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DK2707017T3 - Lixisenatid og metformin til behandling af diabetes type 2 - Google Patents

Lixisenatid og metformin til behandling af diabetes type 2 Download PDF

Info

Publication number
DK2707017T3
DK2707017T3 DK12723132.2T DK12723132T DK2707017T3 DK 2707017 T3 DK2707017 T3 DK 2707017T3 DK 12723132 T DK12723132 T DK 12723132T DK 2707017 T3 DK2707017 T3 DK 2707017T3
Authority
DK
Denmark
Prior art keywords
patients
treatment
lixisenatide
placebo
treated
Prior art date
Application number
DK12723132.2T
Other languages
English (en)
Inventor
Peter Ruus
Louise Silvestre
Patrick Miossec
Jean-Louis Pinquier
Agnes Hincelin-Mery
Original Assignee
Sanofi Aventis Deutschland
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=46148833&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=DK2707017(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Sanofi Aventis Deutschland filed Critical Sanofi Aventis Deutschland
Application granted granted Critical
Publication of DK2707017T3 publication Critical patent/DK2707017T3/da

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22Hormones
    • A61K38/26Glucagons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/155Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/04Anorexiants; Antiobesity agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Endocrinology (AREA)
  • Diabetes (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Child & Adolescent Psychology (AREA)
  • Emergency Medicine (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)

Claims (13)

1. Farmaceutisk kombination til anvendelse til reduktion af niveauet af plasmaglucagon hos diabetes type 2-patienter, hvilken kombination omfatter (a) desPro36Exendin-4(1-39)-Lys6-NH2 og/eller et farmaceutisk acceptabelt salt deraf, (b) metformin og/eller et farmaceutisk acceptabelt salt deraf og (c) et sulfonylurinstof, hvor personen, der skal behandles, har en 2 timers postprandial plasmaglucosekoncentration på mindst 14 mmol/1.
2. Farmaceutisk kombination til anvendelse ifølge krav 1, hvor personen, der skal behandles, er adipøs.
3. Farmaceutisk kombination til anvendelse ifølge et hvilket som helst af ovennævnte krav, hvor personen, der skal behandles, har et BMI (body mass index) på mindst 30 kg/m2.
4. Farmaceutisk kombination til anvendelse ifølge et hvilket som helst af ovennævnte krav, hvor personen, der skal behandles, er en voksen person.
5. Farmaceutisk kombination til anvendelse ifølge et hvilket som helst af ovennævnte krav, hvor personen, der skal behandles, er blevet diagnosticeret med diabetes mellitus type 2 mindst 1 år eller mindst 2 år før behandlingsstart.
6. Farmaceutisk kombination til anvendelse ifølge et hvilket som helst af ovennævnte krav, hvor personen, 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 personen, der skal behandles, har en fastende plasmaglucosekoncentration på mindst 8 mmol/1.
8. Farmaceutisk kombination til anvendelse ifølge et hvilket som helst af ovennævnte krav, hvor personen, der skal behandles, har et glucose-udsving på mindst 2 mmol/1, mindst 3 mmol/1, mindst 4 mmol/1 eller mindst 5 mmol/1, hvor glucose-udsvinget er forskellen mellem plasmaglucosekoncentrationen 2 timer postprandialt og plasmaglucosekoncentrationen 30 minutter før et måltid.
9. Farmaceutisk kombination til anvendelse ifølge et hvilket som helst af ovennævnte krav, hvor personen, der skal behandles, er af orientalsk og/eller asiatisk race.
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, der er udvalgt fra intervallet fra 10 yg til 20 yg.
12. 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.
13. Farmaceutisk kombination til anvendelse ifølge et hvilket som helst af ovennævnte krav, hvor sulfonylurinstoffet er fremstillet til oral administration.
DK12723132.2T 2011-05-13 2012-05-11 Lixisenatid og metformin til behandling af diabetes type 2 DK2707017T3 (da)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP11166120 2011-05-13
EP12163637 2012-04-10
PCT/EP2012/058747 WO2012156298A1 (en) 2011-05-13 2012-05-11 Lixisenatide and metformin for treatment of diabetes type 2

Publications (1)

Publication Number Publication Date
DK2707017T3 true DK2707017T3 (da) 2016-01-04

Family

ID=46148833

Family Applications (1)

Application Number Title Priority Date Filing Date
DK12723132.2T DK2707017T3 (da) 2011-05-13 2012-05-11 Lixisenatid og metformin til behandling af diabetes type 2

Country Status (20)

Country Link
US (1) US20130065828A1 (da)
EP (1) EP2707017B1 (da)
JP (2) JP6442284B2 (da)
KR (1) KR20140043755A (da)
CN (2) CN107693782A (da)
AU (1) AU2012257849B2 (da)
BR (1) BR112013029062A2 (da)
CA (1) CA2835259C (da)
CY (1) CY1117250T1 (da)
DK (1) DK2707017T3 (da)
ES (1) ES2556466T3 (da)
HK (1) HK1194307A1 (da)
HR (1) HRP20151369T1 (da)
HU (1) HUE028459T2 (da)
MX (1) MX362527B (da)
PL (1) PL2707017T3 (da)
PT (1) PT2707017E (da)
RU (1) RU2623023C2 (da)
SI (1) SI2707017T1 (da)
WO (1) WO2012156298A1 (da)

Families Citing this family (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA3016451A1 (en) 2008-10-17 2010-04-22 Sanofi-Aventis Deutschland Gmbh Combination of an insulin and a glp-1 agonist
US10029011B2 (en) 2009-11-13 2018-07-24 Sanofi-Aventis Deutschland Gmbh Pharmaceutical composition comprising a GLP-1 agonist, an insulin and methionine
KR101915454B1 (ko) 2009-11-13 2018-11-06 사노피-아벤티스 도이칠란트 게엠베하 Glp-1 효능제 및 메티오닌을 포함하는 약제학적 조성물
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
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
PL2750699T3 (pl) 2011-08-29 2015-12-31 Sanofi Aventis Deutschland Kombinacja farmaceutyczna do stosowania w kontroli glikemii u pacjentów z cukrzycą typu 2
AR087744A1 (es) 2011-09-01 2014-04-16 Sanofi Aventis Deutschland Composicion farmaceutica para uso en el tratamiento de una enfermedad neurodegenerativa
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
RU2016132340A (ru) 2014-01-09 2018-02-14 Санофи Стабилизированные фармацевтические составы на основе инсулина аспарта
SG11201604710XA (en) 2014-01-09 2016-07-28 Sanofi Sa Stabilized pharmaceutical formulations of insulin analogues and/or insulin derivatives
CA2932875A1 (en) 2014-01-09 2015-07-16 Sanofi Stabilized glycerol free pharmaceutical formulations of insulin analogues and/or insulin derivatives
LT3229828T (lt) 2014-12-12 2023-06-12 Sanofi-Aventis Deutschland Gmbh Insulino glargino/liksisenatido fiksuoto santykio kompozicija
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
EP4450127A2 (en) * 2018-07-23 2024-10-23 Eli Lilly and Company Method of using a gip/glp1 co-agonist for diabetes

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1076066A1 (en) 1999-07-12 2001-02-14 Zealand Pharmaceuticals A/S Peptides for lowering blood glucose levels
EP2248531A1 (en) * 2004-08-03 2010-11-10 Emisphere Technologies, Inc. Antidiabetic oral insulin-biguanide combination
CN101291685A (zh) * 2005-08-19 2008-10-22 安米林药品公司 治疗糖尿病和降低体重的毒蜥外泌肽
EP2057188B1 (en) * 2006-08-17 2013-07-31 Amylin Pharmaceuticals, LLC Dpp-iv resistant gip hybrid polypeptides with selectable properties
CN117547538A (zh) * 2009-02-13 2024-02-13 勃林格殷格翰国际有限公司 包含dpp-4抑制剂(利格列汀)任选地组合其它抗糖尿病药的抗糖尿病药物
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
US20110118180A1 (en) * 2009-11-13 2011-05-19 Sanofi-Aventis Deutschland Gmbh Method of treatment of diabetes type 2 comprising add-on therapy to metformin
HUE026489T2 (en) 2009-11-13 2016-06-28 Sanofi Aventis Deutschland Combination of lixisenatide and metformin to treat type 2 diabetes

Also Published As

Publication number Publication date
WO2012156298A1 (en) 2012-11-22
RU2013155474A (ru) 2015-06-20
US20130065828A1 (en) 2013-03-14
EP2707017A1 (en) 2014-03-19
EP2707017B1 (en) 2015-09-16
CA2835259C (en) 2020-01-07
AU2012257849B2 (en) 2017-03-30
CN103841988A (zh) 2014-06-04
HK1194307A1 (en) 2014-10-17
PL2707017T3 (pl) 2016-03-31
CN107693782A (zh) 2018-02-16
CA2835259A1 (en) 2012-11-22
JP6676108B2 (ja) 2020-04-08
RU2623023C2 (ru) 2017-06-21
HRP20151369T1 (hr) 2016-01-15
JP2018184441A (ja) 2018-11-22
HUE028459T2 (en) 2016-12-28
BR112013029062A2 (pt) 2016-11-29
KR20140043755A (ko) 2014-04-10
ES2556466T3 (es) 2016-01-18
JP2014514356A (ja) 2014-06-19
JP6442284B2 (ja) 2018-12-19
PT2707017E (pt) 2016-01-12
SI2707017T1 (sl) 2016-01-29
MX2013013307A (es) 2014-03-12
MX362527B (es) 2019-01-23
CY1117250T1 (el) 2017-04-05

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