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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

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ClinicalTrials.gov Identifier: NCT03092752
Recruitment Status : Completed
First Posted : March 28, 2017
Results First Posted : July 5, 2019
Last Update Posted : July 5, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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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

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 Drug: oral antidiabetic drugs

Study Design
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Study Type : Observational
Actual Enrollment : 162116 participants
Observational Model: Cohort
Time Perspective: Retrospective
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)
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : March 1, 2017
Actual Study Completion Date : March 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines

Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients with T2DM Drug: oral antidiabetic drugs
OADs usage conditions and dose selection in T2DM patients


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Japan
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03092752


Locations
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Japan
Medical Data Vision Co. Ltd
Shinagawa-ku, Japan
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  Study Documents (Full-Text)

Documents provided by Boehringer Ingelheim:
Study Protocol and Statistical Analysis Plan  [PDF] February 9, 2017

More Information
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Additional Information:

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03092752    
Other Study ID Numbers: 1218.178
First Posted: March 28, 2017    Key Record Dates
Results First Posted: July 5, 2019
Last Update Posted: July 5, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs