423] *

Also Published As

Publication number Publication date
WO2014008374A2 (en) 2014-01-09

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