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WO2005005477A3 - Stabilised insulin compositions - Google Patents

Stabilised insulin compositions Download PDF

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Publication number
WO2005005477A3
WO2005005477A3 PCT/DK2004/000481 DK2004000481W WO2005005477A3 WO 2005005477 A3 WO2005005477 A3 WO 2005005477A3 DK 2004000481 W DK2004000481 W DK 2004000481W WO 2005005477 A3 WO2005005477 A3 WO 2005005477A3
Authority
WO
WIPO (PCT)
Prior art keywords
analogues
insulin
insulin compositions
stabilised insulin
compositions
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/DK2004/000481
Other languages
French (fr)
Other versions
WO2005005477A2 (en
Inventor
Ib Jonassen
Sven Havelund
Thomas Boerglund Kjeldsen
Ulla Ribel-Madsen
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.)
Novo Nordisk AS
Original Assignee
Novo Nordisk AS
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 Novo Nordisk AS filed Critical Novo Nordisk AS
Priority to EP04738978A priority Critical patent/EP1644411A2/en
Publication of WO2005005477A2 publication Critical patent/WO2005005477A2/en
Publication of WO2005005477A3 publication Critical patent/WO2005005477A3/en
Priority to US11/328,606 priority patent/US20060183667A1/en
Anticipated expiration legal-status Critical
Priority to US12/476,712 priority patent/US20090239784A1/en
Priority to US13/080,162 priority patent/US20110245163A1/en
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/28—Insulins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/48—Drugs for disorders of the endocrine system of the pancreatic hormones
    • A61P5/50—Drugs for disorders of the endocrine system of the pancreatic hormones for increasing or potentiating the activity of insulin
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/575—Hormones
    • C07K14/62—Insulins

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Diabetes (AREA)
  • Medicinal Chemistry (AREA)
  • Endocrinology (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Zoology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Immunology (AREA)
  • Toxicology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

The present invention relates to human insulin analogues having a fast onset of action. These analogues may have amino acid in position B26 is substituted with Phe, or be Des(B30) analogues of human insulin. The invention also relates to compositions comprising such insulin analogues, and to compositions comprising a mixture of an insulin analogue having a fast onset of action and insulin having a protracted action.
PCT/DK2004/000481 2003-07-11 2004-07-05 Stabilised insulin compositions Ceased WO2005005477A2 (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
EP04738978A EP1644411A2 (en) 2003-07-11 2004-07-05 Stabilised insulin compositions
US11/328,606 US20060183667A1 (en) 2003-07-11 2006-01-10 Stabilised insulin compositions
US12/476,712 US20090239784A1 (en) 2003-07-11 2009-06-02 Stablised Insulin Compositions
US13/080,162 US20110245163A1 (en) 2003-07-11 2011-04-05 Stabilised Insulin Compositions

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
DKPA200301065 2003-07-11
DKPA200301065 2003-07-11
US48768303P 2003-07-16 2003-07-16
US60/487,683 2003-07-16

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US11/328,606 Continuation US20060183667A1 (en) 2003-07-11 2006-01-10 Stabilised insulin compositions

Publications (2)

Publication Number Publication Date
WO2005005477A2 WO2005005477A2 (en) 2005-01-20
WO2005005477A3 true WO2005005477A3 (en) 2005-03-24

Family

ID=34066438

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/DK2004/000481 Ceased WO2005005477A2 (en) 2003-07-11 2004-07-05 Stabilised insulin compositions

Country Status (2)

Country Link
EP (1) EP1644411A2 (en)
WO (1) WO2005005477A2 (en)

Families Citing this family (48)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8067362B2 (en) 2005-02-02 2011-11-29 Novo Nordisk As Insulin derivatives
EP2292653B1 (en) 2005-02-02 2014-05-21 Novo Nordisk A/S Novel insulin derivatives
ES2371361T3 (en) 2005-12-28 2011-12-30 Novo Nordisk A/S COMPOSITIONS THAT INCLUDE AN INSULIN ACILADA AND ZINC AND METHOD OF PRODUCTION OF SUCH COMPOSITIONS.
EP2256129B1 (en) 2006-02-27 2012-05-09 Novo Nordisk A/S Insulin derivatives
JP5269766B2 (en) 2006-05-09 2013-08-21 ノボ・ノルデイスク・エー／エス Insulin derivative
EP2015770B1 (en) * 2006-05-09 2012-09-26 Novo Nordisk A/S Insulin derivative
DE102006031962A1 (en) * 2006-07-11 2008-01-17 Sanofi-Aventis Deutschland Gmbh Amidated insulin glargine
KR20090047458A (en) 2006-08-08 2009-05-12 사노피-아벤티스 Arylaminoaryl-alkyl-substituted imidazolidine-2,4-diones, methods of preparation thereof, medicaments comprising these compounds and uses thereof
PL2074141T3 (en) 2006-09-22 2017-02-28 Novo Nordisk A/S Protease resistant insulin analogues
DE102007005045B4 (en) 2007-01-26 2008-12-18 Sanofi-Aventis Phenothiazine derivatives, process for their preparation and their use as medicines
US9387176B2 (en) 2007-04-30 2016-07-12 Novo Nordisk A/S Method for drying a protein composition, a dried protein composition and a pharmaceutical composition comprising the dried protein
ES2744384T3 (en) 2007-06-13 2020-02-24 Novo Nordisk As Pharmaceutical formulation comprising an insulin derivative
EP2025674A1 (en) 2007-08-15 2009-02-18 sanofi-aventis Substituted tetra hydro naphthalines, method for their manufacture and their use as drugs
JP5715418B2 (en) 2007-11-08 2015-05-07 ノボ・ノルデイスク・エー／エス Insulin derivative
DE102007063671A1 (en) 2007-11-13 2009-06-25 Sanofi-Aventis Deutschland Gmbh New crystalline diphenylazetidinone hydrates, medicaments containing these compounds and their use
ES2618073T3 (en) 2008-03-14 2017-06-20 Novo Nordisk A/S Insulin analogs stabilized against proteases
PT2254906T (en) 2008-03-18 2017-01-03 Novo Nordisk As Protease stabilized, acylated insulin analogues
UY31968A (en) 2008-07-09 2010-01-29 Sanofi Aventis NEW HETEROCYCLIC DERIVATIVES, THEIR PROCESSES FOR THEIR PREPARATION, AND THEIR THERAPEUTIC USES
ES2607003T3 (en) 2008-10-30 2017-03-28 Novo Nordisk A/S Treatment of diabetes mellitus using insulin injections with an injection frequency less than daily
WO2010068601A1 (en) 2008-12-08 2010-06-17 Sanofi-Aventis A crystalline heteroaromatic fluoroglycoside hydrate, processes for making, methods of use and pharmaceutical compositions thereof
CA2771278A1 (en) 2009-08-26 2011-03-03 Sanofi Novel crystalline heteroaromatic fluoroglycoside hydrates, pharmaceuticals comprising these compounds and their use
WO2011107494A1 (en) 2010-03-03 2011-09-09 Sanofi Novel aromatic glycoside derivatives, medicaments containing said compounds, and the use thereof
DE102010015123A1 (en) 2010-04-16 2011-10-20 Sanofi-Aventis Deutschland Gmbh New benzylamidic diphenylazetidinone compounds, useful for treating lipid disorders, hyperlipidemia, atherosclerotic manifestations or insulin resistance, and for reducing serum cholesterol levels
WO2011157827A1 (en) 2010-06-18 2011-12-22 Sanofi Azolopyridin-3-one derivatives as inhibitors of lipases and phospholipases
US8530413B2 (en) 2010-06-21 2013-09-10 Sanofi Heterocyclically substituted methoxyphenyl derivatives with an oxo group, processes for preparation thereof and use thereof as medicaments
TW201215387A (en) 2010-07-05 2012-04-16 Sanofi Aventis Spirocyclically substituted 1,3-propane dioxide derivatives, processes for preparation thereof and use thereof as a medicament
TW201215388A (en) 2010-07-05 2012-04-16 Sanofi Sa (2-aryloxyacetylamino)phenylpropionic acid derivatives, processes for preparation thereof and use thereof as medicaments
TW201221505A (en) 2010-07-05 2012-06-01 Sanofi Sa Aryloxyalkylene-substituted hydroxyphenylhexynoic acids, process for preparation thereof and use thereof as a medicament
BR112013010345A2 (en) 2010-10-27 2017-07-25 Novo Nordisk As diabetes mellitus treatment using insulin injections administered at varying injection intervals
WO2012120058A1 (en) 2011-03-08 2012-09-13 Sanofi Oxathiazine derivatives which are substituted with benzyl or heteromethylene groups, method for producing them, their use as medicine and drug containing said derivatives and the use thereof
WO2012120056A1 (en) 2011-03-08 2012-09-13 Sanofi Tetrasubstituted oxathiazine derivatives, method for producing them, their use as medicine and drug containing said derivatives and the use thereof
US8828995B2 (en) 2011-03-08 2014-09-09 Sanofi Branched oxathiazine derivatives, method for the production thereof, use thereof as medicine and drug containing said derivatives and use thereof
US8901114B2 (en) 2011-03-08 2014-12-02 Sanofi Oxathiazine derivatives substituted with carbocycles or heterocycles, method for producing same, drugs containing said compounds, and use thereof
EP2683703B1 (en) 2011-03-08 2015-05-27 Sanofi Novel substituted phenyl-oxathiazine derivatives, method for producing them, drugs containing said compounds and the use thereof
WO2012120050A1 (en) 2011-03-08 2012-09-13 Sanofi Novel substituted phenyl-oxathiazine derivatives, method for producing them, drugs containing said compounds and the use thereof
WO2012120054A1 (en) 2011-03-08 2012-09-13 Sanofi Di- and tri-substituted oxathiazine derivates, method for the production thereof, use thereof as medicine and drug containing said derivatives and use thereof
US8710050B2 (en) 2011-03-08 2014-04-29 Sanofi Di and tri- substituted oxathiazine derivatives, method for the production, method for the production thereof, use thereof as medicine and drug containing said derivatives and use thereof
US8809325B2 (en) 2011-03-08 2014-08-19 Sanofi Benzyl-oxathiazine derivatives substituted with adamantane and noradamantane, medicaments containing said compounds and use thereof
WO2013037390A1 (en) 2011-09-12 2013-03-21 Sanofi 6-(4-hydroxy-phenyl)-3-styryl-1h-pyrazolo[3,4-b]pyridine-4-carboxylic acid amide derivatives as kinase inhibitors
EP2567959B1 (en) 2011-09-12 2014-04-16 Sanofi 6-(4-hydroxy-phenyl)-3-styryl-1h-pyrazolo[3,4-b]pyridine-4-carboxylic acid amide derivatives as kinase inhibitors
WO2013045413A1 (en) 2011-09-27 2013-04-04 Sanofi 6-(4-hydroxy-phenyl)-3-alkyl-1h-pyrazolo[3,4-b]pyridine-4-carboxylic acid amide derivatives as kinase inhibitors
KR20150002777A (en) 2012-04-11 2015-01-07 노보 노르디스크 에이/에스 Insulin formulations
US10137172B2 (en) 2013-04-30 2018-11-27 Novo Nordisk A/S Administration regime
RU2673185C2 (en) 2013-10-07 2018-11-22 Ново Нордиск А/С Novel derivative of insulin analogue
AR099569A1 (en) 2014-02-28 2016-08-03 Novo Nordisk As INSULIN DERIVATIVES AND THE MEDICAL USES OF THESE
BR112019011761A2 (en) 2016-12-16 2019-11-05 Novo Nordisk As insulin-containing pharmaceutical compositions
US10335464B1 (en) 2018-06-26 2019-07-02 Novo Nordisk A/S Device for titrating basal insulin
JP7518149B2 (en) 2019-07-12 2024-07-17 ノヴォ ノルディスク アー／エス High-concentration insulin preparations

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5618913A (en) * 1985-08-30 1997-04-08 Novo Nordisk A/S Insulin analogues
WO2000069901A2 (en) * 1999-05-19 2000-11-23 Xencor, Inc. Proteins with insulin-like activity useful in the treatment of diabetes

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5618913A (en) * 1985-08-30 1997-04-08 Novo Nordisk A/S Insulin analogues
WO2000069901A2 (en) * 1999-05-19 2000-11-23 Xencor, Inc. Proteins with insulin-like activity useful in the treatment of diabetes

Non-Patent Citations (8)

* Cited by examiner, † Cited by third party
Title
HEINEMANN L ET AL: "Action profile of the rapid acting insulin analogue: human insulin B28Asp.", DIABETIC MEDICINE : A JOURNAL OF THE BRITISH DIABETIC ASSOCIATION. JUL 1993, vol. 10, no. 6, July 1993 (1993-07-01), pages 535 - 539, XP008041638, ISSN: 0742-3071 *
HELLER SIMON R: "Insulin analogues.", CURRENT MEDICAL RESEARCH AND OPINION. 2002, vol. 18 Suppl 1, 2002, pages s40 - s47, XP002249365, ISSN: 0300-7995 *
HU SHI-QUAN ET AL: "Contribution of the B16 and B26 tyrosine residues to the biological activity of insulin", JOURNAL OF PROTEIN CHEMISTRY, vol. 12, no. 6, 1993, pages 741 - 747, XP008041533, ISSN: 0277-8033 *
KURAPKAT G ET AL: "THE SOLUTION STRUCTURE OF A SUPERPOTENT B-CHAIN-SHORTENED SINGLE-REPLACEMENT INSULIN ANALOGUE", PROTEIN SCIENCE, CAMBRIDGE UNIVERSITY PRESS, CAMBRIDGE, GB, vol. 8, 1999, pages 499 - 508, XP001079187, ISSN: 0961-8368 *
MIRMIRA R G ET AL: "IMPORTANCE OF THE CHARACTER AND CONFIGURATION OF RESIDUES B24 B25 AND B26 IN INSULIN-RECEPTOR INTERACTIONS", JOURNAL OF BIOLOGICAL CHEMISTRY, vol. 266, no. 3, 1991, pages 1428 - 1436, XP002313977, ISSN: 0021-9258 *
ROACH PARIS ET AL: "Clinical pharmacokinetics and pharmacodynamics of insulin lispro mixtures", CLINICAL PHARMACOKINETICS, vol. 41, no. 13, 2002, pages 1043 - 1057, XP008041674, ISSN: 0312-5963 *
XU BIN ET AL: "Diabetes-associated mutations in insulin: Consecutive residues in the B chain contact distinct domains of the insulin receptor", BIOCHEMISTRY, vol. 43, no. 26, 6 July 2004 (2004-07-06), pages 8356 - 8372, XP002313979, ISSN: 0006-2960 *
ZAKOVA LENKA ET AL: "Shortened insulin analogues: Marked changes in biological activity resulting from replacement of TyrB26 and N-methylation of peptide bonds in the C-terminus of the B-chain.", BIOCHEMISTRY, vol. 43, no. 8, 2 March 2004 (2004-03-02), pages 2323 - 2331, XP002313978, ISSN: 0006-2960 *

Also Published As

Publication number Publication date
EP1644411A2 (en) 2006-04-12
WO2005005477A2 (en) 2005-01-20

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