HRP20200828T1 - Farmaceutski pripravak koji sadrži sglt2-inhibitor, dpp-iv-inhibitor i prema potrebi jedno dodatno antidijabetičko sredstvo, te njegove uporabe - Google Patents
Farmaceutski pripravak koji sadrži sglt2-inhibitor, dpp-iv-inhibitor i prema potrebi jedno dodatno antidijabetičko sredstvo, te njegove uporabe Download PDFInfo
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- HRP20200828T1 HRP20200828T1 HRP20200828TT HRP20200828T HRP20200828T1 HR P20200828 T1 HRP20200828 T1 HR P20200828T1 HR P20200828T T HRP20200828T T HR P20200828TT HR P20200828 T HRP20200828 T HR P20200828T HR P20200828 T1 HRP20200828 T1 HR P20200828T1
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- Prior art keywords
- inhibitor
- pharmaceutical preparation
- sglt2
- antidiabetic agent
- patient
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- 229940123518 Sodium/glucose cotransporter 2 inhibitor Drugs 0.000 title claims 13
- 229940125708 antidiabetic agent Drugs 0.000 title claims 11
- 239000003472 antidiabetic agent Substances 0.000 title claims 11
- 239000003112 inhibitor Substances 0.000 title claims 9
- 239000008194 pharmaceutical composition Substances 0.000 title claims 2
- 239000000825 pharmaceutical preparation Substances 0.000 claims 17
- 208000001145 Metabolic Syndrome Diseases 0.000 claims 9
- 201000000690 abdominal obesity-metabolic syndrome Diseases 0.000 claims 9
- 230000002265 prevention Effects 0.000 claims 9
- 206010012601 diabetes mellitus Diseases 0.000 claims 8
- 201000001421 hyperglycemia Diseases 0.000 claims 8
- XZWYZXLIPXDOLR-UHFFFAOYSA-N metformin Chemical compound CN(C)C(=N)NC(N)=N XZWYZXLIPXDOLR-UHFFFAOYSA-N 0.000 claims 8
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims 7
- 239000008103 glucose Substances 0.000 claims 7
- 208000008589 Obesity Diseases 0.000 claims 6
- 229960003105 metformin Drugs 0.000 claims 6
- 235000020824 obesity Nutrition 0.000 claims 6
- LTXREWYXXSTFRX-QGZVFWFLSA-N Linagliptin Chemical compound N=1C=2N(C)C(=O)N(CC=3N=C4C=CC=CC4=C(C)N=3)C(=O)C=2N(CC#CC)C=1N1CCC[C@@H](N)C1 LTXREWYXXSTFRX-QGZVFWFLSA-N 0.000 claims 5
- 206010033307 Overweight Diseases 0.000 claims 5
- 229960002397 linagliptin Drugs 0.000 claims 5
- 208000002705 Glucose Intolerance Diseases 0.000 claims 4
- 239000008280 blood Substances 0.000 claims 4
- 210000004369 blood Anatomy 0.000 claims 4
- 208000004104 gestational diabetes Diseases 0.000 claims 4
- 201000000083 maturity-onset diabetes of the young type 1 Diseases 0.000 claims 4
- 208000030159 metabolic disease Diseases 0.000 claims 4
- 238000000034 method Methods 0.000 claims 4
- 201000009104 prediabetes syndrome Diseases 0.000 claims 4
- 210000002237 B-cell of pancreatic islet Anatomy 0.000 claims 3
- 206010022489 Insulin Resistance Diseases 0.000 claims 3
- 210000000577 adipose tissue Anatomy 0.000 claims 3
- 230000037396 body weight Effects 0.000 claims 3
- 230000006866 deterioration Effects 0.000 claims 3
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 3
- 150000003839 salts Chemical class 0.000 claims 3
- 208000001072 type 2 diabetes mellitus Diseases 0.000 claims 3
- 201000001431 Hyperuricemia Diseases 0.000 claims 2
- 206010054805 Macroangiopathy Diseases 0.000 claims 2
- 208000035475 disorder Diseases 0.000 claims 2
- 230000002641 glycemic effect Effects 0.000 claims 2
- 229960004329 metformin hydrochloride Drugs 0.000 claims 2
- OETHQSJEHLVLGH-UHFFFAOYSA-N metformin hydrochloride Chemical group Cl.CN(C)C(=N)N=C(N)N OETHQSJEHLVLGH-UHFFFAOYSA-N 0.000 claims 2
- 238000002054 transplantation Methods 0.000 claims 2
- YZGOOQZXQOPQNT-DNNBANOASA-N (2r,3r,4s,5s,6r)-2-[4-chloro-3-[[4-[(3s)-oxolan-3-yl]oxyphenyl]methyl]phenyl]-6-(hydroxymethyl)oxane-2,3,4,5-tetrol Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@]1(O)C1=CC=C(Cl)C(CC=2C=CC(O[C@@H]3COCC3)=CC=2)=C1 YZGOOQZXQOPQNT-DNNBANOASA-N 0.000 claims 1
- 208000004611 Abdominal Obesity Diseases 0.000 claims 1
- 208000004476 Acute Coronary Syndrome Diseases 0.000 claims 1
- 206010002383 Angina Pectoris Diseases 0.000 claims 1
- 206010003210 Arteriosclerosis Diseases 0.000 claims 1
- 208000031229 Cardiomyopathies Diseases 0.000 claims 1
- 208000002177 Cataract Diseases 0.000 claims 1
- 206010065941 Central obesity Diseases 0.000 claims 1
- 208000002249 Diabetes Complications Diseases 0.000 claims 1
- 208000008960 Diabetic foot Diseases 0.000 claims 1
- 102000017011 Glycated Hemoglobin A Human genes 0.000 claims 1
- 108010014663 Glycated Hemoglobin A Proteins 0.000 claims 1
- 206010056559 Graft infection Diseases 0.000 claims 1
- 206010019280 Heart failures Diseases 0.000 claims 1
- 206010060378 Hyperinsulinaemia Diseases 0.000 claims 1
- 206010021036 Hyponatraemia Diseases 0.000 claims 1
- 208000000913 Kidney Calculi Diseases 0.000 claims 1
- 206010029148 Nephrolithiasis Diseases 0.000 claims 1
- 208000030831 Peripheral arterial occlusive disease Diseases 0.000 claims 1
- 208000017442 Retinal disease Diseases 0.000 claims 1
- 206010038923 Retinopathy Diseases 0.000 claims 1
- 208000007718 Stable Angina Diseases 0.000 claims 1
- 208000006011 Stroke Diseases 0.000 claims 1
- 206010052779 Transplant rejections Diseases 0.000 claims 1
- 208000007814 Unstable Angina Diseases 0.000 claims 1
- 230000002159 abnormal effect Effects 0.000 claims 1
- 238000009825 accumulation Methods 0.000 claims 1
- 208000011775 arteriosclerosis disease Diseases 0.000 claims 1
- 239000003795 chemical substances by application Substances 0.000 claims 1
- 238000002648 combination therapy Methods 0.000 claims 1
- 230000007850 degeneration Effects 0.000 claims 1
- 230000037213 diet Effects 0.000 claims 1
- 235000005911 diet Nutrition 0.000 claims 1
- 201000010099 disease Diseases 0.000 claims 1
- 230000003451 hyperinsulinaemic effect Effects 0.000 claims 1
- 201000008980 hyperinsulinism Diseases 0.000 claims 1
- 230000001771 impaired effect Effects 0.000 claims 1
- 230000003914 insulin secretion Effects 0.000 claims 1
- 208000028867 ischemia Diseases 0.000 claims 1
- 208000017169 kidney disease Diseases 0.000 claims 1
- 208000010125 myocardial infarction Diseases 0.000 claims 1
- 201000001119 neuropathy Diseases 0.000 claims 1
- 230000007823 neuropathy Effects 0.000 claims 1
- 208000033808 peripheral neuropathy Diseases 0.000 claims 1
- 208000037803 restenosis Diseases 0.000 claims 1
- 230000033764 rhythmic process Effects 0.000 claims 1
- 238000009097 single-agent therapy Methods 0.000 claims 1
- 210000002784 stomach Anatomy 0.000 claims 1
- 210000001519 tissue Anatomy 0.000 claims 1
- 230000002792 vascular Effects 0.000 claims 1
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Claims (15)
1. Farmaceutski pripravak, naznačen time, da obuhvaća:
(a) SGLT2-inhibitor 1-kloro-4-(β-D-glukopiranos-1-il)-2-[4-((S)-tetrahidrofuran-3-iloksi)-benzil]-benzen, i
(b) DPP IV-inhibitor linagliptin ili njegovu farmaceutski prihvatljivu sol, i
(c) treće antidijabetičko sredstvo koje je metformin ili njegova farmaceutski prihvatljivu sol.
2. Farmaceutski pripravak prema patentnom zahtjevu 1, naznačen time, da treće antidijabetičko sredstvo je metformin hidroklorid.
3. Farmaceutski pripravak prema patentnom zahtjevu 1 ili 2, naznačen time, da farmaceutski pripravak sadrži od 1 do 25 mg, prvenstveno 1, 2,5, 5, 7,5, 10, 12,5, 15, 20 ili 25 mg SGLT2-inhibitora.
4. Farmaceutski pripravak prema jednom od prethodnih patentnih zahtjeva, naznačen time, da farmaceutski pripravak sadrži od 1 do 5 mg, prvenstveno 1, 2,5 ili 5 mg linagliptina.
5. Farmaceutski pripravak prema jednom od prethodnih patentnih zahtjeva, naznačen time, da je treće antidijabetičko sredstvo metformin ili njegova farmaceutski prihvatljiva sol, prvenstveno je to metformin hidroklorid, pri čemu raspon količina metformina iznosi od 500 do 1000 mg, prvenstveno iznosi 500, 750, 850 ili 1000 mg.
6. Farmaceutski pripravak prema patentnom zahtjevu 1, naznačen time, da rasponi za doziranje u farmaceutskom pripravku predstavljaju količinu od 1 do 50 mg SGLT2-inhibitora, količinu od 0,5 do 10 mg linagliptina i količinu od 250 do 1000 mg metformina.
7. Farmaceutski pripravak prema patentnom zahtjevu 1, naznačen time, da rasponi za doziranje u farmaceutskom pripravku predstavljaju količinu od 1 to 25 mg SGLT2-inhibitora, količinu od 1 do 5 mg linagliptina i količinu od 250 do 1000 mg metformina.
8. Farmaceutski pripravak prema jednom od prethodnih patentnih zahtjeva, naznačen time, da je pripravak prikladan za kombiniranu ili istovremenu ili uzastopnu uporabu SGLT2-inhibitora, DPP IV-inhibitora i trećeg antidijabetičkog sredstva.
9. SGLT2-inhibitor prema patentnom zahtjevu 1, koji se upotrebljava u postupku prevencije, usporavanja progresije, odgađanja ili liječenja metaboličkog poremećaja odabranog iz skupine koja se sastoji od sljedećih: dijabetes mellitus tipa 1, dijabetes mellitus tipa 2, oštećena tolerancija glukoze, pogoršanje razine glukoze u krvi na prazan želudac, hiperglikemija, hiperglikemija nakon uzimanja jela, prekomjerna težina, pretilost, metabolički sindrom, dijabetes u trudnoći, novi napad dijabetesa nakon transplantacije (NODAT) i komplikacije povezane s time, te post-transplantacijski metabolički sindrom (PTMS) i komplikacije povezane s time, za pacijenta kojemu je to potrebno, naznačen time, da se SGLT2-inhibitor, DPP-IV-inhibitor u skladu s patentnim zahtjevom 1 i treće antidijabetičko sredstvo u skladu s patentnim zahtjevom 1 ili 2, primjenjuju kod pacijenta u kombinaciji ili alternativno.
10. DPP IV-inhibitor prema patentnom zahtjevu 1, koji se upotrebljava u postupku prevencije, usporavanja progresije, odgađanja ili liječenja metaboličkog poremećaja odabranog iz skupine koja se sastoji od sljedećih: dijabetes mellitus tipa 1, dijabetes mellitus tipa 2, oštećena tolerancija glukoze, pogoršanje razine glukoze u krvi na prazan želudac, hiperglikemija, hiperglikemija nakon uzimanja jela, prekomjerna težina, pretilost, metabolički sindrom, dijabetes u trudnoći, novi napad dijabetesa nakon transplantacije (NODAT) i komplikacije povezane s time, te post-transplantacijski metabolički sindrom (PTMS) i komplikacije povezane s time, za pacijenta kojemu je to potrebno, naznačen time, da se SGLT2-inhibitor u skladu s patentnim zahtjevom 1, DPP IV-inhibitor i treće antidijabetičko sredstvo u skladu s patentnim zahtjevom 1 ili 2, primjenjuju kod pacijenta u kombinaciji ili alternativno.
11. Treće antidijabetičko sredstvo u skladu s patentnim zahtjevom 1 ili 2, koje se upotrebljava u postupku prevencije, usporavanja progresije, odgađanja ili liječenja metaboličkog poremećaja odabranog iz skupine koja se sastoji od sljedećih: dijabetes mellitus tipa 1, dijabetes mellitus tipa 2, oštećena tolerancija glukoze, pogoršanje razine glukoze u krvi na prazan želudac, hiperglikemija, hiperglikemija nakon uzimanja jela, prekomjerna težina, pretilost, metabolički sindrom, dijabetes u trudnoći, novi napad dijabetesa nakon transplantacije (NODAT) i komplikacije povezane s time, te post-transplantacijski metabolički sindrom (PTMS) i komplikacije povezane s time, za pacijenta kojemu je to potrebno, naznačeno time, da se SGLT2-inhibitor u skladu s patentnim zahtjevom 1, DPP IV-inhibitor u skladu s patentnim zahtjevom 1 i treće antidijabetičko sredstvo, primjenjuju kod pacijenta u kombinaciji ili alternativno.
12. Farmaceutski pripravak prema jednom od patentnih zahtjeva 1 do 8, naznačen time, da se upotrebljava u postupku za sljedeće:
- prevencija, usporavanje progresije, odgađanje ili liječenje metaboličkog poremećaja odabranog iz skupine koja se sastoji od sljedećih: dijabetes mellitus tipa 1, dijabetes mellitus tipa 2, oštećena tolerancija glukoze, pogoršanje razine glukoze u krvi na prazan želudac, hiperglikemija, hiperglikemija nakon uzimanja jela, prekomjerna težina, pretilost, metabolički sindrom, dijabetes u trudnoći; ili
- poboljšanje glikemijske regulacije i/ili smanjenje glukoze u plazmi na prazan želudac, smanjenje glukoze u plazmi nakon uzimanja jela i/ili smanjenje glikoziliranog hemoglobina HbA1c; ili
- prevencija, usporavanje, odgađanje ili preokretanje progresije od oštećene tolerancije glukoze, otpornosti na inzulin i/ili od metaboličkog sindroma do dijabetesa mellitus tipa 2; ili
- prevencija, usporavanje progresije, odgađanje ili liječenje stanja ili poremećaja odabranog iz skupine koja se sastoji od sljedećih: komplikacije dijabetesa mellitus kao što su katarakte i mikro- i makrovaskularne bolesti, primjerice nefropatija, retinopatija, neuropatija, ishemija tkiva, dijabetičko stopalo, arterioskleroza, infarkt miokarda, akutni koronarni sindrom, nestabilna angina pektoris, stabilna angina pektoris, moždani udar, okluzijska bolest perifernih arterija, kardiomiopatija, zatajenje srca, poremećaji srčanog ritma i vaskularna restenoza; ili
- smanjenje tjelesne težine i /ili tjelesne masnoće ili prevencija povećanja tjelesne težine i/ili tjelesne masnoće ili omogućavanje lakšeg smanjivanja tjelesne težine i/ili tjelesne masnoće; ili
- prevencija, usporavanje, odgađanje ili liječenje degeneracije beta stanica gušterače i/ili propadanja funkcionalnosti beta stanica gušterače i/ili poboljšanje i /ili obnavljanje funkcionalnosti beta stanica gušterače i/ili obnavljanje funkcionalnosti sekrecije inzulina u gušterači; ili
- za prevenciju, usporavanje, odgađanje ili liječenje bolesti ili stanja koja se pripisuju abnormalnoj akumulaciji ektopične masnoće; ili
- održavanje i/ili poboljšanje osjetljivosti na inzulin i/ili za liječenje ili prevenciju hiperinzulinemije i/ili otpornosti na inzulin;
- prevencija, usporavanje progresije, odgađanje ili liječenje novog napada dijabetesa nakon transplantacije (NODAT) i/ili post-transplantacijskog metaboličkog sindroma (PTMS);
- prevencija, odgađanje ili smanjivanje komplikacija koje su povezane s NODAT i/ili PTMS, uključujući mikro- i makrovaskularne bolesti i događaje, odbacivanje presadaka, infekcije te smrt;
- liječenje hiperuricemije i stanja povezanih s hiperuricemijom;
- liječenje ili prevencija bubrežnih kamenaca;
- liječenje hiponatremije;
za pacijenta kojemu je to potrebno.
13. Farmaceutski pripravak za uporabu u skladu s patentnim zahtjevom 12, naznačen time, da je pacijent pojedinac kojemu je dijagnosticirano jedno ili više stanja odabranih iz skupine koja se sastoji od sljedećih: prekomjerna težina, pretilost, organska pretilost i abdominalna pretilost.
14. Farmaceutski pripravak za uporabu u skladu s patentnim zahtjevom 12 ili 13, naznačen time, da rasponi doziranja u farmaceutskom pripravku predstavljaju količinu od 1 do 50 mg, prvenstveno od 1 do 25 mg SGLT2-inhibitora, količinu od 0,5 do 10 mg, prvenstveno od 1 do 5 mg linagliptina i količinu od 250 do 1000 mg, prvenstveno od 250 do 850 mg metformina, te se pritom farmaceutski pripravak daje pacijentu oralno jednom ili dva puta dnevno.
15. Farmaceutski pripravak za uporabu u skladu s patentnim zahtjevom 12, 13 ili 14, naznačen time, da pacijent ima nedovoljnu glikemijsku kontrolu usprkos posebnoj prehrani i tjelovježbama ili usprkos monoterapiji sa SGLT2-inhibitorom ili DPP IV-inhibitorom ili trećim antidijabetskim sredstvom, ili usprkos kombinacijskoj terapiji s dva sredstva zajedno koja su odabrana iz skupine od SGLT2-inhibitora, DPP IV-inhibitora i trećeg antidijabetičkog sredstva.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US15230209P | 2009-02-13 | 2009-02-13 | |
| EP10703288.0A EP2395983B1 (en) | 2009-02-13 | 2010-02-11 | Pharmaceutical composition comprisng a sglt2 inhibitor, a dpp-iv inhibitor and optionally a further antidiabetic agent and uses thereof |
| PCT/EP2010/051736 WO2010092125A1 (en) | 2009-02-13 | 2010-02-11 | Pharmaceutical composition comprising a sglt2 inhibitor, a dpp-iv inhibitor and optionally a further antidiabetic agent and uses thereof |
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| HRP20200828T1 true HRP20200828T1 (hr) | 2020-08-07 |
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| HRP20200828TT HRP20200828T1 (hr) | 2009-02-13 | 2020-05-21 | Farmaceutski pripravak koji sadrži sglt2-inhibitor, dpp-iv-inhibitor i prema potrebi jedno dodatno antidijabetičko sredstvo, te njegove uporabe |
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| KR (1) | KR101694136B1 (hr) |
| CN (2) | CN104906582A (hr) |
| AP (1) | AP2011005794A0 (hr) |
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