重度の腎機能障害または末期腎不全を合併した2型糖尿病患者を対象としたSYR-472（25mg）の第3相無作為化二重盲検並行群間比較試験および第3相多施設非盲検長期試験

基本情報

NCT ID

NCT02512068

ステータス

完了

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

107

治験依頼者名

Takeda

概要

The purpose of this study is to evaluate the efficacy and safety of trelagliptin when administered at a dose of 25 mg once weekly using placebo as a control in patients with type 2 diabetes mellitus complicated by severe renal impairment or end-stage renal disease and inadequate glycemic control despite diet and/or exercise therapy (if given) or despite treatment with one antidiabetic drug in addition to diet and/or exercise therapy (if given); and to evaluate the long-term efficacy and safety of trelagliptin when administered at a dose of 25 mg once weekly to patients with type 2 diabetes mellitus complicated by severe renal impairment or end-stage renal disease.

対象疾患

介入

依頼者（Sponsor）