NCT00849316撤回不适用
A Multicenter, Open Label, Nonrandomized, Non Interventional, Observational, Safety and Efficacy Study of NovoRapid™(Insulin Aspart) in Patients With Coexisting Diabetes and Kidney Disease in India. The NovoRapid™ Nephropathy Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Incidence of major hypoglycaemic episodes
研究概览
简要总结
This study is conducted in Asia. The aim of this observational study is to investigate the clinical safety profile and effectiveness while using SC NovoRapid™ (insulin aspart) in patients with coexisting diabetes and kidney disease under normal clinical practice conditions in India.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Any subject with coexisting kidney disease and type 1 or type 2 diabetes is eligible for the study, including: newly-diagnosed subjects, insulin naïve and subjects who have received insulin or an insulin analogue before
- •Subjects with kidney disease (stage I-IV) including transplant patients will be eligible for the study, if initiated with NovoRapid™"
排除标准
- •Subjects who are unlikely to comply with protocol requirements, e.g., uncooperative attitude, inability to return for the final visit
- •Subjects with stage V of chronic kidney disease
- •Subjects who previously enrolled in this study
- •Known or suspected allergy to trial product(s) or related products
研究组 & 干预措施
A
干预措施: insulin aspart (Drug)
结局指标
主要结局
Incidence of major hypoglycaemic episodes
时间窗: during 26 weeks
次要结局
- Number of serious adverse events(during 26 weeks)
- Number of serious adverse drug reactions(during 26 weeks)
- Number of all daytime and nocturnal major hypoglycaemic events(during 26 weeks)
- Number of major hypoglycaemic events related to omission of a meal after injection(during 26 weeks)
- Number of all minor (daytime and nocturnal) hypoglycaemic events(during 4 weeks proceeding each study visits during Insulin Aspart (NovoRapidTM) therapy)
研究者
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