NCT00865397已完成不适用
Observational Study of Glycaemic Control in Type 2 Diabetic Patients Uncontrolled on Oral Antidiabetic Agents and Starting With Once Daily Levemir® (Insulin Detemir) - 24 Weeks, Prospective, Multicentre Observational Study in Hungary
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
- 1,032
- 试验地点
- 1
- 主要终点
- Change in HbA1c
研究概览
简要总结
This study is conducted in Europe. The aim of this observational study is to evaluate glycaemic control in subjects with type 2 diabetes using once daily Levemir® as initiation of insulin therapy in Hungary.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Patient with type 2 diabetes inadequately controlled by OAD therapy based on the discretion of individual physician
- •Patient willing to sign informed consent
- •Particular attention should be paid to age limits, indications and contraindications and the drug interactions that are listed within the product labels
排除标准
- •Subjects with diagnosed type 1 diabetes mellitus
- •Subjects who are unlikely to comply with observational plan, (e.g., uncooperative attitude, inability to return for further visits)
- •Subjects with hypersensitivity to Levemir® or to any of the ingredients
- •Women of childbearing potential, who are pregnant, breast-feeding or intend to become pregnant within next 12 months.
研究组 & 干预措施
A
干预措施: insulin detemir (Drug)
结局指标
主要结局
Change in HbA1c
时间窗: after 24 weeks
次要结局
- Change in body weight(after 12 weeks and 24 weeks)
- Change in waist and hip circumference(after 12 weeks and 24 weeks)
- Percentage of subjects to reach HbA1c below 7.0% and equal to or more than 6.5%(after 12 weeks and 24 weeks)
- Change in FPG (Fasting Plasma Glucose)(after 12 weeks and 24 weeks)
研究者
研究点 (1)
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