临床试验/NCT01542476

NCT01542476已完成不适用

An Observational Study in Dutch Type 1 and Type 2 Diabetes Patients: The Impact of Initiation of/Switching to Levemir® on Emotional Well-being, Insulin Perceptions and Treatment Satisfaction - CONFIDENCE (Clinical ObservatioNs oF Levemir® In Dutch ExperieNCE)

Novo Nordisk A/S0 个研究点目标入组 299 人开始时间: 2006年8月最近更新: 2016年3月3日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Novo Nordisk A/S
入组人数: 299
主要终点: Change in Patient-Reported Outcomes (PRO) using World Health Organization 5 (WHO-5) item Well-being Index: Insulin Treatment Appraisal Scale (ITAS)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

This study is conducted in Europe. The aim of this study is to assess the well-being of patients following treatment with insulin detemir (Levemir®) in subjects with type 1 or type 2 diabetes in whom either initiation of or a switch to insulin treatment with a long-acting basal insulin analogue is needed.

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

入排标准

性别: All
接受健康志愿者: 否

入选标准

•Any subject with type 1 or type 2 diabetes not optimally controlled (HbA1c above 7.5%) in whom at the discretion of the participating physicians it was decide to either initiate or switch to a treatment with a long-acting insulin analogue
•Subjects with type 1 diabetes should have been treated with insulin for at least 12 months
•Potential pre-study treatment with insulin detemir (Levemir®) should have started no more than two months before baseline

排除标准

未提供

研究组 & 干预措施

IDet users

干预措施: insulin detemir (Drug)

结局指标

主要结局

Change in Patient-Reported Outcomes (PRO) using World Health Organization 5 (WHO-5) item Well-being Index: Insulin Treatment Appraisal Scale (ITAS)

时间窗: Baseline, month 6

次要结局

Hypoglycaemic episodes(Month 6)
Adverse events(Month 6)
Change in Fasting blood glucose (FBG)(Baseline, month 6)
Change in body weight(Baseline, month 6)
Change in Patient-Reported Outcomes (PRO) using Insulin Treatment (ITSQ)(Baseline, month 6)
Change in HbA1c (glycosylated haemoglobin)(Baseline, month 6)

研究者

发起方

Novo Nordisk A/S

申办方类型

Industry

责任方

Sponsor

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