Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of JANUMET in Usual Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,065
- 主要终点
- Percentage of Participants With Any Adverse Experience
研究概览
简要总结
This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of sitagliptin/metformin (JANUMET) through collecting the safety and efficacy information according to the Re-examination Regulation for New Drugs.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has type 2 diabetes mellitus
- •Is treated with sitagliptin/metformin within local label for the first time
排除标准
- •Has a contraindication to sitagliptin/metformin according to the local label
- •Is treated with sitagliptin/metformin before contract and out of enrollment period
研究组 & 干预措施
All participants
Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin
干预措施: Sitagliptin/metformin (Drug)
结局指标
主要结局
Percentage of Participants With Any Adverse Experience
时间窗: Up to 26 weeks
An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.
Change From Baseline to Treatment in Fasting Plasma Glucose (FPG) at Week 12
时间窗: Baseline and Week 12
Blood glucose was measured on a fasting basis (collected after an 8- to 10-hour fast). FPG is expressed as mg/dL. Therefore, this change from baseline reflects the Week 12 FPG minus Week 0 FPG.
Change From Baseline in 2-hour Post Prandial Glucose (2hr-PPG) at Week 12
时间窗: Baseline and Week 12
Blood glucose was measured 2 hours after a meal (2hr-PPG). 2hr-PPG is expressed as mg/dL. Therefore, this change from baseline reflects the Week 12 2hr-PPG minus Week 0 2hr-PPG.
Percentage of Participants With an Overall Efficacy Evaluation by the Investigator of Improved, Stable, or Worse at Week 12
时间窗: At Week 12
Overall efficacy analysis was conducted on participants who have used study drug for more than 12 weeks and whose improvement of the disease has been assessed by Principal investigator. The investigator's global assessment of disease improvement was classified as either: "Improved", "Stable" and "Worse" in a Medical History/Physical Examination form.
Change From Baseline to Treatment in HbA1c at Week 24
时间窗: Baseline and Week 24
HbA1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Therefore, this change from baseline reflects the Week 24 A1C minus Week 0 A1C.
Change From Baseline to Treatment in FPG at Week 24
时间窗: Baseline and Week 24
Blood glucose was measured on a fasting basis (collected after an 8- to 10-hour fast). FPG is expressed as mg/dL. Therefore, this change from baseline reflects the Week 24 FPG minus Week 0 FPG.
Change From Baseline in 2hr-PPG at Week 24
时间窗: Baseline and Week 24
Blood glucose was measured 2 hours after a meal (2hr-PPG). 2hr-PPG is expressed as mg/dL. Therefore, this change from baseline reflects the Week 24 2hr-PPG minus Week 0 2hr-PPG.
Percentage of Participants With an Overall Efficacy Evaluation by the Investigator of Improved, Stable, or Worse at Week 24
时间窗: At Week 24
Overall efficacy analysis was conducted on participants who have used study drug for more than 24 weeks and whose improvement of the disease has been assessed by Principal investigator. The investigator's global assessment of disease improvement was classified as either: "Improved", "Stable" and "Worse" in a Medical History/Physical Examination form.
Change From Baseline to Treatment in Hemoglobin HbA1c (A1C) at Week 12
时间窗: Baseline and Week 12
HbA1C is found when high blood levels of glucose combines with hemoglobin to form glycated hemoglobin. The average amount of glucose in blood over a prolonged periods of time can be determined by measuring a hemoglobin A1c level which is reported as a percentage (%). The change from baseline reflects the Week 12 A1C minus Week 0 A1C.
次要结局
未报告次要终点