N/A
N=523,585
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
Bottom Line
View on ClinicalTrials.gov: NCT03092752 ↗Enrolled (actual)
523,585
Serious AEs
—
Results posted
Jul 2019
Primary outcome: Primary: Number of Index Dates — 91634; 33238; 28211; 26192 Number of Prescriptions
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- oral antidiabetic drugs (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Index Dates |
91634; 33238; 28211; 26192; 16787; 10344 | — |
| PRIMARY Age (Years) |
71.6; 66.5; 72; 71.4; 71.4; 69.7 | — |
| PRIMARY Sex (Male/Female) |
36018; 12681; 10940; 9951; 6549; 3854 | — |
| PRIMARY Estimated Glomerular Filtration Rate (eGFR) |
63; 74; 67.4; 60.1; 59.5; 69.7 | — |
| PRIMARY Prescription Rate of Each Class in Each eGFR Renal Impairment (RI) Level |
1592; 838; 530; 429; 252; 227 | — |
| PRIMARY Percentage of Concomitant Medications by OAD Classes |
3; 40; 32; 37; 56; 34 | — |
| PRIMARY Percentage of Previous Medications (Premedications) by OAD Classes. |
0; 3; 2; 1; 3; 8 | — |
| PRIMARY Percentage of Comorbidities by OAD Classes. |
69; 66; 66; 70; 73; 68 | — |
| SECONDARY Number of Prescriptions of OAD by Each Renal Impairment (RI) Stages |
1592; 4877; 3566; 1411; 11446; 838 | — |
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
Data sourced from ClinicalTrials.gov (NCT03092752). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.