JP6085552B2 - 糖尿病の補助療法としてのディアセレインの使用方法 - Google Patents
糖尿病の補助療法としてのディアセレインの使用方法 Download PDFInfo
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- A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
- A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
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- A61K31/41—Heterocyclic 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
- A61K31/425—Thiazoles
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- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic 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
- A61K31/425—Thiazoles
- A61K31/427—Thiazoles not condensed and containing further heterocyclic rings
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- 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
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- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/12—Drugs for disorders of the urinary system of the kidneys
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
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- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/48—Drugs for disorders of the endocrine system of the pancreatic hormones
- A61P5/50—Drugs for disorders of the endocrine system of the pancreatic hormones for increasing or potentiating the activity of insulin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/04—Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
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Description
本発明は、II型糖尿病患者を治療するための療法に関する。本発明の方法は、現在の抗糖尿病療法で血糖コントロールが不十分なII型糖尿病患者に特に適している。
本発明によれば、ディアセレインは、単独または常套的抗糖尿病薬と組み合わせてII型糖尿病の治療に用いることができる。好ましくは、患者がすでに不充分な反応を示した現在の薬剤の反応性を増強するか、または機能を相乗的にするために、ディアセレインを現在の抗糖尿病薬に加えることができる。
2型糖尿病のコントロール不良の患者におけるディアセレインの無作為化二重盲検プラセボ対照試験
表1
全無作為化対象の抗糖尿病薬治療
単独療法:メトホルミンまたはスルホニルウレアのみで処置。
薬剤併用:2、3、または4種の経口抗糖尿病薬(メトホルミン、スルホニルウレア、アカルボース、レパグリニド、ピオグリタゾン、およびシタグリプチンから選ばれる)で処置。
血糖症
空腹時血漿グルコールレベルは、24週間でプラセボ群よりディアセレイン群で一貫して低かった。図2参照。
β細胞の機能
ベースラインレベルと第24週のレベル間の体重(図4)、血圧(表2および3)、脈拍数(表4)、および脂質プロフィール(表5〜8)には処置群間で統計的有意差はみられなかった。心血管安全性評価項目の結果は、ディアセレインを現抗糖尿病治療に追加しても心臓発作および心血管障害のリスクは増加しないことを示した。
表2
Claims (6)
- 抗糖尿病薬に対する反応が不適切なII型糖尿病の対象におけるII型糖尿病の補助治療剤の製造における、ディアセレインまたはその医薬的に許容される塩、モノアセチルレイン、あるいはレインの使用であって、前記対象が、少なくとも1つの抗糖尿病薬を投与されており、ヘモグロビンA1c値が7%以上であるII型糖尿病のヒト患者である、該使用。
- 抗糖尿病薬に対する反応が不適切なII型糖尿病の対象における血糖コントロールを改善する薬剤の製造における組み合わせ薬剤の使用であって、該組み合わせ薬剤が、a)治療的有効量のディアセレインまたはその医薬的に許容される塩、モノアセチルレイン、あるいはレイン、およびb)該抗糖尿病薬を含むものであり、前記対象が、少なくとも1つの抗糖尿病薬を投与されており、ヘモグロビンA1c値が7%以上であるII型糖尿病のヒト患者である、該使用。
- 該抗糖尿病薬が、スルホニルウレア、ビグアニド、アルファ-グルコシダーゼ阻害剤、チアゾリジンジオン、ジペプチジルペプチダーゼ-4阻害剤、メトホルミン、グリブリド、グリメピリド、グリピリド、グリピジド、クロルプロパミド、グリクラジド、アカルボース、ミグリトール、ピオグリタゾン、トログリタゾン、ロシグリタゾン、イサグリタゾン、ムラグリチザル、ペリグリタザル、シタグリプチン、サキサグリプチン、ビルダグリプチン、アログリプチン、リナグリプチン、デュトグリプチン、レパグリニド、ナテグリニド、ミチグリンジン、エキセナチド、リラグルチド、アルビグルチド、およびインスリンからなる群から選ばれる少なくとも1の薬剤である請求項1または2に記載の使用。
- 該対象が、インスリン耐性、耐糖能異常、高血糖、または高インスリン血症からなる群から選ばれる病状を有するII型糖尿病患者である請求項1〜3のいずれか1項に記載の使用。
- 治療的有効量のディアセレインが25〜200mg/日である、請求項1〜4のいずれか1項に記載の使用。
- 治療的有効量の医薬的許容される塩、モノアセチルレインまたはレインが、ディアセレインの25〜200mg/日と等価である、請求項1〜4のいずれか1項に記載の使用。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US32193110P | 2010-04-08 | 2010-04-08 | |
US61/321,931 | 2010-04-08 | ||
PCT/US2011/031517 WO2011127240A1 (en) | 2010-04-08 | 2011-04-07 | Methods of using diacerein as an adjunctive therapy for diabetes |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
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JP2015218824A Division JP2016041739A (ja) | 2010-04-08 | 2015-11-06 | 糖尿病の補助療法としてのディアセレインの使用方法 |
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Publication Number | Publication Date |
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JP2013523832A JP2013523832A (ja) | 2013-06-17 |
JP6085552B2 true JP6085552B2 (ja) | 2017-02-22 |
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JP2013503938A Expired - Fee Related JP6085552B2 (ja) | 2010-04-08 | 2011-04-07 | 糖尿病の補助療法としてのディアセレインの使用方法 |
JP2015218824A Pending JP2016041739A (ja) | 2010-04-08 | 2015-11-06 | 糖尿病の補助療法としてのディアセレインの使用方法 |
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JP2015218824A Pending JP2016041739A (ja) | 2010-04-08 | 2015-11-06 | 糖尿病の補助療法としてのディアセレインの使用方法 |
Country Status (16)
Country | Link |
---|---|
US (1) | US8536152B2 (ja) |
EP (1) | EP2555618B1 (ja) |
JP (2) | JP6085552B2 (ja) |
KR (1) | KR101567925B1 (ja) |
CN (1) | CN102858155B (ja) |
AU (1) | AU2011237600B2 (ja) |
BR (1) | BR112012024936A2 (ja) |
CA (1) | CA2794566C (ja) |
ES (1) | ES2560310T3 (ja) |
IL (1) | IL222133A (ja) |
MX (1) | MX2012011517A (ja) |
NZ (1) | NZ602583A (ja) |
PT (1) | PT2555618E (ja) |
RU (1) | RU2563988C2 (ja) |
TW (1) | TWI519297B (ja) |
WO (1) | WO2011127240A1 (ja) |
Families Citing this family (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
PT2555618E (pt) * | 2010-04-08 | 2016-03-08 | Twi Biotechnology Inc | Métodos de utilização da diacereína como terapia adjuvante para a diabetes |
CN101822660B (zh) * | 2010-05-13 | 2013-07-10 | 中国人民解放军肾脏病研究所 | 大黄酸类化合物或其盐在制备预防和治疗胰岛β细胞功能衰退药物中的应用 |
CA2990948A1 (en) | 2015-07-01 | 2017-01-05 | Twi Biotechnology, Inc. | Diacerein or rhein topical formulations and uses thereof |
MX2018002049A (es) * | 2015-08-17 | 2018-06-15 | Twi Biotechnology Inc | Diacereina o sus analogos para inhibir la expresion de proteina como mota relacionada a la apoptosis que contiene un dominio de reclutamiento de caspasa (asc), expresion de dominios de pirina y familia nlr que contienen 3 (nlrp3) y/o formacion de complejo de inflamasoma de nlrp3. |
TW201739448A (zh) * | 2016-05-06 | 2017-11-16 | 安成生物科技股份有限公司 | 用於治療及/或預防血液相關疾病之方法及配方 |
Family Cites Families (9)
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IT1276781B1 (it) * | 1995-06-23 | 1997-11-03 | Gentili Ist Spa | Derivati antrachinonmono- e disolfon- sostituiti e composizioni farmaceutiche che li contengono per il trattamento delle patologie |
CN1086289C (zh) * | 1997-09-30 | 2002-06-19 | 中国人民解放军肾脏病研究所 | 大黄酸或大黄酸盐在制备治疗糖尿病肾病药中的用途 |
AR026801A1 (es) * | 2000-01-12 | 2003-02-26 | Medidom Lab | Sustancias para uso en el tratamiento de la psoriasis |
US20060252670A1 (en) * | 2004-10-14 | 2006-11-09 | Intercept Pharmaceuticals Inc. | Method of reducing drug-induced adverse side effects in a patient |
CN1748675A (zh) * | 2005-07-11 | 2006-03-22 | 丛晓东 | 大黄酸类化合物的复合物及制备方法与治疗糖尿病的应用 |
TWI473610B (zh) * | 2008-10-28 | 2015-02-21 | Twi Biotechnology Inc | 包含雙醋瑞因(diacerein)之醫藥組合物 |
US20110045522A1 (en) * | 2009-08-20 | 2011-02-24 | Danchen Gao | Methods for diagnosing diabetes and determining effectiveness of treatments |
PT2555618E (pt) * | 2010-04-08 | 2016-03-08 | Twi Biotechnology Inc | Métodos de utilização da diacereína como terapia adjuvante para a diabetes |
CA2829101C (en) * | 2011-03-11 | 2019-08-20 | Twi Biotechnology, Inc. | Methods and compositions for treating hyperuricemia and metabolic disorders associated with hyperuricemia |
-
2011
- 2011-04-07 PT PT117667022T patent/PT2555618E/pt unknown
- 2011-04-07 EP EP11766702.2A patent/EP2555618B1/en not_active Not-in-force
- 2011-04-07 CN CN201180018154.8A patent/CN102858155B/zh not_active Expired - Fee Related
- 2011-04-07 ES ES11766702.2T patent/ES2560310T3/es active Active
- 2011-04-07 MX MX2012011517A patent/MX2012011517A/es active IP Right Grant
- 2011-04-07 JP JP2013503938A patent/JP6085552B2/ja not_active Expired - Fee Related
- 2011-04-07 KR KR1020127029213A patent/KR101567925B1/ko active IP Right Grant
- 2011-04-07 US US13/081,548 patent/US8536152B2/en not_active Expired - Fee Related
- 2011-04-07 CA CA2794566A patent/CA2794566C/en not_active Expired - Fee Related
- 2011-04-07 WO PCT/US2011/031517 patent/WO2011127240A1/en active Application Filing
- 2011-04-07 AU AU2011237600A patent/AU2011237600B2/en not_active Ceased
- 2011-04-07 RU RU2012147449/15A patent/RU2563988C2/ru not_active IP Right Cessation
- 2011-04-07 NZ NZ602583A patent/NZ602583A/en not_active IP Right Cessation
- 2011-04-07 BR BR112012024936A patent/BR112012024936A2/pt not_active Application Discontinuation
- 2011-04-08 TW TW100112312A patent/TWI519297B/zh not_active IP Right Cessation
-
2012
- 2012-09-24 IL IL222133A patent/IL222133A/en not_active IP Right Cessation
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- 2015-11-06 JP JP2015218824A patent/JP2016041739A/ja active Pending
Also Published As
Publication number | Publication date |
---|---|
CN102858155B (zh) | 2015-02-04 |
ES2560310T3 (es) | 2016-02-18 |
PT2555618E (pt) | 2016-03-08 |
WO2011127240A1 (en) | 2011-10-13 |
BR112012024936A2 (pt) | 2015-09-15 |
RU2563988C2 (ru) | 2015-09-27 |
TW201210586A (en) | 2012-03-16 |
US20110251155A1 (en) | 2011-10-13 |
AU2011237600B2 (en) | 2016-06-23 |
TWI519297B (zh) | 2016-02-01 |
KR20130045266A (ko) | 2013-05-03 |
EP2555618A4 (en) | 2013-11-13 |
CA2794566C (en) | 2018-06-12 |
CN102858155A (zh) | 2013-01-02 |
IL222133A (en) | 2017-01-31 |
AU2011237600A1 (en) | 2012-10-11 |
CA2794566A1 (en) | 2011-10-13 |
RU2012147449A (ru) | 2014-05-20 |
EP2555618B1 (en) | 2015-12-30 |
KR101567925B1 (ko) | 2015-11-10 |
EP2555618A1 (en) | 2013-02-13 |
MX2012011517A (es) | 2012-11-29 |
JP2013523832A (ja) | 2013-06-17 |
JP2016041739A (ja) | 2016-03-31 |
NZ602583A (en) | 2014-10-31 |
US8536152B2 (en) | 2013-09-17 |
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