DK2187879T3 - Farmaceutisk sammensætning omfattende et glucopyranosyl-substitueret benzenderivat. - Google Patents

Farmaceutisk sammensætning omfattende et glucopyranosyl-substitueret benzenderivat. Download PDF

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DK2187879T3
DK2187879T3 DK08787264.4T DK08787264T DK2187879T3 DK 2187879 T3 DK2187879 T3 DK 2187879T3 DK 08787264 T DK08787264 T DK 08787264T DK 2187879 T3 DK2187879 T3 DK 2187879T3
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pharmaceutical composition
inhibitor
dpp
glucopyranosyl
substituted benzene
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DK08787264.4T
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Klaus Dugi
Michael Mark
Leo Thomas
Frank Himmelsbach
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Boehringer Ingelheim Int
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    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
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    • A61K31/52—Purines, e.g. adenine
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Claims (19)

1. Farmaceutisk sammensætning omfattende det glucopyranosyl-substituerede ben-zenderivat l-chlor-4-(p-D-glucopyranos-l-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy)-benzyl]-benzen i kombination med DPP-IV-inhibitoren l-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-l-yl)-8-(3-(R)-amino-pipendin-l-yl)-xanthin eller et farmaceutisk acceptabelt salt deraf.
2. Farmaceutisk sammensætning ifølge krav 1, kendetegnet ved, at sammensætningen er egnet til kombineret eller samtidig eller sekventiel anvendelse af det glucopyranosyl-substituerede benzenderivat og DPP-IV-inhibitoren.
3. Farmaceutisk sammensætning ifølge ét af de foregående krav, kendetegnet ved, at det glucopyranosyl-substituerede benzenderivat og DPP-IV-inhibitoren er til stede i en enkelt doseringsform.
4. Farmaceutisk sammensætning ifølge ét af de foregående krav, kendetegnet ved, at det glucopyranosyl-substituerede benzenderivat og DPP-IV-inhibitoren er hver til stede i en separat doseringsform.
5. Farmaceutisk sammensætning ifølge ét af de foregående krav, omfattende en mængde af 5 til 50 mg af det glucopyranosyl-substituerede benzenderivat.
6. Farmaceutisk sammensætning ifølge krav 5, omfattende en mængde af 5 mg, 10 mg, 15 mg, 20 mg, 25 mg eller 50 mg af det glucopyranosyl-substituerede benzenderivat.
7. Farmaceutisk sammensætning ifølge ét af de foregående krav, omfattende en mængde af 0,5 til 10 mg af DPP-IV-inhibitoren.
8. Farmaceutisk sammensætning ifølge krav 7, omfattende en mængde af 1 mg, 2,5 mg eller 5 mg af DPP-IV-inhibitoren.
9. Farmaceutisk sammensætning ifølge krav 1, 2, 3 eller 4, omfattende en mængde af 5 til 50 mg af det glucopyranosyl-substituerede benzenderivat og en mængde af 0,5 til 10 mg af DPP-IV-inhibitoren.
10. Farmaceutisk sammensætning ifølge ét hvilket som helst af de foregående krav, kendetegnet ved, at den farmaceutiske sammensætning er formuleret til oral indgivelse i fast form.
11. Farmaceutisk sammensætning ifølge ét af kravene 1 til 10, til anvendelse af -at forebygge, at bremse progressionen af, at udskyde eller at behandle en stofskiftelidelse valgt fra gruppen bestående af diabetes mellitus type 1, diabetes mellitus type 2, nedsat glukosetolerance, let forhøjet fasteblodsukker, hyperglykæmi, postprandial hy-perglykæmi, overvægt, fedme og metabolisk syndrom; eller - at forbedre glykæmisk kontrol og/eller til at reducere fasteplasmaglukose, postprandial plasmaglukose og/eller glykosyleret hæmoglobin HbAlc; eller - at forebygge, at bremse, at udskyde eller at vende progression fra nedsat glukosetolerance, let forhøjet fasteblodsukker, insulinresistens og/eller fra metabolisk syndrom til type 2-diabetes mellitus; eller - at forebygge, at bremse progressionen af, at udskyde eller at behandle en tilstand eller lidelse valgt fra gruppen bestående af komplikationer af diabetes mellitus såsom katarakt og mikro- og macrovaskulære sygdomme, såsom nefropati, retinopati, neuropati, vævsiskæmi, arteriosklerose, myokardieinfarkt, slagtilfælde og perifer arteriel okklusiv sygdom; eller - at reducere legemsvægt eller at forebygge en forøgelse af legemsvægt eller at faci-litere en reduktion i legemsvægt; eller - at forebygge, at bremse, at udskyde eller at behandle degenereringen af pankreati-ske beta-celler og/eller nedgangen i pankreatiske beta-cellefunktionalitet og/eller for at forbedre og/eller at genoprette funktionaliteten af pankreatiske beta-celler og/eller at genoprette funktionaliteten af pankreatisk insulinsekretion; eller - at forebygge, at bremse, at udskyde eller at behandle sygdomme eller tilstande henført af en abnorm akkumulering af leverfedt; eller - at opretholde og/eller at forbedre insulinsensitiviteten og/eller til at behandle eller at forebygge hyperinsulinæmi og/eller insulinresistens; hos en patient med behov derfor.
12. Farmaceutisk sammensætning ifølge krav 11 til anvendelse i forbedringen af gly-kæmisk kontrol i patienter med diabetes mellitus type 2.
13. Farmaceutisk sammensætning til anvendelse ifølge krav 11 eller 12, k e n d e t e g n e t ved, at det glucopyranosyl-substituerede benzenderivat indgives i kombination eller skiftevis med DPP-IV-inhibitoren.
14. Farmaceutisk sammensætning til anvendelse ifølge krav 11, 12 eller 13, hvor patienten er et individ diagnosticeret med én eller flere af tilstandene valgt fra gruppen bestående af overvægt, fedme, visceral fedme og abdominal fedme.
15. Farmaceutisk sammensætning til anvendelse ifølge krav 11, 12 eller 13, hvor patienten er et individ, der viser én, to eller flere af de følgende tilstande: (a) en fasteblodglukose- eller serumglukosekoncentration større end 110 mg/dL, i særdeleshed større end 125 mg/dL; (b) en postprandial plasmaglukose lig med eller større end 140 mg/dL; (c) en HbAlc værdig lig med eller større end 6,5 %, i særdeleshed lig med eller større end 8,0 %.
16. Farmaceutisk sammensætning til anvendelse ifølge krav 11, 12 eller 13, hvor patienten er et individ, hvor én, to, tre eller flere af de følgende tilstande er til stede: (a) fedme, visceral fedme og/eller abdominal fedme, (b) blodniveau af triglycerid > 150 mg/dL, (c) blodniveau af HDL- kolesterol < 40 mg/dL i kvindelige patienter og < 50 mg/dL i mandlige patienter, (d) et systolisk blodtryk > 130 mm Hg og et diastolisk blodtryk > 85 mm Hg, (e) et fasteblodglukoseniveau > 110 mg/dL.
17. Farmaceutisk sammensætning til anvendelse ifølge krav 11, 12 eller 13, hvor patienten er et individ for hvem monoterapien med metformin er kontraindiceret og/eller hvem der har en intolerance mod metformin ved terapeutiske doser.
18. Farmaceutisk sammensætning til anvendelse ifølge krav 11, 12 eller 13, hvor patienten er et individ med insufficient glykæmisk kontrol til trods for monoterapi med en SGLT2-inhibitor, i særdeleshed det glucopyranosyl-substituerede benzenderivat ifølge krav 1.
19. Farmaceutisk sammensætning til anvendelse ifølge krav 11, 12 eller 13, hvor patienten er et individ med insufficient glykæmisk kontrol til trods for monoterapi med en DPP-IV-inhibitor, i særdeleshed DPP-IV-inhibitoren ifølge krav 1.
DK08787264.4T 2007-08-16 2008-08-15 Farmaceutisk sammensætning omfattende et glucopyranosyl-substitueret benzenderivat. DK2187879T3 (da)

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Application Number Priority Date Filing Date Title
EP07114459 2007-08-16
PCT/EP2008/060736 WO2009022007A1 (en) 2007-08-16 2008-08-15 Pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivative

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DK2187879T3 true DK2187879T3 (da) 2017-01-09

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US7501426B2 (en) 2004-02-18 2009-03-10 Boehringer Ingelheim International Gmbh 8-[3-amino-piperidin-1-yl]-xanthines, their preparation and their use as pharmaceutical compositions
CN103030617A (zh) * 2004-03-16 2013-04-10 贝林格尔.英格海姆国际有限公司 吡喃葡萄糖基取代的苯基衍生物、含该化合物的药物、其用途及其制造方法
DE102004054054A1 (de) 2004-11-05 2006-05-11 Boehringer Ingelheim Pharma Gmbh & Co. Kg Verfahren zur Herstellung chiraler 8-(3-Amino-piperidin-1-yl)-xanthine
US7772191B2 (en) 2005-05-10 2010-08-10 Boehringer Ingelheim International Gmbh Processes for preparing of glucopyranosyl-substituted benzyl-benzene derivatives and intermediates therein
DE102005035891A1 (de) 2005-07-30 2007-02-08 Boehringer Ingelheim Pharma Gmbh & Co. Kg 8-(3-Amino-piperidin-1-yl)-xanthine, deren Herstellung und deren Verwendung als Arzneimittel
AU2006289093A1 (en) * 2005-09-08 2007-03-15 Boehringer Ingelheim International Gmbh Crystalline forms of 1-chloro-4-(beta-D-glucopyranos-1-yl)-2-(4-ethynyl-benzyl)-benzene, methods for its preparation and the use thereof for preparing medicaments
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