NCT00676741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) or Levemir® (Insulin Detemir) - for Treatment of 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
- 3,809
- 试验地点
- 1
- 主要终点
- Metabolic control measured as HbA1c
研究概览
简要总结
The study is conducted in Europe. The aim of this observational study is to evaluate the blood glucose control in patients using a modern insulin: NovoRapid®, NovoMix® 30 or Levemir® for the treatment type 2 diabetes.
Full acronym for this study: COMMIT - CLEAN SWITCH
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
- •Patients with type 2 diabetes
- •Patients treated with human soluble insulin, NPH insulin or premixed human insulin
- •Patients willing to sign informed consent
- •Selection of study participants at the discretion of the physician
排除标准
- •Subjects currently being treated with insulin aspart, insulin detemir or biphasic insulin aspart 30
- •Subjects who were previously enrolled in this study
- •Subjects with a hypersensitivity to insulin aspart, insulin detemir or biphasic insulin aspart 30 or to any of the excipients
研究组 & 干预措施
A
干预措施: insulin aspart (Drug)
B
干预措施: biphasic insulin aspart 30 (Drug)
C
干预措施: insulin detemir (Drug)
结局指标
主要结局
Metabolic control measured as HbA1c
时间窗: for the duration of the study
次要结局
- Percentage of subjects achieving HbA1c below 7.0% and below or equal 6.5%(after 12 weeks and 24 weeks)
- Change in FPG (glucose variability)(after 12 weeks and 24 weeks)
- Change in PPG (postprandial control)(after 12 weeks and 24 weeks)
- Change in insulin dose and number of injections(after 12 weeks and 24 weeks)
- Change in oral antidiabetic drug therapy(after 12 weeks and 24 weeks)
- Change in body weight(after 12 weeks and 24 weeks)
- Change in number of hypoglycaemic events during 4 weeks proceeding routine visits(after 12 weeks and 24 weeks)
- Number of adverse drug reactions (ADR)(after 12 weeks and 24 weeks)
研究者
研究点 (1)
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