Clinical Characteristics and Practice Patterns of Type 2 Diabetes Mellitus Patients Treated With OADs in Japan: Analysis of Medical and Health Care Database of the MDV

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: oral antidiabetic drugs

• Registration Number: NCT03092752
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-20
• Study Start: 2017-03-01
• Primary Completion: 2017-03-01
• Study Completion: 2017-03-01
• Study First Submitted QC: 2017-03-24
• Study First Posted: 2017-03-28
• Results First Submitted: 2018-02-27
• Status Verified: 2019-04
• Results First Submitted QC: 2019-04-12
• Last Update Submitted: 2019-04-12
• Results First Posted: 2019-07-05
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162116

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with T2DM	oral antidiabetic drugs	-

Primary Outcome Measures

Name	Time	Method
Number of Index Dates	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)	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)	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)	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	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	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.	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.	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.

Secondary Outcome Measures

Name	Time	Method
Number of Prescriptions of OAD by Each Renal Impairment (RI) Stages	Within 6 months from index date	This outcome observes number of index dates for each class of OAD as per RI classes. RI classes were defined based on eGFR values. Results observed were based on index dates used for comparing drugs between the classes.

Trial Locations

Locations (1)

Medical Data Vision Co. Ltd; 🇯🇵 Shinagawa-ku, Japan