DK2750699T3 - Farmaceutisk kombination til anvendelse til glykæmisk kontrol hos diabetes-type 2-patienter - Google Patents

Farmaceutisk kombination til anvendelse til glykæmisk kontrol hos diabetes-type 2-patienter Download PDF

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Publication number
DK2750699T3
DK2750699T3 DK12756417.7T DK12756417T DK2750699T3 DK 2750699 T3 DK2750699 T3 DK 2750699T3 DK 12756417 T DK12756417 T DK 12756417T DK 2750699 T3 DK2750699 T3 DK 2750699T3
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Denmark
Prior art keywords
patients
patient
pharmaceutical combination
lixisenatide
treatment
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DK12756417.7T
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English (en)
Inventor
Elisabeth Niemöller
Isabel Mühlen-Bartmer
Louise Silvestre
Gabor Boka
Patrick Miossec
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Sanofi Aventis Deutschland
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    • 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
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/425Thiazoles
    • A61K31/427Thiazoles not condensed and containing further heterocyclic rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4427Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • A61K31/4439Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
    • 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)
  • 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)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Emergency Medicine (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines Containing Plant Substances (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Peptides Or Proteins (AREA)

Claims (16)

1. Farmaceutisk kombination til anvendelse til glykæmisk kontrol hos diabetes-type 2-patienter, hvilken kombination omfatter (a) desPro36Exendin-4 (1-39)-Lys6-NH2 og/eller et farmaceutisk acceptabelt salt deraf og (b) en glitazon og/eller et farmaceutisk acceptabelt salt deraf.
2. Farmaceutisk kombination til anvendelse ifølge krav 1, der yderligere omfatter (c) metformin og/eller et farmaceutisk acceptabelt salt deraf.
3. Farmaceutisk kombination til anvendelse ifølge krav 2, hvor metformin og/eller et farmaceutisk acceptabelt salt deraf er fremstillet til oral administration.
4. Farmaceutisk kombination til anvendelse ifølge et hvilket som helst af ovennævnte krav, hvor diabetes-type 2-patienten er adipøs.
5. Farmaceutisk kombination til anvendelse ifølge et hvilket som helst af ovennævnte krav, hvor diabetes-type 2-patienten har et BMI (body mass index) på mindst 30 kg/m2.
6. Farmaceutisk kombination til anvendelse ifølge et hvilket som helst af ovennævnte krav, hvor diabetes-type 2-patienten er en voksen patient.
7. Farmaceutisk kombination til anvendelse ifølge et hvilket som helst af ovennævnte krav, hvor diabetes-type 2-patienten ikke modtager en antidiabetisk behandling.
8. Farmaceutisk kombination til anvendelse ifølge et hvilket som helst af ovennævnte krav, hvor diabetes mellitus-type 2 hos diabetes-type 2-patienten er blevet diagnosticeret mindst 1 år eller mindst 2 år før behandlingsstart.
9. Farmaceutisk kombination til anvendelse ifølge et hvilket som helst af ovennævnte krav, hvor diabetes-type 2-patienten har en HbAic-værdi på ca. 7 % to ca. 10 %.
10. Farmaceutisk kombination til anvendelse ifølge et hvilket som helst af ovennævnte krav, hvor diabetes-type 2-patienten har en fastende plasmaglucosekoncentration på mindst 8 mmol/L.
11. Farmaceutisk kombination til anvendelse ifølge et hvilket som helst af ovennævnte krav, hvor diabetes-type 2-patienten har en plasmaglucosekoncentration 2 timer postprandialt på mindst 10 mmol/L, mindst 12 mmol/L eller mindst 14 mmol/L.
12. Farmaceutisk kombination til anvendelse ifølge et hvilket som helst af ovennævnte krav, hvor diabetes-type 2-patienten har et glucoseudsving på mindst 2 mmol/L, mindst 3 mmol/L, mindst 4 mmol/L eller mindst 5 mmol/L, hvor glucoseudsvinget er forskellen mellem plasmaglucosekoncentrationen 2 timer postprandialt og plasmaglucosekoncentrationen 30 minutter før en måltidstest.
13. 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.
14. 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.
15. Farmaceutisk kombination til anvendelse ifølge et hvilket som helst af ovennævnte krav, hvor glitazon og/eller det farmaceutisk acceptable salt deraf er fremstillet til oral administration.
16. Farmaceutisk kombination til anvendelse ifølge et hvilket som helst af ovennævnte krav, hvor glitazon er pioglitazon.
DK12756417.7T 2011-08-29 2012-08-27 Farmaceutisk kombination til anvendelse til glykæmisk kontrol hos diabetes-type 2-patienter DK2750699T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP11179149 2011-08-29
PCT/EP2012/066617 WO2013030160A1 (en) 2011-08-29 2012-08-27 Pharmaceutical combination for use in glycemic control in diabetes type 2 patients

Publications (1)

Publication Number Publication Date
DK2750699T3 true DK2750699T3 (da) 2015-10-26

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DK12756417.7T DK2750699T3 (da) 2011-08-29 2012-08-27 Farmaceutisk kombination til anvendelse til glykæmisk kontrol hos diabetes-type 2-patienter

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Country Link
US (5) US9408893B2 (da)
EP (1) EP2750699B1 (da)
JP (1) JP6367115B2 (da)
KR (1) KR101983982B1 (da)
CN (2) CN103917241A (da)
AR (1) AR087693A1 (da)
AU (1) AU2012300978B2 (da)
BR (1) BR112014004726A2 (da)
CA (1) CA2846413C (da)
CY (1) CY1116803T1 (da)
DK (1) DK2750699T3 (da)
ES (1) ES2550357T3 (da)
HK (1) HK1196267A1 (da)
HR (1) HRP20151068T1 (da)
HU (1) HUE027989T2 (da)
MX (1) MX370264B (da)
PL (1) PL2750699T3 (da)
PT (1) PT2750699E (da)
RU (1) RU2650616C2 (da)
SI (1) SI2750699T1 (da)
TW (1) TWI608847B (da)
WO (1) WO2013030160A1 (da)

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KR101772372B1 (ko) 2009-11-13 2017-08-29 사노피-아벤티스 도이칠란트 게엠베하 Glp-1 효능제 및 메티오닌을 포함하는 약제학적 조성물
AU2010317995B2 (en) 2009-11-13 2014-04-17 Sanofi-Aventis Deutschland Gmbh Pharmaceutical composition comprising a GLP-1 agonist, an insulin, and methionine
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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TWI559929B (en) 2011-09-01 2016-12-01 Sanofi Aventis Deutschland Pharmaceutical composition for use in the treatment of a neurodegenerative disease
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
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AR103415A1 (es) * 2015-01-16 2017-05-10 Sanofi Aventis Deutschland Tratamiento de pacientes pediátricos con diabetes mellitus de tipo 2
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
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