NCT00789711已完成不适用
A Multicentre, Open-label, Nonrandomised, Non-interventional, Observational Study to Compare Safety and Effectiveness of Biphasic Insulin Aspart 30 (NovoMix 30) and Insulin Detemir (Levemir) for the 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
- 3,131
- 试验地点
- 1
- 主要终点
- Number of all (Major/Minor/Nocturnal) hypoglycaemic events, reported as serious adverse drug reactions.
研究概览
简要总结
This study is conducted in Asia. The aim of this observational study is to compare the clinical safety profile and effectiveness of NovoMix® 30 and Levemir™ for the treatment of diabetes in the Philippines.
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
- •Patients diagnosed with type 1 or type 2 diabetes mellitus
- •Patients uncontrolled on oral antidiabetic drugs
- •Insulin naïve patients or patients currently on human insulin
排除标准
- •Subjects who are unlikely to comply with protocol requirements
- •Subjects who are previously enrolled in NovoMix® 30 and Levemir™ study
- •Subjects on NovoMix® 30 and Levemir™ therapy
- •Subjects with hypersensitivity to NovoMix® 30 or to any of the excipients
- •Subjects with hypersensitivity to Levemir™ or to any of the excipients
- •Females of child bearing potential who are pregnant, breast feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures are required by local law or practice
- •Contraindications and warnings specified in the current prescribing information
研究组 & 干预措施
A
干预措施: biphasic insulin aspart 30 (Drug)
B
干预措施: insulin detemir (Drug)
结局指标
主要结局
Number of all (Major/Minor/Nocturnal) hypoglycaemic events, reported as serious adverse drug reactions.
时间窗: during 12 months of treatment
次要结局
- HbA1c(at the end of the study)
- FBG (Fasting Blood Glucose)(at the end of the study)
- Number of minor (including nocturnal) hypoglycaemic events(during 12 months of treatment)
- Average (mean) fasting plasma glucose level(at the end of the study)
- Number of major (including nocturnal) hypoglycaemic events(during 12 months of treatment)
研究者
研究点 (1)
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