DK2707015T3 - Lixisenatid som tillægsbehandling til basisinsulin ved type 2-diabetes - Google Patents
Lixisenatid som tillægsbehandling til basisinsulin ved type 2-diabetes Download PDFInfo
- Publication number
- DK2707015T3 DK2707015T3 DK12721268.6T DK12721268T DK2707015T3 DK 2707015 T3 DK2707015 T3 DK 2707015T3 DK 12721268 T DK12721268 T DK 12721268T DK 2707015 T3 DK2707015 T3 DK 2707015T3
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- DK
- Denmark
- Prior art keywords
- patients
- insulin
- treated
- patient
- week
- Prior art date
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Classifications
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- 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
- A61K38/26—Glucagons
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- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/04—Anorexiants; Antiobesity agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2121/00—Preparations for use in therapy
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2123/00—Preparations for testing in vivo
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/155—Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Endocrinology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Immunology (AREA)
- Gastroenterology & Hepatology (AREA)
- Zoology (AREA)
- Diabetes (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Hematology (AREA)
- Obesity (AREA)
- Emergency Medicine (AREA)
- Child & Adolescent Psychology (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Peptides Or Proteins (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Claims (14)
1. Farmaceutisk kombination til anvendelse til glykæmisk kontrol hos type 2-diabetespatienter, hvilken kombination omfatter (a) desPro36Exendin-4 (1-39)-Lys6~NH2 og/eller et farmaceutisk acceptabelt salt deraf, (b) en basisinsulin og/eller et farmaceutisk acceptabelt salt deraf og (c) eventuelt metformin og/eller et farmaceutisk acceptabelt salt deraf, hvor den type 2-diabetes, der skal behandles, ikke kontrolleres tilstrækkeligt med basisinsulinen og eventuelt metformin alene, og patienten, der skal behandles, har en 2-timers postprandial plasmaglucosekoncentration på mindst 14 mmo1/1.
2. Farmaceutisk kombination til anvendelse ifølge krav 1, hvor patienten, der skal behandles, er overvægtig.
3. Farmaceutisk kombination til anvendelse ifølge krav 1 eller 2, hvor patienten, der skal behandles, har et BMI på mindst 30 kg/m2.
4. Farmaceutisk kombination til anvendelse ifølge et hvilket som helst af ovennævnte krav, hvor patienten, der skal behandles, er en voksen person.
5. Farmaceutisk kombination til anvendelse ifølge et hvilket som helst af ovennævnte krav, hvor hos patienten, der skal behandles, type 2-diabetes mellitus er blevet diagnosticeret mindst 1 år eller mindst 2 år før behandlingsstart.
6. Farmaceutisk kombination til anvendelse ifølge et hvilket som helst af ovennævnte krav, hvor patienten, der skal behandles, har en HbAic-værdi på ca. 7 til ca. 10 %.
7. Farmaceutisk kombination til anvendelse ifølge et hvilket som helst af ovennævnte krav, hvor patienten, der skal behandles, har en HbAic-værdi på mindst 8 %.
8. Farmaceutisk kombination til anvendelse ifølge et hvilket som helst af ovennævnte krav, hvor patienten, der skal behandles, har en faste-plasmaglucosekoncentration på mindst 8 mmo1/1.
9. Farmaceutisk kombination til anvendelse ifølge et hvilket som helst af ovennævnte krav, hvor patienten, der skal behandles, har et glucoseudsving på mindst 2 mmol/1, mindst 3 mmol/1, mindst 4 mmol/1 eller mindst 5 mmol/1, hvor glucoseudsvinget er forskellen mellem plasmaglucosekoncentrationen 2 timer postprandialt og plasmaglucosekoncentrationen 30 minutter før en måltidstest.
10. Farmaceutisk kombination til anvendelse ifølge et hvilket som helst af ovennævnte krav, hvor desPro36Exendin-4 (1-39) -Lys6-NH2 og/eller det farmaceutisk acceptable salt deraf er fremstillet til parenteral administration.
11. Farmaceutisk kombination til anvendelse ifølge et hvilket som helst af ovennævnte krav, hvor desPro36Exendin-4 (1-39) -Lys6_NH2 og/eller det farmaceutisk acceptable salt deraf er fremstillet til administration i en daglig dosis udvalgt fra intervallet 10 pg til 20 pg.
12. Farmaceutisk kombination til anvendelse ifølge et hvilket som helst af ovennævnte krav, hvor basisinsulinen er udvalgt blandt insulin glargin, insulin detemir, isofan insulin, lente insulin, ultralente insulin og blandinger deraf.
13. Farmaceutisk kombination til anvendelse ifølge et hvilket som helst af ovennævnte krav, hvor basisinsulinen og/eller det farmaceutisk acceptable salt deraf er fremstillet til parenteral administration.
14. Farmaceutisk kombination til anvendelse ifølge et hvilket som helst af ovennævnte krav, hvor metformin og/eller det farmaceutisk acceptable salt deraf er fremstillet til oral administration.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP11166111 | 2011-05-13 | ||
PCT/EP2012/058749 WO2012156299A1 (en) | 2011-05-13 | 2012-05-11 | Lixisenatide as add-on therapy to basal insulin in type 2 diabetes |
Publications (1)
Publication Number | Publication Date |
---|---|
DK2707015T3 true DK2707015T3 (da) | 2017-02-20 |
Family
ID=46085609
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DK12721268.6T DK2707015T3 (da) | 2011-05-13 | 2012-05-11 | Lixisenatid som tillægsbehandling til basisinsulin ved type 2-diabetes |
Country Status (21)
Country | Link |
---|---|
US (4) | US9821032B2 (da) |
EP (1) | EP2707015B2 (da) |
JP (1) | JP6410604B2 (da) |
KR (1) | KR20140038410A (da) |
CN (2) | CN106075405A (da) |
AU (1) | AU2012257850B2 (da) |
BR (1) | BR112013029158A2 (da) |
CA (1) | CA2835265C (da) |
CY (1) | CY1118616T1 (da) |
DK (1) | DK2707015T3 (da) |
ES (1) | ES2614287T5 (da) |
HR (1) | HRP20170209T1 (da) |
HU (1) | HUE031715T2 (da) |
LT (1) | LT2707015T (da) |
MX (1) | MX362503B (da) |
PL (1) | PL2707015T5 (da) |
PT (1) | PT2707015T (da) |
RS (1) | RS55678B1 (da) |
RU (1) | RU2606154C2 (da) |
SI (1) | SI2707015T1 (da) |
WO (1) | WO2012156299A1 (da) |
Families Citing this family (18)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
KR101820024B1 (ko) | 2008-10-17 | 2018-01-18 | 사노피-아벤티스 도이칠란트 게엠베하 | 인슐린과 glp-1 효능제의 병용물 |
US20110118178A1 (en) * | 2009-11-13 | 2011-05-19 | Sanofi-Aventis Deutschland Gmbh | Method of treatment of diabetes type 2 comprising add-on therapy to insulin glargine and metformin |
HUE037735T2 (hu) | 2009-11-13 | 2018-09-28 | Sanofi Aventis Deutschland | DesPro36exendin-4(1-39)-Lys6-NH2-t és metionint tartalmazó gyógyszerkészítmény |
ES2534191T3 (es) | 2009-11-13 | 2015-04-20 | Sanofi-Aventis Deutschland Gmbh | Composición farmacéutica que comprende un agonista de GLP-1, una insulina y metionina |
BR112013004756B1 (pt) | 2010-08-30 | 2020-04-28 | Sanofi Aventis Deutschland | uso de ave0010 para a fabricação de um medicamento para o tratamento da diabetes melito tipo 2 |
EP2670427A1 (en) * | 2011-02-02 | 2013-12-11 | Sanofi-Aventis Deutschland GmbH | Prevention of hypoglycaemia in diabetes mellitus type 2 patients |
US9821032B2 (en) | 2011-05-13 | 2017-11-21 | Sanofi-Aventis Deutschland Gmbh | Pharmaceutical combination for improving glycemic control as add-on therapy to basal insulin |
RU2650616C2 (ru) | 2011-08-29 | 2018-04-16 | Санофи-Авентис Дойчланд Гмбх | Фармацевтическая комбинация для применения при гликемическом контроле у пациентов с сахарным диабетом 2 типа |
TWI559929B (en) | 2011-09-01 | 2016-12-01 | Sanofi Aventis Deutschland | Pharmaceutical composition for use in the treatment of a neurodegenerative disease |
MY170713A (en) * | 2011-10-28 | 2019-08-27 | Sanofi Aventis Deutschland | Treatment protocol of diabetes type 2 |
TWI641381B (zh) | 2013-02-04 | 2018-11-21 | 法商賽諾菲公司 | 胰島素類似物及/或胰島素衍生物之穩定化醫藥調配物 |
SG11201604706TA (en) | 2014-01-09 | 2016-07-28 | Sanofi Sa | Stabilized pharmaceutical formulations of insulin aspart |
US9895424B2 (en) | 2014-01-09 | 2018-02-20 | Sanofi | Stabilized pharmaceutical formulations of insulin analogues and/or insulin derivatives |
US9839692B2 (en) | 2014-01-09 | 2017-12-12 | Sanofi | Stabilized pharmaceutical formulations of insulin analogues and/or insulin derivatives |
JP6970615B2 (ja) * | 2014-12-12 | 2021-11-24 | サノフィ−アベンティス・ドイチュラント・ゲゼルシャフト・ミット・ベシュレンクテル・ハフツング | インスリングラルギン/リキシセナチド固定比処方 |
TWI706779B (zh) * | 2015-01-16 | 2020-10-11 | 德商賽諾菲阿凡提斯德意志有限公司 | 小兒第2型糖尿病病患之治療 |
TWI748945B (zh) * | 2015-03-13 | 2021-12-11 | 德商賽諾菲阿凡提斯德意志有限公司 | 第2型糖尿病病患治療 |
TW201705975A (zh) * | 2015-03-18 | 2017-02-16 | 賽諾菲阿凡提斯德意志有限公司 | 第2型糖尿病病患之治療 |
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- 2012-05-11 LT LTEP12721268.6T patent/LT2707015T/lt unknown
- 2012-05-11 JP JP2014509753A patent/JP6410604B2/ja active Active
- 2012-05-11 KR KR1020137030090A patent/KR20140038410A/ko active Search and Examination
- 2012-05-11 BR BR112013029158A patent/BR112013029158A2/pt active Search and Examination
- 2012-05-11 AU AU2012257850A patent/AU2012257850B2/en active Active
- 2012-05-11 SI SI201230866A patent/SI2707015T1/sl unknown
- 2012-05-11 CA CA2835265A patent/CA2835265C/en active Active
- 2012-05-11 RU RU2013155481A patent/RU2606154C2/ru active
- 2012-05-11 MX MX2013013242A patent/MX362503B/es active IP Right Grant
- 2012-05-11 CN CN201280034316.1A patent/CN103717232A/zh active Pending
- 2012-05-11 HU HUE12721268A patent/HUE031715T2/en unknown
- 2012-05-11 DK DK12721268.6T patent/DK2707015T3/da active
- 2012-05-11 RS RS20170136A patent/RS55678B1/sr unknown
- 2012-05-11 PL PL12721268.6T patent/PL2707015T5/pl unknown
- 2012-05-11 PT PT127212686T patent/PT2707015T/pt unknown
- 2012-05-11 ES ES12721268T patent/ES2614287T5/es active Active
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2017
- 2017-02-08 CY CY20171100174T patent/CY1118616T1/el unknown
- 2017-02-08 HR HRP20170209TT patent/HRP20170209T1/hr unknown
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2018
- 2018-04-23 US US15/960,488 patent/US20180339023A1/en not_active Abandoned
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2019
- 2019-12-26 US US16/727,848 patent/US20200338171A1/en not_active Abandoned
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2022
- 2022-03-15 US US17/695,343 patent/US20220347269A1/en active Pending
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