NCT00715351已完成不适用
Efficacy and Safety of Glycaemic Control of Levemir® or Insulatard® in Patients With Type 2 Diabetes
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 342
- 试验地点
- 1
- 主要终点
- Body weight change
研究概览
简要总结
This trial is conducted in Europe. The aim of this observational study is to evaluate the glycaemic control, weight change and hypoglycaemic effects in patients with type 2 diabetes with Levemir® compared to Insulatard® under normal clinical practice conditions.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes failing on oral blood glucose lowering therapy, and requiring insulin therapy.
排除标准
- •Type 1 diabetes
- •Previous use of insulin
研究组 & 干预措施
A
干预措施: insulin detemir (Drug)
B
干预措施: insulin NPH (Drug)
结局指标
主要结局
Body weight change
时间窗: at 3 months and 6 months after baseline
次要结局
- Hypoglycemic events(at 3 months and 6 months after baseline)
- Changes in glycaemic parameters(at 3 months and 6 months after baseline)
- Safety parameters by collecting (serious) adverse events and the pregnancies.(at 3 months and 6 months after baseline)
- Evaluation of general well-being by using the WHO-5 well-being questionnaire (Appendix I).(at 3 months and 6 months after baseline)
- Treatment satisfaction of subjects treated with insulin Levemir or NPH insulin by using insulin satisfaction ('Tevredenheid met insuline behandeling': Appendix II)(at 3 months and 6 months after baseline)
- Satisfaction of physicians who treat the subjects with insulin Levemir or NPH in-sulin by using a scale of 0-10 (Appendix III).(at 3 months and 6 months after baseline)
- Changes in doses(at 3 months and 6 months after baseline)
- HbA1c(at 3 months and 6 months after baseline)
- Changes in daily blood glucose values(at 3 months and 6 months after baseline)
研究者
研究点 (1)
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