DK1965823T3 - Fremgangsmåder til indgivelse af hypoglykæmiske midler - Google Patents

Fremgangsmåder til indgivelse af hypoglykæmiske midler Download PDF

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Publication number
DK1965823T3
DK1965823T3 DK06839697.7T DK06839697T DK1965823T3 DK 1965823 T3 DK1965823 T3 DK 1965823T3 DK 06839697 T DK06839697 T DK 06839697T DK 1965823 T3 DK1965823 T3 DK 1965823T3
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DK
Denmark
Prior art keywords
glp
use according
agonist composition
composition
polypeptide
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DK06839697.7T
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English (en)
Inventor
Mark A Bush
Mary Colleen O'neill
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Glaxosmithkline Llc Corp Service Company
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Application filed by Glaxosmithkline Llc Corp Service Company filed Critical Glaxosmithkline Llc Corp Service Company
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Publication of DK1965823T3 publication Critical patent/DK1965823T3/da

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22Hormones
    • A61K38/26Glucagons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/155Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
    • 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
    • A61K31/425Thiazoles
    • A61K31/4261,3-Thiazoles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/64Sulfonylureas, e.g. glibenclamide, tolbutamide, chlorpropamide
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22Hormones
    • A61K38/28Insulins
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/38Albumins
    • A61K38/385Serum albumin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/04Anorexiants; Antiobesity agents
    • 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

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Diabetes (AREA)
  • Endocrinology (AREA)
  • Hematology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Obesity (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Dermatology (AREA)
  • Emergency Medicine (AREA)
  • Child & Adolescent Psychology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Claims (21)

1. Glucagon-lignende peptid-(GLP-l)-agonistsammensætning omfattende mindst ét polypeptid, der har GLP-l-aktivitet, til anvendelse i en fremgangsmåde til behandling af Type-1 diabetes, Type-II diabetes, fedme eller hyperglykæmi, kendetegnet ved, at sammensætningen indgives subkutant via en injektionsindretning omfattende et rør, der har en nål-gauge på 28 eller højere, og hvor sammensætningen indgives én gang ugentligt, og yderligere, hvor sammensætningen omfatter 0,01 mg til 104 mg af polypeptidet, der har GLP-l-aktivitet.
2. GLP-l-agonistsammensætning til anvendelse ifølge krav 1, omfattende mindst to G LP-1-fragmenter eller -varianter, hvor de mindst to G LP-1-fragmenter eller -varianter er tandem-orienteret.
3. GLP-l-agonistsammensætning til anvendelse ifølge krav 1, hvor det mindst éne polypeptid omfatter GLP-1 eller et fragment, en variant eller et konjugat deraf.
4. GLP-l-agonistsammensætning til anvendelse ifølge krav 3, hvor det mindst éne polypeptid yderligere omfatter humant serumalbumin.
5. GLP-l-agonistsammensætning til anvendelse ifølge krav 4, hvor det humane serumalbumin er genetisk splejset sammen med nævnte GLP-1 eller fragmentet eller varianten deraf.
6. GLP-l-agonistsammensætning til anvendelse ifølge et hvilket som helst af krav 3 til 5, hvor GLP-1-fragmentet eller -varianten deraf omfatter GLP-1(7-36(A8G)).
7. GLP-l-agonistsammensætning til anvendelse ifølge krav 6, hvor GLP-1-fragmentet eller -varianten deraf omfatter mindst to GLP-1(7-36(A8G)) tandem-orienteret og genetisk splejset sammen med det humane serumalbumin.
8. GLP-l-agonistsammensætning til anvendelse ifølge krav 7, hvor de mindst to GLP-1(7-36(A8G)) er genetisk splejset sammen ved N-terminalen af det humane serumalbumin.
9. GLP-l-agonistsammensætning til anvendelse ifølge et hvilket som helst foregående krav, hvor mindst ét polypeptid, der har GLP-l-aktivitet omfatter SEQ ID NO: 1.
10. GLP-l-agonistsammensætning til anvendelse ifølge et hvilket som helst foregående krav, hvor GLP-l-agonistsammensætningen er frysetørret.
11. GLP-l-agonistsammensætning til anvendelse ifølge krav 10, yderligere omfattende at iblande GLP-l-agonistsammensætningen en væske forud for indgivelse af GLP-l-agonistsammensætningen.
12. GLP-l-agonistsammensætning til anvendelse ifølge et hvilket som helst foregående krav, hvor GLP-l-agonistsammensætningen er i væskeform.
13. GLP-l-agonistsammensætning til anvendelse ifølge et hvilket som helst foregående krav, hvor GLP-l-agonistsammensætningen indgives via selv-indgivelse.
14. GLP-l-agonistsammensætning til anvendelse ifølge et hvilket som helst foregående krav, hvor injektionsindretningen er genanvendelig.
15. GLP-l-agonistsammensætning til anvendelse ifølge et hvilket som helst foregående krav, hvor injektionsindretningen er en engangsvare.
16. GLP-l-agonistsammensætning til anvendelse ifølge et hvilket som helst foregående krav, hvor injektionsindretningen omfatter en nål.
17. GLP-l-agonistsammensætning til anvendelse ifølge et hvilket som helst foregående krav, hvor injektionsindretningen omfatter et kateter.
18. GLP-l-agonistsammensætning til anvendelse ifølge krav 1, hvor mindst ét poly-peptid, der har GLP-l-aktivitet, indgives i en dosis på omkring 0,25 mg til omkring 32 mg ugentligt.
19. GLP-l-agonistsammensætning til anvendelse ifølge et hvilket som helst foregående krav, yderligere omfattende trinnet af at co-indgive en forbindelse valgt fra gruppen af: peroxisom-prolifererende-aktiveret receptor-ligand, thiazolidindion, metformin, insulin, og sulfonylurea.
20. Injektionsindretning omfattende et rør, der har en gauge på 28 eller højere og yderligere omfattende en GLP-l-agonistsammensætning til anvendelse ifølge et hvilket som helst af krav 1 til 19.
21. GLP-l-agonistsammensætning til anvendelse ifølge et hvilket som helst af krav 1 til 19, hvor sygdommen erType-II diabetes.
DK06839697.7T 2005-11-04 2006-11-03 Fremgangsmåder til indgivelse af hypoglykæmiske midler DK1965823T3 (da)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US73392005P 2005-11-04 2005-11-04
US74260005P 2005-12-06 2005-12-06
PCT/US2006/060508 WO2007056681A2 (en) 2005-11-04 2006-11-03 Methods for administering hypoglycemic agents

Publications (1)

Publication Number Publication Date
DK1965823T3 true DK1965823T3 (da) 2016-08-22

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ID=38024051

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DK06839697.7T DK1965823T3 (da) 2005-11-04 2006-11-03 Fremgangsmåder til indgivelse af hypoglykæmiske midler

Country Status (13)

Country Link
US (4) US8202837B2 (da)
EP (2) EP3095456A1 (da)
JP (2) JP2009514900A (da)
CY (1) CY1118007T1 (da)
DK (1) DK1965823T3 (da)
ES (1) ES2586236T3 (da)
HR (1) HRP20160866T1 (da)
HU (2) HUE029798T2 (da)
LT (2) LT1965823T (da)
PL (1) PL1965823T3 (da)
PT (1) PT1965823T (da)
SI (1) SI1965823T1 (da)
WO (1) WO2007056681A2 (da)

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Publication number Publication date
JP2014159431A (ja) 2014-09-04
HUS1600047I1 (hu) 2017-01-30
ES2586236T3 (es) 2016-10-13
EP1965823A4 (en) 2010-08-04
CY1118007T1 (el) 2017-05-17
SI1965823T1 (sl) 2016-09-30
US20130225489A1 (en) 2013-08-29
PL1965823T3 (pl) 2017-08-31
US8202837B2 (en) 2012-06-19
US20130231282A1 (en) 2013-09-05
EP1965823A2 (en) 2008-09-10
LT1965823T (lt) 2016-10-10
JP2009514900A (ja) 2009-04-09
WO2007056681A3 (en) 2008-04-10
PT1965823T (pt) 2016-08-18
EP3095456A1 (en) 2016-11-23
WO2007056681A2 (en) 2007-05-18
EP1965823B1 (en) 2016-05-18
HRP20160866T1 (hr) 2016-10-07
HUE029798T2 (en) 2017-03-28
US20160022781A1 (en) 2016-01-28
LTPA2016032I1 (lt) 2016-12-12
US20080254087A1 (en) 2008-10-16

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