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PPAR-COMBO With Sulfonylurea 第III相・フェーズ3 534 無作為化 二重盲検 プラセボ対照

完了
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT00162175 は 治療 の研究で、Metabolics Diabetes Nos を対象とした 第III相・フェーズ3 介入研究 臨床試験 でした。現在は 完了 です。2003年7月1日 に開始し、534 名の参加者 が参加しました。この試験は ブリストル・マイヤーズ スクイブ によって主導され、2005年11月1日 に完了しました。ClinicalTrials.gov からの最新更新日は 2010年9月14日 です。
概要
A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 in Combination with Glyburide Therapy in Subjects with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Sulfonylurea Therapy Alone.
公式タイトル

A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 in Combination With Glyburide Therapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Sulfonylurea Therapy Alone

疾患名
Metabolics Diabetes Nos
刊行物
この臨床試験について発表された科学記事と研究論文：
その他の研究識別子
  • CV168-021
NCT番号
NCT00162175
開始日
2003-07
最終更新日
2010-09-14
終了予定日
2005-11
目標参加者数
534
試験の種類
介入研究
治験の相・段階
第III相・フェーズ3
状況
完了
主目的
治療
割付方法
無作為化
介入モデル
並行割当
盲検化
二重盲検
群（アーム）／介入
参加グループ/群介入/治療法
該当なし
Muraglitazar
主要評価項目
評価指標指標の説明時間枠
Compare change from baseline in HbA1c after 24 weeks of treatment with muraglitazar + glyburide vs placebo + glyburide
副次評価項目
評価指標指標の説明時間枠
Change in FPG from basline to W24, proportion of subjects receiving therapeutic response at W24, percent change of fasting lipid levels from baseline to W11/12, change in hs-CRP from baseline to W24
適格基準

対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
  • Type 2 Diabetes, HbA1c > 7.0% and < 10.0%, mean serum triglyceride < 600 mg/dL, body mass index < 41 kg/m2, fasting c-peptide . 1.5 ng/mL.

  • History of MI (myocardial infarction), coronary angioplasty or bypass graft(s), valvular disease or repair, unstable angina pectoris, transient ischemic attack (TIA), cerebrovascular attack, or cerebrovascular accident (CVA) within 6 months, congestive heart failure (NYHA Class III and IV, uncontrolled hypertension, history or renal disease, peripheral vascular disease (PVD), pulmonary disease, gastrointestinal disease, active liver disease or endocrine disease.
Bristol-Myers Squibb logoブリストル・マイヤーズ スクイブ448 件のアクティブな治験を探索
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