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TOFOインスリン併用療法の臨床試験
基本情報
- NCT ID
- NCT02201004
- ステータス
- 完了
- 試験のフェーズ
- 第4相
- 試験タイプ
- 介入
- 目標被験者数
- 211
- 治験依頼者名
- Sanofi
概要
Primary Objectives: To assess the effects of tofogliflozin on glycemic control in comparison to placebo as an add-on treatment to insulin treatment in terms of glycated hemoglobin (HbA1c) reduction over a period of 16 weeks in patients with type 2 diabetes mellitus. To assess the safety of tofogliflozin in combination with insulin treatment throughout 52 weeks. Secondary Objectives: To assess the effects of tofogliflozin in comparison to placebo on: * Body weight * Fasting plasma glucose (FPG) * Postprandial plasma glucose (PPG) To assess the long term safety and tolerability of tofogliflozin.
対象疾患
Type 2 Diabetes Mellitus
介入
TOFOGLIFLOZIN CSG452(DRUG)
insulin(DRUG)
placebo(DRUG)