NCT00825643已完成不适用
A Multicentre, Open Label, Observational 24-week Study to Evaluate Safety of Initiating Insulin Therapy With Levemir® (Insulin Detemir) Once-daily in Oral Antidiabetic Drug-treated Patients With Type 2 Diabetes
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
- 18,481
- 试验地点
- 1
- 主要终点
- Incidence of serious adverse drug reactions (SADRs) including major hypoglycaemia
研究概览
简要总结
This study is conducted in Europe, North America and Asia. The aim of this observational study is to evaluate the safety and effectiveness while using Levemir® once daily in combination with oral antidiabetic drugs in type 2 diabetics during 24 weeks under normal clinical practice.
Data from the NN304-3573 study (NCT00740519) will be pooled with data from this study and reported together in the final study report for this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •After the participating physician's decision has been made to initiate once-daily Levemir® therapy, any patient with Type 2 diabetes who is currently treated with diet, exercise and one or more OADs can be offered to participate
排除标准
- •Current treatment with insulin
- •Known or suspected allergy to Levemir® or excipients
- •Children below the age of 6 years
- •Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant within the next 6 months or are not using adequate contraceptive methods (contraceptive measures as required by local law or practice)
研究组 & 干预措施
Insulin detemir
干预措施: insulin detemir (Drug)
结局指标
主要结局
Incidence of serious adverse drug reactions (SADRs) including major hypoglycaemia
时间窗: during 24 weeks of treatment
次要结局
- HbA1c and its change from trial start(at the 12 and 24 week visits)
- Incidence of all adverse drug reactions (ADRs)(during 24 weeks of treatment)
- Incidence of major and minor hypoglycaemic events(in the 4 weeks preceding trial start, and at the 12 and 24 week visits)
- Body weight and its change from trial start(at the 12 and 24 week visits)
- FBG variability (measured as standard deviation of FBG) and its change from trial start(at the 12 and 24 weeks visits)
- Fasting blood glucose (FBG) (average of the self-monitored blood glucose measurements) and its change from trial start(at the 12 and 24 week visits)
研究者
研究点 (1)
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