Tresiba®の長期使用に関する市販後調査（特殊使用結果調査）

基本情報

NCT ID

NCT01984372

ステータス

完了

試験のフェーズ

-

試験タイプ

観察

目標被験者数

6,163

治験依頼者名

Novo Nordisk A/S

概要

This study is conducted in Asia. The aim of this post marketing surveillance (PMS) is to assess safety and effectiveness of long-term treatment with Tresiba® (insulin degludec) in patients with diabetes mellitus requiring insulin therapy under normal clinical practice conditions. A total of 4000 patients will be enrolled to investigate long term (3 years of treatment) safety of Tresiba® and additional 2000 patients will be enrolled to assess the safety in an early stage of the PMS more precisely. At the time of enrolment the patients will be randomly allocated to either 3 years or 6 months observation group.

対象疾患

介入

依頼者（Sponsor）