日本人1型糖尿病患者におけるダパグリフロジンとインスリン併用療法の安全性および有効性

基本情報

NCT ID

NCT02582814

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

151

治験依頼者名

AstraZeneca

概要

This study will enroll eligible subjects into a long-term safety study (Part B). Japanese male and female patients with T1DM and age 18 to 75 years, with inadequate glycemic control on insulin defined as HbA1c ≥ 7.5% and ≤ 10.5% at screening visit. As a condition of enrollment, subjects must be on a total daily insulin dose of ≥ 0.3 U/kg/day for at least 3 months prior to the screening visit. The study design of Part B is a randomized, open-label, 2 arm, parallel-group design. 140 Japanese subjects in total will be randomized in a 1:1 ratio into one of the two treatment arms; dapagliflozin 5 mg or dapagliflozin 10 mg.

対象疾患

介入

依頼者（Sponsor）