AU2016207964B2 - Treatment of pediatric type 2 diabetes mellitus patients with lixisenatide - Google Patents

Treatment of pediatric type 2 diabetes mellitus patients with lixisenatide Download PDF

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Publication number
AU2016207964B2
AU2016207964B2 AU2016207964A AU2016207964A AU2016207964B2 AU 2016207964 B2 AU2016207964 B2 AU 2016207964B2 AU 2016207964 A AU2016207964 A AU 2016207964A AU 2016207964 A AU2016207964 A AU 2016207964A AU 2016207964 B2 AU2016207964 B2 AU 2016207964B2
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AU
Australia
Prior art keywords
lixisenatide
treatment
patient
patients
study
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Active
Application number
AU2016207964A
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English (en)
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AU2016207964A1 (en
Inventor
Karin Bergmann
Agnes Hincelin-Méry
Christelle JAN
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Sanofi Aventis Deutschland GmbH
Original Assignee
Sanofi Aventis Deutschland GmbH
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.)
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Application filed by Sanofi Aventis Deutschland GmbH filed Critical Sanofi Aventis Deutschland GmbH
Publication of AU2016207964A1 publication Critical patent/AU2016207964A1/en
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Publication of AU2016207964B2 publication Critical patent/AU2016207964B2/en
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Classifications

    • 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
    • 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
    • A61K38/28—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
    • 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
    • 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

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)
AU2016207964A 2015-01-16 2016-01-15 Treatment of pediatric type 2 diabetes mellitus patients with lixisenatide Active AU2016207964B2 (en)

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 (2)

Publication Number Publication Date
AU2016207964A1 AU2016207964A1 (en) 2017-08-31
AU2016207964B2 true AU2016207964B2 (en) 2021-10-14

Family

ID=52354814

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2016207964A Active AU2016207964B2 (en) 2015-01-16 2016-01-15 Treatment of pediatric type 2 diabetes mellitus patients with lixisenatide

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 (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010138671A1 (en) * 2009-05-28 2010-12-02 Amylin Pharmaceuticals, Inc. Glp-1 receptor agonist compounds for sleep enhancement
EP2324853A1 (en) * 2009-11-13 2011-05-25 Sanofi-Aventis Deutschland GmbH Lixisenatide as add-on to metformin in the treatment of diabetes type 2
WO2013060850A1 (en) * 2011-10-28 2013-05-02 Sanofi-Aventis Deutschland Gmbh Treatment protocol of diabetes type 2

Family Cites Families (6)

* 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
AR075204A1 (es) * 2009-01-29 2011-03-16 Boehringer Ingelheim Int Inhibidores de dpp-4 y composiciones farmaceuticas que los comprenden, utiles para tratar enfermedades metabolicas en pacientes pediatricos, particularmente diabetes mellitus tipo 2
EP2707017B1 (en) * 2011-05-13 2015-09-16 Sanofi-Aventis Deutschland GmbH Lixisenatide and metformin for treatment of diabetes type 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

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010138671A1 (en) * 2009-05-28 2010-12-02 Amylin Pharmaceuticals, Inc. Glp-1 receptor agonist compounds for sleep enhancement
EP2324853A1 (en) * 2009-11-13 2011-05-25 Sanofi-Aventis Deutschland GmbH Lixisenatide as add-on to metformin in the treatment of diabetes type 2
WO2013060850A1 (en) * 2011-10-28 2013-05-02 Sanofi-Aventis Deutschland Gmbh Treatment protocol of diabetes type 2

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
Anonymous (2014-05-23), Retrieved from the Internet: https://clinicaltrials.gov/ct2/show/NCT01572649?term=NCT01572649&draw=2&rank=1 [retrieved on 2020-10-26] *
Raman Vandana S; Heptulla Rubina A, "New potential adjuncts to treatment of children with type 1 diabetes mellitus", Pediatric Research, (2010), vol. 65, no. 4, pages 370 - 374 *
SHEHADEH NAIM ET AL, "Can GLP-1 preparations be used in children and adolescents with diabetes mellitus?", PEDIATRIC ENDOCRINOLOGY REVIEWS, (2014), vol. 11, no. 3, pages 324 - 327 *

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
JP7274258B2 (ja) 2023-05-16
WO2016113404A1 (en) 2016-07-21
US20240173384A1 (en) 2024-05-30
KR102614574B1 (ko) 2023-12-18
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

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