HRP20161620T1 - Uporaba ave0010 za proizvodnju lijeka za liječenje dijabetes melitusa tip 2 - Google Patents
Uporaba ave0010 za proizvodnju lijeka za liječenje dijabetes melitusa tip 2 Download PDFInfo
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- HRP20161620T1 HRP20161620T1 HRP20161620TT HRP20161620T HRP20161620T1 HR P20161620 T1 HRP20161620 T1 HR P20161620T1 HR P20161620T T HRP20161620T T HR P20161620TT HR P20161620 T HRP20161620 T HR P20161620T HR P20161620 T1 HRP20161620 T1 HR P20161620T1
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- pharmaceutical preparation
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- 201000000083 maturity-onset diabetes of the young type 1 Diseases 0.000 title claims 2
- XVVOERDUTLJJHN-UHFFFAOYSA-N Lixisenatide Chemical compound C=1NC2=CC=CC=C2C=1CC(C(=O)NC(CC(C)C)C(=O)NC(CCCCN)C(=O)NC(CC(N)=O)C(=O)NCC(=O)NCC(=O)N1C(CCC1)C(=O)NC(CO)C(=O)NC(CO)C(=O)NCC(=O)NC(C)C(=O)N1C(CCC1)C(=O)N1C(CCC1)C(=O)NC(CO)C(=O)NC(CCCCN)C(=O)NC(CCCCN)C(=O)NC(CCCCN)C(=O)NC(CCCCN)C(=O)NC(CCCCN)C(=O)NC(CCCCN)C(N)=O)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)CC)NC(=O)C(NC(=O)C(CC(C)C)NC(=O)C(CCCNC(N)=N)NC(=O)C(NC(=O)C(C)NC(=O)C(CCC(O)=O)NC(=O)C(CCC(O)=O)NC(=O)C(CCC(O)=O)NC(=O)C(CCSC)NC(=O)C(CCC(N)=O)NC(=O)C(CCCCN)NC(=O)C(CO)NC(=O)C(CC(C)C)NC(=O)C(CC(O)=O)NC(=O)C(CO)NC(=O)C(NC(=O)C(CC=1C=CC=CC=1)NC(=O)C(NC(=O)CNC(=O)C(CCC(O)=O)NC(=O)CNC(=O)C(N)CC=1NC=NC=1)C(C)O)C(C)O)C(C)C)CC1=CC=CC=C1 XVVOERDUTLJJHN-UHFFFAOYSA-N 0.000 title 1
- 239000003814 drug Substances 0.000 title 1
- 229960001093 lixisenatide Drugs 0.000 title 1
- 108010004367 lixisenatide Proteins 0.000 title 1
- 238000004519 manufacturing process Methods 0.000 title 1
- 239000000825 pharmaceutical preparation Substances 0.000 claims 10
- 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
- XVVOERDUTLJJHN-IAEQDCLQSA-N lixisenatide Chemical compound C([C@@H](C(=O)N[C@@H]([C@@H](C)CC)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(N)=O)C(=O)NCC(=O)NCC(=O)N1[C@@H](CCC1)C(=O)N[C@@H](CO)C(=O)N[C@@H](CO)C(=O)NCC(=O)N[C@@H](C)C(=O)N1[C@@H](CCC1)C(=O)N1[C@@H](CCC1)C(=O)N[C@@H](CO)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CCCCN)C(N)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCCNC(N)=N)NC(=O)[C@@H](NC(=O)[C@H](C)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CCSC)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CCCCN)NC(=O)[C@H](CO)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](CC=1C=CC=CC=1)NC(=O)[C@@H](NC(=O)CNC(=O)[C@H](CCC(O)=O)NC(=O)CNC(=O)[C@@H](N)CC=1N=CNC=1)[C@@H](C)O)[C@@H](C)O)C(C)C)C1=CC=CC=C1 XVVOERDUTLJJHN-IAEQDCLQSA-N 0.000 claims 3
- 235000012054 meals Nutrition 0.000 claims 3
- 150000003839 salts Chemical class 0.000 claims 3
- 208000001072 type 2 diabetes mellitus Diseases 0.000 claims 2
- 239000002671 adjuvant Substances 0.000 claims 1
- 230000003178 anti-diabetic effect Effects 0.000 claims 1
- 239000003472 antidiabetic agent Substances 0.000 claims 1
- 239000003937 drug carrier Substances 0.000 claims 1
- 239000008194 pharmaceutical composition Substances 0.000 claims 1
- 230000000291 postprandial effect Effects 0.000 claims 1
- 239000000126 substance Substances 0.000 claims 1
- 238000002560 therapeutic procedure Methods 0.000 claims 1
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
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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
-
- 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
-
- 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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- C07K14/46—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates
- C07K14/463—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from amphibians
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- C07K14/575—Hormones
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2121/00—Preparations for use in therapy
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Organic Chemistry (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Gastroenterology & Hepatology (AREA)
- Zoology (AREA)
- Endocrinology (AREA)
- Diabetes (AREA)
- Epidemiology (AREA)
- Immunology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Biochemistry (AREA)
- Toxicology (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Molecular Biology (AREA)
- Hematology (AREA)
- Obesity (AREA)
- Emergency Medicine (AREA)
- Child & Adolescent Psychology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines Containing Plant Substances (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Saccharide Compounds (AREA)
Claims (9)
1. Farmaceutski pripravak koji sadrži desPro36Exendin-4(1-39)-Lys6-NH2 ili/i njegovu farmaceutski prihvatljivu sol, te proizvoljno sadrži farmaceutski prihvatljive nosače, adjuvante, ili/i pomoćne tvari, naznačen time da je za uporabu za smanjenje koncentracije glukoze u plazmi poslije jela kod pacijenta s dijabetesom tipa 2, naznačen time da pacijent s dijabetesom tipa 2 koji se treba liječiti ima koncentraciju glukoze u plazmi 2 sata poslije jela od najmanje 14 mmol/L i indeks tjelesne težine od najmanje 30 kg/m2, pri čemu pacijent koji se treba liječiti ne prima protudijabetički tretman.
2. Farmaceutski pripravak za uporabu prema zahtjevu 1, naznačen time da pacijent koji se treba liječiti je odrasli subjekt.
3. Farmaceutski pripravak za uporabu prema bilo kojem od prethodnih zahtjeva, naznačen time da je kod pacijenta koji se treba liječiti, dijabetes melitus tip 2 dijagnosticiran najmanje 1 godinu ili najmanje 2 godine prije početka terapije.
4. Farmaceutski pripravak za uporabu prema bilo kojem od prethodnih zahtjeva, naznačen time da pacijent koji se treba liječiti ima HbA1c vrijednost od oko 7 do oko 10%.
5. Farmaceutski pripravak za uporabu prema bilo kojem od prethodnih zahtjeva, naznačen time da pacijent koji se treba liječiti ima koncentraciju glukoze u plazmi natašte od najmanje 8 mmol/L.
6. Farmaceutski pripravak za uporabu prema bilo kojem od prethodnih zahtjeva, naznačen time da pacijent koji se treba liječiti ima ekskurziju glukoze od najmanje 2 mmol/L, najmanje 3 mmol/L, najmanje 4 mmol/L ili najmanje 5 mmol/L, pri čemu ekskurzija glukoze je razlika koncentracije glukoze u plazmi 2 sata poslije obroka i koncentracije glukoze u plazmi 30 minuta prije testa s obrokom.
7. Farmaceutski pripravak za uporabu prema bilo kojem od prethodnih zahtjeva, naznačen time da se desPro36Exendin-4(1-39)-Lys6-NH2 ili/i njegova farmaceutski prihvatljiva sol primjenjuje parenteralno.
8. Farmaceutski pripravak za uporabu prema bilo kojem od prethodnih zahtjeva, naznačen time da je farmaceutski pripravak pripremljen za davanje desPro36Exendin-4(1-39)-Lys6-NH2 ili/i njegove farmaceutski prihvatljive soli u dnevnoj dozi koja je odabrana iz raspona od 10 µg do 20 µg.
9. Farmaceutski pripravak za uporabu prema bilo kojem od prethodnih zahtjeva, naznačen time da je farmaceutski pripravak pripremljen za davanje jednom dnevno.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP10747854.7A EP2611458B1 (en) | 2010-08-30 | 2010-08-30 | Use of ave0010 for the manufacture of a medicament for the treatment of diabetes mellitus type 2 |
PCT/EP2010/062638 WO2012028172A1 (en) | 2010-08-30 | 2010-08-30 | Use of ave0010 for the manufacture of a medicament for the treatment of diabetes mellitus type 2 |
Publications (1)
Publication Number | Publication Date |
---|---|
HRP20161620T1 true HRP20161620T1 (hr) | 2017-01-13 |
Family
ID=43617007
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20161620TT HRP20161620T1 (hr) | 2010-08-30 | 2016-12-02 | Uporaba ave0010 za proizvodnju lijeka za liječenje dijabetes melitusa tip 2 |
Country Status (22)
Country | Link |
---|---|
US (5) | US20140148384A1 (hr) |
EP (1) | EP2611458B1 (hr) |
JP (1) | JP6199186B2 (hr) |
KR (1) | KR101823320B1 (hr) |
CN (1) | CN103179978A (hr) |
AU (1) | AU2010360116B2 (hr) |
BR (1) | BR112013004756B1 (hr) |
CA (1) | CA2809321C (hr) |
DK (1) | DK2611458T3 (hr) |
ES (1) | ES2606554T3 (hr) |
HR (1) | HRP20161620T1 (hr) |
HU (1) | HUE031181T2 (hr) |
IL (1) | IL224951A (hr) |
LT (1) | LT2611458T (hr) |
MX (1) | MX339614B (hr) |
PL (1) | PL2611458T3 (hr) |
PT (1) | PT2611458T (hr) |
RS (1) | RS55378B1 (hr) |
RU (1) | RU2546520C2 (hr) |
SG (1) | SG187904A1 (hr) |
SI (1) | SI2611458T1 (hr) |
WO (1) | WO2012028172A1 (hr) |
Families Citing this family (17)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
RS56632B1 (sr) | 2008-10-17 | 2018-03-30 | Sanofi Aventis Deutschland | Kombinacija insulina i glp-1-agonista |
ES2855146T3 (es) | 2009-11-13 | 2021-09-23 | Sanofi Aventis Deutschland | Composición farmacéutica que comprende un agonista de GLP-1, una insulina y metionina |
PT3345593T (pt) | 2009-11-13 | 2023-11-27 | Sanofi Aventis Deutschland | Composição farmacêutica compreendendo despro36exendina- 4(1-39)-lys6-nh2 e metionina |
AU2011202239C1 (en) | 2010-05-19 | 2017-03-16 | Sanofi | Long-acting formulations of insulins |
HUE031181T2 (en) | 2010-08-30 | 2017-06-28 | Sanofi Aventis Deutschland | Use of AVE0010 for the manufacture of a medicament for the treatment of type 2 diabetes |
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 |
CN103917241A (zh) | 2011-08-29 | 2014-07-09 | 赛诺菲-安万特德国有限公司 | 用于2型糖尿病患者中的血糖控制的药物组合 |
AR087744A1 (es) | 2011-09-01 | 2014-04-16 | Sanofi Aventis Deutschland | Composicion farmaceutica para uso en el tratamiento de una enfermedad neurodegenerativa |
TWI780236B (zh) | 2013-02-04 | 2022-10-11 | 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 |
MX369511B (es) | 2013-04-03 | 2019-11-11 | Sanofi Sa | Tratamiento de la diabetes mellitus mediante formulaciones de insulinas de acción prolongada. |
BR112016013832A2 (pt) | 2014-01-09 | 2017-08-08 | Sanofi Sa | Uso de análogo e/ou derivado de insulina, formulação farmacêutica e processo para a preparação da mesma, kit e dispositivo médico |
EP3091964A1 (en) | 2014-01-09 | 2016-11-16 | Sanofi | Stabilized pharmaceutical formulations of insulin aspart |
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 |
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 |
CN117881510A (zh) | 2021-08-24 | 2024-04-12 | Edgewell个人护理品牌有限责任公司 | 用于涂覆刀片的***和方法 |
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