NCT00665808已完成不适用
Insulin Detemir (Levemir®) Versus Isophane (NPH) Insulin (Protaphane®) in Combination With Oral Antidiabetic Agents (OAD) in Patients With Diabetes Mellitus Type 2 Comparing Treatment Satisfaction, Diabetes-related and General Health-related Quality of Life, as Well as Diabetes-control
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8,125
- 试验地点
- 1
- 主要终点
- treatment satisfaction (DTSQs and DTSQc)
研究概览
简要总结
This NON INTERVENTIONAL OBSERVATIONAL STUDY is conducted in Europe. The purpose of this NON INTERVENTIONAL OBSERVATIONAL STUDY is to primarily investigate treatment satisfaction when using Levemir® versus Protaphane® in combination with OADs in daily settings.
研究设计
- 研究类型
- Observational
- 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
- •Written informed consent obtained from patient before first documentation of treatment in the observational study.
- •Type 2 diabetes mellitus
- •Patients, who should intensify treatment with long acting insulin in addition to their treatment with oral antidiabetic agents, due to insufficient blood glucose control
- •No contraindication for use of Protaphane® or Levemir®
排除标准
- 未提供
研究组 & 干预措施
A
干预措施: insulin detemir (Drug)
B
干预措施: isophane human insulin (Drug)
结局指标
主要结局
treatment satisfaction (DTSQs and DTSQc)
时间窗: over whole study duration, 24 weeks per patient
次要结局
- diabetes-related quality of life (ADDQoL)(over whole study duration, 24 weeks per patient)
- Insulin dose(over whole study duration, 24 weeks per patient)
- Pregnancy(over whole study duration, 24 weeks per patient)
- Body weight(over whole study duration, 24 weeks per patient)
- metabolic control (HbA1c, fasting morning blood glucose)(over whole study duration, 24 weeks per patient)
- general health-related quality of life (EQ-5D)(over whole study duration, 24 weeks per patient)
- concomitant diabetes therapy (OADs)(over whole study duration, 24 weeks per patient)
- Hypoglycemia(over whole study duration, 24 weeks per patient)
- Serious adverse drug reactions, SADR(over whole study duration, 24 weeks per patient)
- Adverse drug reactions, ADR(over whole study duration, 24 weeks per patient)
研究者
研究点 (1)
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