NCT00670722已完成不适用
Observational Study on Evaluation of Glycaemic Control in Patients Using a Modern Insulin - NovoRapid® (Insulin Aspart), NovoMix® 30 (Biphasic Insulin Aspart 30) or Levemir® (Insulin Detemir) for Treatment of Type 2 Diabetes Mellitus
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
- 6,500
- 试验地点
- 1
- 主要终点
- HbA1c after switch from human insulin to modern insulin treatment
研究概览
简要总结
This study is conducted in Europe. An observational study evaluating the blood glucose control in patients using a modern insulin: NovoRapid®, NovoMix® 30 or Levemir® for treatment of Type 2 diabetes mellitus in Czech Republic.
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
- •Type 2 diabetes
- •Current treatment with human soluble insulin, insulin NPH or premixed human insulin
- •The selection of the subjects will be at the discretion of the individual physician
排除标准
- •Current treatment with insulin aspart, insulin detemir or biphasic insulin aspart 30
- •Previous enrolment in this study
- •Hypersensitivity to insulin aspart, insulin detemir or biphasic insulin aspart 30 or to any of the excipients.
- •Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months and considered to be treated by biphasic insulin aspart 30 or insulin detemir
研究组 & 干预措施
D
干预措施: insulin detemir (Drug)
D
干预措施: insulin aspart (Drug)
A
干预措施: insulin aspart (Drug)
B
干预措施: insulin detemir (Drug)
C
干预措施: biphasic insulin aspart 30 (Drug)
结局指标
主要结局
HbA1c after switch from human insulin to modern insulin treatment
时间窗: After 24 weeks
次要结局
- Postprandial glycaemic control as measured by PPG(After 12 and 24 weeks)
- Glucose variability as measured by FPG(After 12 and 24 weeks)
- Insulin dose and number of injections(After 12 and 24 weeks)
- Percentage of subjects to reach HbA1c below 7.0% and = 6.5% at approximately 12 weeks and 24 weeks of treatment(After 12 and 24 weeks)
- Body weight(After 12 and 24 weeks)
- Number of hypoglycaemic events(During treatment)
- Number of adverse drug reactions (ADR)(After 12 and 24 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Observational Study of Glycaemic Control in Patients Uncontrolled on Oral Antidiabetic Agents and Starting With 1 (Once) Daily Levemir® (Insulin Detemir) as the Treatment of Type 2 Diabetes MellitusDiabetesDiabetes Mellitus, Type 2NCT00687284Novo Nordisk A/S2,188
已完成
不适用
Observational Study on Blood Glucose Control in Patients With Diabetes Using Modern InsulinDiabetesDiabetes Mellitus, Type 2NCT00676741Novo Nordisk A/S3,809
已完成
不适用
Observational Study Describing Conditions for Administering Slow-acting Insulin Analogue With Oral Antidiabetic Agents in Type 2 Diabetes on Blood Glucose ControlDiabetesDiabetes Mellitus, Type 2NCT00700960Novo Nordisk A/S2,745
已完成
不适用
Observational Study in Type 2 Diabetics Failing on Oral Antidiabetic Therapy and Starting on Insulin TreatmentDiabetesDiabetes Mellitus, Type 2NCT00865397Novo Nordisk A/S1,032
已完成
不适用
Observational Study on Effectiveness and Safety of Liraglutide in Subjects With Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2NCT01288326Novo Nordisk A/S254