NCT01492153已完成不适用
A Post Marketing Surveillance on the Use of NovoLet® Human Insulin System in Indonesia
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
- 1,981
- 试验地点
- 1
- 主要终点
- Change in body weight
研究概览
简要总结
This study is conducted in Asia. The aim of this study is to investigate the safety and efficacy of NovoLet® human insulin delivery system in an outpatient setting.
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 1 diabetes mellitus
- •Type 2 diabetes mellitus
- •Other types of diabetes mellitus (gestational, drug induced [thiazide] or metabolic syndrome-related)
排除标准
- 未提供
研究组 & 干预措施
NovoLet® device
干预措施: human soluble insulin (Drug)
NovoLet® device
干预措施: biphasic human insulin (Drug)
NovoLet® device
干预措施: isophane human insulin (Drug)
结局指标
主要结局
Change in body weight
次要结局
- Fasting blood glucose (FBG)
- 2 hours postprandial blood glucose (2-hr PPBG)
- HbA1c (glycosylated haemoglobin)
- Adverse events (AEs) including hypoglycaemic episodes
研究者
研究点 (1)
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