NCT00755833已完成不适用
A Prospective, Multicentre, Open Label, Un-controlled , Observational, 12-month Study in Subjects Using: NovoMix® 50 (Biphasic Insulin Aspart 50) for Treatment of Type 2 Diabetes Mellitus in Slovenia
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
- 270
- 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 the blood glucose control when using NovoMix® 50 up to 12 months after initiation subjects with type 2 diabetes currently on a therapy with human biphasic insulin. An additional objective is also to observe the different regimes of starting and maintaining the treatment with NovoMix® 50 during one year.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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 treated with biphasic human insulin with or without metformin
- •Inadequate glycaemic control or is experiencing hypoglycaemic events or would, in the physician's opinion, benefit from treatment with NovoMix® 50
排除标准
- •Subjects with diagnosed type 1 diabetes mellitus
- •Subjects treated with short acting or intermediate acting human insulin or any insulin analogue
- •Subjects who are unlikely to comply with study description, e.g. uncooperative attitude, inability to come for regular visits
- •Subjects with a hypersensitivity to biphasic insulin aspart 50 (NovoMix® 50 )or to any of the excipients
- •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: biphasic insulin aspart 50 (Drug)
结局指标
主要结局
Change in HbA1c
时间窗: At 0, 3, 6, 9, 12 months
次要结局
- Change in PPG (postprandial glucose)(At 0, 3, 6, 9, 12 months)
- Change in number of hypoglycaemic events(At 0, 3, 6, 9, 12 months)
- Change in insulin presentation(At 0, 3, 6, 9, 12 months)
- Dose and number of injections(At 0, 3, 6, 9, 12 months)
- Percentage of subjects achieving target HbA1c(At 0, 3, 6, 9, 12 months)
- Change in FPG (fasting plasma glucose)(At 0, 3, 6, 9, 12 months)
- Number of ADRs (adverse drug reaction)(At 0, 3, 6, 9, 12 months)
研究者
研究点 (1)
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