NCT01355718已完成不适用
A 26-week, Multicentre, Open-labelled, Non-randomised, Non-interventional, Observational, Safety Study of NovoNorm® (Repaglinide) and Insulin Analogue Combination Therapy in Type 2 Diabetes in Korea
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
- 120
- 主要终点
- Incidence of serious Adverse Drug Reactions (SADRs) including major (serious) hypoglycaemic episodes
研究概览
简要总结
This trial is conducted in Asia. The primary objective of this study is to evaluate the clinical safety profile during 26 weeks of NovoNorm® (repaglinide) and insulin analogue combination therapy in type 2 diabetes under normal clinical practice conditions in Korea while the secondary objective is to evaluate the safety and efficacy after 13 and 26 weeks of NovoNorm® and insulin analogue combination therapy in type 2 diabetes under normal clinical practice conditions in Korea.
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
- •Informed consent obtained before any study-related activities. (Study-related activities are any procedure related to recording of data according to the protocol.)
- •Patients with type 2 diabetes mellitus
- •Patients who are currently treated with NovoNorm® alone or in combination with metformin or TZD
- •Age: at least 18 years old
- •Patients who will be prescribed with insulin analogue in addition to current NovoNorm® (with/without metformin/TZD) treatment at the discretion by the Physician
排除标准
- •Known or suspected allergy to study product(s) or related products
- •Previous participation in this study. Participation is defined as screened
- •Patients who have been treated with insulin preparations (including insulin analogues) previously
- •Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice)
- •Patients who are unlikely to comply with protocol requirements, e.g. uncooperative attitude, inability to return for the final visit
- •Any other disease or condition that the Physician feels would interfere with study participation or evaluation of results
研究组 & 干预措施
Repaglinide
干预措施: repaglinide (Drug)
结局指标
主要结局
Incidence of serious Adverse Drug Reactions (SADRs) including major (serious) hypoglycaemic episodes
时间窗: weeks 0-26
次要结局
- Incidence of Adverse Drug Reactions (ADRs)(week 13 and 26)
- Incidence of Adverse Events (AEs)(week 13 and 26)
- Incidence of Serious Adverse Event (SAEs)(week 13 and 26)
- Change in HbA1c(after 13 and 26 weeks of NovoNorm® and insulin analogue combination therapy)
研究者
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