既存の抗糖尿病薬で血糖コントロールが不十分な高齢2型糖尿病患者におけるHOE901-U300とランタスの安全性および有効性の比較

基本情報

NCT ID

NCT02320721

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

1,014

治験依頼者名

Sanofi

概要

Primary Objective: To demonstrate the non-inferiority of H0E901-U300 to Lantus, in change of glycated hemoglobin A1c (HbA1c). Secondary Objectives: To demonstrate the superiority of H0E901-U300 in comparison with Lantus in: * Percentage of participants with at least one severe and/or confirmed (by plasma glucose ≤70mg/dL \[3.9mmol/L\]) hypoglycemia event from 22:00 to 08:59 next morning * Percentage of participants with at least one nocturnal (from 00:00-05:59) severe and/or confirmed (≤70mg/dL \[3.9mmol/L\]) hypoglycemia event * Percentage of participants with at least one severe and/or confirmed (by plasma glucose ≤70mg/dL \[3.9mmol/L\]) hypoglycemia event occurring at any time of day * HbA1c change

対象疾患

介入

依頼者（Sponsor）