A Multi-centre Prospective, Non-interventional Study of Ability and Willingness to Pay for BIAsp 30 in a Real World Population With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 516
- 试验地点
- 1
- 主要终点
- Proportion of patients who are using BIAsp 30 as their primary insulin
研究概览
简要总结
The purpose of this study is to collect information about the participant's ability and willingness to pay for NovoMix 30 using a modern device, which is prescribed to the participant by the study doctor for Type 2 Diabetes Mellitus according to routine clinical practice. The study aims to obtain data that can guide prescribers' understanding of the ability and willingness to pay for NovoMix 30 FlexPen or Penfill among participants in the growing middle class in India and Egypt. The decision to prescribe NovoMix 30 FlexPen or Penfill has been made independent from this study.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The decision to initiate treatment with commercially available BIAsp 30 has been made by the patient and the treating physician before and independently from the decision to include the patient in this study - Patients selected by their physician for participation in the study, who are likely to be able and willing to pay for the BIAsp 30 treatment for at least 12 weeks from baseline visit as assessed by the treating physician - Signed informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol) - Male or female greater than or equal to 18 years at time of informed consent - Diagnosed with T2DM and treated with BHI in vials for at least three consecutive months at time of informed consent
排除标准
- •Previous participation in this study. Participation is defined as having given informed consent in this study - Concurrent participation in any other clinical trial or study - Patients previously treated with insulin analogues - Known or suspected hypersensitivity to study product (or any of the excipients of the study product; a full list of excipients is provided in Summary of product characteristics (SmPC) of NovoMix® 30) or related products - Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation - Patients who are unable to read or write (illiterate)
研究组 & 干预措施
Participants with Type 2 Diabetes Mellitus
Participants will be prescribed and treated with commercially available BIAsp 30 according to routine clinical practice at the discretion of the treating physician, independent of this study. The study will gather data over the course of routine treatment on willingness to pay for BIAsp 30 in FlexPen® or Penfill®.
干预措施: BIAsp 30 (Drug)
结局指标
主要结局
Proportion of patients who are using BIAsp 30 as their primary insulin
时间窗: Week 12
Proportion of patients
次要结局
- Demographic and socio-economic characteristics of patients still using BIAsp 30 and of patients no longer using BIAsp 30 as their primary insulin, measured by Ability to Pay Questionnaire(Week 12)
- Change from baseline to Week 12 after first prescription of BIAsp 30 in patient evaluation of delivery system, measured by Treatment Related Impact Measure for Diabetes (TRIM-D) Device(Week 0, week 12)
- Diabetes Pen Experience Measure (DPEM) Scores (frequency of each item)(Week 0)
- Diabetes Pen Experience Measure (DPEM) Scores (proportions of each item)(Week 0)
- Change from baseline to Week 12 after first prescription of BIAsp 30 in treatment satisfaction, measured by Diabetes Treatment Satisfaction Questionnaire (status)(Week 0, week 12)
- Weighted patient preferences for treatment attributes derived from the Discrete Choice Experiment (DCE)(Week 0)