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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03092752
• Other study ID #: 1218.178
• Status: Completed
• Start date: March 1, 2017
• Est. completion date: March 1, 2017

Study information

• Verified date: April 2019
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162116
• Est. completion date: March 1, 2017
• Est. primary completion date: March 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion criteria:

• Patients with T2DM (ICD code: E11 or E14).

• Patients must have their first prescription (defined as index date*) for any study drugs between 01/01/2014 and 30/09/2016.

• Patients must have at least 6 months enrolment verified by the presence of any record except for the study drug prescriptions within the database (look back period) prior to the index date for each drug.

Exclusion criteria:

• Patients who were under 40 years at the time of diagnosis of diabetes.

• Patients with record of type 1 diabetes mellitus.

• Patients who prescribed the study drugs during 6 month prior to index date for each drug.

• Patients whose mean visit interval are more than 92 days

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• oral antidiabetic drugs
OADs usage conditions and dose selection in T2DM patients

Locations

Country	Name	City	State
Japan	Medical Data Vision Co. Ltd	Shinagawa-ku

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Index Dates	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.	From 1st January 2014 to 30th September 2016 (At index date)
Primary	Age (Years)	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.	From 1st January 2014 to 30th September 2016 (At index date)
Primary	Sex (Male/Female)	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.	From 1st January 2014 to 30th September 2016 (At index date)
Primary	Estimated Glomerular Filtration Rate (eGFR)	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.	Within 6 months from index date
Primary	Prescription Rate of Each Class in Each eGFR Renal Impairment (RI) Level	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.	Within 6 months from index date
Primary	Percentage of Concomitant Medications by OAD Classes	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.	On the index month
Primary	Percentage of Previous Medications (Premedications) by OAD Classes.	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	On the index month
Primary	Percentage of Comorbidities by OAD Classes.	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.	On the index month
Secondary	Number of Prescriptions of OAD by Each Renal Impairment (RI) Stages	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.	Within 6 months from index date

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