NCT00709683已完成不适用
An Observational Study Evaluating the Safety and Efficacy of the Treatment With Biphasic Insulin Aspart (NovoMix® 30 FlexPen®) in the Treatment of Type 2 Diabetics After Failing on Basal/ Intermediate Mono or Combination Therapy
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
- 216
- 主要终点
- Incidence of major hypoglycaemic events reported as serious adverse drug reactions
研究概览
简要总结
This study is conducted in Africa. The aim of this observational study is to evaluate the incidence of adverse events while using NovoMix® 30 FlexPen® under normal clinical practice conditions.
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 having failed on basal insulin with or without OAD
- •HbA1c greater than 7.0%
排除标准
- •Subjects being unlikely to comply with protocol requirements
- •Subjects who previously enrolled in this study
- •Subjects with hypersensitivity to biphasic insulin aspart or any of the excipients
- •Women who are pregnant, breast feeding and women in child bearing capacity who are not using reliable contraceptive method
研究组 & 干预措施
A
干预措施: biphasic insulin aspart 30 (Drug)
结局指标
主要结局
Incidence of major hypoglycaemic events reported as serious adverse drug reactions
时间窗: during 26 weeks of treatment
次要结局
- Number of serious adverse drug reactions(during 26 weeks of treatment)
- Number of serious adverse events(during 26 weeks of treatment)
- Number of all major (daytime and nocturnal) hypoglycaemic events(during 26 weeks of treatment)
- Weight (BMI) change from baseline(At the end of the study)
- HbA1c change from baseline(At the end of the study)
- Number of all minor (daytime and nocturnal) hypoglycaemic events(during 26 weeks of treatment)
- Average post-breakfast (90-120 mins), post-lunch (90-120 mins), post-dinner (90-120 mins) plasma glucose level(At the end of the study)
- Percentage of patients reaching the target of HbA1c of less than or equal to 7.0%(At the end of the study)
- Average (mean) fasting plasma glucose level(At the end of the study)
研究者
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