Clinical trial NCT03092752: 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
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2017-03-28
Enrollment: 162116
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Japan

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


Eligibility criteria: 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

Primary outcomes:
measure: Number of Index Dates
timeFrame: From 1st January 2014 to 30th September 2016 (At index date)
measure: Age (Years)
timeFrame: From 1st January 2014 to 30th September 2016 (At index date)
measure: Sex (Male/Female)
timeFrame: From 1st January 2014 to 30th September 2016 (At index date)
measure: Estimated Glomerular Filtration Rate (eGFR)
timeFrame: Within 6 months from index date
measure: Prescription Rate of Each Class in Each eGFR Renal Impairment (RI) Level
timeFrame: Within 6 months from index date
measure: Percentage of Concomitant Medications by OAD Classes
timeFrame: On the index month
measure: Percentage of Previous Medications (Premedications) by OAD Classes.
timeFrame: On the index month
measure: Percentage of Comorbidities by OAD Classes.
timeFrame: On the index month
Secondary outcomes:
measure: Number of Prescriptions of OAD by Each Renal Impairment (RI) Stages
timeFrame: Within 6 months from index date
Other outcomes:
Locations:
city: Shinagawa-ku
country: Japan
facility: Medical Data Vision Co. Ltd
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: