JP6250196B2 - 糖尿病治療用組成物 - Google Patents
糖尿病治療用組成物 Download PDFInfo
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- JP6250196B2 JP6250196B2 JP2016571755A JP2016571755A JP6250196B2 JP 6250196 B2 JP6250196 B2 JP 6250196B2 JP 2016571755 A JP2016571755 A JP 2016571755A JP 2016571755 A JP2016571755 A JP 2016571755A JP 6250196 B2 JP6250196 B2 JP 6250196B2
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- OUDSBRTVNLOZBN-UHFFFAOYSA-N tolazamide Chemical compound C1=CC(C)=CC=C1S(=O)(=O)NC(=O)NN1CCCCCC1 OUDSBRTVNLOZBN-UHFFFAOYSA-N 0.000 description 1
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- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 description 1
- 235000013337 tricalcium citrate Nutrition 0.000 description 1
- ITMCEJHCFYSIIV-UHFFFAOYSA-N triflic acid Chemical compound OS(=O)(=O)C(F)(F)F ITMCEJHCFYSIIV-UHFFFAOYSA-N 0.000 description 1
- HRXKRNGNAMMEHJ-UHFFFAOYSA-K trisodium citrate Chemical compound [Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O HRXKRNGNAMMEHJ-UHFFFAOYSA-K 0.000 description 1
- GXPHKUHSUJUWKP-UHFFFAOYSA-N troglitazone Chemical compound C1CC=2C(C)=C(O)C(C)=C(C)C=2OC1(C)COC(C=C1)=CC=C1CC1SC(=O)NC1=O GXPHKUHSUJUWKP-UHFFFAOYSA-N 0.000 description 1
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- 229940100445 wheat starch Drugs 0.000 description 1
- 239000003871 white petrolatum Substances 0.000 description 1
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- 235000010493 xanthan gum Nutrition 0.000 description 1
- 239000000230 xanthan gum Substances 0.000 description 1
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- SXONDGSPUVNZLO-UHFFFAOYSA-N zenarestat Chemical compound O=C1N(CC(=O)O)C2=CC(Cl)=CC=C2C(=O)N1CC1=CC=C(Br)C=C1F SXONDGSPUVNZLO-UHFFFAOYSA-N 0.000 description 1
- 229950006343 zenarestat Drugs 0.000 description 1
- 239000011701 zinc Substances 0.000 description 1
- 229910052725 zinc Inorganic materials 0.000 description 1
- XOOUIPVCVHRTMJ-UHFFFAOYSA-L zinc stearate Chemical compound [Zn+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O XOOUIPVCVHRTMJ-UHFFFAOYSA-L 0.000 description 1
- UHVMMEOXYDMDKI-JKYCWFKZSA-L zinc;1-(5-cyanopyridin-2-yl)-3-[(1s,2s)-2-(6-fluoro-2-hydroxy-3-propanoylphenyl)cyclopropyl]urea;diacetate Chemical compound [Zn+2].CC([O-])=O.CC([O-])=O.CCC(=O)C1=CC=C(F)C([C@H]2[C@H](C2)NC(=O)NC=2N=CC(=CC=2)C#N)=C1O UHVMMEOXYDMDKI-JKYCWFKZSA-L 0.000 description 1
Classifications
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
- A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
-
- 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)
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- 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic 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
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
- A61K31/4439—Non 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
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- A—HUMAN NECESSITIES
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- 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
- A61K38/18—Growth factors; Growth regulators
- A61K38/1816—Erythropoietin [EPO]
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- A—HUMAN NECESSITIES
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- 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
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
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- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
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- Zoology (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
Description
そして、本発明は、輸液製剤の形態、又は経口製剤の形態とすることができる。
1)その組成物による治療及び/又は予防効果の補完及び/又は増強、
2)その組成物の動態・吸収改善、投与量の低減、
及び/又は
3)その組成物による副作用を軽減するために他の薬剤と組み合わせた医薬として投与してもよい。
以下、本発明の好適な実施形態について詳細に説明する。本発明に係る糖尿病治療用組成物は、血中乳酸値を実質的に上昇させずに血糖値を降下させる作用を有し、その組成物が、分岐鎖アミノ酸又は分岐鎖アミノ酸の誘導体と、ビグアニド誘導体又は該ビグアニド誘導体の塩とを有効成分とする。
ロイシン、イソロイシン又はバリンは、それぞれ、下記の化学構造式(1)〜(3)で示される化合物である。
本発明の糖尿病治療用組成物の投与方法は特に制限されないが、例えば、前記分岐鎖アミノ酸又は分岐鎖アミノ酸の誘導体と、ビグアニド誘導体又は該ビグアニド誘導体の塩と、前述の添加成分とを用いて医薬組成物(製剤)とし、経口的又は非経口的に投与することができる。
当該糖尿病治療用組成物は、製剤の形態で好適に使用される。かかる製剤の形態としては、特に限定されず、例えば輸液製剤、経口製剤、経皮吸収型製剤、坐剤、貼付剤、軟膏剤、ハップ剤、ローション剤等の形態が挙げられる。
なお、上述した本発明の糖尿病治療用組成物は、DPP4が介在する疾患及び/又は症状の治療、予防及び/又は改善剤として有効であり、
1)その組成物による治療及び/又は予防効果の補完及び/又は増強、
2)その組成物の動態・吸収改善、投与量の低減、
及び/又は
3)その組成物による副作用を軽減するために他の薬剤と組み合わせた医薬として投与してもよい。例えば、分岐鎖アミノ酸(BCAA)と、メトホルミン等のビグアニド誘導体又は該ビグアニド誘導体又は分岐鎖アミノ酸の誘導体の塩と、さらに糖尿病治療薬とを組み合わせた医薬として投与することができる。
α−グルコシダーゼ阻害薬としては、例えば、アカルボース、ボグリボース、ミグリトール等が挙げられる。
インスリン分泌促進薬としては、例えば、ナテグリニド、レパグリニド、ミチグリニド等が挙げられる。 インスリン増感薬としては、例えば、ONO−5816、YM−440、JTT−501、NN−2344等が挙げられる。
アルドース還元酵素阻害薬としては、例えば、エパルレスタット、フィダレスタット、ゼナレスタット等が挙げられる。
リパーゼ阻害薬としては、例えばオルリスタット等が挙げられる。
性別 女性
年齢 99歳
処方期間 H27年6月13日 HbA1c…6.6mg/dl
H27年7月18日 HbA1c…5.6mg/dl 乳酸値…8.1
H27年7月29日 HbA1c…5.5mg/dl
H27年8月17日 乳酸値…15.9
H27年9月4日 乳酸値…12.1
H27年9月5日 HbA1c…5.1mg/dl
H27年11月5日 乳酸値…17.2
○医師による所感
高齢者で腎機能障害も合併していたが、ほぼ1ヶ月でHbA1c値が1.0(約15%)下が、血糖値が下がるにつれて食欲も出てきて、副作用も出ていない。観察期間終了時における乳酸値も正常値である8.1(<16.0)で安定している。
本処方例に患者は99歳の女性であり、平成27年6月13日から平成27年11月29日の約5ヶ月半にわたり治療にあたった。初診時HbA1c6.6であり、腎性貧血もあり、6月27日におけるHb5.5であり、Ht17.3であった。
17歳の頃からインシュリンを使用している糖尿病患者であるが、メトフォルミンとBCAA(Branched Chain Amino Acid:分岐鎖アミノ酸)を併用して治療した。
性別 女性
年齢 41歳
処方期間 H27年8月12日 乳酸5.9
H27年8月26日 乳酸4.7
H27年9月12日 乳酸3.6
○医師による所感
血糖値は下がらなかったものの、乳酸値は5.9から3.6へと下がった。
寝たきりになってから食事が摂れず、高カロリー輸液になり、その後徐々に血糖値が上がってきていた。メトホルミン(250mg)を1錠及び、低アルブミン血症のためBCAAを処方。
性別 女性
年齢 89歳
処方期間 H27年7月7日 HbA1c…6.2mg/dl
H27年8月5日 HbA1c…5.7mg/dl 乳酸値…10.8
○医師による所感
1ヶ月でHbA1c値が0.5mg/dl(約8%)下がっており、途中下がりすぎる傾向があるので、メトホルミンは125mg/日としている。境界型糖尿病を正常値まで持って行くのは比較的難しいと思われるが、乳酸値も高齢者でもあるにもかかわらず副作用なく正常域(<16.0)に達した。
低血糖からくる低酸素脳症が原因で寝たきりとなっている患者に、インシュリン治療と併せて、メトホルミン(250mg)×1〜2錠を処方した。
性別 男性
年齢 68歳
処方期間 H25年10月29日 HbA1c…7.6mg/dl
H26年3月16日 HbA1c…5.9mg/dl(基準値6.2)
H27年6月6日 HbA1c…5.9mg/dl 乳酸値…5.1
○医師による所感
処方当初と比べてHbA1c値が7.6mg/dlから5.9mg/dl(約20%)まで下がっており、観察期間における乳酸の最終値が正常値である5.1(<16.0)で安定している。
性別 男性
年齢 49歳
処方期間 H26年3月13日 HbA1c…9.2mg/dl
H26年12月8日 HbA1c…11.1mgdl 乳酸値…16.3
H27年3月18日 HbA1c…8.6mg/dl
H27年4月1日 HbA1c…8.2mg/dl 乳酸値…9.3
H27年6月12日 HbA1c…7.4mg/dl 乳酸値…12.3
○医師による所感
インシュリン治療と併せて、BCAAとメトホルミン(250mg)×6錠により、平成27年に入ってからの2ヶ月間でHbA1c値が8.6mg/dlから7.4mg/dl(約14%)まで下がり、最高値11.1mg/dlからは約30%下がっている。乳酸値も正常値である12.3で安定している。
糖尿病治療に際し、メトホルミンとBCAAを処方。
性別 女性
年齢 74歳
処方期間 H26年3月27日 HbA1c…9.4mg/dl
H26年7月10日 HbA1c…6.1mg/dl
H27年3月28日 乳酸値…6.1
H27年6月6日 HbA1c…5.6mg/dl
○医師による所感
初期段階で平成26年3月〜7月という短期間にHbA1c値が9.4mg/dlから6.1mg/dl(約35%)まで下がり、この期間を含む1年数ヶ月でHbA1c値が9.4mg/dlから5.6mg/dlまで約40%も落ちている。平成27年6月の時点で乳酸値も、正常値である9.6(<16.0)で安定している。
性別 男性
年齢 76歳
処方期間 H27年9月11日 HbA1c…7.0mg/dl
H27年10月4日 HbA1c…6.3mg/dl
H27年10月16日 乳酸値…14.2
○医師による所感
初期段階で平成27年9月〜10月という短い期間にHbA1c値が7.0mg/dlから6.3mg/dl(約10%)まで下がり、平成27年10月の時点で乳酸値も14.2(<16.0)で安定している。
性別 男性
年齢 75歳(糖尿病、認知症)
処方期間 H27年10月14日 HbA1c…8.6mg/dl 乳酸値…18.6
H28年6月29日 HbA1c…7.9mg/dl
H28年7月4日 乳酸値…15.1
○医師による所感
当患者は、初診時(平成27年10月14日)の検査結果はHbA1c8.6 乳酸値18.6>16.0であり、投薬経口糖尿病薬(5種類そのうち1種類はメトホルミンで500mg使用)を投与し、さらに24時間持続性のインスリン(5単位)を使用した。
年齢 52歳
処方期間 H28年2月24日 HbA1c…9.1mg/dl
H28年6月25日 HbA1c…7.6mg/dl
○医師による所感
発明の糖尿病治療用組成物によるメトホルミン+BCAA療法の結果として、HbA1cの改善とともに脂肪肝(非アルコール性)によると思われる肝臓酵素(Liver enzyme)の改善例として付け加えておく。
性別 男性
年齢 73歳
処方期間 H27年6月11日 HbA1c…6.4mg/dl
H27年8月5日 乳酸値…9.5
H28年2月5日 HbA1c…5.5mg/dl
H28年7月5日 HbA1c…5.5mg/dl 乳酸値…15.1
○医師による所感
一般的に糖尿病の治療は、運動療法も必要なものと思われている。血糖のコントロールに確かに身体を動かした方が血糖は下がる。
平成27年6月 HbA1c 6.4(メトホルミン250mg 乳酸値9.5)
平成28年7月 HbA1c 5.5(乳酸値15.1)
であり、本発明の糖尿病治療用組成物によれば、初診時から一年数ヶ月全く体動のない人の血糖コントロールも可能であることを示している。さらにIVHは直接血管の中にブドウ糖が入っていくが、血糖のコントロールが可能であることを示している。血糖のコントロールにはやはり糖尿病の軽いうちに本発明の糖尿病治療用組成物によるメトホルミン+BCAA療法を行うのがよいことを示している。
性別 男性
年齢 85歳
処方期間 H28年4月19日 HbA1c…6.4mg/dl 乳酸値…8.4
H28年5月17日 HbA1c…5.6mg/dl 乳酸値…14.7
H28年6月28日 HbA1c…5.1mg/dl 乳酸値…12.2
H28年7月20日 HbA1c…5.2mg/dl
H28年8月24日 乳酸値…13.3
H28年10月1日 HbA1c…5.4mg/dl 乳酸値…10.2
○医師による所感
糖尿病治療薬である新薬(DPP4阻害薬:ザファテック)を単独及び併用した場合のメトホルミン+BCAA療法における、当患者に関するHbA1cの推移を図1に示す。当患者について、新薬(DPP4阻害薬)のみでHbA1c5.6になっていたのに気づいたのはメトホルミン250mg+BCAAを使用する時点である。食後血糖値が平成28年5月9日に246mg/dlと血糖コントロールが悪かったので平成28年5月18日にメトホルミン+BCAAとの併用を開始した。平成28年6月28日、HbA1cが5.1に下がったため当該新薬の投与を中止し、メトホルミン+BCAA療法のみに変更した。平成28年7月20日HbA1cは5.2と0.1上昇した。入院当初は食欲があまりなかったが7月20日現在、食事は全量摂取している。血糖のコントロールも良くなっている(空腹時血糖、食後血糖など)。
入院時(平成28年4月19日)は、HbA1c6.4、乳酸値8.4であり、平成28年5月17日には、HbA1c5.6で乳酸値14.7であった。メトホルミンを使用したのは平成28年5月18日からである。その後、平成28年8月24日に乳酸値13,3であり、平成28年10月1日はHbA1cが5.4であり、新薬の影響は全くなく、同等の効果が認められる。
性別 女性
年齢 89歳
処方期間 H28年7月21日 HbA1c…6.9mg/dl
H28年8月3日 HbA1c…6.9mg/dl
H28年8月24日 乳酸値…8.4
H28年9月1日 HbA1c…6.9mg/dl
H28年10月1日 HbA1c…6.4mg/dl 乳酸値…9.1
○医師による所感
本処方例では、慎重投与の薬剤を併用した副作用を抑えた例と思われる。初診時(平成28年7月21日)には、HbA1c6.9、乳酸値17.9であった。この患者は糖尿病患者に慎重投与となっている利尿降圧剤フルイトランを多めの4mgを使用していたが、フルイトランは糖尿病を悪化させるため別の降圧剤に変更し少し様子を見た。
Claims (14)
- 血中乳酸値を実質的に上昇させずに血糖値を降下させる作用を有する糖尿病治療用組成物であって、該組成物が、
分岐鎖アミノ酸と、
ビグアニド誘導体と
を有効成分とし、
前記分岐鎖アミノ酸として、ロイシン、イソロイシン及びバリンを含有し、
前記ビグアニド誘導体として、メトホルミン塩酸塩を含有するとともに、
1投与あたりの1単位が、メトホルミン塩酸塩、イソロイシン、ロイシン及びバリンが、重量比で1:3.8:7.6:4.6の比率とされる
ことを特徴とする糖尿病治療用組成物。 - DPP4が介在する疾患及び/又は症状の治療、予防及び/又は改善剤である請求項1記載の糖尿病治療用組成物。
- 糖尿病治療薬をさらに組み合わせてなることを特徴とする請求項1に記載の糖尿病治療用組成物。
- 前記ビグアニド誘導体は、メトホルミン塩酸塩250mgが1単位として投与されることを特徴とする請求項1乃至3のいずれかに記載の糖尿病治療用組成物。
- 投与の対象が高齢者であることを特徴とする請求項1乃至4のいずれかに記載の糖尿病治療用組成物。
- 投与対象者の血糖状態をHbA1c(ヘモグロビンA1c)及び乳酸値の変化に応じた単位数で投与されることを特徴とする請求項1に記載の糖尿病治療用組成物。
- エリスロポエチンをさらに組み合わせてなることを特徴とする請求項1に記載の糖尿病治療用組成物。
- 経口薬としてのピオグリタゾン及びインスリンをさらに組み合わせてなることを特徴とする請求項1に記載の糖尿病治療用組成物。
- 前記糖尿病治療薬が、ジペプチジルペプチダーゼIV阻害薬、スルホニル尿素系血糖低下薬、ビグアナイド系製剤、α−グルコシダーゼ阻害薬、速効型インスリン分泌促進薬、インスリン製剤、PPARアゴニスト、β3アドレナリン受容体作動薬、アルドース還元酵素阻害薬、GLP−1類縁体及びSGLT阻害薬からなる群より選択される1種以上であることを特徴とする請求項3に記載の糖尿病治療用組成物。
- 対象となる疾患が乳酸アシドーシスの既往を伴う糖尿病、腎機能障害を伴う糖尿病、肝機能障害を伴う糖尿病、心血管系の障害を伴う糖尿病、肺機能の障害を伴う糖尿病、低酸素血症を伴いやすい糖尿病、過度のアルコール摂取者における糖尿病、胃腸障害を伴う糖尿病、2型糖尿病及び高齢者の糖尿病からなる群より選ばれる少なくとも一つであることを特徴とする請求項1乃至3のいずれかに記載の糖尿病治療用組成物。
- 対象となる疾患が腎機能障害を伴う糖尿病であることを特徴とする請求項1乃至3のいずれかに記載の糖尿病治療用組成物。
- 乳酸アシドーシスの予防及び/又は治療用である請求項1乃至3のいずれかに記載の糖尿病治療用組成物。
- 輸液製剤の形態である請求項1乃至3のいずれかに記載の糖尿病治療用組成物。
- 経口製剤の形態である請求項1乃至3のいずれかに記載の糖尿病治療用組成物。
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