NCT03862690撤回不适用
A Prospective Non-interventional Study Investigating the Treatment Effect of NovoMix® 30 (Biphasic Insulin Aspart 30) in a Real World Adult Population With Type 2 Diabetes in Algeria
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in glycosylated haemoglobin A1c (HbA1c)
研究概览
简要总结
The purpose of the study is to collect information about how NovoMix® 30 works in real world adult population with type 2 diabetes. Participants will get NovoMix® 30 as prescribed by the study doctor. The study will last for about 6-8 months. Participants will be asked questions about their health and their diabetes treatment as part of their study doctor's appointment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol)
- •The decision to initiate treatment with commercially available NovoMix® 30 has been made by the patient and the treating physician before and independently from the decision to include the patient in this study
- •Male or female, greater than or equal to 19 years at the time of signing informed consent
- •Diagnosed with type 2 diabetes and treated with basal insulin plus 1-3 bolus insulin injections per day for at least 24 weeks prior to informed consent
- •Available and documented HbA1c value less than or equal to 12 weeks prior to initiation of NovoMix® 30 treatment
排除标准
- •Previous participation in this study. Participation is defined as having given informed consent in this study
- •Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
- •Participation in any clinical trial of an approved or non- approved investigational medicinal product within 24 weeks prior to initiation of NovoMix® 30 treatment. Clinical trials do not include non-interventional studies
- •Hypersensitivity to NovoMix® 30 or to any of the excipients
- •Pregnancy or intention of becoming pregnant
研究组 & 干预措施
Participants with Type 2 Diabetes Mellitus
A broad adult population of patients with type 2 diabetes (T2D) requiring insulin therapy in different basal-bolus treatment regimens.
干预措施: BIAsp 30 (Drug)
结局指标
主要结局
Change in glycosylated haemoglobin A1c (HbA1c)
时间窗: From baseline (week 0) to end of study (week 24)
Measured in % point.
次要结局
- Participants achieving HbA1c below 7.0%(At end of study (week 24))
- Particpants achieving HbA1c below 7.5%(At end of study (week 24))
- Partcipants achieving HbA1c below 8.0%(At end of study (week 24))
- Change in rate of severe hypoglycaemia(From baseline (week 0) to end of study visit (as recalled at week 24))
- Change in total insulin dose(From baseline (week 0) to end of study (week 24))
- Change in Diabetes Treatment Satisfaction (DTSQ) score(From baseline (week 0) to end of study (week 24))
- Change in health-related quality of life (EQ-5D)(From baseline (week 0) to end of study (week 24))
研究者
研究点 (1)
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