DK2349324T3 - Kombination af et insulin og en glp-1-agonist - Google Patents
Kombination af et insulin og en glp-1-agonist Download PDFInfo
- Publication number
- DK2349324T3 DK2349324T3 DK09783905.4T DK09783905T DK2349324T3 DK 2349324 T3 DK2349324 T3 DK 2349324T3 DK 09783905 T DK09783905 T DK 09783905T DK 2349324 T3 DK2349324 T3 DK 2349324T3
- Authority
- DK
- Denmark
- Prior art keywords
- insulin
- arg
- composition
- pharmaceutical composition
- medicament
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Claims (14)
1. Lægemiddel omfattende en første farmaceutisk sammensætning og en anden farmaceutisk sammensætning og i givet fald i det mindste en yderligere farmaceutisk sammensætning, som hver især omfatter 100 U/ml Gly(A21)-Arg(B31)-Arg(B32)-humaninsulin og 20 til 150 yg/ml desPro36Exendin-4 (1-39)-Lys6-NH2 og indeholder Gly(A21)-Arg(B31)-Arg(B32)-humaninsulin og desPro36Exendin-4 (1-39)-Lys6~ NH2 i forskellige vægtandele baseret på den samlede vægt af sammensætningen.
2. Lægemiddel ifølge krav 1, idet vægtandelene af Gly(A21)-Arg (B31)-Arg (B32)-humaninsulinet og af desPro36Exendin-4 (1-39)-Lys6-NH2 i den første farmaceutiske sammensætning, i den anden farmaceutiske sammensætning og i den i givet fald i det mindste ene yderligere farmaceutiske sammensætning er udvalgt således, at de farmaceutiske sammensætninger indeholder forskellige forhold mellem Gly(A21)-Arg(B31)-Arg(B32)-humaninsulin og desPro36Exendin-4(1-39)-Lys6_NH2 baseret på vægtandelen.
3. Lægemiddel omfattende en første farmaceutisk sammensætning og en anden farmaceutisk sammensætning og i givet fald i det mindste en yderligere farmaceutisk sammensætning, idet den første farmaceutiske sammensætning omfatter 100 U/ml Gly(A21)-Arg(B31)-Arg(B32)-humaninsulin, og idet den anden farmaceutiske sammensætning omfatter 100 U/ml Gly(A21)-Arg(B31)-Arg(B32)-humaninsulin og 20 til 150 yg/ml desPro36Exendin-4 (1-39)-Lys6~NH2, og idet den i det mindste ene yderligere farmaceutiske sammensætning omfatter Gly(A21)-Arg(B31)-Arg(B32)-humaninsulin og i det mindste et yderligere aktivstof.
4. Kit omfattende et lægemiddel ifølge et af kravene 1 til 3.
5. Farmaceutisk kombination omfattende (a) Gly(A21)- Arg (B31)-Arg(B32)-humaninsulin eller/og et farmakologisk acceptabelt salt heraf i en koncentration på 100 U/ml og (b) desPro36Exendin-4(1-39)-Lys6-NH2 eller/og et farmakologisk acceptabelt salt heraf i en koncentration på 20 til 150 pg/ml.
6. Farmaceutisk sammensætning omfattende (a) Gly(A21)- Arg (B31)-Arg(B32)-humaninsulin eller/og et farmakologisk acceptabelt salt heraf i en koncentration på 100 U/ml og (b) desPro36Exendin-4(1-39)-Lys6-NH2 eller/og et farmakologisk acceptabelt salt heraf i en koncentration på 20 til 150 pg/ml.
7. Anvendelse af et lægemiddel ifølge et af kravene 1 til 3 eller en farmaceutisk kombination ifølge krav 5 eller en farmaceutisk sammensætning ifølge krav 6 til fremstilling af et medikament til behandling af en patient med diabetes, navnlig diabetes type 1 eller 2, til indstilling af den nøgterne, den postprandiale eller/og den postabsorptive blodglukosekoncentration, til forbedring af glukosetolerancen, til prævention af en hypoglykæmi, til prævention af et funktionstab i β-cellerne i pankreas, til vægttab eller/og til prævention af en vægtstigning.
8. Anvendelse af et lægemiddel ifølge krav 1 eller af et kit omfattende et sådant lægemiddel til fremstilling af et medikament til behandling af en patient med diabetes, navnlig diabetes type 1 eller 2, til indstilling af den nøgterne, den postprandiale eller/og den postabsorptive blodglukosekoncentration, til forbedring af glukosetolerancen, til prævention af en hypoglykæmi, til prævention af et funktionstab i β-cellerne i pankreas, til vægttab eller/og til prævention af en vægtstigning ved hjælp af en fremgangsmåde omfattende (a) valg af en dosis af Gly(A21)-Arg(B31)-Arg(B32)- humaninsulinet, som skal administreres, (b) valg af en dosis af desPro36Exendin-4 (1-39)-Lys6-NH2, som skal administreres, (c) valg af en sammensætning af den første, anden og i givet fald den i det mindste ene yderligere sammensætning af lægemidlet, som indeholder doserne af (a) og (b) i en koncentration, således at doserne af (a) og (b) foreligger i samme volumen, og (d) bestemmelse og administration af en mængde, som svarer til doserne af (a) og (b).
9. Anvendelse ifølge krav 8, idet trin (c) gennemføres ved hjælp af en tabel.
10. Anvendelse af et lægemiddel ifølge krav 3 eller af et kit omfattende et sådant lægemiddel til fremstilling af et medikament til behandling af en patient med diabetes, navnlig diabetes type 1 eller 2, til indstilling af den nøgterne, den postprandiale eller/og den postabsorptive blodglukosekoncentration, til forbedring af glukosetolerancen, til prævention af en hypoglykæmi, til prævention af et funktionstab i β-cellerne i pankreas, til vægttab eller/og til prævention af en vægtstigning ved hjælp af en fremgangsmåde omfattende: (i) valg af en dosis af Gly(A21)-Arg(B31)-Arg (B32)-humaninsulinet, som skal administreres, og bestemmelse af den samlede mængde af den første, anden og i givet fald i det mindste ene yderligere sammensætning, således af den valgte dosis af Gly(A21)-Arg(B31)-Arg(B32)-humaninsulinet er indeholdt i den samlede mængde, (ii) valg af en dosis af desPro36Exendin-4 (1-39)-Lys6~NH2, som skal administreres, og bestemmelse af mængden af den anden sammensætning, således af den valgte dosis af desPro36Exendin-4 (1-39)-Lys6-NH2 er indeholdt i mængden af den anden sammensætning, (iii) i givet fald valg af en dosis af det i det mindste ene yderligere aktivstof, som skal administreres, og bestemmelse af mængden af den i det mindste ene yderligere sammensætning, således at den valgte dosis af det i det mindste ene yderligere aktivstof er indeholdt i mængden af den i det mindste ene yderligere sammensætning, (iv) administration af en mængde af den første sammensætning til patienten, idet den administrerede mængde svarer til den samlede mængde ifølge trin (i) minus mængden af den anden sammensætning ifølge trin (ii) og i givet fald minus mængden af den i det mindste ene yderligere sammensætning ifølge trin (iii)t og (v) administration af mængden af den anden sammensætning, som blev bestemt i trin (ii) , og i givet fald af mængden i den i det mindste ene yderligere sammensætning, som blev bestemt i trin (iii), til patienten.
11. Anvendelse ifølge krav 10, idet trinnene (i), (ii) eller/og (iii) gennemføres ved hjælp af en tabel.
12. Fremgangsmåde til fremstilling af et lægemiddel ifølge et af kravene 1 til 3 omfattende formulering eller/og konfektionering, således at den indeholder Gly(A21)-Arg(B31) -Arg (B32)-humaninsulin og desPro36Exendin-4 (1-39) -Lys6~NH2 i en hver gang forud bestemt mængde og kan administreres i en dosis, der er tilpasset til den enkelte patients behov.
13. Anordning omfattende lægemidlet ifølge et af kravene 1 til 3 eller kittet ifølge krav 4, idet anordningen indeholder de farmaceutiske sammensætninger af lægemidlet i adskilte beholdere, og tillader dosering af de farmaceutiske sammensætninger uafhængigt af hinanden.
14. Anordning ifølge krav 13 til injektion.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
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| DE102008051834A DE102008051834A1 (de) | 2008-10-17 | 2008-10-17 | Kombination von einem Insulin und einem GLP-1-Agonisten |
| DE102008053048A DE102008053048A1 (de) | 2008-10-24 | 2008-10-24 | Kombination von einem Insulin und einem GLP-1-Agonisten |
| DE102009038210A DE102009038210A1 (de) | 2009-08-20 | 2009-08-20 | Kombination von einem Insulin und einem GLP-1-Agonisten |
| PCT/EP2009/063195 WO2010043566A2 (de) | 2008-10-17 | 2009-10-09 | Kombination von einem insulin und einem glp-1-agonisten |
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| WO2009087081A2 (de) | 2008-01-09 | 2009-07-16 | Sanofi-Aventis Deutschland Gmbh | Neue insulinderivate mit extrem verzögertem zeit-/wirkungsprofil |
| DK2349324T3 (da) * | 2008-10-17 | 2017-12-11 | Sanofi Aventis Deutschland | Kombination af et insulin og en glp-1-agonist |
| PH12011502708B1 (en) * | 2009-07-06 | 2017-11-10 | Sanofi Aventis Deutschland | Insulin preparations containing methionine |
| ES2965209T3 (es) * | 2009-11-13 | 2024-04-11 | Sanofi Aventis Deutschland | Composición farmacéutica que comprende desPro36exendina-4(1-39)-Lys6-NH2 y metionina |
| KR101836070B1 (ko) | 2009-11-13 | 2018-03-09 | 사노피-아벤티스 도이칠란트 게엠베하 | Ｇｌｐ－１ 작용제, 인슐린 및 메티오닌을 포함하는 약제학적 조성물 |
| AU2011202239C1 (en) | 2010-05-19 | 2017-03-16 | Sanofi | Long-acting formulations of insulins |
| CN103179978A (zh) | 2010-08-30 | 2013-06-26 | 赛诺菲-安万特德国有限公司 | Ave0010用于制造供治疗2型糖尿病用的药物的用途 |
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