Clinical Characteristics and Disease Burden of Diabetic Patients Based on Tianjin Regional Database

An observational study of Diabetes, run by Boehringer Ingelheim at 1 site in China.

Completed

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

Trial summary

The study aims to investigate the clinical characteristics, treatment, and economic burden of disease of Chinese diabetic/non-diabetic patients with/without established cardiovascular disease (CVD), chronic kidney disease (CKD), or at high cardiovascular risk, including: Primary objectives: describe the proportion of… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes
How many people: 1,233,162 participants
Where: 1 siteChina
Study dates: 6 Sep 2021to 24 Jun 2022
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Diabetic/non-diabetic patients with/without established cardiovascular disease, chronic kidney disease, or at high cardiovascular risk.

Who may be able to join

Patients in the Tianjin regional database from 01/01/2015 to 31/12/2019
Group A: patients with diagnosis of diabetes, and with diagnosis of cardiovascular disease, heart failure, chronic kidney disease or at high cardiovascular risk
Group B: patients with diagnosis of diabetes, but not with diagnosis of cardiovascular disease, heart failure, chronic kidney disease or at high cardiovascular risk
Group C: patients with diagnosis of cardiovascular disease, heart failure, chronic kidney disease or at high cardiovascular risk, but not with diagnosis of diabetes
Group D: patients without diagnosis of cardiovascular disease, heart failure, chronic kidney disease or at high cardiovascular risk, and without diagnosis of diabetes. We will randomly select a group of non-diabetic patients without any of the above diseases by matching on age and gender
Definition of diabetes, cardiovascular disease, chronic kidney disease and high cardiovascular risk:

Show all 11Show fewer

Diabetes: patients with at least 1 discharged diagnosis or 2 outpatient diagnosis of diabetes (the first diagnosis will be the index diagnosis, and the time interval between diagnoses is not restricted) (International classification of disease (ICD)-10 E10-E14);
Cardiovascular disease: patients with at least 1 discharged diagnosis or 2 outpatient diagnosis of ischemic heart diseases (the first diagnosis will be the index diagnosis, and the time interval between diagnoses is not restricted) (ICD-10 I20~I25); or patients with at least 1 discharged diagnosis or 2 outpatient diagnosis of cerebrovascular diseases (the first diagnosis will be the index diagnosis, and the time interval between diagnoses is not restricted) (ICD-10 I60~I69); or patients with at least 1 discharged diagnosis or 2 outpatient diagnosis of ischemic peripheral artery disease (the first diagnosis will be the index diagnosis, and the time interval between diagnoses is not restricted) (ICD-10 E10.501, E11.603, E14.501, E14.606, E14.503, I73.9, I99.03, I99.04);
Heart failure: patients with at least 1 discharged diagnosis or 2 outpatient diagnosis of heart failure (the first diagnosis will be the index diagnosis, and the time interval between diagnoses is not restricted) (ICD-10 I50);
Chronic kidney disease (CKD): inpatients with at least once 1 discharged diagnosis CKD (ICD-10 N18), or inpatients with the last estimated glomerular filtration rate (eGFR, calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation) <60 mL/min/1.73 m2 or prescription of dialysis, but not with the diagnosis of acute kidney injury (ICD-10 N17); or outpatients with at least 2 diagnosis of CKD (the first diagnosis will be the index diagnosis, and the time interval between diagnoses is not restricted) or with two consecutive eGFR (calculated by CKD-EPI equation) <60 mL/min/1.73 m2 by 90 days or more;
High cardiovascular risk: patients with at least 1 discharged diagnosis or 2 outpatient diagnosis of hypertension (the first diagnosis will be the index diagnosis, and the time interval between diagnoses is not restricted) (ICD-10 I10~I15); or at least 1 discharged diagnosis or 2 outpatient diagnosis of hyperlipidemia (ICD-10 E78.001-E78.003, E78.101, E78.203, E78.301-E78.304, E78.306, E78.401, E78.501, E78.902);

Who cannot join

Patients with non-Chinese nationalities
Duplicated storage (records with same inpatient code)

Trial locations and contacts

1 site in 1 country.

China1 site

Chengdu Big Data Association
Chengdu, 610041

Other trials in China

About this study

Official title: Characteristics, Treatment, and Economic Burden of Disease of Chinese Diabetic/Non-diabetic Patients With/Without Established Cardiovascular Disease, Chronic Kidney Disease, or at High Cardiovascular Risk

Primary objectives: describe the proportion of Chinese diabetic/non-diabetic patients with established cardiovascular disease, CKD, or at high cardiovascular risk including hypertension and hyperlipidemia
Secondary objectives: describe the demographic characteristics of the last visit for all patients, and the demographic characteristics of inpatients over time; investigate the clinical characteristic for all patients

Conditions: Diabetes
Medical subject headings: Diabetes Mellitus

What participants receive

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

Study groups in NCT04903496
Study group	Role	What they receive
In- and outpatients: diabetic with risk factors (RF) [Arm A]		In- and outpatients with diagnosis of diabetes, and with diagnosis of risk factors cardiovascular disease (CVD), heart failure (HF), chronic kidney disease (CKD) or at high cardiovascular (CV) risk identified in the Tianjin regional medical database.
In- and outpatients: diabetic without RF [Arm B]		In- and outpatients with diagnosis of diabetes, but not with diagnosis of risk factors CVD, HF, CKD or at high CV risk identified in the Tianjin regional medical database.
In- and outpatients: non-diabetic with RF [Arm C]		In- and outpatients without diabetes but with diagnosis of risk factors CVD, HF, CKD or at high CV risk identified in the Tianjin regional medical database.
In- and outpatients: non-diabetic without RF [Arm D]		In- and outpatients without diabetes and without diagnosis of risk factors CVD, HF, CKD or at high CV risk identified in the Tianjin regional medical database.

What is being measured

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

Number of Participants With Established Cardiovascular Disease, or Chronic Kidney Disease, or High Cardiovascular Risk
Number of participants with established cardiovascular disease (CVD), chronic kidney disease (CKD), and/or high cardiovascular (CV) risk was calculated as (100%* Number of patients with labels of interested diseases from 2015 to the given year)/ (Number of diabetic or non-diabetic patients from 2015 to the given year).
To compare diabetic with non-diabetic patients within a year and across years
- the arms with diabetic in- and outpatients [Arm A and B together] were combined
- the arms with non-diabetic in- and outpatients [Arm C and D together] were combined by year.
Patients with risk factors were patients with diagnosis of CVD, HF, CKD or at high CV risk. Each participant could potentially have multiple diagnoses simultaneously.
The data presented for this outcome is an retrospective analysis of electronic healthcare records of the Tianjin regional data base. Participants with diagnoses of interest were identified by International Classification of Disease (ICD) code.
Measured: up to 5 years (2015 up to 2019)

Secondary outcomes (24)

Mean Age of Inpatients and All Participants (In-and Outpatients) at Their Last Visit in 2015
The mean age was calculated for inpatients grouped by their diagnoses category [Arm A, B, C, D - inpatients only] and for all participants [All in- and outpatients] at their last visit in 2015. The Arms A, B, C, D - inpatients only were mutually exclusive in 2015.
Patients with risk factors (RF) were patients with diagnosis of CVD, HF, CKD or at high CV risk. Each participant could potentially have multiple diagnoses simultaneously.
The data presented for this outcome is an retrospective analysis of electronic healthcare records of the Tianjin regional data base. Participants with diagnoses of interest were identified by International Classification of Disease (ICD) code.
Measured: Last visit in 2015, up to 1 day
Mean Age of Inpatients and All Participants (In-and Outpatients) at Their Last Visit in 2017
The mean age was calculated for inpatients grouped by their diagnoses category [Arm A, B, C, D - inpatients only] and for all participants [All in- and outpatients] at their last visit in 2017. The Arms A, B, C, D - inpatients only were mutually exclusive in 2017.
Patients with risk factors (RF) were patients with diagnosis of CVD, HF, CKD or at high CV risk. Each participant could potentially have multiple diagnoses simultaneously.
The data presented for this outcome is an retrospective analysis of electronic healthcare records of the Tianjin regional data base. Participants with diagnoses of interest were identified by International Classification of Disease (ICD) code.
Measured: Last visit in 2017, up to 1 day
Mean Age of Inpatients and All Participants (In-and Outpatients) at Their Last Visit in 2019
The mean age was calculated for inpatients grouped by their diagnoses category [Arm A, B, C, D - inpatients only] and for all participants [All in- and outpatients] at their last visit in 2019. The Arms A, B, C, D - inpatients only were mutually exclusive in 2019.
Patients with risk factors (RF) were patients with diagnosis of CVD, HF, CKD or at high CV risk. Each participant could potentially have multiple diagnoses simultaneously.
The data presented for this outcome is an retrospective analysis of electronic healthcare records of the Tianjin regional data base. Participants with diagnoses of interest were identified by International Classification of Disease (ICD) code.
Measured: Last visit in 2019, up to 1 day
Number of Female and Male Inpatients and All Participants (In-and Outpatients) at Their Last Visit in 2015
The number of female and male was calculated for inpatients grouped by their diagnoses category [Arm A, B, C, D - inpatients only] and for all participants [All in- and outpatients] at their last visit in 2015. The Arms A, B, C, D - inpatients only were mutually exclusive in 2015.
Patients with risk factors (RF) were patients with diagnosis of CVD, HF, CKD or at high CV risk. Each participant could potentially have multiple diagnoses simultaneously.
The data presented for this outcome is an retrospective analysis of electronic healthcare records of the Tianjin regional data base. Participants with diagnoses of interest were identified by International Classification of Disease (ICD) code.
Measured: Last visit in 2015, up to 1 day
Number of Female and Male Inpatients and All Participants (In-and Outpatients) at Their Last Visit in 2017
The number of female and male was calculated for inpatients grouped by their diagnoses category [Arm A, B, C, D - inpatients only] and for all participants [All in- and outpatients] at their last visit in 2017. The Arms A, B, C, D - inpatients only were mutually exclusive in 2017.
Patients with risk factors (RF) were patients with diagnosis of CVD, HF, CKD or at high CV risk. Each participant could potentially have multiple diagnoses simultaneously.
The data presented for this outcome is an retrospective analysis of electronic healthcare records of the Tianjin regional data base. Participants with diagnoses of interest were identified by International Classification of Disease (ICD) code.
Measured: Last visit in 2017, up to 1 day
Number of Female and Male Inpatients and All Participants (In-and Outpatients) at Their Last Visit in 2019
The number of female and male was calculated for inpatients grouped by their diagnoses category [Arm A, B, C, D - inpatients only] and for all participants [All in- and outpatients] at their last visit in 2019. The Arms A, B, C, D - inpatients only were mutually exclusive in 2019.
Patients with risk factors (RF) were patients with diagnosis of CVD, HF, CKD or at high CV risk. Each participant could potentially have multiple diagnoses simultaneously.
The data presented for this outcome is an retrospective analysis of electronic healthcare records of the Tianjin regional data base. Participants with diagnoses of interest were identified by International Classification of Disease (ICD) code.
Measured: Last visit in 2019, up to 1 day
Number of Inpatients and All Participants (In-and Outpatients) With Insurance Payment at Their Last Visit in 2015
The number of participants with insurance payment was calculated for inpatients grouped by their diagnoses category [Arm A, B, C, D - inpatients only] and for all participants [All in- and outpatients] at their last visit in 2015. The Arms A, B, C, D - inpatients only were mutually exclusive in 2015.
Patients with risk factors (RF) were patients with diagnosis of CVD, HF, CKD or at high CV risk. Each participant could potentially have multiple diagnoses simultaneously.
The data presented for this outcome is an retrospective analysis of electronic healthcare records of the Tianjin regional data base. Participants with diagnoses of interest were identified by International Classification of Disease (ICD) code.
Measured: Last visit in 2015, up to 1 day
Number of Inpatients and All Participants (In-and Outpatients) With Insurance Payment at Their Last Visit in 2017
The number of participants with insurance payment was calculated for inpatients grouped by their diagnoses category [Arm A, B, C, D - inpatients only] and for all participants [All in- and outpatients] at their last visit in 2017. The Arms A, B, C, D - inpatients only were mutually exclusive in 2017.
Patients with risk factors (RF) were patients with diagnosis of CVD, HF, CKD or at high CV risk. Each participant could potentially have multiple diagnoses simultaneously.
The data presented for this outcome is an retrospective analysis of electronic healthcare records of the Tianjin regional data base. Participants with diagnoses of interest were identified by International Classification of Disease (ICD) code.
Measured: Last visit in 2017, up to 1 day
Number of Inpatients and All Participants (In-and Outpatients) With Insurance Payment at Their Last Visit in 2019
The number of participants with insurance payment was calculated for inpatients grouped by their diagnoses category [Arm A, B, C, D - inpatients only] and for all participants [All in- and outpatients] at their last visit in 2019. The Arms A, B, C, D - inpatients only were mutually exclusive in 2019.
Patients with risk factors (RF) were patients with diagnosis of CVD, HF, CKD or at high CV risk. Each participant could potentially have multiple diagnoses simultaneously.
The data presented for this outcome is an retrospective analysis of electronic healthcare records of the Tianjin regional data base. Participants with diagnoses of interest were identified by International Classification of Disease (ICD) code.
Measured: Last visit in 2019, up to 1 day
Number of Inpatients and All Participants (In-and Outpatients) by Discharge Department at Their Last Visit in 2015
The number of participants in a particular discharge department was calculated for inpatients grouped by their diagnoses category [Arm A, B, C, D - inpatients only] and for all participants [All in- and outpatients] at their last visit in 2015. The Arms A, B, C, D - inpatients only were mutually exclusive in 2015.
Patients with risk factors (RF) were patients with diagnosis of CVD, HF, CKD or at high CV risk. Each participant could potentially have multiple diagnoses and records in multiple discharge departments simultaneously. Thus, one participant could potentially occur more than once per arm.
The data presented for this outcome is an retrospective analysis of electronic healthcare records of the Tianjin regional data base. Participants with diagnoses of interest were identified by International Classification of Disease (ICD) code.
Measured: Last visit in 2015, up to 1 day
Number of Inpatients and All Participants (In-and Outpatients) by Discharge Department at Their Last Visit in 2017
The number of participants in a particular discharge department was calculated for inpatients grouped by their diagnoses category [Arm A, B, C, D - inpatients only] and for all participants [All in- and outpatients] at their last visit in 2017. The Arms A, B, C, D - inpatients only were mutually exclusive in 2017.
Patients with risk factors (RF) were patients with diagnosis of CVD, HF, CKD or at high CV risk. Each participant could potentially have multiple diagnoses and records in multiple discharge departments simultaneously. Thus, one participant could potentially occur more than once per arm. Thus, one participant could potentially occur more than once per arm.
The data presented for this outcome is an retrospective analysis of electronic healthcare records of the Tianjin regional data base. Participants with diagnoses of interest were identified by International Classification of Disease (ICD) code.
Measured: Last visit in 2017, up to 1 day
Number of Inpatients and All Participants (In-and Outpatients) by Discharge Department at Their Last Visit in 2019
The number of participants in a particular discharge department was calculated for inpatients grouped by their diagnoses category [Arm A, B, C, D - inpatients only] and for all participants [All in- and outpatients] at their last visit in 2019. The Arms A, B, C, D - inpatients only were mutually exclusive in 2019.
Patients with risk factors (RF) were patients with diagnosis of CVD, HF, CKD or at high CV risk. Each participant could potentially have multiple diagnoses and records in multiple discharge departments simultaneously. Thus, one participant could potentially occur more than once per arm.
The data presented for this outcome is an retrospective analysis of electronic healthcare records of the Tianjin regional data base. Participants with diagnoses of interest were identified by International Classification of Disease (ICD) code.
Measured: Last visit in 2019, up to 1 day
Number of Deaths in Inpatients and All Participants (In-and Outpatients) at Their Last Visit in 2015
The number of participants who were diagnosed as dead in 2015 was calculated for inpatients grouped by their diagnoses category [Arm A, B, C, D - inpatients only] and for all participants [All in- and outpatients] at their last visit in 2015. The Arms A, B, C, D - inpatients only were mutually exclusive in 2015.
Patients with risk factors (RF) were patients with diagnosis of CVD, HF, CKD or at high CV risk. Each participant could potentially have multiple diagnoses simultaneously.
The data presented for this outcome is an retrospective analysis of electronic healthcare records of the Tianjin regional data base. Participants with diagnoses of interest were identified by International Classification of Disease (ICD) code.
Measured: On the last visit (1 day) in 2015 data was retrospectively assessed for the last 12 months in 2015.
Number of Deaths in Inpatients and All Participants (In-and Outpatients) at Their Last Visit in 2017
The number of participants who were diagnosed as dead in 2017 was calculated for inpatients grouped by their diagnoses category [Arm A, B, C, D - inpatients only] and for all participants [All in- and outpatients] at their last visit in 2017. The Arms A, B, C, D - inpatients only were mutually exclusive in 2017.
Patients with risk factors (RF) were patients with diagnosis of CVD, HF, CKD or at high CV risk. Each participant could potentially have multiple diagnoses simultaneously.
The data presented for this outcome is an retrospective analysis of electronic healthcare records of the Tianjin regional data base. Participants with diagnoses of interest were identified by International Classification of Disease (ICD) code.
Measured: On the last visit (1 day) in 2017 data was retrospectively assessed for the last 12 months in 2017.
Number of Deaths in Inpatients and All Participants (In-and Outpatients) at Their Last Visit in 2019
The number of participants who were diagnosed as dead in 2019 was calculated for inpatients grouped by their diagnoses category [Arm A, B, C, D - inpatients only] and for all participants [All in- and outpatients] at their last visit in 2019. The Arms A, B, C, D - inpatients only were mutually exclusive in 2019.
Patients with risk factors (RF) were patients with diagnosis of CVD, HF, CKD or at high CV risk. Each participant could potentially have multiple diagnoses simultaneously.
The data presented for this outcome is an retrospective analysis of electronic healthcare records of the Tianjin regional data base. Participants with diagnoses of interest were identified by International Classification of Disease (ICD) code.
Measured: On the last visit (1 day) in 2019 data was retrospectively assessed for the last 12 months in 2019.
The Value of Glycated Hemoglobin (HbA1c) in Inpatients and in All Participants (in- and Outpatients) at Their Last Visit in 2015
The value of glycated hemoglobin (HbA1c) was calculated for inpatients grouped by their diagnoses category [Arm A, B, C, D - inpatients only] and for all participants [All in- and outpatients] at their last visit in 2015. The Arms A, B, C, D - inpatients only were mutually exclusive in 2015.
Patients with risk factors (RF) were patients with diagnosis of CVD, HF, CKD or at high CV risk. Each participant could potentially have multiple diagnoses simultaneously.
The data presented for this outcome is an retrospective analysis of electronic healthcare records of the Tianjin regional data base. Participants with diagnoses of interest were identified by International Classification of Disease (ICD) code.
Measured: Last visit in 2015, up to 1 day
The Value of Glycated Hemoglobin (HbA1c) in Inpatients and in All Participants (in- and Outpatients) at Their Last Visit in 2017
The value of glycated hemoglobin (HbA1c) was calculated for inpatients grouped by their diagnoses category [Arm A, B, C, D - inpatients only] and for all participants [All in- and outpatients] at their last visit in 2017. The Arms A, B, C, D - inpatients only were mutually exclusive in 2017.
Patients with risk factors (RF) were patients with diagnosis of CVD, HF, CKD or at high CV risk. Each participant could potentially have multiple diagnoses simultaneously.
The data presented for this outcome is an retrospective analysis of electronic healthcare records of the Tianjin regional data base. Participants with diagnoses of interest were identified by International Classification of Disease (ICD) code.
Measured: Last visit in 2017, up to 1 day
The Value of Glycated Hemoglobin (HbA1c) in Inpatients and in All Participants (in- and Outpatients) at Their Last Visit in 2019
The value of glycated hemoglobin (HbA1c) was calculated for inpatients grouped by their diagnoses category [Arm A, B, C, D - inpatients only] and for all participants [All in- and outpatients] at their last visit in 2019. The Arms A, B, C, D - inpatients only were mutually exclusive in 2019.
Patients with risk factors (RF) were patients with diagnosis of CVD, HF, CKD or at high CV risk. Each participant could potentially have multiple diagnoses simultaneously.
The data presented for this outcome is an retrospective analysis of electronic healthcare records of the Tianjin regional data base. Participants with diagnoses of interest were identified by International Classification of Disease (ICD) code.
Measured: Last visit in 2019, up to 1 day
Concentration of Random Blood Glucose in Inpatients and in All Participants (in- and Outpatients) at Their Last Visit in 2015
The concentration (Millimole per liter (mmol/L)) of random blood glucose was calculated for inpatients grouped by their diagnoses category [Arm A, B, C, D - inpatients only] and for all participants [All in- and outpatients] at their last visit in 2015. The Arms A, B, C, D - inpatients only were mutually exclusive in 2015.
Patients with risk factors (RF) were patients with diagnosis of CVD, HF, CKD or at high CV risk. Each participant could potentially have multiple diagnoses simultaneously.
The data presented for this outcome is an retrospective analysis of electronic healthcare records of the Tianjin regional data base. Participants with diagnoses of interest were identified by International Classification of Disease (ICD) code.
Measured: Last visit in 2015, up to 1 day
Concentration of Random Blood Glucose in Inpatients and in All Participants (in- and Outpatients) at Their Last Visit in 2017
The concentration (Millimole per liter (mmol/L)) of random blood glucose was calculated for inpatients grouped by their diagnoses category [Arm A, B, C, D - inpatients only] and for all participants [All in- and outpatients] at their last visit in 2017. The Arms A, B, C, D - inpatients only were mutually exclusive in 2017.
Patients with risk factors (RF) were patients with diagnosis of CVD, HF, CKD or at high CV risk. Each participant could potentially have multiple diagnoses simultaneously.
The data presented for this outcome is an retrospective analysis of electronic healthcare records of the Tianjin regional data base. Participants with diagnoses of interest were identified by International Classification of Disease (ICD) code.
Measured: Last visit in 2017, up to 1 day
Concentration of Random Blood Glucose in Inpatients and in All Participants (in- and Outpatients) at Their Last Visit in 2019
The concentration (Millimole per liter (mmol/L)) of random blood glucose was calculated for inpatients grouped by their diagnoses category [Arm A, B, C, D - inpatients only] and for all participants [All in- and outpatients] at their last visit in 2019. The Arms A, B, C, D - inpatients only were mutually exclusive in 2019.
Patients with risk factors (RF) were patients with diagnosis of CVD, HF, CKD or at high CV risk. Each participant could potentially have multiple diagnoses simultaneously.
The data presented for this outcome is an retrospective analysis of electronic healthcare records of the Tianjin regional data base. Participants with diagnoses of interest were identified by International Classification of Disease (ICD) code.
Measured: Last visit in 2019, up to 1 day
Serum Creatine Concentration in Inpatients and in All Participants (in- and Outpatients) at Their Last Visit in 2015
Serum creatine concentration (μmol/L) was calculated for inpatients grouped by their diagnoses category [Arm A, B, C, D - inpatients only] and for all participants [All in- and outpatients] at their last visit in 2015. The Arms A, B, C, D - inpatients only were mutually exclusive in 2015.
Patients with risk factors (RF) were patients with diagnosis of CVD, HF, CKD or at high CV risk. Each participant could potentially have multiple diagnoses simultaneously.
The data presented for this outcome is an retrospective analysis of electronic healthcare records of the Tianjin regional data base. Participants with diagnoses of interest were identified by International Classification of Disease (ICD) code.
Measured: Last visit in 2015, up to 1 day
Serum Creatine Concentration in Inpatients and in All Participants (in- and Outpatients) at Their Last Visit in 2017
Serum creatine concentration (μmol/L) was calculated for inpatients grouped by their diagnoses category [Arm A, B, C, D - inpatients only] and for all participants [All in- and outpatients] at their last visit in 2017. The Arms A, B, C, D - inpatients only were mutually exclusive in 2017.
Patients with risk factors (RF) were patients with diagnosis of CVD, HF, CKD or at high CV risk. Each participant could potentially have multiple diagnoses simultaneously.
The data presented for this outcome is an retrospective analysis of electronic healthcare records of the Tianjin regional data base. Participants with diagnoses of interest were identified by International Classification of Disease (ICD) code.
Measured: Last visit in 2017, up to 1 day
Serum Creatine Concentration in Inpatients and in All Participants (in- and Outpatients) at Their Last Visit in 2019
Serum creatine concentration (μmol/L) was calculated for inpatients grouped by their diagnoses category [Arm A, B, C, D - inpatients only] and for all participants [All in- and outpatients] at their last visit in 2019. The Arms A, B, C, D - inpatients only were mutually exclusive in 2019.
Patients with risk factors (RF) were patients with diagnosis of CVD, HF, CKD or at high CV risk. Each participant could potentially have multiple diagnoses simultaneously.
The data presented for this outcome is an retrospective analysis of electronic healthcare records of the Tianjin regional data base. Participants with diagnoses of interest were identified by International Classification of Disease (ICD) code.
Measured: Last visit in 2019, up to 1 day

Timeline

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

6 Sep 202124 Jun 2022

First posted26 May 2021
Study start6 Sep 2021
Primary completion24 Jun 2022
Study completion24 Jun 2022

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 DiabetesStudies 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: Other
Time perspective: Cross-sectional
Enrolment: 1,233,162 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04903496
Sponsor's protocol ID: 1245-0203
Status last verified: Sep 2024
First submitted: 25 May 2021
Last updated: 12 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

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 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Characteristics, Treatment, and Economic Burden of Disease of Chinese Diabetic/Non-diabetic Patients With/Without Established Cardiovascular Disease, Chronic Kidney Disease, or at High Cardiovascular Risk
ClinicalTrials.gov ID: NCT04903496
Acronym / sponsor ID: 1245-0203
Conditions: Diabetes
Study type: Observational
Recruitment status: Completed
Enrolment: 1,233,162 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Collaborators: Chengdu Big Data Association
Study start: 6 Sep 2021 (actual)
Primary completion: 24 Jun 2022 (actual)
Study completion: 24 Jun 2022 (actual)
First posted: 26 May 2021 (actual)
Results: Posted 12 Nov 2024

Clinical summary

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

Primary objectives: describe the proportion of Chinese diabetic/non-diabetic patients with established cardiovascular disease, CKD, or at high cardiovascular risk including hypertension and hyperlipidemia
Secondary objectives: describe the demographic characteristics of the last visit for all patients, and the demographic characteristics of inpatients over time; investigate the clinical characteristic for all patients

Study design

Observational model: Other
Time perspective: Cross-sectional
Number of arms: 4

Arm	Type	Receives
In- and outpatients: diabetic with risk factors (RF) [Arm A]	–	–In- and outpatients with diagnosis of diabetes, and with diagnosis of risk factors cardiovascular disease (CVD), heart failure (HF), chronic kidney disease (CKD) or at high cardiovascular (CV) risk identified in the Tianjin regional medical database.
In- and outpatients: diabetic without RF [Arm B]	–	–In- and outpatients with diagnosis of diabetes, but not with diagnosis of risk factors CVD, HF, CKD or at high CV risk identified in the Tianjin regional medical database.
In- and outpatients: non-diabetic with RF [Arm C]	–	–In- and outpatients without diabetes but with diagnosis of risk factors CVD, HF, CKD or at high CV risk identified in the Tianjin regional medical database.
In- and outpatients: non-diabetic without RF [Arm D]	–	–In- and outpatients without diabetes and without diagnosis of risk factors CVD, HF, CKD or at high CV risk identified in the Tianjin regional medical database.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Diabetic/non-diabetic patients with/without established cardiovascular disease, chronic kidney disease, or at high cardiovascular risk.

Key inclusion criteria (11 listed)

Patients in the Tianjin regional database from 01/01/2015 to 31/12/2019
Group A: patients with diagnosis of diabetes, and with diagnosis of cardiovascular disease, heart failure, chronic kidney disease or at high cardiovascular risk
Group B: patients with diagnosis of diabetes, but not with diagnosis of cardiovascular disease, heart failure, chronic kidney disease or at high cardiovascular risk
Group C: patients with diagnosis of cardiovascular disease, heart failure, chronic kidney disease or at high cardiovascular risk, but not with diagnosis of diabetes
Group D: patients without diagnosis of cardiovascular disease, heart failure, chronic kidney disease or at high cardiovascular risk, and without diagnosis of diabetes. We will randomly select a group of non-diabetic patients without any of the above diseases by matching on age and gender

Key exclusion criteria (2 listed)

Patients with non-Chinese nationalities
Duplicated storage (records with same inpatient code)

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

Primary outcome

Number of Participants With Established Cardiovascular Disease, or Chronic Kidney Disease, or High Cardiovascular Risk
Time frame: up to 5 years (2015 up to 2019)
Number of participants with established cardiovascular disease (CVD), chronic kidney disease (CKD), and/or high cardiovascular (CV) risk was calculated as (100%* Number of patients with labels of interested diseases from 2015 to the given year)/ (Number of diabetic or non-diabetic patients from 2015 to the given year). To compare diabetic with non-diabetic patients within a year and across years * the arms with diabetic in- and outpatients [Arm A and B together] were combined * the arms with non-diabetic in- and outpatients [Arm C and D together] were combined by year. Patients with risk factors were patients with diagnosis of CVD, HF, CKD or at high CV risk. Each participant could potentially have multiple diagnoses simultaneously. The data presented for this outcome is an retrospective analysis of electronic healthcare records of the Tianjin regional data base. Participants with diagnoses of interest were identified by International Classification of Disease (ICD) code.

24 secondary outcomes

Mean Age of Inpatients and All Participants (In-and Outpatients) at Their Last Visit in 2015
Time frame: Last visit in 2015, up to 1 day
Mean Age of Inpatients and All Participants (In-and Outpatients) at Their Last Visit in 2017
Time frame: Last visit in 2017, up to 1 day
Mean Age of Inpatients and All Participants (In-and Outpatients) at Their Last Visit in 2019
Time frame: Last visit in 2019, up to 1 day
Number of Female and Male Inpatients and All Participants (In-and Outpatients) at Their Last Visit in 2015
Time frame: Last visit in 2015, up to 1 day
Number of Female and Male Inpatients and All Participants (In-and Outpatients) at Their Last Visit in 2017
Time frame: Last visit in 2017, up to 1 day
Number of Female and Male Inpatients and All Participants (In-and Outpatients) at Their Last Visit in 2019
Time frame: Last visit in 2019, up to 1 day
Number of Inpatients and All Participants (In-and Outpatients) With Insurance Payment at Their Last Visit in 2015
Time frame: Last visit in 2015, up to 1 day
Number of Inpatients and All Participants (In-and Outpatients) With Insurance Payment at Their Last Visit in 2017
Time frame: Last visit in 2017, up to 1 day
Number of Inpatients and All Participants (In-and Outpatients) With Insurance Payment at Their Last Visit in 2019
Time frame: Last visit in 2019, up to 1 day
Number of Inpatients and All Participants (In-and Outpatients) by Discharge Department at Their Last Visit in 2015
Time frame: Last visit in 2015, up to 1 day
Number of Inpatients and All Participants (In-and Outpatients) by Discharge Department at Their Last Visit in 2017
Time frame: Last visit in 2017, up to 1 day
Number of Inpatients and All Participants (In-and Outpatients) by Discharge Department at Their Last Visit in 2019
Time frame: Last visit in 2019, up to 1 day
Number of Deaths in Inpatients and All Participants (In-and Outpatients) at Their Last Visit in 2015
Time frame: On the last visit (1 day) in 2015 data was retrospectively assessed for the last 12 months in 2015.
Number of Deaths in Inpatients and All Participants (In-and Outpatients) at Their Last Visit in 2017
Time frame: On the last visit (1 day) in 2017 data was retrospectively assessed for the last 12 months in 2017.
Number of Deaths in Inpatients and All Participants (In-and Outpatients) at Their Last Visit in 2019
Time frame: On the last visit (1 day) in 2019 data was retrospectively assessed for the last 12 months in 2019.
The Value of Glycated Hemoglobin (HbA1c) in Inpatients and in All Participants (in- and Outpatients) at Their Last Visit in 2015
Time frame: Last visit in 2015, up to 1 day
The Value of Glycated Hemoglobin (HbA1c) in Inpatients and in All Participants (in- and Outpatients) at Their Last Visit in 2017
Time frame: Last visit in 2017, up to 1 day
The Value of Glycated Hemoglobin (HbA1c) in Inpatients and in All Participants (in- and Outpatients) at Their Last Visit in 2019
Time frame: Last visit in 2019, up to 1 day
Concentration of Random Blood Glucose in Inpatients and in All Participants (in- and Outpatients) at Their Last Visit in 2015
Time frame: Last visit in 2015, up to 1 day
Concentration of Random Blood Glucose in Inpatients and in All Participants (in- and Outpatients) at Their Last Visit in 2017
Time frame: Last visit in 2017, up to 1 day
Concentration of Random Blood Glucose in Inpatients and in All Participants (in- and Outpatients) at Their Last Visit in 2019
Time frame: Last visit in 2019, up to 1 day
Serum Creatine Concentration in Inpatients and in All Participants (in- and Outpatients) at Their Last Visit in 2015
Time frame: Last visit in 2015, up to 1 day
Serum Creatine Concentration in Inpatients and in All Participants (in- and Outpatients) at Their Last Visit in 2017
Time frame: Last visit in 2017, up to 1 day
Serum Creatine Concentration in Inpatients and in All Participants (in- and Outpatients) at Their Last Visit in 2019
Time frame: Last visit in 2019, up to 1 day

Results and safety

Results posted to the registry on 12 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
In- and Outpatients: Diabetic With Risk Factors (RF) [Arm A]	166,056	166,056
In- and Outpatients: Diabetic Without RF [Arm B]	113,787	113,787
In- and Outpatients: Non-diabetic With RF [Arm C]	66,525	66,525
In- and Outpatients: Non-diabetic Without RF [Arm D]	51,640	51,640

Primary outcome: Number of Participants With Established Cardiovascular Disease, or Chronic Kidney Disease, or High Cardiovascular Risk

Time frame: up to 5 years (2015 up to 2019). Count of participants. Unit: Participants

Measure	Diabetic In-and Outpatients in 2015 [Arm A and B] n = 279843	Non-diabetic In-and Outpatients in 2015 [Arm C and D] n = 118165	Diabetic In-and Outpatients in 2017 [Arm A and B] n = 568507	Non-diabetic In-and Outpatients in 2017 [Arm C and D] n = 268323	Diabetic In-and Outpatients in 2019 [Arm A and B] n = 829985	Non-diabetic In-and Outpatients in 2019 [Arm C and D] n = 403177
With cardiovascular disease	127726	43819	295882	99128	448063	138069
With chronic kidney disease	16143	2465	47900	7059	89826	13012
High cardiovascular risk	113261	52628	293826	115692	473348	159502

Population analysed: In- and outpatients in 2015, 2017, and 2019 with and without diabetes and with and without diagnosis of risk factors CVD, HF, CKD, and high CV risk. For this outcome, groups were combined as per protocol to 'Diabetic Patients \[Arm A and B\]' and 'Non-Diabetic Patients \[Arm C and D\]'. Arms were not mutually exclusive. Only patients with available data were included in this analysis.

24 secondary outcomes are reported in the full results.

Adverse events

Time frame: On the last visit (1 day) in 2015, 2017, and 2019 data was retrospectively assessed for the last 12 months in 2015, 2017, and 2019.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Diabetic Inpatients With Risk Factors (RF) [Arm A Inpatients Only] - in 2015	0 of 0	0 of 0	303 of 84,600
Diabetic Inpatients Without RF [Arm B Inpatients Only] - in 2015	0 of 0	0 of 0	18 of 14,322
Non-diabetic Inpatients With RF [Arm C Inpatients Only] - 2015	0 of 0	0 of 0	94 of 21,682
Non-diabetic Inpatients Without RF [Arm D Inpatients Only] - in 2015	0 of 0	0 of 0	15 of 6,573
All in- and Outpatients in 2015 = Total in 2015	0 of 0	0 of 0	430 of 398,008
Diabetic Inpatients With Risk Factors (RF) [Arm A Inpatients Only] - in 2017	0 of 0	0 of 0	504 of 116,799
Diabetic Inpatients Without RF [Arm B Inpatients Only] - in 2017	0 of 0	0 of 0	29 of 22,121
Non-diabetic Inpatients With RF [Arm C Inpatients Only] - in 2017	0 of 0	0 of 0	141 of 26,955
Non-diabetic Inpatients Without RF [Arm D Inpatients Only] - in 2017	0 of 0	0 of 0	30 of 8,908
All in- and Outpatients in 2017 = Total in 2017	0 of 0	0 of 0	704 of 580,958
Diabetic Inpatients With Risk Factors (RF) [Arm A Inpatients Only] - in 2019	0 of 0	0 of 0	225 of 139,535
Diabetic Inpatients Without RF [Arm B Inpatients Only] - in 2019	0 of 0	0 of 0	8 of 21,549
Non-diabetic Inpatients With RF [Arm C Inpatients Only] - in 2019	0 of 0	0 of 0	41 of 28,868
Non-diabetic Inpatients Without RF [Arm D Inpatients Only] - in 2019	0 of 0	0 of 0	20 of 9,012
All in- and Outpatients in 2019 = Total in 2019	0 of 0	0 of 0	294 of 680,438

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

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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.

The record lists no contact. Use the official record to reach the sponsor.

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, run by Boehringer Ingelheim at 1 site in China.

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 11 inclusion and 2 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 12 Nov 2024. 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 China. 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 12 Nov 2024). 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 Participants With Established Cardiovascular Disease, or Chronic Kidney Disease, or High Cardiovascular Risk (time frame: up to 5 years (2015 up to 2019)). 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 NCT04903496.

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 12 Nov 2024.