JP5719099B2 - 糖尿病治療における優れた血糖コントロール - Google Patents
糖尿病治療における優れた血糖コントロール Download PDFInfo
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- JP5719099B2 JP5719099B2 JP2008504512A JP2008504512A JP5719099B2 JP 5719099 B2 JP5719099 B2 JP 5719099B2 JP 2008504512 A JP2008504512 A JP 2008504512A JP 2008504512 A JP2008504512 A JP 2008504512A JP 5719099 B2 JP5719099 B2 JP 5719099B2
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Description
本出願は、35U.S.C.§119(e)の下で、米国仮特許出願番号60/667,393(2005年3月31日出願)への優先権を主張して、米国特許出願番号11/329,686(2006年1月10日出願)の一部継続出願であり、このいずれもそのまま参照により本明細書に組み込まれる。
本発明は、糖尿病を治療して血糖のコントロールを改善する方法に関する。具体的には、本発明の方法は、非糖尿病個体のインスリン応答動態を模倣することによって、後期食後低血糖のリスクを抑える一方で、食後血糖値の優れたコントロールを提供する。
糖尿病には、現在、全世界で少なくとも2億人が罹患している。1型糖尿病は、この数の約10%を占め、膵臓のランゲルハンス島にあるインスリン分泌性β細胞の自己免疫破壊より生じる。生存は、1日数回のインスリン注射に依存する。2型糖尿病は、罹患個体の残る90%を占め、罹患率は増加している。2型糖尿病は、しばしば、必ずではないが、肥満を伴い、かつては後期発症又は成人の糖尿病と呼ばれていたが、今日では、より若い個体でますます顕著になっている。これは、インスリン抵抗性と不十分なインスリン分泌の組合せにより引き起こされる。
本発明は、糖尿病の患者において、糖尿病を治療して、血糖値の優れたコントロールを生じる方法を提供する。本方法は、吸入インスリン組成物を食事の開始時又はその直後に投与することによって低血糖症のリスクを抑える一方で、食後血糖値のホメオスタシス制御の再主張(reassertion)を可能にして、非糖尿病個体のインスリン放出動態を模倣する。
本発明を説明する前に、下記に使用するいくつかの用語の理解を深めることは役に立つかもしれない。
糖尿病の治療用のインスリン療法に伴う一般的な問題は、食事グルコース負荷を制御するのに十分なインスリン用量が、食後に存続し得る延長期間の間に上昇するグルコース消失速度をもたらして、食後低血糖を導くことである。皮下投与後のインスリンの血中レベルの増加は、正常個体において見られる食事グルコースへの生理学的な応答より、糖尿病患者において有意に遅い。故に、血清インスリンレベルのより迅速な上昇をもたらしてから下降する、インスリンの組成物及び方法は、最大のグルコース消失速度を達成するためのより生理学的な手段をもたらす。このことは、投与されるインスリンの効果の大部分を食事付近の時間間隔へ圧縮して、それにより食後低血糖のリスクを抑えて、食事グルコースに対するより正常な生理学的インスリン応答をもたらす効果を有する。
実施例1
異なる用量レベルでのインスリン濃度は、線形吸収を示す
様々な投与量のTechnosphere(登録商標)/Insulin(TI,MannKind Corporation)をヒト被検者へ投与して、血中インスリン濃度を測定した(図7A)。インスリン吸収は、AUCとして、少なくとも100U TIまでは投与量と比例した(図7B)。
ヒトにおける初期相インスリン応答を迅速に生体利用される吸入インスリンで模倣すると、より遅いバイオアベイラビリティのインスリンに比較して、食後グルコース処理が加速される
12名の2型糖尿病被検者の群において、等血糖クランプ(isoglycemic clamp)の間の時間、インスリン濃度、及びグルコース消失速度の間の関連性を試験した。各被検者は、24IU皮下インスリン(Actrapid(登録商標)、ノボ・ノルディスク)又は48U Technosphere(登録商標)/Insulin(TI)を別々の試験日に、クロスオーバー法で服用した。
速いインスリンスパイクは、低血糖のリスクを高めない
高濃度のインスリンは、特にその亢進効果と組み合わされると、グルコース消失速度をあまりに高く誘導して、低血糖を誘発する危険をもたらすと危惧されることだろう。しかしながら、事実はそうではない。正常血糖クランプ下の健常なヒト被検者に静脈内、皮下、又は肺へインスリンを与えて、投与後20分から始まる血中インスリン濃度に対してGIRをプロットした。正常被検者では、インスリンへ応答するGIRヒステレシスが、上記の実施例1に開示されるように、2型糖尿病患者よりずっと目立たない。このように、正常被検者では、インスリン投与後20分とそれ以降で、GIRとインスリン濃度の間の関係は、真の数学的な関数に近似する。より低いインスリン濃度では、その関数が直線的に見える一方で、より高い濃度の考察は、その関係が実際に対数的であることを示し、インスリン濃度が上昇するにつれて、GIRのさらに小さな増加が得られることが観察された(図15)。このように、グルコース消失は、破局的なほど高い速度に到達せず、そのようにすることができないように見えた。
吸入Technosphere(登録商標)/Insulinの変動性及び時間−作用プロフィールは、皮下へのヒト標準インスリンのそれに対して好ましく比較される
インスリンの代謝効果のタイミング及び再現性は、正常に近い血糖コントロールを達成して、患者と医師が適切な用量調整をすることを可能にするのにきわめて重要である。反復用量の48U吸入Technosphere(登録商標)/Insulin(TI)及び24IU皮下注射ヒト標準インスリン(SC)の間で、時間−作用プロフィールとインスリン吸収及びインスリン効果における患者内変動性を比較した。
2型糖尿病患者における吸入Technosphere(登録商標)/Insulinの効果及び安全性に関する無作為化、二重盲検、プラセボ対照試験
小さなMannKindTM吸入器より送達されるTechnosphere(登録商標)乾燥粉末肺インスリンは、正常な食事関連の第一相又は初期相インスリン放出を模倣するバイオアベイラビリティを有する。この多施設、無作為化、二重盲検、プラセボ対照試験は、食事又は経口剤療法で十分制御されない2型糖尿病患者(HbA1c>6.5%〜10.5%)において実施した。全部で123名の患者を登録し、119名の治療意思集団(ITT)を、6〜48の間の単位のヒトインスリン(rDNA起源)を含有する単位用量カートリッジ由来の食事吸入Technosphere(登録商標)/Insulin(TI)又は吸入Technosphere(登録商標)/プラセボを12週間受けるように、1:1の比で無作為化した。TIは、12週の試験を通して、1日の各主食又は主食相当食の最初1口の食事を摂るときに吸入して、1日につき3又は4回の投与に相当した。被検者は、試験に入る前に使用していたどんな経口糖尿病薬でも継続した。最初と最後の治療通院からのHbA1cの差異と最初の通院と2回の中間通院の間の差異を、血糖の変化として、様々な時点のAUCと、食事チャレンジ後のCmax及びTmaxとして定量した。
FDKP/Insulinは、食事開始の10分前〜30分後に投与するときに血糖コントロールを提供する
乾燥粉末としてのFDKP−インスリン複合体(FDKP/Insulin;Technosphere(登録商標)/Insulin,TIとも呼ぶ)の肺投与のタイミングの効果を評価するために臨床治験を実施した。被検者は、その糖尿病の治療にインスリン以外の薬物も、炭水化物代謝に影響を及ぼす他の薬物も服用していない1型糖尿病患者であった。この治験は、前向き、単一施設、無作為化、クロスオーバー、オープンラベル試験であった。それぞれ8回の治療通院時に、ヒト被検者は、1回の個別用量を、等カロリー食(I;ほぼ500キロカロリー)又は高カロリー食(H;ほぼ720キロカロリー)の摂取の10分前(B10)、直前(C0)、15分後(A15)、又は30分後(A30)に吸入した。各被検者は、別々の時機にランダムな順序で、治療通院の間は1〜14日経過して、8種の可能な投与タイミング/食事の組合せ(即ち、B10I、B10H、C0I、C0H、A15I、A15H、A30I、及びA30H)のいずれかを受けた(図20を参照のこと)。TIの吸入と食事消費の前と後で採取した血液試料を使用して、グルコースとインスリンの薬物動態変数を決定した。
IU用量=(BE*Fi)/0.30
[ここで:
IU用量は、投与するTIのIU数である。
食事消費の開始後の最高(Cmax)及び最低(Cmin)血糖濃度(ベースライン値に対して補正する)。
AUC:食事開始10分前〜食事開始後240分
AUC1:10分前〜TXまで、及び
AUC2:TX〜食事開始後240分まで。
ジケトピペラジン肺投与製剤におけるインスリンのバイオアベイラビリティ
被検者と方法
本試験は、5名の男性ボランティアを用いて実施した。包含基準は、良好な健康(身体検査により判定する)、年齢:18〜40歳、ボディマス指数:18〜26kg/m2、4L/秒以上のピーク呼吸フローに達する能力(コンピュータ支援肺活量測定により測定する)、及び予測正常値の80%以上のFEV1(FEV1=1秒努力呼気量)であった。除外基準は、1若しくは2型糖尿病患者、ヒトインスリン抗体の罹病性、試験医薬品又は類似化学構造の薬物に対する過敏症の既往歴、重症アレルギー又は多重アレルギーの既往歴、試験エントリー前3ヶ月での他の治験薬での治療、進行性の致命的な疾患、薬物又はアルコール乱用の既往歴、他の薬物で薬物療法を受けていること、重大な心臓血管系、呼吸系、胃腸、肝臓、腎臓、神経系、精神医学系、及び/又は血液疾患の既往歴、進行性の気道感染症、明白な喫煙者又はタバコ又はニコチン使用の既往歴ありと判定される被検者であった。
試験日の朝、被検者(夜中から水以外は絶食)は午前7:30に来院した。被検者には、各処置日の24時間前から、過度の身体活動とアルコールの摂取を制限した。彼らを3つの処置アームの1つへ無作為に割り当てた。被検者は、0時点の前の2時間の間、血清インスリン濃度が10〜15μU/mLで確立されるように、0.15mU分−1kg−1に保つ一定の静脈内標準ヒトインスリン注入を受けた。この低用量注入を試験全体で継続して、内因性インスリン分泌を抑制した。血糖は、このグルコースクランプを通して、グルコース制御注入システム(BiostatorTM)により90mg/dLのレベルで一定に保った。グルコースクランプのアルゴリズムは、実際に測定される血糖濃度と、血糖濃度を一定に保つためのグルコース注入速度を計算する前の数分における変動性の度合いに基づいた。インスリンの適用(5IU IV又は10 IU SCの注射、又はカプセルにつき3回の深呼吸での吸入(各50Uで2つのカプセル)、市販の吸入デバイス(ベーリンガー・インゲルハイム)で適用する)は、0時点の直前に終了させなければならなかった。クランプ実験の時間は、0時点から6時間であった。グルコース注入速度、血糖、血清インスリン、及びCペプチドを測定した。
生体効果を定量するために、グルコース注入速度の曲線下面積を投与後最初の3時間(AUC0−180)と投与後6時間の全観察期間(AUC0−360)について計算して、適用したインスリンの量へ関連づけた。バイオアベイラビリティを定量するために、インスリン濃度の曲線下面積を投与後最初の3時間(AUC0−180)と投与後6時間の全観察期間(AUC0−360)について計算して、適用したインスリンの量へ関連づけた。
薬物動態の結果を図23及び24と表9に図示する。
100UのTIの吸入は、インスリン濃度のピークを13分後に(静脈内(IV)(5IU):5分、皮下(SC)(10IU):121分)、そしてインスリンレベルのベースラインへの復帰を180分後に(IV:60分、SC:360分)示した。グルコース注入速度により測定される生物学的作用は、39分後に(IV:14分、SC:163分)ピークになり、360分より多く(IV:240分、SC:>360分)続いた。絶対バイオアベイラビリティ(IV適用との比較)は、最初の3時間で14.6±5.1%であり、最初の6時間で15.5±5.6%であった。相対バイオアベイラビリティ(SC適用との比較)は、最初の3時間で25.8±11.7%であり、最初の6時間で16.4±7.9%であった。
Technosphere(登録商標)/Insulinは、すべての患者において安全であることが示された。1名の患者が吸入の間に咳をしていたが、さらなる症状も、呼吸系の悪化の徴候もなかった。
100UのTIの吸入は、十分忍容されて、達成された血清インスリン濃度から計算されるように、最初の3時間は25.8%の相対バイオアベイラビリティで実質的な血糖低下効果を有することが証明された。
本試験において、TIの吸入が、健常なヒト被検者において、インスリン濃度の迅速なピーク(Tmax:13分)と迅速な作用発現(Tmax:39分)、並びに6時間以上にわたる持続作用を伴う時間−作用プロフィールを有することが証明された。100UのTIの吸入後に測定された全代謝効果は、10IUのインスリンの皮下注射後より大きかった。TIの相対的な生体効果が19.0%であると計算された一方で、相対バイオアベイラビリティは、最初の3時間で25.8%であると定量された。
食事のTechnosphere(登録商標)/Insulinは、食事の皮下インスリンより有意に優れた食事関連血糖変動のコントロールを提供する
Technosphere(登録商標)/Insulin(TI)は、フマリルジケトピペラジン微粒子へ複合したインスリンを含んでなる、ヒトインスリンの乾燥粉末製剤である。乾燥粉末吸入器(MedTone(登録商標)Inhaler)を用いた肺投与によりTechnosphere(登録商標)/Insulinを送達して、迅速な作用発現と食事関連のグルコース吸収を受けるのに十分長い作用時間を達成した。本試験の主要目的は、食事前投与TIの安全性と血糖濃度に対する効力を7日の治療期間にわたり皮下(SC)標準インスリンに比較して評価することであった。
2型糖尿病の被検者における、SC注射標準インスリンと比較した、吸入Technosphere(登録商標)/Insulinによる食後血糖変動の顕著な低下−ANOVAを用いた実施例8データの再解析
ベースライン補正した食後の全インスリン曝露(INS−AUC0−240分)は、TIとSCで同等であった(8187±4269に対して8302±4025分*μU/dL;ns)が、TIのベースライン補正した食後血糖変動(BG−AUC0−240分)は、SCの約50%にすぎなかった(5095±5923分*mg/dLに対して9851±5593分*mg/dL;p<0.008)。このように、上記単位でのインスリン曝露に対する血糖変動の比(吸収されるインスリン用量の有効性の指標)は、TIでは約0.62でしかなかったのに対して、SCでは約1.2であった。言い換えると、吸収されるインスリンの単位あたりで見て、血液からグルコースを除去することにおいて、TIは、ほぼ2倍効率的であった。TIでは、SCよりメジアンインスリンTmaxがより短く、(15分対120分;p<0.001)、メジアンCmaxはより高かった(100μU/mL対54μU/mL;p=0.001)。従って、食後最高値で補正した血糖変動は、SCに比較してTIで28%低かった(49mg/dL対82mg/dL;p<0.003)。低血糖の発症(BG<63mg/dL、又は低血糖症状)は、治療で生じた(軽度〜中等度)副作用の件数(5エピソード対4エピソード)と同じように、TIとSCの間で同等(6エピソード対5エピソード)であった。高血糖(BG>280mg/dL)は、TIでより頻繁に生じた(12エピソード対4エピソード)が、2名の患者だけで8回のエピソードであった。
通院状況において食事TIを受ける2型患者の多施設試験
Technosphere(登録商標)/Insulin(TI)を使用する肺吸入により標準ヒトインスリンを投与する薬物動態および薬力学試験は、最高血漿インスリン濃度を吸入後約10〜14分のメジアンで達成することができて、これは第一相インスリン放出を再現するのに理想的であることを示した。このきわめて再現可能な動態プロフィールのインスリンを通院患者へ投与することは、現在利用可能な他のインスリンシステムでは可能でなかった。上記の実施例のような試験は、食前に与える皮下インスリン(SC)の生体利用可能な同等量に比較して、TIでの食後血糖変動が48%低下したことを実証した。通院状況において食事TIを12週間受ける2型患者の別の多施設試験では、前向きにモニタリングした低血糖の頻度が、通院使用のSCでこれまで報告されている頻度の10%未満であった。
基礎/食事治療方式における食事インスリンとしての吸入Technosphere(登録商標)/Insulin又はSC投与速効性インスリン類似体の1型糖尿病患者での3ヶ月比較
本試験は、Technosphere(登録商標)/Insulin(TI)を比較対照としての速効性インスリン類似体(RAA,Novolog(登録商標))と比較する、1型糖尿病患者の長期コントロールの一次評価を表す。TIのこれまでの試験では、2型糖尿病患者において240分にわたり標準ヒトインスリンより有意に優れた食後コントロールが示された。
Claims (16)
- インスリン関連障害のある患者の治療に使用の医薬品の製造におけるインスリン組成物の使用であって、該組成物はジケトピペラジンとインスリンを含み、インスリン関連障害のある患者において、肺投与ができるように適合されていて、食後血糖変動を抑えるために、長期作用型基礎インスリンと組み合わせて使用し、ここで臨床上重要な後期食後低血糖の発症は抑えられる、前記使用。
- 前記インスリン組成物は、食事の開始近くで投与できるように適合されている、請求項1に記載の使用。
- 前記ジケトピペラジンがフマリルジケトピペラジンである、請求項1に記載の使用。
- 前記インスリンが、乾燥粉末として吸入により投与できるように適合されている、請求項3に記載の使用。
- 前記インスリン組成物が、食事の開始に先立つ10分〜食事の開始後30分に投与できるように適合されている、請求項2に記載の使用。
- 前記インスリン関連障害が糖尿病である、請求項1に記載の使用。
- 前記インスリン関連障害が2型糖尿病である、請求項6に記載の使用。
- 前記インスリン関連障害が1型糖尿病である、請求項6に記載の使用。
- 前記食後血糖変動が、同様のインスリン曝露をもたらす皮下投与インスリンの用量より生じる食後血糖変動より小さく、ここで平均血糖変動は、皮下投与の場合より少なくとも25%小さい、請求項1に記載の使用。
- 前記食後血糖変動が、インスリン単独の適正な皮下用量での治療により産生されるものより抑えられる、請求項1に記載の使用。
- 前記臨床上重要な後期食後低血糖のエピソードの頻度が、インスリン単独の適正な皮下用量での治療に比べて抑えられる、請求項1に記載の使用。
- インスリン関連障害のある患者の治療に使用の医薬品の製造におけるインスリン組成物の使用であって、該組成物はジケトピペラジンとインスリンを含み、インスリン関連障害のある患者において、肺投与ができるように適合されていて、食後血糖変動を抑えるために、長期作用型基礎インスリンと組み合わせて使用し、ここで患者の全インスリン曝露(INS−AUC0−y,3≦y≦6時間)は、インスリンの適正な皮下用量により産生されるものを超えず、そしてここで食後血糖変動は抑えられ、臨床上重要な後期食後低血糖の発症は抑えられる、前記使用。
- インスリン関連障害のある患者の治療に使用の医薬品の製造におけるインスリン組成物の使用であって、該組成物はジケトピペラジンとインスリンを含み、肺投与に適していて、長期作用型基礎インスリンと組み合わせて使用され、ここで臨床上重要な後期食後低血糖の発症は抑えられる、前記使用。
- 体重増加が抑えられる、請求項13に記載の使用。
- インスリン関連障害のある患者の治療に使用の医薬品の製造におけるインスリン組成物の使用であって、該組成物はジケトピペラジンとインスリンを含み、インスリン関連障害のある患者において、食後血糖変動を抑えるために使用され、肺投与に適していて、ここで患者の全インスリン曝露(INS−AUC0−y,3≦y≦6時間)は、インスリンの適正な皮下用量により産生されるものを超えず、ここで臨床上重要な後期食後低血糖の発症は抑えられる、前記使用。
- インスリン関連障害のある患者の治療に使用の医薬品の製造におけるインスリン組成物の使用であって、該組成物はジケトピペラジンとインスリンを含み、肺投与に適していて、経口糖尿病薬と組み合わせて使用され、ここで臨床上重要な後期食後低血糖の発症は抑えられる、前記使用。
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