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NCT Number: 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

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

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical Data Vision Co. Ltd

Shinagawa-ku, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

oral antidiabetic drugs

Drug

OADs usage conditions and dose selection in T2DM patients

Primary outcomes

  1. Number of Index Dates

    Time frame: 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.

  2. Age (Years)

    Time frame: 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.

  3. Sex (Male/Female)

    Time frame: 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.

  4. Estimated Glomerular Filtration Rate (eGFR)

    Time frame: 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.

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

    Time frame: 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.

  6. Percentage of Concomitant Medications by OAD Classes

    Time frame: 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.

  7. Percentage of Previous Medications (Premedications) by OAD Classes.

    Time frame: 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

  8. Percentage of Comorbidities by OAD Classes.

    Time frame: 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 outcomes

  1. Number of Prescriptions of OAD by Each Renal Impairment (RI) Stages

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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)

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 28, 2017
Registry last updated
Jul 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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