Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of Januvia in Usual Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,483
- 主要终点
- Percentage of participants with any adverse experience
研究概览
简要总结
The objectives of this survey are: 1) To examine the safety/efficacy profile of Januvia in Korean participants, and 2) To identify factors that might have an influence on the safety and efficacy profile of Januvia in Korean participants.
Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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 Mellitus
- •Treated With Januvia within local label for the first time
排除标准
- •Contraindication to Januvia according to the local label
- •Treated with Januvia before contract and out of enrollment period
- •Inclusion criteria for long-term surveillance
- •Treated with Januvia for more than or equal to 24 weeks
研究组 & 干预措施
All participants
Participants administered Januvia up to 100 mg once daily as monotherapy or combination therapy with a sulfonylurea or with insulin during the re-examination period (up to 6 years)
干预措施: Sitagliptin (Drug)
All participants
Participants administered Januvia up to 100 mg once daily as monotherapy or combination therapy with a sulfonylurea or with insulin during the re-examination period (up to 6 years)
干预措施: Sulfonylurea (Drug)
All participants
Participants administered Januvia up to 100 mg once daily as monotherapy or combination therapy with a sulfonylurea or with insulin during the re-examination period (up to 6 years)
干预措施: Insulin (Biological)
结局指标
主要结局
Percentage of participants with any adverse experience
时间窗: up to 14 days following cessation of treatment
Mean change in Hemoglobin A1c (HbA1c)
时间窗: 12 weeks ± 2 weeks and 24 weeks ± 2 weeks after first treatment
Mean change in fasting plasma glucose (FPG)
时间窗: 12 weeks ± 2 weeks and 24 weeks ± 2 weeks after first treatment
Mean change in 2hr-postprandial glucose (PPG)
时间窗: 12 weeks ± 2 weeks and 24 weeks ± 2 weeks after first treatment
次要结局
未报告次要终点