JP6199186B2 - 2型糖尿病の治療用の医薬の製造のためのave0010の使用 - Google Patents
2型糖尿病の治療用の医薬の製造のためのave0010の使用 Download PDFInfo
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Description
配列番号1:AVE0010 (44 AS)
H−G−E−G−T−F−T−S−D−L−S−K−Q−M−E−E−E−A−V−R−L−F−I−E−W−L−K−N−G−G−P−S−S−G−A−P−P−S−K−K−K−K−K−K−NH2
配列番号2:エキセンジン−4(39 AS)
H−G−E−G−T−F−T−S−D−L−S−K−Q−M−E−E−E−A−V−R−L−F−I−E−W−L−K−N−G−G−P−S−S−G−A−P−P−P−S−NH2
実施例の主題は、12ヵ国の61の施設において行われた、抗糖尿病剤で治療されない2型糖尿病に罹患した患者におけるリキシセナチドの有効性及び安全性を評価する、無作為化、二重盲検、プラセボ対照、並行群間、多施設共同12週間研究である。研究の主要目的は、12週間にわたってのHbA1c減少(絶対変化)に関してのプラセボと比較しての2段階用量漸増レジメンで使用した血糖コントロールに対するリキシセナチドの効果を評価することであった。
1.1 主要目的
この実施例の主要目的は、抗糖尿病剤で治療されない2型糖尿病に罹患した患者における12週間にわたるHbA1c減少(絶対変化)に関してのプラセボと比較しての2段階用量漸増レジメンで使用した血糖コントロールに対するリキシセナチドの効果を評価することであった。
この研究の副次的目的は以下であった:
・以下に対するリキシセナチドの効果を評価するため:
− 12週間にわたって1段階用量漸増レジメンで使用した場合のHbA1c減少に関するプラセボと比較しての血糖コントロール、
− 第12週での体重、
− 第12週での空腹時血漿中グルコース(FPG)、
− 選択した施設の全ての患者のサブグループ(無作為化患者のおよそ50%)における第12週での標準食事負荷試験後の食後2時間血漿中グルコース、
・12週間にわたってのリキシセナチド安全性及び耐容性を評価するため、
・集団PKアプローチを使用してリキシセナチドPKを評価するため、
・抗リキシセナチド抗体出現を評価するため。
これは、二重盲検、無作為化、プラセボ対照、4治療群、不均衡デザイン、並行群間多国間研究であった:2段階漸増(120人のリキシセナチド治療患者及び60人のプラセボ治療患者)及び1段階漸増(120人のリキシセナチド治療患者及び60人のプラセボ治療患者)。研究は、活性薬物及びプラセボ治療に関して二重盲検であった。治験薬量(即ち、活性薬物又は一致するプラセボの用量)及び漸増レジメン(即ち、1段階及び2段階)は盲検化しなかった。
3.1 主要エンドポイント
主要有効性変数は、ベースラインから第12週までのHbA1cの絶対変化でり、これを次のように定義した:第12週でのHbA1c値−ベースラインでのHbA1c値。
[LOCF]手順)。
副次的有効性変数について、主要有効性変数についてのと同一の手順を、12週間二重盲検治療期間の間の欠けている評価/早期中止の取り扱いについて適用した。
・ベースラインから第12週までの標準食事試験後の食後2時間血漿中グルコース変化(mmol/L)、
・ベースラインから第12週までの体重変化(kg)、
・ベースラインから第12週までの空腹時血漿中グルコース変化(mmol/L)、
・ベースラインから第12週までの標準食事試験後のグルコース可動域変化(mmol/L)(治験薬投与前の、食後2時間血漿中グルコース−食事試験30分前の血漿中グルコース)。
・第12週でHbA1c<7%を有した患者のパーセンテージ、
・第12週でHbA1c≦6.5%を有した患者のパーセンテージ、
・二重盲検治療期間の間に救助治療を必要とした患者のパーセンテージ、
・第12週でベースラインからの≧5%体重減少(kg)を有した患者のパーセンテージ。
主要有効性変数である、ベースラインから第12週までのHbA1c変化に基づいて、標本サイズ/パワー計算を行った。
5.1 分析集団
修正ITT集団は、研究プロトコル及び手順の順守に関係なく、無作為化され(「無作為化」として分析)、少なくとも1用量の二重盲検被験薬を受容し、ベースライン評価及び主要又は副次的有効性変数の少なくとも1つのベースライン後の評価の両方を有した全ての患者からなった。
主要有効性変数(ベースラインから第12週までのHbA1c変化)を、固定効果として治療群(2段階漸増リキシセナチド及びプラセボ治療群、1段階漸増リキシセナチド及びプラセボ治療群)、スクリーニングHbA1c(<8.0、≧8.0%)の無作為化層、スクリーニングBMI(<30、≧30kg/m2)値の無作為化層、及び国を用い、共変数としてベースラインHbA1c値を使用する、共分散分析(ANCOVA)モデルを使用して分析した。ANCOVAモデルにおいて、2つの漸増プラセボ治療群を、別箇の治療レベルとして含めたが、適切なコントラストを使用して比較する場合には、それらを1つの群として組み合わせた(例えば、1段階漸増プラセボ、2段階漸増プラセボ、1段階漸増リキシセナチド及び2段階漸増リキシセナチド群の順序で、2段階漸増リキシセナチド群と混合プラセボとを比較するため[−0.5,−0.5,0,+1])。
いったん主要変数が両方の比較についてα=0.05で統計的に有意となると、副次的有効性変数を試験するために試験手順を行った;図2参照。
・第12週でHbA1c<7.0%を有した患者のパーセンテージ、
・第12週でHbA1c≦6.5%を有した患者のパーセンテージ、
・12週間治療期間の間に救助治療を必要とした患者のパーセンテージ。
治療により発現したAE(TEAE)を、治療中の期間の間に発現又は悪化した(研究者の見解による)か又は深刻になったAEと定義した。治療中の期間を、二重盲検被験薬(IP)の最初の投薬からIP投与の最後の注射後3日までの時間と定義した。3日間の間隔はIPの半減期に基づいて選択した(半減期のおよそ5倍)。
6.1 研究患者
6.1.1 患者責任
スクリーニングした患者795人のうち、434人(54.6%)の患者は二重盲検治療へ無作為化しなかった。主な理由は、HbA1c値がスクリーニング受診時に定義したプロトコル範囲を超えていたことであった(318人(40.0%)の患者)。
下記の表2は、各治療群についての患者配置の要約を提供する。無作為化患者361人のうち、30人(8.3%)の患者が、主に「その他」(即ち、対象者の決断、患者18人)続いて有害事象(患者9人)と分類される理由に起因して、時期尚早に研究治療を中止した。治療中止までの時間を図3に示し、特別なパターンは観察されなかった。
下記の表3は、各治療群及び全体についてのベースライン及びデモグラフィック特徴の要約を提供する。デモグラフィック及びベースライン情報は、安全性集団について治療群にわたって概して同様であった。試験集団の性別のバランスを取り、中央の年齢は54歳であった。大多数の患者が白色人種(72.9%)であった。
治療曝露及び投薬量を下記の表6、表7及び表8に要約する。平均治療曝露は、治療群にわたって同様であった。安全性患者361人のうち、335人(92.8%)を57日以上曝露し、349人(96.7%)が漸増の終了時に標的用量20μgに達し、335人(92.8%)が二重盲検治療の終了時に標的用量20μgを含む最終用量を有した。
6.2.1 主要有効性パラメータ
主要分析
表1は、LOCF ANCOVA解析を使用しての、主要有効性パラメータ、HbA1cのベースラインからエンドポイントまでの変化の結果を要約する。図4は、12週間二重盲検治療の間の経時的なHbA1cのベースラインからの平均値(±SE)変化を示す。
表10は、治療反応(それぞれ、エンドポイントでHbA1c≦6.5又は<7%)を有する患者の割合を要約する。治療反応はリキシセナチド治療群間で同様であり、各々のリキシセナチド治療群とプラセボとの治療差は統計的に有意であった。
表11、表12、表13及び表15は、それぞれ、食後2時間血漿中グルコース、グルコース可動域、体重及びFPGのANCOVA解析を要約する。
下記の表17は、二重盲検治療の間に有害事象を有した患者の全体の要約を示し、表18及び表19は、それぞれ、深刻なTEAE、及び治療中止へ至るTEAEを示す。TEAEを有した患者の割合は、プラセボ群とリキシセナチド治療群とで概して同等であった。深刻なTEAEの発生率は低く、プラセボ群において5人発生(4.1%)、リキシセナチド2段階漸増群において1人(0.8%)、リキシセナチド1段階漸増群において0人であった。この試験において死亡は報告されなかった。プラセボ群(1人[0.8%])よりもリキシセナチド治療群においてより多くの患者(2段階漸増について5人[4.2%];1段階漸増について3人[2.5%])が、主に胃腸障害に起因して、治療を中止した。
Claims (12)
- 2型糖尿病患者における食後血漿中グルコース濃度を減少させるための医薬の製造のためのdesPro36エキセンジン−4(1−39)−Lys6−NH2又は/及びその薬学的に許容される塩の使用であって、治療しようとする2型糖尿病患者が少なくとも14mmol/Lの食後2時間血漿中グルコース濃度を有し、少なくとも30kg/m 2 のボディマス指数を有し、抗糖尿病治療を受けない、上記使用。
- 治療しようとする患者が肥満である、請求項1に記載の使用。
- 治療しようとする患者が成人の患者である、請求項1又は2に記載の使用。
- 治療しようとする患者において、2型糖尿病が治療の開始の少なくとも1年前又は少なくとも2年前に診断されている、請求項1〜3のいずれか一項に記載の使用。
- 治療しようとする患者が7〜10%のHbA1c値を有する、請求項1〜4のいずれか一項に記載の使用。
- 治療しようとする患者が、少なくとも8mmol/Lの空腹時血漿中グルコース濃度を有する、請求項1〜5のいずれか一項に記載の使用。
- 治療しようとする患者が、少なくとも2mmol/L、少なくとも3mmol/L、少なくとも4mmol/L又は少なくとも5mmol/Lのグルコース可動域を有し、ここで、グルコース可動域は、食後2時間血漿中グルコース濃度と食事試験30分前の血漿中グルコース濃度との差である、請求項1〜6のいずれか一項に記載の使用。
- desPro36エキセンジン−4(1−39)−Lys6−NH2又は/及びその薬学的に許容される塩を非経口投与する、請求項1〜7のいずれか一項に記載の使用。
- 医薬は、10μg〜20μgの範囲より選択される日用量でのdesPro36エキセンジン−4(1−39)−Lys6−NH2又は/及びその薬学的に許容される塩の投与用に調製される、請求項1〜8のいずれか一項に記載の使用。
- 医薬は、1日1回の投与用に調製される、請求項1〜9のいずれか一項に記載の使用。
- 2型糖尿病患者における食後血漿中グルコース濃度を減少させるのに使用するための、desPro36エキセンジン−4(1−39)−Lys6−NH2又は/及びその薬学的に許容される塩を含み、薬学的に許容される担体、アジュバント、又は/及び補助物質を場合により含む、薬学的組成物であって、治療しようとする2型糖尿病患者が少なくとも14mmol/Lの食後2時間血漿中グルコース濃度を有し、少なくとも30kg/m 2 のボディマス指数を有し、抗糖尿病治療を受けない、上記薬学的組成物。
- 請求項2〜7のいずれか一項に定義される患者の治療における使用のための、請求項11に記載の組成物。
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