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Efficacy and Tolerability of Saxagliptin add-on Compared to Uptitration of Metformin in Patients With Type 2 Diabetes (PROMPT) 第IV相・フェーズ4 286

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 NCT01006590 (PROMPT) は 治療 の研究で、2型糖尿病 を対象とした 第IV相・フェーズ4 介入研究 臨床試験 でした。現在は 完了 です。2009年10月1日 に開始し、286 名の参加者 が参加しました。この試験は アストラゼネカ によって主導され、2010年12月1日 に完了しました。ClinicalTrials.gov からの最新更新日は 2012年1月19日 です。
概要
The study will evaluate the efficacy and tolerability of saxagliptin compared to uptitration of metformin in patients with type 2 diabetes who have inadequate glycaemic control on a submaximal dose of metformin.
公式タイトル

A 24-Week, Randomised, Double-Blind, Active-Controlled, Multi-Centre Phase IIIb/IV Study to Evaluate the Efficacy and Tolerability of Saxagliptin Add-On Compared to Uptitration of Metformin in Patients With Type 2 Diabetes Mellitus With Inadequate Glycaemic Control on Sub-Maximal Doses of Metformin

疾患名
2型糖尿病
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
  • PROMPT
  • D1680L00003
NCT番号
NCT01006590
開始日
2009-10
最終更新日
2012-01-19
終了予定日
2010-12
目標参加者数
286
試験の種類
介入研究
治験の相・段階
第IV相・フェーズ4
状況
完了
キーワード
Type 2 Diabetes Mellitus
Saxagliptin
Randomised
Double-blind
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
三重盲検
群（アーム）／介入
参加グループ/群介入/治療法
実験的1
Saxagliptin 5 mg
Saxagliptin
5 mg, oral tablet, once daily
実薬対照薬2
Metformin 500 -1000 mg
メトホルミン
500 mg, oral tablet, 1 or 2 additional tablets per day added to background therapy
主要評価項目
評価指標指標の説明時間枠
Absolute Change From Baseline in HbA1c at Week 24
Baseline and 24 weeks
副次評価項目
評価指標指標の説明時間枠
Proportion of Patients Achieving a Therapeutic Response at Week 24 Defined as HbA1c<7.0%
Proportion, percentage of patients in each treatment group, achieving therapeutic response, HbA1c below 7.0 percent
24 Weeks
Proportion of Patients Achieving a Therapeutic Response at Week 24 Defined as HbA1c<=6.5%
Proportion, percentage of patients in each treatment group, achieving therapeutic response, HbA1c below or equal to 6.5 percent
24 Weeks
Change From Baseline to Week 24 in Fasting Plasma Glucose
Baseline and 24 weeks
Change From Baseline to Week 24 in Fasting Insulin
Baseline and 24 weeks
Change From Baseline to Week 24 in Beta-cell Function as Measured by Homeostasis Model Assessment-2-beta
Baseline and 24 weeks
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
  • Provision of signed informed consent
  • Established clinical diagnosis of type 2 diabetes. Treatment with a stable dose of metformin monotherapy (1500-1700 mg/day) for at least 8 weeks prior to visit 1.
  • HbA1c ≥7.0% and ≤10.0%

  • Type 1 diabetes, history of diabetic ketoacidosis or hyperosmolar non-ketonic coma.
  • Renal impairment as defined by a creatinine clearance <60 mL/min/1.73 m2
  • Individuals who, in the opinion of the investigator, in which participation in this study may pose a significant risk to the patient and could render the patient unable to successfully complete the study
AstraZeneca logoアストラゼネカ772 件のアクティブな治験を探索
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
連絡先情報がありません。
51 7カ国の場所

Belgium

Research Site, Brussels (woluwe-st-lambert), Belgium, Belgium
Research Site, Halen, Belgium, Belgium
Research Site, Lommel, Belgium, Belgium
Research Site, Oostham, Belgium, Belgium
Research Site, Sint-Gillis-Waas, Belgium, Belgium
Research Site, Zoersel, Belgium, Belgium
Research Site, Bruges, Belgium
Research Site, Moerkerke, Belgium
Research Site, Tielt, Belgium
Research Site, Châtellerault, France
Research Site, Corbeil-Essonnes, France
Research Site, La Rochelle, France
Research Site, La Seyne-sur-Mer, France
Research Site, Paris, France
Research Site, Seysses, France
Research Site, Tiercé, France
Research Site, Berlin, Germany
Research Site, Freiburg im Breisgau, Germany
Research Site, Leipzig, Germany
Research Site, Ludwigshafen, Germany
Research Site, Mannheim, Germany
Research Site, Rhaunen, Germany
Research Site, Schmiedeberg, Germany
Research Site, Wahlstedt, Germany

BG

Research Site, Bergamo, BG, Italy

FC

Research Site, Forlì, FC, Italy

MI

Research Site, Milan, MI, Italy

PD

Research Site, Padova, PD, Italy

PN

Research Site, Pordenone, PN, Italy

SI

Research Site, Siena, SI, Italy
Research Site, Roma, Italy

Andalusia

Research Site, Seville, Andalusia, Spain

Catalonia

Research Site, Barcelona, Catalonia, Spain

Galicia

Research Site, A Coruña, Galicia, Spain

Madrid

Research Site, Madrid, Madrid, Spain
Research Site, San Sebastián de los Reyes, Madrid, Spain

Principality of Asturias

Research Site, Oviedo, Principality of Asturias, Spain

Valencia

Research Site, Alicante, Valencia, Spain

Turkey

Research Site, Ankara, Turkey, Turkey (Türkiye)
Research Site, Bursa, Turkey, Turkey (Türkiye)
Research Site, Kırıkkale, Turkey, Turkey (Türkiye)
Research Site, Ankara, Turkey (Türkiye)

Berks

Research Site, Reading, Berks, United Kingdom

Warwickshire

Research Site, Atherstone, Warwickshire, United Kingdom

Warwks

Research Site, Royal Leamington Spa, Warwks, United Kingdom

Wiltshire

Research Site, Warminster, Wiltshire, United Kingdom
Research Site, Westbury, Wiltshire, United Kingdom
Research Site, Ashford, United Kingdom
Research Site, Bath, United Kingdom
Research Site, Coventry, United Kingdom
Research Site, Peterborough, United Kingdom