JP6215862B2 - 超速効型インスリン製剤 - Google Patents
超速効型インスリン製剤 Download PDFInfo
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Description
本出願は、米国仮特許出願第61/087,943号(出願日:2008年8月11日)、第61/097,495号及び第61/097,516号(出願日:2008年9月16日)、並びに第61/138,863(出願日:2008年12月18日)による35U.S.C.§119(e)に基づく優先権の利益を主張し、これら各出願の内容は、参照によりその全体が本明細書に組み込まれる。
本発明は、超速効型食事時インスリンで真性糖尿病を治療する方法に関する。本発明の特定の態様は、このような製剤の独自の動態プロファイルを利用した種々の投与様式、並びに2型真性糖尿病の標準治療計画における1種以上の経口糖尿病薬をこのようなインスリンに置き換えることに関する。
非ストレス状態の正常個体では、基礎グルコースレベルは固有のフィードバック・ループのために日々同じ状態に保持される傾向がある。血漿グルコース濃度のあらゆる増加傾向は、インスリン分泌の増加及びグルカゴン分泌の抑制によって相殺される。これらは肝臓グルコース産生(糖新生およびグリコーゲン貯蔵からの放出)と組織のグルコース取り込みとを調節して血漿グルコース濃度を一定に保つ。患者の体重が増加するか、もしくはその他の何らかの理由でインスリン抵抗性になった場合、血中グルコースレベルは増加し、その結果、インスリン抵抗性を補うためにインスリン分泌が増加する。従って、グルコースおよびインスリン濃度の変化を最小にし、その一方でグルコースの比較的正常な産生および利用が維持されるように、グルコースおよびインスリンレベルが調節される。
糖尿病の重要な特徴はβ細胞機能不全である。1型および2型糖尿病の両方における疾患の進行中の早期におきる1つの異常は、食べることにより誘起される速やかなインスリン反応の喪失である。その結果、肝臓はグルコースを生産し続け、それは、食事の基本的成分から摂取、吸収されるグルコースに加わる。
インスリン治療は1型糖尿病の標準的治療である。初期2型糖尿病は食事療法および運動で処置できるが、現在は、大部分の早期2型糖尿病患者は経口抗糖尿病薬で治療されているが成功例は限られている。患者は病気が進むにつれてインスリン治療に移行する。しかしながらこれらの治療では治癒しない。
詳細な開示を説明する前に、以後に使われる幾つかの用語を理解することは有用であると思われる。
インスリン組成物:本明細書に使用される「インスリン組成物」は、哺乳動物への投与に適したインスリンのあらゆる形態を意味して、臨床的に重要な血中グルコース低下活性を保持している限り、哺乳動物より単離されたインスリン、組み換えインスリン、他の分子と結合や誘導体化したインスリン、配列を変えたインスリン分子が含まれる。また、肺、皮下、鼻内、経口、頬内、及び舌下を含むあらゆる経路による投与に適したインスリン組成物も含まれる。インスリン組成物は、吸入用の乾燥粉末、水溶液もしくは懸濁液、または、非水溶液もしくは懸濁液(計量式吸入器に通常用いられる);皮下、舌下、頬内、鼻内または経口投与用の水溶液もしくは懸濁液;及び経口及び舌下投与用の固体投与形として製剤化できる。
食後:本明細書に使用される「食後」は、一般的に食事開始後1時間以上の時間及び食事摂取を終了した後の時間を意味する。本明細書に使用される「後期食後」は、食事あるいは間食を摂取した後の2時間を越える時間を意味する。
間食:本明細書に使用される用語「間食」は、具体的には、確定した食事と食事の間に摂取される食物を意味する。
測定単位:皮下および静脈内インスリン投与量は標準化生物学的測定により定義されるIUで表される。フマリルジケトピペラジンと共に製剤化されたインスリンの量も、血中インスリンの測定値と同様に、IUで表される。TECHNOSPHERE(登録商標)/インスリンの用量は、その用量で製剤化されたインスリン量に数値的に等しい任意の単位(U)で表される。
インスリン−FDKPは、生理学的食事時間初期相インスリン放出を模倣することができる超速効型インスリンであることが見出された。この独自の薬物動態学的プロファイルを有するインスリン製剤が、2型糖尿病の治療において如何に有利に使用できる可能性があるかを探る中で、これまで、他のインスリン製剤との比較で評価されてきた(例えば、米国特許出願第11/032,278号、第11/329,686号、第11/278,381号、及び第11/461,746号、それらの各々は、そのまま全体が、参照により本明細書に組み込まれる)。本明細書に開示された態様は、如何にして、このようなインスリン製剤の特定の用量及び投与方法が個々の患者に対して選択され、かつ、様々な患者集団に有益な効果があるように適用されるかに関係している。ある態様は、如何にして、このようなインスリン製剤が、同様の効果または有利な効果を達成するために、インスリン増感剤や分泌促進物質等の経口抗糖尿病薬剤と併用、及び/または置き換えることができるかに関係している。ある他の態様は、如何にして、このようなインスリン製剤が、同様の効果または有利な効果を達成するために、体外から投与される基礎インスリンと併用、及び/または置き換えることができるかに関係している。同様な開示は、また、米国仮特許出願第61/087,943号、第61/097,495号、第61/097,516号及び第61/138,863号でも記載されており、これら各々は、参照によりその全体が本明細書に組み込まれる。
インスリン−FDKPは、吸入器に挿入する予め秤量した粉末を含有するカートリッジで供給される吸入用の乾燥粉末製剤である。このインスリンは、肺に粉末を送達する吸入器から吸入することによって投与される。種々の用量を含むカートリッジが供給され、個体の用量は、所望の用量を含む単一のカートリッジを用いるか、複数のカートリッジ(一度に1個)を用いるかのいずれかで得られる。
伝統的な食事時インスリン治療は、その量と内容に基づいた個々の食事の予測される血糖負荷に対する慎重な調整を必然的に伴ってきた。この必要性は、超速効的インスリン製剤を使用することにより回避、または少なくとも小さくすることができる。伝統的な食事時インスリン製剤は、皮下注射/注入による投与であれ、吸入による投与であれ、主に比較的長時間に渡りグルコース排出速度を高めることによって、血中グルコースレベルに効果を及ぼす。引き起こされる全グルコース排出は、投与した用量に一般的に比例する。それに対し、超速効型インスリン製剤は、比較的制約された時間で効果を及ぼし、かつ、血中グルコースレベルに対する効果の大部分は、迅速に肝臓グルコース放出を基準値まで減少させる結果である。超速効型インスリンで得られる血中インスリンレベルの急速な上昇は、グルコース排出活性の迅速な上昇を強化し、また、グルコース放出を減らすための信号を肝臓に送る。しかしながら、これらの効果をもたらすために達成されたインスリンのこの高濃度は、グルコース排出速度(GER)がインスリン濃度に比例する範囲を超えている。このようにして、インスリン用量を増加させることはGERが上昇する期間を延ばすが、これは、GERがインスリン濃度に比例する範囲をインスリン濃度が越える期間を延ばすことによって引き起こされる。従って、超速効型インスリンによる全グルコース排出は、用量に対して感受性がかなり低い。その上、相対的には長時間で作用する伝統的な短時間作用性製剤を用いた場合よりも、インスリン濃度は、投与後より早く基準値に戻り、効果も限られた時間で発揮され、恒常性維持機構もはるかに早く再び働き、それによって、外因性インスリンの活性によって、後期食後低血糖症の可能性が小さくなる。
(分割、追加、及び遅延用量の使用)
伝統的な食事時インスリン投与療法では、摂取される食物量の予測に基づいて用量を選び、次に、摂取をこの事前の予測に一致させる試みを行う。食物がより多量に摂取される、あるいは、炭水化物、食物繊維、及び脂肪の比率が通常や予測と異なる場合、これらの因子を高い確信度で分かっていても、伝統的な製剤の投与と作用の開始との間に遅れがあるため、食事に続く2次用量の投与によって、血糖制御を改良するのは不可能である。それに対し、超速効型インスリン製剤は即効性があるので、食事に続く2次用量の単回投与によって、インスリンの用量を食事に適応させるのに好都合である可能性がある。分割投与の使用は、優れた内因性インスリン産生とほんの中程度のインスリン抵抗性を有する2型糖尿病患者以外の糖尿病患者、例えば、(この病気の「ハネムーン」段階を超えた)1型糖尿病患者及びこの病気の進行の後期である2型糖尿病患者等の糖尿病患者に特に最適である。
インスリン−FDKPの利点の多くはその超速効動態と関連している。しかしながら、インスリン−FDKPは、通常は、乾燥粉末製剤の吸引により投与される。その投与の経路のために、この製剤から付加的な恩恵を受けることができる患者群があり、即ち、それは皮下インスリン抵抗性の患者である。この現象は、2型糖尿病と通常は関係する、体全体の細胞のインスリンに対する応答性の低下に起因すると一般には理解されているインスリン抵抗性とは異なり、無関係である。
超速効型インスリンの使用方法は、基礎−ボーラス療法において、それを長期作用性インスリンと併用することである。基礎−ボーラス療法において、長時間作用性インスリンは、インスリンの基礎レベルを供給または補足し、次いで、短時間作用性のボーラスは、食事の結果の増加したグルコース負荷を処理するために食事と共に投与される。超速効型インスリンは様々な有利な特性を有するので、このような療法における短時間作用性インスリンとしての使用には理想の選択である。
インスリンポンプは血糖値制御を助けるために適切な時間に様々な形態のインスリンを送達する小型の装置である。正しく使えば、これらの装置は、血中グルコース制御を改善し、低血糖症の発現を少なくし、より優れた長期間の制御をもたらす。ポンプはプログラム可能であり、ポンプにより、インスリン送達速度を1日の様々な時間に適合させ、何を、いつ、あるいはどの位食べるかを変える自由度が患者に与えられる。インスリンポンプの最新モデルは、比較的使用し易く、運搬に便利である。これらの新しいポンプは、以前、患者が行っていた複雑なインスリン用量計算を処理する計算機が内蔵されている。患者は、変化するニーズに応じて、様々な基礎インスリン送達速度を1日の様々な時間に対して行うのと同様にボーラス用量を食事と一致させるようにプログラムすることができる。これらのポンプは、前回のボーラス用量からどれだけのインスリンがまだ働いているかも計算する。中には、プログラム可能な催促通知と警告、患者に正確な記録管理のために情報をコンピューターに保存する情報ダウンロード能力、食事で摂取した炭水化物量を計算する炭水化物データベース及び特定の安全機能等の追加の高性能機能を有するポンプもある。
2型糖尿病の治療における看護の標準は、米国糖尿病協会及び欧州糖尿病学会が共同で発表した合意文書に定義され、定期的に更新されている。下記に提唱、要約された治療の一般的なコースは、治療アルゴリズムにGLP−1作用薬を追加するという最新の更新版での非常に重要な修正はあったが、近年はほとんど変更がない(例えば、Nathan et al. Diabetes Care 29:1963-1972, 2006; Nathan et al. Diabetes Care 31:173-175, 2008; 及び Nathan et al. Diabetes Care 32:193-203, 2009を比較のこと)。
超速効型インスリン及びメトホルミル等のビグアナイド薬剤は、共に、肝臓グルコース産生抑制剤として働く。しかしながら、使用状況では、これらの薬剤は24時間中効果を発揮するが、食事時超速効型インスリンは特に食後により効果を発揮する。従って、超速効型インスリンは、経口の肝臓グルコース産生抑制剤の活性の代わりに、あるいは、その活性を強化することができる。
スルホニル尿素とグリニド等のインスリン分泌促進物質は、インスリン分泌を増加させ、それにより循環血液中のインスリン濃度を増加させる。超速効型インスリン製剤もまた循環血液中のインスリン濃度を増加させる。しかしながら、使用状況では、これらの薬剤は24時間中効果を発揮するが、食事時超速効型インスリンは特に食後に効果を発揮する。従って、超速効型インスリンは、インスリン分泌促進物質の活性の代わりをすることができる。一態様において、超速効型インスリン製剤はインスリン−FDKPである。別の態様において、超速効型インスリンの投与は、肺への吸入によって行われる。
ピオグリタゾン及びその他のTZD等のインスリン増感剤は、種々の組織でのインスリンの利用を改善し、インスリン抵抗性を下げ、循環インスリンレベルの減少につながる。TZDによる治療は、FBGの顕著な減少をもたらす。食事時超速効型インスリンによる治療は、空腹時には食事時超速効型インスリンによる直接のグルコース排出活性がないという事実にかかわらず、FBGの減少を招く。超速効型インスリン製剤の空腹時血中グルコースレベルに対するこの影響は予想外であり、超速効型インスリンがインスリン抵抗性を下げるか、インスリン増感剤として働く可能性があることが示唆された。興味深いことに、超速効型インスリンによって得られる急速なインスリンの最大濃度はその後に続くインスリン活性を強化する。これは、効果は長い時間残る可能性あるが、特に投与直後の時間枠で2型糖尿病患者に顕著である。従って、食事時超速効型インスリンによる治療はインスリン増感剤と同様な効果を有する。
2種の経口薬剤による治療が、適切に血糖制御できない場合、看護の標準が、基礎インスリンの使用、または第3の経口薬剤の使用に至る道筋を示す。インスリンを追加する代わりに第3の経口薬剤を追加するという選択は、明白な針恐怖症、低血糖症の危険性、及び体重増加の可能性がない場合でも、毎日の注射をしたがらないということに影響される場合が多い。従って、本発明のいくつかの態様はインスリンを含むが、針がなく、かつ体重増加を最小限に抑えるか体重増加させない組み合わせ経口療法の後継治療法を提供する。吸入インスリンエクスベラ(登録商標)は、その皮内送達インスリン様動態のため、超速効型インスリン製剤と同じ恩恵を提供することは期待できない。超速効型インスリン製剤を使用することによって、食事時超速効型インスリンが基礎インスリン一般の初期使用に対する優れた代替物であり、針の使用、低血糖症の危険性、あるいは体重増加の可能性が特に問題である患者集団にとっては特別な利点を提供することが分かる。
超速効型インスリンの効果を特定する実験を行った。具体的には、インスリン−FDKPを含む吸入製剤と、皮内投与インスリンリスプロ(リスプロ、ヒューマログ(登録商標)、イーライリリー社)及び吸入用組み換え型ヒトインスリン(エクスベラ(登録商標)、ファイザー社)との比較を、2型糖尿病の被験者の摂食負荷後及び正常血糖グルコースクランプ処置中の内因性グルコース産生について行った。インスリン−FDKP製剤は、MEDTONE(登録商標)乾燥粉吸入器(MannKind社)を用い、経口吸入によって被験者に投与された。
(SC基礎インスリン及び食事時吸入インスリン−FDKP対SC基礎インスリン及び食事時インスリンによる、52週間にわたる治療と4週間の追跡調査を受ける1型糖尿病の被験者における、有効性と安全性の比較をする前向き、多施設、非盲検、無作為、対照臨床試験)
これは、基礎インスリン及び食事時インスリン−FDKP(TI)吸入粉末を受ける1型糖尿病被験者(TI吸入粉末グループ)の血糖制御を、基礎インスリン及びSC迅速作用性インスリンアスパルトを受ける被験者(比較グループ)と比較する、前向き、多国間、多施設、非盲検、無作為、対照臨床試験であった。この調査は、52週間の治療段階及び4週間の追跡調査を含む。4週間の追跡調査の期間中、肺機能及び厳選された臨床実験室評価が計画された。
1週間目、被験者は下記の2種:
基礎インスリン+食事時TI吸入粉末
基礎インスリン+食事時SC迅速作用性インスリン
の治療の1つに無作為に割り付けられる。
(SC基礎インスリン及び食事時吸入TI対SC事前混合インスリン治療による、52週間にわたる治療と4週間の追跡調査を受けるT2DMの被験者における有効性と安全性の比較をする前向き、多施設、非盲検、無作為、対照臨床試験)
この試験により、SCインスリン±経口抗高血糖薬剤の投薬計画で前もって治療された、準最適に制御された2型糖尿病の被験者の中で、52週間にわたるHbA1cの変化によって表した有効性を、基礎インスリン治療と組み合わせたTI吸入粉末の食事時投与(TIグループ)を中間作用性と迅速作用性のインスリンの事前混合(比較グループ)と比較した。HbA1cの減少は、TI+基礎インスリン及び事前混合インスリンとでは同程度であった。調査終了時にHbA1cが7.0%以下であった反応者は、TI+基礎インスリンのグループと事前混合インスリンのグループとの間で同程度であり、統計学的な差異は無かった。注目すべきことに、事前混合インスリンと比べ、TI+基礎インスリンによる治療によって、空腹時血中グルコースは大きく減少した(図13を参照)。更に、TI+基礎インスリングループでは、空腹血中グルコース及びグルコース可動域が共に、治療期間の始めから終わりの間で減少した(図14を参照)。実施例2で述べたように、TI+基礎インスリンに関しては、基準値血中グルコースレベルは、1日の間で上昇傾向であった(図14を参照)。
この研究は、メトホルミン及び分泌促進物質の組合せで準最適に制御された2型真性糖尿病の被験者において、食事時TECHNOSPHERE(登録商標)/インスリン(インスリン−FDKP,TI)単独、またはメトホルミンとの組合せを、現在の標準看護療法であるメトホルミン+分泌促進物質と対比して有益性と安全性を評価するために設計された第3相、24週間、非盲検試験である。図15及び図16に、臨床試験の試験設計及び本調査に登録した患者の基準値の人口統計学的データを示している。被験者は、1:1:1で無作為に3種の治療グループに割り付けられ、最初の12週間は、割りつけられたグループに基づいて、抗糖尿病治療を受けた。それに続く12週間の試験期間は、観察期間と見なされた。
試験を完了した被験者に対して、食事時TI+メトホルミンは、24週間の治療後、HbA1cで、1.68(1.0)%という臨床的に意義のある基準値からの平均低下を提供したが、標準抗高血糖治療計画と同程度であった。しかしながら、TI+メトホルミンは、12週間及び24週間後に、メトホルミン+分泌促進物質に比べ、統計的に優れた食事後制御を提供し、かつ24週間後のFPGの基準値からの同程度の平均低下を提供した。この治療グループでは、24週間で平均体重減少が−0.75Kgで、軽度から中等度の低血糖症の発生率は全体で35.0%であった。
試験を完了した被験者に対して、食事時TI単独は、24週間の治療後に、HbA1cで、1.82(1.1)%という臨床的に意義のある基準値からの平均低下を提供するのに成功した。基準値からのこの変化は、メトホルミン+分泌促進物質の標準抗高血糖投薬計画よりも数値的に勝る。試験の終点では、TI単独は、FPGの基準値から平均低下は同程度である比較用よりも、はるかに効率的な食後制御を提供した。この治療グループでは、24週間で平均体重減少が−0.04Kgで、軽度から中等度の低血糖症の発生率は全体で27.6%であった。
試験を完了した被験者に対して、メトホルミン+分泌促進物質は、24週間の治療後に、HbA1cにおいて、1.23(1.1)%という基準値からの臨床的に意義のある平均低下を提供するのに成功したが、TI治療グループよりも食後制御の効果では大きく劣っていた(図17及び図18)。FPG及び体重の基準値からの平均低下は、TI+メトホルミン治療グループで観察された低下と同程度であった(図21、図22)。軽度から中等度の低血糖症の発生率は全体で20.8%であった。
データから、食事時TI単独、またはメトホルミンとの組み合わせは、12週間及び24週間にわたり、体重増加を伴わずに臨床的に大幅にHbA1cを減少させたことが分かる。食事時TI単独、またはメトホルミンとの組み合わせは、7点血中グルコースレベルに基づくと、メトホルミン+分泌促進物質よりも1日全体の血中グルコースレベルの制御に優れている。
全体的に、低血糖症の発生率は、全治療グループで低かった。
さらに、本明細書を通して、多くの特許および出版刊行物が参照されている。上記に引用した各文献および出版刊行物の全内容は、個々に、参照により本明細書に組み入れられる。
2型糖尿病の治療方法であって、
肝臓グルコース産生抑制剤及びインスリン分泌促進物質により現在治療を受けている2型糖尿病患者を選択し、
該インスリン分泌促進物質による治療を中止し、かつ
少なくとも1回の確定した食事と共に超速効型インスリン製剤を日常的に投与すること、を含む治療方法。
[付記2]
肝臓グルコース産生抑制剤による治療もまた中止される、付記1に記載の方法。
[付記3]
患者が、インスリン抵抗性スペクトルの下部におけるインスリン抵抗性を有する者に対して更に選択される、付記2に記載の方法。
[付記4]
患者が、体重増加を減らすまたは避ける必要がある者に対して更に選択される、付記1に記載の方法。
[付記5]
投与の工程が注射を含まない、付記1に記載の方法。
[付記6]
患者が更にインスリンによる治療の候補者であり、かつ、針恐怖症であることもしくは頻繁な注射を避けたいと望むということに基づいて更に選択される、付記5に記載の方法。
[付記7]
肝臓グルコース産生抑制剤がメトホルミンである、付記1に記載の方法。
[付記8]
インスリン分泌促進物質がスルホニル尿素である、付記1に記載の方法。
[付記9]
患者が十分にまたは適度に制御された空腹時血中グルコースを有する者に対して更に選択される、付記1に記載の方法。
[付記10]
超速効型インスリン製剤が吸入により投与される、付記1に記載の方法。
[付記11]
超速効型インスリン製剤が乾燥粉末である、付記10に記載の方法。
[付記12]
超速効型インスリン製剤がインスリンと連合したフマリルジケトピペラジン(FDKP)を含む、付記11に記載の方法。
[付記13]
超速効型インスリン製剤がインスリン−FDKPを含む、付記11に記載の方法。
[付記14]
患者が、HbA1cレベルが8以上の者に対して更に選択される、付記1に記載の方法。
[付記15]
患者が、グルコース可動域の平均振幅の上昇がある者に対して更に選択される、付記1に記載の方法。
[付記16]
超速効型インスリンが、15gを超える炭水化物を含有する各々の食事と共に投与される、付記1に記載の方法。
[付記17]
超速効型インスリン製剤が、投与後60分以内に肝臓グルコース産生を極限まで減少させるのに十分な用量で投与される、付記1に記載の方法。
[付記18]
超速効型インスリン製剤が1〜32皮下当量単位の範囲の用量で投与される、付記1に記載の方法。
[付記19]
2型糖尿病の治療方法であって、
血糖値制御の改善を必要とし、かつ肝臓グルコース産生抑制剤及びインスリン分泌促進物質の組み合わせ治療に対する候補者となる、肝臓グルコース産生抑制剤で現在治療を受けている2型糖尿病患者を選択し、かつ、代わりに、
該肝臓グルコース産生抑制剤での治療と、少なくとも1回の確定した食事と共に超速効型インスリン製剤の日常的な投与と組み合わせること、を含む治療方法。
[付記20]
2型糖尿病の治療方法であって、
インスリン増感剤及びインスリン分泌促進物質により現在治療を受けている2型糖尿病患者を選択し、
該インスリン分泌促進物質による治療を中止し、かつ、
各食事と共に日常的に超速効型インスリン製剤を投与すること、を含む治療方法。
[付記21]
インスリン増感剤による治療もまた中止される、付記20に記載の方法。
[付記22]
患者が、インスリン抵抗性スペクトルの上部におけるインスリン抵抗性を有する者に対して更に選択される、付記21に記載の方法。
[付記23]
インスリン増感剤がチアゾリジンジオン(TZD)である、付記20に記載の方法。
[付記24]
TZDがピオグリタゾンである、付記23に記載の方法。
[付記25]
超速効型インスリン及び長時間作用性インスリン類似体との組み合わせによる高血糖症の改善された治療方法であって、
該超速効型インスリンの食事時投与、及び
1日の目覚め後6時間以内の長時間作用性インスリン類似体の投与、を含む方法。
[付記26]
長時間作用性インスリン類似体の投与が目覚め後3時間以内である、付記25に記載の方法。
[付記27]
長時間作用性インスリン類似体がインスリンデテミルまたはインスリングラルギンである、付記25に記載の方法。
[付記28]
長時間作用性インスリンがインスリングラルギンであり、かつ、2回目のインスリングラルギンの投与を更に含み、2回目の用量が朝の投与から8時間〜14時間後に投与される、付記27に記載の方法。
[付記29]
超速効型インスリンがインスリン及びジケトピペラジンを含む製剤を含む、付記25に記載の方法。
[付記30]
超速効型インスリンがインスリン−FDKPを含む、付記25に記載の方法。
[付記31]
超速効型インスリンが肺への吸入により投与される、付記25に記載の方法。
[付記32]
高血糖症が2型糖尿病の結果である、付記25に記載の方法。
[付記33]
超速効型インスリン及び外因性基礎インスリンとの組み合わせによる高血糖症の改善された治療方法であって、
該超速効型インスリンの食事時投与、及び
インスリンポンプによる短時間作用性インスリンの連続注入、を含む方法。
[付記34]
短期間作用性インスリンが、通常のヒトインスリンまたは迅速作用性インスリン類似体である、付記33に記載の方法。
[付記35]
食事量に合わせてインスリン用量を調整することなく日常食に関する血糖を制御する方法であり、毎日の各食事に対し、食事時間に所定の用量の超速効型インスリン製剤を投与することを含む方法。
[付記36]
食事量が、所定の用量を決定する際に用いられる通常の食事量の25%以上から200%以下である、付記35に記載の方法。
[付記37]
超速効型インスリン製剤がインスリン−FDKPである、付記35に記載の方法。
[付記38]
遅延型あるいは長時間型栄養吸収の患者のための日常食に関する血糖制御の方法であって、
遅延型栄養吸収の患者を選択し、
日常食に対し、食事時間に所定の用量の超速効型インスリン製剤の50%〜75%を投与し、かつ、
所定の用量の残量を日常食開始から30〜120分後に投与すること、を含む方法。
[付記39]
超速効型インスリン製剤がインスリン−FDKPである、付記38に記載の方法。
[付記40]
遅延型栄養吸収が病状に関連する、付記38に記載の方法。
[付記41]
遅延型栄養吸収が脂肪や繊維の含量が高い食事に関連する、付記38に記載の方法。
[付記42]
長時間型栄養吸収が長時間の食事と関連する、付記38に記載の方法。
[付記43]
摂取した食事の血糖負荷に合わせてインスリン用量を調整する日常食に関連する血糖を制御する方法であって、
日常食に対して、食事時間に最初の所定の用量の超速効型インスリン製剤を投与し、
日常食の開始から1〜2時間後に食後の血中グルコースを定量し、
食後血中グルコースが140mg/dlを超える場合、初回の用量の25%〜100%の用量である2回目の超速効型インスリン製剤を投与すること、を含む方法。
[付記44]
超速効型インスリン製剤がインスリン−FDKPである、付記43に記載の方法。
[付記45]
皮下インスリン抵抗性の糖尿病患者を治療する方法であって、
通常とは異なる高インスリン投与量に基づいて皮下インスリン抵抗性の患者を選択し、
皮下投与用の迅速作用性、短期作用性、または中間作用性のインスリン製剤を用いる治療を中止し、かつ、
食後低血糖症の制御に効果的な吸入によるインスリン−FDKPの食事時用量の投与による治療を開始すること、を含む方法。
[付記46]
通常とは異なる高インスリン投与量が2単位/Kg/日以上である、付記45に記載の方法。
[付記47]
選択工程が、患者が正常または正常に近い内因性基礎インスリンを有するという基準の選択を更に含む、付記45に記載の方法。
[付記48]
内因性基礎インスリンのレベルが50μU/ml以下である、付記47に記載の方法。
[付記49]
選択工程が注射部位の皮下脂肪萎縮または脂肪異栄養症に基づく選択を更に含む、付記45に記載の方法。
[付記50]
選択工程が強化インスリン療法中の6〜9ヶ月の期間において、2回のHbA1cレベル測定が9%以上である患者という基準の選択を更に含む、付記45に記載の方法。
[付記51]
選択工程が、インスリン療法及び食事もしくは運動療法の順守にもかかわらず、高血糖症及び/又は低血糖症の期間によって特徴付けられる生命にかかわるほど血糖値が不安定な患者という基準の選択を更に含む、付記45に記載の方法。
[付記52]
相対的生体利用度に基づいた調節の後、実質的により少ないインスリン投与量によって、同程度あるいは改良された血糖制御が達成されているという判断により患者が皮下インスリン抵抗性を持っていることを確認する工程を更に含む、付記45に記載の方法。
[付記53]
日常食1回あたりの超速効型インスリンの個体の用量を決定する方法であって、
1週間以下の用量設定期間内の少なくとも3日間の1日毎に用量設定する日常食に対して、食事時間に低用量の超速効型インスリンを投与し、
各々の続く用量設定期間に低用量分によって反復的に用量を増量し、用量設定の終点に達するまで用量設定期間の少なくとも3日間の各々の日に用量設定する日常食に対し、食事時間に投与すること、を含む方法。
[付記54]
低用量が1〜5皮下当量単位である、付記53に記載の方法。
[付記55]
超速効型インスリン製剤がインスリン−FDKPを含む、付記53に記載の方法。
[付記56]
用量設定の終点が、以下の中から選択される付記53に記載の方法:
1)到達した2時間後の食後平均グルコースが70mg/dlと110mg/dlの間である、
2)皮下当量単位に基づいた投与量が最大投与量である、
3)確認されたSMBGが36mg/dl未満である重症の低血糖症が発現し、投与量が1個の低用量カートリッジの同等物によって減少する、および
4)確認されたSMBGが70mg/dl未満である軽度から中度の低血糖症が発現し、投与量は1週間あたり1個の低用量カートリッジの同等物によって減り、次に、用量設定を再開し、該1)〜3)のいずれかの終点に到達するまで行うか、投与量を軽度から中度の低血糖症が再び現れるレベルよりも少ないレベルに設定する。
[付記57]
2回以上の日常食に対する投与量が同時に用量設定される、付記56に記載の方法。
[付記58]
2回以上の日常食に対する該投与量が食後2時間後の血中グルコースが最も高くなる日常食から、食後2時間後の血中グルコースが最も低くなる日常食まで連続的に用量設定される、付記56に記載の方法。
[付記59]
最大投与量が24皮下当量単位である、付記56に記載の方法。
[付記60]
最大投与量が32皮下当量単位である、付記56に記載の方法。
Claims (27)
- 日常食に関連する糖尿病患者の血糖を制御するための超速効型インスリン製剤であって、
前記製剤は、インスリンに結び付けられているフマリルジケトピペラジンを含み、
前記製剤は、前記患者で約30分以内に血清インスリンレベルのピークを誘導し、
前記製剤は、投与後20分〜30分以内に最大となる血中インスリン濃度の上昇をもたらし、
前記製剤は、前記日常食の食事時間に初回用量の前記製剤を投与する工程と、食事の開始から30から120分後に2回目用量の前記製剤を投与する工程とを含む方法により使用されるものである、
ことを特徴とする製剤。 - 前記患者は、遅延型栄養吸収の、または、栄養吸収に時間がかかる患者であり、
前記初回用量は、前記製剤をまとめて服用する場合の食事毎の前記製剤の服用量の50%から75%であり、
前記2回目用量は、前記製剤をまとめて服用する場合の食事毎の前記製剤の服用量から前記初回用量を差し引いた分である、
請求項1に記載の製剤。 - 前記患者は、病状により栄養吸収が遅延される、請求項2に記載の製剤。
- 前記患者は、脂肪や繊維の含量が高い食事により栄養吸収が遅延される、請求項2に記載の製剤。
- 前記患者は、食事時間が長いため栄養吸収に時間がかかる、請求項2に記載の製剤。
- 前記方法は、
前記日常食の開始から1から2時間後に食後血中グルコースを定量する工程、
該食後血中グルコースが140mg/dlを超える場合、前記初回用量の25%から100%の前記2回目用量で前記製剤を投与する工程、
を含む、請求項1に記載の製剤。 - 前記投与は注射を含まない、請求項1、2、または6に記載の製剤。
- 最大グルコース排出速度が前記製剤の投与後30から90分後に生じる、請求項1に記載の製剤。
- 前記初回用量は1−5皮下当量単位である、請求項1、2、または6に記載の製剤。
- 前記初回用量は1−4皮下当量単位である、請求項1、2、6、または9に記載の製剤。
- 前記初回用量は1−2皮下当量単位である、請求項10に記載の製剤。
- 食後2時間血中グルコースは前記日常食について測定される、請求項9に記載の製剤。
- 1週間のうち少なくとも3日、前記日常食時に血中グルコースを測定する、請求項9に記載の製剤。
- 3日間連続して、前記日常食時に血中グルコースを測定する、請求項10に記載の製剤。
- 7日間連続して、前記日常食時に血中グルコースを測定する、請求項10に記載の製剤。
- 治療は、食後2時間平均グルコースが110mg/dlを超えていれば、前記初回用量の分だけ前記日常食に対する用量を増加することで前記超速効型インスリン製剤の用量を調節することをさらに含む、請求項10に記載の製剤。
- 前記超速効型インスリン製剤の用量は、約18、24、または32皮下当量単位から選択される最大用量まで増加される、請求項16に記載の製剤。
- 前記製剤は吸入により投与される、請求項17に記載の製剤。
- 前記製剤は乾燥粉末である、請求項1、2、6、または9に記載の製剤。
- 用量が単位用量カートリッジで提供される、請求項1、2、6、または9に記載の製剤。
- 前記単位用量カートリッジは4、8、または12皮下当量単位を含む、請求項20に記載の製剤。
- 最大グルコース排出速度が前記製剤の投与後45から60分後に生じる、請求項9に記載の製剤。
- 前記製剤は、15gを超える炭水化物を含有する各々の食事と共に投与される、請求項1、2、6、または9に記載の製剤。
- 前記製剤は、投与後60分以内に肝臓グルコース産生を極限まで減少させるのに十分な用量で投与される、請求項23に記載の製剤。
- 前記製剤は、1−32皮下当量単位の範囲の用量で投与される、請求項1、2、6、または9に記載の製剤。
- 前記患者は、インスリン製剤による治療の候補者であり、かつ、針恐怖症であるもしくは頻繁な注射を避けたいと望む者である、請求項1、2、6、または9に記載の製剤。
- ヒトインスリンを含む、請求項1、2、6、または9に記載の製剤。
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