JP7274258B2 - リキシセナチドを用いた小児２型真性糖尿病患者の治療 - Google Patents

リキシセナチドを用いた小児２型真性糖尿病患者の治療 Download PDF

Info

Publication number
JP7274258B2
JP7274258B2 JP2017537500A JP2017537500A JP7274258B2 JP 7274258 B2 JP7274258 B2 JP 7274258B2 JP 2017537500 A JP2017537500 A JP 2017537500A JP 2017537500 A JP2017537500 A JP 2017537500A JP 7274258 B2 JP7274258 B2 JP 7274258B2
Authority
JP
Japan
Prior art keywords
lixisenatide
patient
treatment
study
patients
Prior art date
Legal status (The legal status 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 status listed.)
Active
Application number
JP2017537500A
Other languages
English (en)
Japanese (ja)
Other versions
JP2018503644A5 (enExample
JP2018503644A (ja
Inventor
カーリン・ベルクマン
アニエス・インセリン－メリー
クリステル・ヤン
Original Assignee
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
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=52354814&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=JP7274258(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by 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 filed Critical 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
Publication of JP2018503644A publication Critical patent/JP2018503644A/ja
Publication of JP2018503644A5 publication Critical patent/JP2018503644A5/ja
Application granted granted Critical
Publication of JP7274258B2 publication Critical patent/JP7274258B2/ja
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

Classifications

    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • 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
    • 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
    • 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
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Diabetes (AREA)
  • Endocrinology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Zoology (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Hematology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Obesity (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Child & Adolescent Psychology (AREA)
  • Emergency Medicine (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Inorganic Chemistry (AREA)
  • Dermatology (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)
  • Peptides Or Proteins (AREA)
JP2017537500A 2015-01-16 2016-01-15 リキシセナチドを用いた小児２型真性糖尿病患者の治療 Active JP7274258B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP15151488.2 2015-01-16
EP15151488 2015-01-16
PCT/EP2016/050804 WO2016113404A1 (en) 2015-01-16 2016-01-15 Treatment of pediatric type 2 diabetes mellitus patients with lixisenatide

Publications (3)

Publication Number Publication Date
JP2018503644A JP2018503644A (ja) 2018-02-08
JP2018503644A5 JP2018503644A5 (enExample) 2019-02-14
JP7274258B2 true JP7274258B2 (ja) 2023-05-16

Family

ID=52354814

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2017537500A Active JP7274258B2 (ja) 2015-01-16 2016-01-15 リキシセナチドを用いた小児２型真性糖尿病患者の治療

Country Status (21)

Country Link
US (4) US20160235818A1 (enExample)
EP (1) EP3244912B1 (enExample)
JP (1) JP7274258B2 (enExample)
KR (1) KR102614574B1 (enExample)
CN (1) CN107405386A (enExample)
AR (1) AR103415A1 (enExample)
AU (1) AU2016207964B2 (enExample)
CL (1) CL2017001843A1 (enExample)
CR (1) CR20170376A (enExample)
EA (1) EA035423B1 (enExample)
ES (1) ES2895513T3 (enExample)
IL (1) IL253460B (enExample)
MX (1) MX381944B (enExample)
PH (1) PH12017501290A1 (enExample)
PL (1) PL3244912T3 (enExample)
PT (1) PT3244912T (enExample)
SG (1) SG11201705755UA (enExample)
TN (1) TN2017000292A1 (enExample)
TW (1) TWI706779B (enExample)
WO (1) WO2016113404A1 (enExample)
ZA (1) ZA201704512B (enExample)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PT3228320T (pt) 2008-10-17 2020-03-26 Sanofi Aventis Deutschland Combinação de uma insulina e de um agonista do glp-1
SG10201500871TA (en) 2009-11-13 2015-04-29 Sanofi Aventis Deutschland Pharmaceutical composition comprising a glp-1 agonist and methionine
CN107206058A (zh) 2014-12-12 2017-09-26 赛诺菲-安万特德国有限公司 甘精胰岛素/利西拉来固定比率配制剂
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
DE102019129444A1 (de) * 2019-10-31 2021-05-06 Lts Lohmann Therapie-Systeme Ag Lagtime-Verkürzung/Eisspray
US20240201166A1 (en) * 2021-04-11 2024-06-20 Vikas Khurana Diagnosis and treatment of congestive colon failure (ccf)
WO2024133412A1 (en) 2022-12-21 2024-06-27 Novo Nordisk A/S Methods and systems for estimating fbg value from cgm data

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2012516309A (ja) 2009-01-29 2012-07-19 ベーリンガー インゲルハイム インターナショナル ゲゼルシャフト ミット ベシュレンクテル ハフツング 小児患者の糖尿病の治療のためのｄｐｐ−ｉｖインヒビター
JP2014514356A (ja) 2011-05-13 2014-06-19 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 ２型糖尿病の処置のためのリキシセナチド及びメトホルミン

Family Cites Families (7)

* 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
US20120231022A1 (en) * 2009-05-28 2012-09-13 Amylin Pharmaceuticals, Inc. Glp-1 receptor agonist compounds for sleep enhancement
SI2324853T1 (sl) * 2009-11-13 2015-12-31 Sanofi-Aventis Deutschland Gmbh Liksisenatid kot dodatek metforminu pri zdravljenju sladkorne bolezni tipa 2
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
WO2013003449A2 (en) * 2011-06-27 2013-01-03 Phasebio Pharmaceuticals, Inc. Methods of treatment with glp-1 receptor agonists
JP6367115B2 (ja) * 2011-08-29 2018-08-01 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 ２型糖尿病患者の血糖コントロールに使用する組合せ医薬
SG11201401175SA (en) * 2011-10-28 2014-09-26 Sanofi Aventis Deutschland Treatment protocol of diabetes type 2

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2012516309A (ja) 2009-01-29 2012-07-19 ベーリンガー インゲルハイム インターナショナル ゲゼルシャフト ミット ベシュレンクテル ハフツング 小児患者の糖尿病の治療のためのｄｐｐ−ｉｖインヒビター
JP2014514356A (ja) 2011-05-13 2014-06-19 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 ２型糖尿病の処置のためのリキシセナチド及びメトホルミン

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
Ｕ．Ｓ． Ｎａｔｉｏｎａｌ Ｉｎｓｔｉｔｕｔｅｓ ｏｆ Ｈｅａｌｔｈ， " Ｅｖａｌｕａｔｉｏｎ ｏｆ ｔｈｅ Ｂｌｏｏｄ Ｌｅｖｅｌｓ ｏｆ ｔｈｅ Ｄｒｕｇ （Ｌｉｘｉｓｅｎａｔｉｄｅ）， ｔｈｅ Ｐｌａｓｍａ Ｇｌｕｃｏｓｅ Ｌｅｖｅｌｓ ａｎｄ Ｓａｆｅｔｙ ｉｎ Ｐａｅｄｉａｔｒｉｃ ａｎｄ Ａｄｕｌｔ Ｐａｔｉｅｎｔｓ Ｗｉｔｈ Ｔｙｐｅ ２ Ｄｉａｂｅｔｅｓ"， ｌａｓｔ ｕｐｄａｔｅ：２０１４．０５．２３， ［ｒｅｔｒｉｅｖｅｄ ｏｎ ２０２０．０７．１０］， ｒｅｔｒｉｅｖｅｄ ｆｒｏｍ ｔｈｅ ｉｎｔｅｒｎｅｔ： ＜ＵＲＬ： ｈｔｔｐｓ：／／ｃｌｉｎｉｃａｌｔｒｉａｌｓ．ｇｏｖ／ｃｔ２／ｓｈｏｗ／ＮＣＴ０１５７２６４９？ｔｅｒｍ＝ＮＣＴ０１５７２６４９＆ｄｒａｗ＝２＆ｒａｎｋ＝１＞

Also Published As

Publication number Publication date
TWI706779B (zh) 2020-10-11
SG11201705755UA (en) 2017-08-30
IL253460A0 (en) 2017-09-28
EP3244912A1 (en) 2017-11-22
CN107405386A (zh) 2017-11-28
EA201791611A1 (ru) 2017-11-30
ES2895513T3 (es) 2022-02-21
MX2017009294A (es) 2017-11-20
KR20170102550A (ko) 2017-09-11
JP2018503644A (ja) 2018-02-08
BR112017015099A2 (pt) 2018-04-17
ZA201704512B (en) 2019-07-31
AU2016207964A1 (en) 2017-08-31
PH12017501290A1 (en) 2018-02-05
NZ734595A (en) 2022-03-25
PT3244912T (pt) 2021-10-27
CA2973632A1 (en) 2016-07-21
TW201639551A (zh) 2016-11-16
CL2017001843A1 (es) 2018-02-23
EP3244912B1 (en) 2021-08-18
WO2016113404A1 (en) 2016-07-21
US20240173384A1 (en) 2024-05-30
KR102614574B1 (ko) 2023-12-18
AU2016207964B2 (en) 2021-10-14
EA035423B1 (ru) 2020-06-11
MX381944B (es) 2025-03-13
US20160235818A1 (en) 2016-08-18
TN2017000292A1 (en) 2019-01-16
US20190365864A1 (en) 2019-12-05
US20210187075A1 (en) 2021-06-24
AR103415A1 (es) 2017-05-10
IL253460B (en) 2022-06-01
CR20170376A (es) 2017-09-25
PL3244912T3 (pl) 2021-12-20

Similar Documents

Publication Publication Date Title
Capehorn et al. Efficacy and safety of once-weekly semaglutide 1.0 mg vs once-daily liraglutide 1.2 mg as add-on to 1–3 oral antidiabetic drugs in subjects with type 2 diabetes (SUSTAIN 10)
US20210187075A1 (en) Treatment of pediatric type 2 diabetes mellitus patients
US12186374B2 (en) Insulin glargine/lixisenatide fixed ratio formulation
Haak et al. Lower within‐subject variability of fasting blood glucose and reduced weight gain with insulin detemir compared to NPH insulin in patients with type 2 diabetes
Baruah et al. Management of hyperglycemia in geriatric patients with diabetes mellitus: South Asian consensus guidelines
TW202500575A (zh) 具有或不具有體重相關合併症之過重或肥胖成人之治療
CA2973632C (en) Treatment of pediatric type 2 diabetes mellitus patients with lixisenatide
Milenkovikj et al. Once-weekly semaglutide use in glucagon-like peptide-1 receptor agonist naïve patients with type 2 diabetes in North Macedonia: Real-world data from the MIRAGE study
Sheehan et al. Obesity and type 2 diabetes mellitus
HK1239556B (en) Treatment of pediatric type 2 diabetes mellitus patients with lixisenatide
BR112017015099B1 (pt) Uso de lixisenatida e/ou um sal farmaceuticamente aceitável da mesma para tratar pacientes pediátricos portadores de diabetes mellitus tipo 2
NZ734595B2 (en) Treatment of pediatric type 2 diabetes mellitus patients with lixisenatide
Harris CLINICAL PROTOCOL APPROVAL FORM
Cuthbertson Emily Brown, Moon M Wilton, 3 Victoria S Sprung, 4 Joanne A Harrold, 3 Jason CG Halford, 5 Andrej Stancak, 3 Malcolm Burgess, 6 Elaine Howarth, 7 A Margot Umpleby, 8 Graham J Kemp, 9, 10 John PH Wilding

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20181226

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20181226

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20191203

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20200804

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20201104

A02 Decision of refusal

Free format text: JAPANESE INTERMEDIATE CODE: A02

Effective date: 20210518

C60 Trial request (containing other claim documents, opposition documents)

Free format text: JAPANESE INTERMEDIATE CODE: C60

Effective date: 20210917

C116 Written invitation by the chief administrative judge to file amendments

Free format text: JAPANESE INTERMEDIATE CODE: C116

Effective date: 20211005

C22 Notice of designation (change) of administrative judge

Free format text: JAPANESE INTERMEDIATE CODE: C22

Effective date: 20211005

C22 Notice of designation (change) of administrative judge

Free format text: JAPANESE INTERMEDIATE CODE: C22

Effective date: 20220412

C22 Notice of designation (change) of administrative judge

Free format text: JAPANESE INTERMEDIATE CODE: C22

Effective date: 20220719

C22 Notice of designation (change) of administrative judge

Free format text: JAPANESE INTERMEDIATE CODE: C22

Effective date: 20230214

C23 Notice of termination of proceedings

Free format text: JAPANESE INTERMEDIATE CODE: C23

Effective date: 20230307

C03 Trial/appeal decision taken

Free format text: JAPANESE INTERMEDIATE CODE: C03

Effective date: 20230404

C30A Notification sent

Free format text: JAPANESE INTERMEDIATE CODE: C3012

Effective date: 20230404

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20230501

R150 Certificate of patent or registration of utility model

Ref document number: 7274258

Country of ref document: JP

Free format text: JAPANESE INTERMEDIATE CODE: R150

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250