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临床试验/NCT03092752
NCT03092752已完成不适用

Clinical Characteristics and Practice Patterns of Type 2 Diabetes Mellitus (T2D) Patients Treated With Oral Antidiabetic Drugs (OAD) in Japan: Analysis of Medical and Health Care Database of the Medical Data Vision (MDV)

Boehringer Ingelheim1 个研究点 分布在 1 个国家目标入组 162,116 人开始时间: 2017年3月1日最近更新:
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
162,116
试验地点
1
主要终点
Number of Index Dates

研究概览

简要总结

Appropriate use of oral antidiabetic drugs (OADs) including dose-reduction is important for patient's safety in T2DM patients with renal impairment (RI). However, there are insufficient data on dose adjustment in accordance with the prescription pattern and the risk of RI of OADs, in particular Dipeptidyl-peptidase-4 inhibitors, in clinical practice in Japan. Therefore, we will investigate OADs usage conditions and dose selection in T2DM patients with RI in clinical practice in Japan

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Patients with T2DM

干预措施: oral antidiabetic drugs (Drug)

结局指标

主要结局

Number of Index Dates

时间窗: From 1st January 2014 to 30th September 2016 (At index date)

The date at which patients having their first prescription for any study drugs between 1st January 2014 and 30th September 2016 is defined as index date. Results observed were based on index dates used for comparing drugs between the classes. The reported data represent the number of time a prescription was written between 1st January 2014 and 30th September 2016.

Age (Years)

时间窗: From 1st January 2014 to 30th September 2016 (At index date)

Age of all patients in years calculated for index dates computed from patients in the database. Analysis was done based on index dates used for comparing drugs between the classes. The reported data represent the number of time a prescription was written between 1st January 2014 and 30th September 2016.

Sex (Male/Female)

时间窗: From 1st January 2014 to 30th September 2016 (At index date)

Gender of all patients observed for index dates computed from patients in the database. Results observed were based on index dates used for comparing drugs between the classes. The reported data represent the number of time a prescription was written between 1st January 2014 and 30th September 2016.

Estimated Glomerular Filtration Rate (eGFR)

时间窗: Within 6 months from index date

Estimated glomerular filtration rate (eGFR) was calculated based on the age at index date and the latest serum creatinine at index date (or during the observation period) using formula eGFR millilitre/minute/1.73 meter\^2 (mL/min/1.73 m\^2) = 194 × (Creatinine)\^-1.094 × (age in year)\^-0.287 (× 0.739 if female). Analysis was done based on index dates used for comparing drugs between the classes.

Prescription Rate of Each Class in Each eGFR Renal Impairment (RI) Level

时间窗: Within 6 months from index date

Renal impairment (RI) is a common complication in patients with type 2 diabetes mellitus (T2DM). Results observed were based on index dates used for comparing drugs between the classes.

Percentage of Concomitant Medications by OAD Classes

时间窗: On the index month

Concomitant medication is the drug prescribed other than drug under study in the OAD class on index date. Results observed were based on index dates used for comparing drugs between the classes.

Percentage of Previous Medications (Premedications) by OAD Classes.

时间窗: On the index month

Previous medication is the drug prescribed other than drug under study in the OAD class before index date. Results observed were based on index dates used for comparing drugs between the classes

Percentage of Comorbidities by OAD Classes.

时间窗: On the index month

The additional diseases co-occuring, defined by International classification of Diseases, tenth revision (ICD-10) code. Results observed were based on index dates used for comparing drugs between the classes.

次要结局

  • Number of Prescriptions of OAD by Each Renal Impairment (RI) Stages(Within 6 months from index date)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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