Diabetes Mellitus, Type 2EDCOSNCT04098575

A Study Based on Data From German Registries That Looks at Characteristics of People Who Take the Medicine Empagliflozin for Type 2 Diabetes

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

Completed

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

Trial summary

Description of the real-life treatment of adult patients with type-2 diabetes mellitus (T2DM) receiving Empagliflozin, comparing the characteristics of patients starting Empagliflozin in three time intervals Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: Empagliflozin
How many people: 9,571 participants
Where: 1 siteGermany
Study dates: 16 Sep 2019to 31 Dec 2019
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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients with Diabetes Mellitus, Type 2, treated with Empagliflozin

Who may be able to join

At least two outpatient T2DM diagnoses (ICD E11.-) in two different quarters and/or at least one inpatient T2DM diagnosis (ICD E11)
At least one prescription of an empagliflozin-containing antidiabetic drug: Jardiance® (Empagliflozin, ATC A10BK03, former A10BX12) or Synjardy® (Empagliflozin/ Met¬for¬min, ATC A10BD20)

Who cannot join

Any diagnosis of T1DM

Trial locations and contacts

1 site in 1 country.

Germany1 site

Diabetes Agenda 2010 GmbH
Mahlow, 15831

Other trials in Germany

About this study

Official title: Treatment of T2DM Patients in Germany Receiving Empagliflozin: A Retrospective RWE Study Description of Treatment and Population Characteristics of Type 2 Diabetic Patients in Germany Receiving Empagliflozin: A Retrospective Real-World Evidence (RWE) Study Based on German Registries DPV&DIVE

Conditions: Diabetes Mellitus, Type 2
Being tested: Empagliflozin
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.

EmpagliflozinDrug
drug

Study groups in NCT04098575
Study group	Role	What they receive
Patients receiving Empagliflozin until mid Sep 2015		Patients receiving Empagliflozin before the EMPA-REG-OUTCOME study was published time until mid-Sept. 2015; Cohort 1 Receives: Drug: Empagliflozin
Patients receiving Empagliflozin until CV Label Change time		Patients receiving Empagliflozin starting from the EMPA-REG-OUTCOME study being published until CV Label Change time from mid-Sept. 2015-mid-Jan. 2017; Cohort 2 Receives: Drug: Empagliflozin
Patients receiving Empagliflozin until last available data cut		Patients receiving Empagliflozin starting from mid-Jan. 2017 until last; Cohort 3 Receives: Drug: Empagliflozin

What is being measured

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

Percentage of Participants With Previous Occurence of Cardiovascular Comorbidities
Percentage of patients with previous occurence of cardiovascular (CV) comorbidities, including myocardial infarction, stroke, coronary artery disease, peripheral arterial disease, congestive heart failure.
Measured: At baseline.
Percentage of Participants With Previous Occurence of Other Typical Diabetes Complications
Percentage of participants with previous occurence of other typical diabetes complications, including, Neuropathy, Nephropathy, Chronic Kidney Disease, Microalbuminuria, Macroalbuminuria, estimated glomerular filtration rate (eGFR), diabetic foot syndrome, retinopathy (background and proliferative).
Measured: At baseline.
Percentage of Participants With Antidiabetic and Cardiovascular Co-medication
Percentage of participants with antidiabetic and cardiovascular co-medication, including lipid-lowering agents, other antihypertensives, antiplatelets and anticoagulants.
Measured: At baseline.

Secondary outcomes (11)

Percentage of Participants by Age Category
Percentage of participants by age category; younger than 65 (< 65), from 65 to 74 (65 ≤ 75) , from 75 to 80 (75 - 80) , older than 80 (> 80).
Measured: At baseline.
Percentage of Male Participants
The percentage of male participants is reported.
Measured: At baseline.
Weight of Participants
Weight of participants.
Measured: At baseline.
Height of Participants
Height of participants.
Measured: At baseline.
Glycated Hemoglobin (HbA1c)
Glycated hemoglobin (HbA1c).
Measured: At baseline.
Duration of Diabetes
Duration of diabetes (time since diagnosis).
Measured: At baseline.
Percentage of Participants With Previous Glucose-lowering Treatment
Percentage of participants with glucose-lowering treatment prior to empagliflozin initiation.
Measured: At baseline.
Percentage of Patients Participated in Disease Management Programme (DMP) Type 2 Diabetes
Percentage of patients participated in Disease Management Programme (DMP) Type 2 Diabetes.
Measured: At baseline.
Number of Participants With Hospitalizations
Number of participants with hospitalizations.
Measured: At baseline.
Dosage of Empagliflozin
Dosage of empagliflozin. Number of patients on 10 milligram versus patients on 25 milligram empagliflozin.
Measured: At baseline.
Fasting Plasma Glucose (FPG)
Fasting plasma glucose (FPG).
Measured: At baseline.

Timeline

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

16 Sep 201931 Dec 2019

First posted23 Sep 2019
Study start16 Sep 2019
Primary completion31 Dec 2019
Study completion31 Dec 2019

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: 9,571 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04098575
Sponsor's protocol ID: 1245-0198
Acronym: EDCOS
Status last verified: Mar 2021
First submitted: 19 Sep 2019
Last updated: 29 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
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, except for the following exclusions: 1. Studies in products where Boehringer Ingelheim is not the license holder 2. Studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials 3. Studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). Requestors can use the following link http://trials.boehringer-ingelheim.com/

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?

See locations

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All Diabetes Mellitus, Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treatment of T2DM Patients in Germany Receiving Empagliflozin: A Retrospective RWE Study Description of Treatment and Population Characteristics of Type 2 Diabetic Patients in Germany Receiving Empagliflozin: A Retrospective Real-World Evidence (RWE) Study Based on German Registries DPV&DIVE
ClinicalTrials.gov ID: NCT04098575
Acronym / sponsor ID: EDCOS / 1245-0198
Conditions: Diabetes Mellitus, Type 2
Study type: Observational
Recruitment status: Completed
Enrolment: 9,571 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 16 Sep 2019 (actual)
Primary completion: 31 Dec 2019 (actual)
Study completion: 31 Dec 2019 (actual)
First posted: 23 Sep 2019 (actual)
Results: Posted 29 Mar 2021

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: 3

Arm	Type	Receives
Patients receiving Empagliflozin until mid Sep 2015	–	Drug: EmpagliflozinPatients receiving Empagliflozin before the EMPA-REG-OUTCOME study was published time until mid-Sept. 2015; Cohort 1
Patients receiving Empagliflozin until CV Label Change time	–	Drug: EmpagliflozinPatients receiving Empagliflozin starting from the EMPA-REG-OUTCOME study being published until CV Label Change time from mid-Sept. 2015-mid-Jan. 2017; Cohort 2
Patients receiving Empagliflozin until last available data cut	–	Drug: EmpagliflozinPatients receiving Empagliflozin starting from mid-Jan. 2017 until last; Cohort 3

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with Diabetes Mellitus, Type 2, treated with Empagliflozin

Key inclusion criteria (2 listed)

At least two outpatient T2DM diagnoses (ICD E11.-) in two different quarters and/or at least one inpatient T2DM diagnosis (ICD E11)
At least one prescription of an empagliflozin-containing antidiabetic drug: Jardiance® (Empagliflozin, ATC A10BK03, former A10BX12) or Synjardy® (Empagliflozin/ Met¬for¬min, ATC A10BD20)

Key exclusion criteria (1 listed)

Any diagnosis of T1DM

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
Empagliflozindrug	Drug	Patients receiving Empagliflozin until CV Label Change time, Patients receiving Empagliflozin until last available data cut, Patients receiving Empagliflozin until mid Sep 2015

Primary outcome

Percentage of Participants With Previous Occurence of Cardiovascular Comorbidities
Time frame: At baseline.
Percentage of patients with previous occurence of cardiovascular (CV) comorbidities, including myocardial infarction, stroke, coronary artery disease, peripheral arterial disease, congestive heart failure.
Percentage of Participants With Previous Occurence of Other Typical Diabetes Complications
Time frame: At baseline.
Percentage of participants with previous occurence of other typical diabetes complications, including, Neuropathy, Nephropathy, Chronic Kidney Disease, Microalbuminuria, Macroalbuminuria, estimated glomerular filtration rate (eGFR), diabetic foot syndrome, retinopathy (background and proliferative).
Percentage of Participants With Antidiabetic and Cardiovascular Co-medication
Time frame: At baseline.
Percentage of participants with antidiabetic and cardiovascular co-medication, including lipid-lowering agents, other antihypertensives, antiplatelets and anticoagulants.

11 secondary outcomes

Percentage of Participants by Age Category
Time frame: At baseline.
Percentage of Male Participants
Time frame: At baseline.
Weight of Participants
Time frame: At baseline.
Height of Participants
Time frame: At baseline.
Glycated Hemoglobin (HbA1c)
Time frame: At baseline.
Duration of Diabetes
Time frame: At baseline.
Percentage of Participants With Previous Glucose-lowering Treatment
Time frame: At baseline.
Percentage of Patients Participated in Disease Management Programme (DMP) Type 2 Diabetes
Time frame: At baseline.
Number of Participants With Hospitalizations
Time frame: At baseline.
Dosage of Empagliflozin
Time frame: At baseline.
Fasting Plasma Glucose (FPG)
Time frame: At baseline.

Results and safety

Results posted to the registry on 29 Mar 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Early Users: Patients Receiving Empagliflozin Until Mid-September 2015	505	505
Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017	2,961	2,961
Late Users: Patients Receiving Empagliflozin After Mid-January 2017	6,105	6,105

Primary outcome: Percentage of Participants With Previous Occurence of Cardiovascular Comorbidities

Time frame: At baseline.. Number. Unit: Percentage of participants

Measure	Early Users: Patients Receiving Empagliflozin Until Mid-September 2015 n = 505	Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017 n = 2961	Late Users: Patients Receiving Empagliflozin After Mid-January 2017 n = 6105
Value	20.4	21.6	26.4

Early Users: Patients Receiving Empagliflozin Until Mid-September 2015 vs Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017 vs Late Users: Patients Receiving Empagliflozin After Mid-January 2017: p <0.001, Chi-squared

Population analysed: All patients from the two largest German registries (Diabetes-Patienten-Verlaufs-Dokumentation and Diabetes Versorgungs-Evaluation) with Type-2 Diabetes Mellitus and with empagliflozin treatment were included in the analysis.

Primary outcome: Percentage of Participants With Previous Occurence of Other Typical Diabetes Complications

Time frame: At baseline.. Number. Unit: Percentage of participants

Measure	Early Users: Patients Receiving Empagliflozin Until Mid-September 2015 n = 505	Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017 n = 2961	Late Users: Patients Receiving Empagliflozin After Mid-January 2017 n = 6105
Value	59.6	57.6	59.8

Early Users: Patients Receiving Empagliflozin Until Mid-September 2015 vs Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017 vs Late Users: Patients Receiving Empagliflozin After Mid-January 2017: p = 0.835, Chi-squared

Primary outcome: Percentage of Participants With Antidiabetic and Cardiovascular Co-medication

Time frame: At baseline.. Number. Unit: Percentage of participants

Measure	Early Users: Patients Receiving Empagliflozin Until Mid-September 2015 n = 505	Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017 n = 2961	Late Users: Patients Receiving Empagliflozin After Mid-January 2017 n = 6105
Antihypertensive drugs	45.4	49.5	59.8
Lipid-lowering agents	28.3	36.4	46.0
Antplatelet, anticoagulant drugs	11.7	17.4	25.3
Glucose-lowering therapies	80.2	83.1	90.6

Early Users: Patients Receiving Empagliflozin Until Mid-September 2015 vs Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017 vs Late Users: Patients Receiving Empagliflozin After Mid-January 2017: p <0.001, Chi-squared
Early Users: Patients Receiving Empagliflozin Until Mid-September 2015 vs Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017 vs Late Users: Patients Receiving Empagliflozin After Mid-January 2017: p <0.001, Chi-squared
Early Users: Patients Receiving Empagliflozin Until Mid-September 2015 vs Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017 vs Late Users: Patients Receiving Empagliflozin After Mid-January 2017: p <0.001, Chi-squared

11 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events
Early Users: Patients Receiving Empagliflozin Until Mid-September 2015	0 of 0	0 of 0
Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017	0 of 0	0 of 0
Late Users: Patients Receiving Empagliflozin After Mid-January 2017	0 of 0	0 of 0

Limitations and caveats (from the sponsor): The main limitation of the study is that patients were recruited from specialized centers that were participating in diabetes registries, which could bias the results toward patients requiring specialist care. The cross-sectional nature of the study precludes the identification of causal links between findings.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2021.
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, except for the following exclusions: 1. Studies in products where Boehringer Ingelheim is not the license holder 2. Studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials 3. Studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). Requestors can use the following link http://trials.boehringer-ingelheim.com/

Related trials for Diabetes Mellitus, Type 2

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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 Mellitus, Type 2, run by Boehringer Ingelheim at 1 site in Germany.

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 2 inclusion and 1 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 29 Mar 2021. 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 Germany. 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 29 Mar 2021). 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?

Percentage of Participants With Previous Occurence of Cardiovascular Comorbidities (time frame: At baseline.). The study lists 3 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 NCT04098575.

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 29 Mar 2021.