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

An observational study of Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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… Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: oral antidiabetic drugs
Type of treatment: Pill or oral medicine
How many people: 162,116 participants
Where: 1 siteJapan
Study dates: 1 Mar 2017to 1 Mar 2017
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Japan

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Japan1 site

Medical Data Vision Co. Ltd
Shinagawa-ku

Other trials in Japan

About this study

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)

Conditions: Diabetes Mellitus, Type 2
Being tested: oral antidiabetic drugs
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

oral antidiabetic drugsDrug
OADs usage conditions and dose selection in T2DM patients

Study groups in NCT03092752
Study group	Role	What they receive
Patients with T2DM		Not described Receives: Drug: oral antidiabetic drugs

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: From 1st January 2014 to 30th September 2016 (At index date)
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.
Measured: From 1st January 2014 to 30th September 2016 (At index date)
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.
Measured: From 1st January 2014 to 30th September 2016 (At index date)
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.
Measured: Within 6 months from index date
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.
Measured: Within 6 months from index date
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.
Measured: On the index month
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
Measured: On the index month
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.
Measured: On the index month

Secondary outcomes (1)

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.
Measured: Within 6 months from index date

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 20171 Mar 2017

First posted28 Mar 2017
Study start1 Mar 2017
Primary completion1 Mar 2017
Study completion1 Mar 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 162,116 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03092752
Sponsor's protocol ID: 1218.178
Status last verified: Apr 2019
First submitted: 20 Feb 2017
Last updated: 5 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT03092752
Acronym / sponsor ID: 1218.178
Conditions: Diabetes Mellitus, Type 2
Study type: Observational
Recruitment status: Completed
Enrolment: 162,116 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 1 Mar 2017 (actual)
Primary completion: 1 Mar 2017 (actual)
Study completion: 1 Mar 2017 (actual)
First posted: 28 Mar 2017 (actual)
Results: Posted 5 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
Patients with T2DM	–	Drug: oral antidiabetic drugs

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Japan

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
oral antidiabetic drugsOADs usage conditions and dose selection in T2DM patients	Drug	Patients with T2DM

Primary outcome

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.
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.
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.
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.
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.
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.
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
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.

1 secondary outcome

Number of Prescriptions of OAD by Each Renal Impairment (RI) Stages
Time frame: Within 6 months from index date

Results and safety

Results posted to the registry on 5 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Oral Antibiotic Drugs	523,585	162,116

Primary outcome: Number of Index Dates

Time frame: From 1st January 2014 to 30th September 2016 (At index date). Number. Unit: Number of Prescriptions

Measure	Oral Antibiotic Drugs n = 162116
Dipeptidyl-peptidase 4 inhibitor (DPP4i)	91634
Biguanides (BG)	33238
Sulfonylurea (SU)	28211
α-glucosidase (AGI)	26192
Glinide	16787
Thiazolidinedione (TZD)	10344

Population analysed: All index dates computed from patients included in the study were considered for this analysis. Some patients were prescribed for more than one study drug and thus we can observe more number of index dates than number of patients.

Primary outcome: Age (Years)

Time frame: From 1st January 2014 to 30th September 2016 (At index date). Mean (Standard Deviation). Unit: Years

Measure	Dipeptidyl-peptidase 4 Inhibitor (DPP4i) n = 91634	Biguanides (BG) n = 33238	Sulfonylurea (SU) n = 28211	α-glucosidase (AGI) n = 26192	Glinide n = 16787	Thiazolidinedione (TZD) n = 10344	Total n = 206406
Value	71.6 (11)	66.5 (11)	72 (11.1)	71.4 (10.8)	71.4 (10.8)	69.7 (11.4)	70.7 (11.2)

Primary outcome: Sex (Male/Female)

Time frame: From 1st January 2014 to 30th September 2016 (At index date). Number. Unit: Participants

Measure	Dipeptidyl-peptidase 4 Inhibitor (DPP4i) n = 91634	Biguanides (BG) n = 33238	Sulfonylurea (SU) n = 28211	α-glucosidase (AGI) n = 26192	Glinide n = 16787	Thiazolidinedione (TZD) n = 10344	Total n = 206406
Female	36018	12681	10940	9951	6549	3854	79993
Male	55616	20557	17271	16241	10238	6490	126413

Primary outcome: Estimated Glomerular Filtration Rate (eGFR)

Time frame: Within 6 months from index date. Mean (Standard Deviation). Unit: millilitre/minute/1.73 meter^2

Measure	Dipeptidyl-peptidase 4 Inhibitor (DPP4i) n = 11446	Biguanides (BG) n = 3523	Sulfonylurea (SU) n = 3274	α-glucosidase (AGI) n = 3147	Glinide n = 1890	Thiazolidinedione (TZD) n = 1306	Total n = 25386
Value	63 (28.8)	74 (23.9)	67.4 (26.4)	60.1 (29.4)	59.5 (30.2)	69.7 (23.7)	65.2 (28.1)

Population analysed: All index dates computed from patients with eGFR data included in the study were considered for this analysis. Some patients were prescribed for more than one study drug and thus we can observe more number of index dates than number of patients.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Safety reporting is not applicable for this study. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events
Dipeptidyl-peptidase 4 Inhibitor (DPP4i)	0 of 0	0 of 0
Biguanides (BG)	0 of 0	0 of 0
Sulfonylurea (SU)	0 of 0	0 of 0
α-glucosidase (AGI)	0 of 0	0 of 0
Glinide	0 of 0	0 of 0
Thiazolidinedione (TZD)	0 of 0	0 of 0

Limitations and caveats (from the sponsor): The data available was hospital data and not general practitioners data. Only 13.5% patients had laboratory data including eGFR. Some patients who already had other disease compared to the T2DM population were likely to get included in the study

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Index Dates (time frame: From 1st January 2014 to 30th September 2016 (At index date)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03092752.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.