ME01546B - Liksisenatid kao dodatna terapija insulin glarginu i metforminu za liječenje dijabetesa tipa 2 - Google Patents
Liksisenatid kao dodatna terapija insulin glarginu i metforminu za liječenje dijabetesa tipa 2Info
- Publication number
- ME01546B ME01546B MEP-2012-147A MEP14712A ME01546B ME 01546 B ME01546 B ME 01546B ME P14712 A MEP14712 A ME P14712A ME 01546 B ME01546 B ME 01546B
- Authority
- ME
- Montenegro
- Prior art keywords
- pharmaceutically acceptable
- combination
- metformin
- acceptable salt
- use according
- Prior art date
Links
- XZWYZXLIPXDOLR-UHFFFAOYSA-N metformin Chemical compound CN(C)C(=N)NC(N)=N XZWYZXLIPXDOLR-UHFFFAOYSA-N 0.000 title claims 8
- 229960003105 metformin Drugs 0.000 title claims 8
- 108010057186 Insulin Glargine Proteins 0.000 title claims 6
- COCFEDIXXNGUNL-RFKWWTKHSA-N Insulin glargine Chemical compound C([C@@H](C(=O)N[C@@H](CC(C)C)C(=O)N[C@H]1CSSC[C@H]2C(=O)N[C@H](C(=O)N[C@@H](CO)C(=O)N[C@H](C(=O)N[C@H](C(N[C@@H](CO)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC=3C=CC(O)=CC=3)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CC=3C=CC(O)=CC=3)C(=O)N[C@@H](CSSC[C@H](NC(=O)[C@H](C(C)C)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC=3C=CC(O)=CC=3)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](C)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](C(C)C)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC=3NC=NC=3)NC(=O)[C@H](CO)NC(=O)CNC1=O)C(=O)NCC(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CCCNC(N)=N)C(=O)NCC(=O)N[C@@H](CC=1C=CC=CC=1)C(=O)N[C@@H](CC=1C=CC=CC=1)C(=O)N[C@@H](CC=1C=CC(O)=CC=1)C(=O)N[C@@H]([C@@H](C)O)C(=O)N1[C@@H](CCC1)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CCCNC(N)=N)C(O)=O)C(=O)NCC(O)=O)=O)CSSC[C@@H](C(N2)=O)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](C(C)C)NC(=O)[C@@H](NC(=O)CN)[C@@H](C)CC)[C@@H](C)CC)[C@@H](C)O)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@@H](NC(=O)[C@@H](N)CC=1C=CC=CC=1)C(C)C)C1=CN=CN1 COCFEDIXXNGUNL-RFKWWTKHSA-N 0.000 title claims 6
- 229960002869 insulin glargine Drugs 0.000 title claims 6
- 208000001072 type 2 diabetes mellitus Diseases 0.000 title claims 6
- 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
- 229960001093 lixisenatide Drugs 0.000 title 1
- 108010004367 lixisenatide Proteins 0.000 title 1
- 238000002560 therapeutic procedure Methods 0.000 title 1
- 150000003839 salts Chemical class 0.000 claims 11
- 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 5
- NOESYZHRGYRDHS-UHFFFAOYSA-N insulin Chemical compound N1C(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(NC(=O)CN)C(C)CC)CSSCC(C(NC(CO)C(=O)NC(CC(C)C)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CCC(N)=O)C(=O)NC(CC(C)C)C(=O)NC(CCC(O)=O)C(=O)NC(CC(N)=O)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CSSCC(NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2C=CC(O)=CC=2)NC(=O)C(CC(C)C)NC(=O)C(C)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2NC=NC=2)NC(=O)C(CO)NC(=O)CNC2=O)C(=O)NCC(=O)NC(CCC(O)=O)C(=O)NC(CCCNC(N)=N)C(=O)NCC(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC(O)=CC=3)C(=O)NC(C(C)O)C(=O)N3C(CCC3)C(=O)NC(CCCCN)C(=O)NC(C)C(O)=O)C(=O)NC(CC(N)=O)C(O)=O)=O)NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C1CSSCC2NC(=O)C(CC(C)C)NC(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)CC=1C=CC=CC=1)C(C)C)CC1=CN=CN1 NOESYZHRGYRDHS-UHFFFAOYSA-N 0.000 claims 4
- 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 2
- 108090001061 Insulin Proteins 0.000 claims 2
- 102000004877 Insulin Human genes 0.000 claims 2
- 239000008103 glucose Substances 0.000 claims 2
- 229940125396 insulin Drugs 0.000 claims 2
- 102000017011 Glycated Hemoglobin A Human genes 0.000 claims 1
- 108010014663 Glycated Hemoglobin A Proteins 0.000 claims 1
- 238000011374 additional therapy Methods 0.000 claims 1
- 239000008194 pharmaceutical composition Substances 0.000 claims 1
- 230000000291 postprandial effect Effects 0.000 claims 1
- -1 salts salt Chemical class 0.000 claims 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
-
- 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)
-
- 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
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Endocrinology (AREA)
- Zoology (AREA)
- Gastroenterology & Hepatology (AREA)
- Engineering & Computer Science (AREA)
- Immunology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Diabetes (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Claims (12)
1. Kombinacija za upotrebu u lečenju dijabetes melitusa tipa 2, naznačena time, što sadrži (a) desPro36Eksendin-4(1-39)-Lys6-NH2 i/ili a njegovu farmaceutski prihvatljivu so, (b) insulin glargine i/ili njegovu farmaceutski prihvatljivu so, i (c) metformin i/ili njegovu farmaceutski prihvatljivu so.
2. Kombinacija za upotrebu prema zahtevu 1, naznačena time, što desPro36Eksendin-4(1-39)-Lys6-NH2 i/ili njegova farmaceutski prihvatljiva so je subkutano administriran .
3. Kombinacija za upotrebu prema prema zahtevu 1 ili 2, naznačena time, što je insulin glargin i/ili njegova farmaceutski prihvatljiva so subkutano administriran.
4. Kombinacija za upotrebu prema jednom od zahteva 1 do 3, naznačena time, što je metformin oralno administriran.
5. Kombinacija za upotrebu prema jedno od prethodnih zahteva, naznačena time, što je desPro36Eksendin-4(1-39)-Lys6-NH2 i/ili njegova farmaceutski prihvatljiva so administriran kao dodatna terapija admisnitraciji metformina i insulin glargina.
6. Kombinacija za upotrebu prema jednom od prethodnih zahteva, naznačena time, što je subjekt koji se tretira, odraslo lice.
7. Kombinacija za upotrebu prema jednom od prethodnih zahteva, naznačena time, što dijabetes melitus tipa 2 nije adekvatno kontrolisan samo metforminom i insulinom.
8. Kombinacija za upotrebu prema 7, naznačena time, što tretman samo dozom od najmanje 1.5 g/dan metformina i najmanje 10 jedinica /dan insulina tokom tri meseca adekvatno ne kontroliše dijabetes melitus tipa 2.
9. Kombinacija za upotrebu prema jednom od prethodnih zahteva, naznačena time, što subjekat koji se tretira ima vrednosti za HbA1 c u opsegu od 7% do 10% i/ili koncetraciju glukoze u plazmi, natašte od najmanje 7 mmol/L i/ili 2 h postprandialnu glukozu u plazmi od najmanje 11.1 mmol/L.
10. Farmaceutska kombinaciaj koja sadrži (a) desPro36Eksendin-4(1-39)-Lys6-NH2 i/ili njegovu farmaceutski prihvatljivu so, (b) insulin glargina i/ili njegovu farmaceutski prihvatljivu so, i (c) metformin i/ili njegovu farmaceutski prihvatljivu so.
11. Kombinacija prema zahtevu 10, naznačena time, što je za uptorebu u lečenju dijabetes melitusa tipa 2.
12. Upotreba kombinacije (a) desPro36Eksendin-4(1-39)-Lys6-NH2 i/ili njegove farmaceutski prihvatljive soli, (b) insulin glargina i/ili njegove farmaceutski prihvatljive soli i (c) metformin i/ili njegove farmaceutski prihvatljive soli, za proizvodnju farmaceutske kompozicije za lečenje dijabetes melitusa tipa 2.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP09175877.1A EP2329848B2 (en) | 2009-11-13 | 2009-11-13 | Lixisenatide as add-on therapy to insulin glargine and metformin for treating type 2 diabetes |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ME01546B true ME01546B (me) | 2014-04-20 |
Family
ID=41800749
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MEP-2012-147A ME01546B (me) | 2009-11-13 | 2009-11-13 | Liksisenatid kao dodatna terapija insulin glarginu i metforminu za liječenje dijabetesa tipa 2 |
Country Status (11)
| Country | Link |
|---|---|
| EP (1) | EP2329848B2 (me) |
| CY (1) | CY1113755T1 (me) |
| DK (1) | DK2329848T4 (me) |
| ES (1) | ES2398012T5 (me) |
| HR (1) | HRP20121029T4 (me) |
| ME (1) | ME01546B (me) |
| PL (1) | PL2329848T5 (me) |
| PT (1) | PT2329848E (me) |
| RS (1) | RS52629B2 (me) |
| SI (1) | SI2329848T2 (me) |
| SM (1) | SMT201300013B (me) |
Families Citing this family (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| LT2349324T (lt) | 2008-10-17 | 2017-12-27 | Sanofi-Aventis Deutschland Gmbh | Insulino ir glp-1 agonisto derinys |
| JP5832439B2 (ja) | 2009-11-13 | 2015-12-16 | 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 | Ｇｌｐ−１アゴニスト、インスリン及びメチオニンを含む薬学的組成物 |
| CN102711804B (zh) | 2009-11-13 | 2015-09-16 | 赛诺菲-安万特德国有限公司 | 包含glp-1激动剂和甲硫氨酸的药物组合物 |
| 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 |
| CN107375909A (zh) * | 2011-02-02 | 2017-11-24 | 赛诺菲-安万特德国有限公司 | 在2型糖尿病患者中预防低血糖症 |
| 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 |
| WO2013030160A1 (en) | 2011-08-29 | 2013-03-07 | Sanofi-Aventis Deutschland Gmbh | Pharmaceutical combination for use in glycemic control in diabetes type 2 patients |
| TWI559929B (en) | 2011-09-01 | 2016-12-01 | Sanofi Aventis Deutschland | Pharmaceutical composition for use in the treatment of a neurodegenerative disease |
| CA2851690C (en) * | 2011-10-28 | 2022-07-26 | Sanofi-Aventis Deutschland Gmbh | Treatment protocol of diabetes type 2 |
| SG11201506888VA (en) | 2013-04-03 | 2015-09-29 | Sanofi Sa | Treatment of diabetes mellitus by long-acting formulations of insulins |
| LT3010530T (lt) * | 2013-06-17 | 2019-04-10 | Sanofi-Aventis Deutschland Gmbh | Kompozicija su fiksuotu insulino glargino / liksisenatido santikiu |
| MA41138B1 (fr) | 2014-12-12 | 2023-07-31 | Sanofi Aventis Deutschland | Formulation à rapport fixe d'insuline glargine/lixisenatide |
| 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 |
Family Cites Families (1)
| 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 |
-
2009
- 2009-11-13 PT PT91758771T patent/PT2329848E/pt unknown
- 2009-11-13 RS RS20120571 patent/RS52629B2/sr unknown
- 2009-11-13 PL PL09175877T patent/PL2329848T5/pl unknown
- 2009-11-13 ES ES09175877T patent/ES2398012T5/es active Active
- 2009-11-13 DK DK09175877.1T patent/DK2329848T4/da active
- 2009-11-13 ME MEP-2012-147A patent/ME01546B/me unknown
- 2009-11-13 SI SI200930473T patent/SI2329848T2/sl unknown
- 2009-11-13 EP EP09175877.1A patent/EP2329848B2/en active Active
-
2012
- 2012-12-13 HR HRP20121029TT patent/HRP20121029T4/hr unknown
-
2013
- 2013-01-09 CY CY20131100022T patent/CY1113755T1/el unknown
- 2013-01-30 SM SM201300013T patent/SMT201300013B/xx unknown
Also Published As
| Publication number | Publication date |
|---|---|
| EP2329848B2 (en) | 2019-06-19 |
| EP2329848A1 (en) | 2011-06-08 |
| EP2329848B1 (en) | 2012-10-24 |
| DK2329848T3 (da) | 2013-02-04 |
| PL2329848T5 (pl) | 2019-12-31 |
| RS52629B2 (sr) | 2019-11-29 |
| HRP20121029T1 (hr) | 2013-01-31 |
| DK2329848T4 (da) | 2019-09-09 |
| ES2398012T5 (es) | 2020-02-26 |
| RS52629B (sr) | 2013-06-28 |
| CY1113755T1 (el) | 2016-07-27 |
| SI2329848T1 (sl) | 2013-02-28 |
| HRP20121029T4 (hr) | 2019-10-18 |
| SMT201300013B (it) | 2013-03-08 |
| ES2398012T3 (es) | 2013-03-13 |
| PT2329848E (pt) | 2013-01-23 |
| PL2329848T3 (pl) | 2013-05-31 |
| SI2329848T2 (sl) | 2019-10-30 |
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