A Study Based on Data From German Sick Funds That Looks at the Costs of Treatment of Type-2 Diabetic Patients With Empagliflozin vs. DPP-4 Inhibitors vs. GLP-1 Receptor Agonists

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

Empagliflozin vs. Dipeptidyl Peptidase 4 (DPP-4) Inhibitors and Glucagon-like Peptide-1 Receptor Agonists (GLP-1-RA) Cost of Care Study: a German claims data analysis Read more about this study

Who is it for?: Any age
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: Empagliflozin, DPP-4i and GLP-1-RA
Type of treatment: Pill or oral medicine, Injection or infusion
How many people: 24,500 participants
Where: 1 siteGermany
Study dates: 16 Nov 2020to 30 Sep 2021
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Type 2 diabetes mellitus (T2DM) patients who have been treated with either Empagliflozin, DPP-4i /Sitagliptin or GLP-1-RA (new users only, at least one prescription).

Who may be able to join

Continuous insurance by the sickness fund for the entire period (01/01/2014 - 31/12/2018; death of a patient is the only accepted exception from this rule)
At least two outpatient T2DM diagnoses (ICD E11.-) in two different quarters and/or at least one inpatient T2DM diagnosis (ICD E11.-) in the period 01/01/2014 to 31/12/2016, but before or on index date (i.e. first Empagliflozin or DPP-4i /Sitagliptin prescription).
At least one prescription of Empagliflozin or a DPP-4i /Sitagliptin in the inclusion period (01/01/2015 - 31/12/2016)

Who cannot join

At least one prescription of a sodium glucose transporter 2 inhibitor (SGLT-2i), DPP-4i or GLP-1-RA in the baseline period (01/01/2014 - 31/12/2014)
During follow-up, patients will be censored if they switch to any SGLT-2i, DPP-4i or GLP-1-RA or initiate a concomitant use of any SGLT-2i, DPP-4i or GLP-1-RA (free or fixed-dose combinations).

Trial locations and contacts

1 site in 1 country.

Germany1 site

Boehringer Ingelheim
Ingelheim, 55216

Other trials in Germany

About this study

Official title: The Empagliflozin vs. DPP-4 Inhibitors and GLP-1 Receptor Agonists Cost of Care Study: a German Claims Data Analysis

Empagliflozin vs. Dipeptidyl Peptidase 4 (DPP-4) Inhibitors and Glucagon-like Peptide-1 Receptor Agonists (GLP-1-RA) Cost of Care Study: a German claims data analysis

Conditions: Diabetes Mellitus, Type 2
Being tested: Empagliflozin, DPP-4i, GLP-1-RA
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
film coated tablet
DPP-4iDrug
film coated tablets, specifically Sitagliptin
GLP-1-RADrug
subcutaneous injection or tablet

Study groups in NCT04295005
Study group	Role	What they receive
All patients who started an Empagliflozin therapy		All participants who met the inclusion criteria and none of the exclusion criteria of this study, who had at least two outpatient diagnoses and/or one inpatient diagnosis of Type 2 diabetes mellitus (T2DM) and received at least one outpatient prescription with Empagliflozin (EMPA) between 2015 - 2018 from the Gesellschaft für Qualität und Wirtschaftlichkeit bei Krankenkassen (GWQ) dataset. Receives: Drug: Empagliflozin
All patients who started a DPP-4 inhibitor (specifically Sitagliptin) therapy		All participants who met the inclusion criteria and none of the exclusion criteria of this study, who had at least two outpatient diagnoses and/or one inpatient diagnosis of Type 2 diabetes mellitus (T2DM) and received at least one outpatient prescription with Dipeptidyl peptidase 4 (DPP-4) inhibitor (DPP-4i) (specifically Sitagliptin) between 2015 - 2018 from the Gesellschaft für Qualität und Wirtschaftlichkeit bei Krankenkassen (GWQ) dataset. Receives: Drug: DPP-4i
All patients who started a GLP-1 receptor agonist therapy		All participants who met the inclusion criteria and none of the exclusion criteria of this study, who had at least two outpatient diagnoses and/or one inpatient diagnosis of Type 2 diabetes mellitus (T2DM) and received at least one outpatient prescription with Glucagon-like peptide-1 (GLP-1) receptor agonist (GLP-1-RA) between 2015 - 2018 from the Gesellschaft für Qualität und Wirtschaftlichkeit bei Krankenkassen (GWQ) dataset. Receives: Drug: GLP-1-RA

What is being measured

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

Direct Healthcare Cost
The direct healthcare cost is reported, including inpatient cost, outpatient cost, medication cost, and total cost. Patients starting Empagliflozin (EMPA) versus either Dipeptidyl peptidase 4 inhibitor (DPP-4i), Sitagliptin (SITA) or Glucagon-like peptide-1 receptor agonist (GLP-1-RA) were matched 1:1 based on a propensity score using a nearest-neighbor matching algorithm without replacement and a maximum caliper of 0.001. The propensity scores were derived by logistic regression models estimating the probability of a patient belonging to the different treatment groups (three estimations: EMPA versus DPP-4i, EMPA versus SITA, and EMPA versus GLP-1-RA). The cost per observed patient year is calculated as the sum of the cost/ sum of the observed time [year] over all patients. Final values were rounded to the nearest digit.
Measured: Dataset included all adult persons, who were continuously insured between 01 january 2014 until 31 december 2018 (except for death), approximately a 4 year period.
Healthcare Resource Utilization
Healthcare resource utilization includes hospitalizations, hospital stays. outpatient visits, and rehabilitation stays.
Measured: Dataset included all adult persons, who were continuously insured between 01 january 2014 until 31 december 2018 (except for death), approximately a 4 year period.

Secondary outcomes (1)

Indirect Healthcare Costs (Including Indirect Costs of Days Absent From Work)
Indirect healthcare costs (including indirect costs of days absent from work) includes indirect costs for hospitalization, outpatient visits, absent from work, and rehabilitation stays.
Measured: Dataset included all adult persons, who were continuously insured between 01 january 2014 until 31 december 2018 (except for death), approximately a 4 year period.

Timeline

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

16 Nov 202030 Sep 2021

First posted4 Mar 2020
Study start16 Nov 2020
Primary completion30 Sep 2021
Study completion30 Sep 2021

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: 24,500 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04295005
Sponsor's protocol ID: 1245-0221
Status last verified: Apr 2024
First submitted: 3 Mar 2020
Last updated: 30 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
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?

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 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Empagliflozin vs. DPP-4 Inhibitors and GLP-1 Receptor Agonists Cost of Care Study: a German Claims Data Analysis
ClinicalTrials.gov ID: NCT04295005
Acronym / sponsor ID: 1245-0221
Conditions: Diabetes Mellitus, Type 2
Study type: Observational
Recruitment status: Completed
Enrolment: 24,500 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 16 Nov 2020 (actual)
Primary completion: 30 Sep 2021 (actual)
Study completion: 30 Sep 2021 (actual)
First posted: 4 Mar 2020 (actual)
Results: Posted 30 Aug 2024

Clinical summary

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

Empagliflozin vs. Dipeptidyl Peptidase 4 (DPP-4) Inhibitors and Glucagon-like Peptide-1 Receptor Agonists (GLP-1-RA) Cost of Care Study: a German claims data analysis

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 3

Arm	Type	Receives
All patients who started an Empagliflozin therapy	–	Drug: EmpagliflozinAll participants who met the inclusion criteria and none of the exclusion criteria of this study, who had at least two outpatient diagnoses and/or one inpatient diagnosis of Type 2 diabetes mellitus (T2DM) and received at least one outpatient prescription with Empagliflozin (EMPA) between 2015 - 2018 from the Gesellschaft für Qualität und Wirtschaftlichkeit bei Krankenkassen (GWQ) dataset.
All patients who started a DPP-4 inhibitor (specifically Sitagliptin) therapy	–	Drug: DPP-4iAll participants who met the inclusion criteria and none of the exclusion criteria of this study, who had at least two outpatient diagnoses and/or one inpatient diagnosis of Type 2 diabetes mellitus (T2DM) and received at least one outpatient prescription with Dipeptidyl peptidase 4 (DPP-4) inhibitor (DPP-4i) (specifically Sitagliptin) between 2015 - 2018 from the Gesellschaft für Qualität und Wirtschaftlichkeit bei Krankenkassen (GWQ) dataset.
All patients who started a GLP-1 receptor agonist therapy	–	Drug: GLP-1-RAAll participants who met the inclusion criteria and none of the exclusion criteria of this study, who had at least two outpatient diagnoses and/or one inpatient diagnosis of Type 2 diabetes mellitus (T2DM) and received at least one outpatient prescription with Glucagon-like peptide-1 (GLP-1) receptor agonist (GLP-1-RA) between 2015 - 2018 from the Gesellschaft für Qualität und Wirtschaftlichkeit bei Krankenkassen (GWQ) dataset.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Type 2 diabetes mellitus (T2DM) patients who have been treated with either Empagliflozin, DPP-4i /Sitagliptin or GLP-1-RA (new users only, at least one prescription).

Key inclusion criteria (3 listed)

Continuous insurance by the sickness fund for the entire period (01/01/2014 - 31/12/2018; death of a patient is the only accepted exception from this rule)
At least two outpatient T2DM diagnoses (ICD E11.-) in two different quarters and/or at least one inpatient T2DM diagnosis (ICD E11.-) in the period 01/01/2014 to 31/12/2016, but before or on index date (i.e. first Empagliflozin or DPP-4i /Sitagliptin prescription).
At least one prescription of Empagliflozin or a DPP-4i /Sitagliptin in the inclusion period (01/01/2015 - 31/12/2016)

Key exclusion criteria (2 listed)

At least one prescription of a sodium glucose transporter 2 inhibitor (SGLT-2i), DPP-4i or GLP-1-RA in the baseline period (01/01/2014 - 31/12/2014)

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
Empagliflozinfilm coated tablet	Drug	All patients who started an Empagliflozin therapy
DPP-4ifilm coated tablets, specifically Sitagliptin	Drug	All patients who started a DPP-4 inhibitor (specifically Sitagliptin) therapy
GLP-1-RAsubcutaneous injection or tablet	Drug	All patients who started a GLP-1 receptor agonist therapy

Primary outcome

Direct Healthcare Cost
Time frame: Dataset included all adult persons, who were continuously insured between 01 january 2014 until 31 december 2018 (except for death), approximately a 4 year period.
The direct healthcare cost is reported, including inpatient cost, outpatient cost, medication cost, and total cost. Patients starting Empagliflozin (EMPA) versus either Dipeptidyl peptidase 4 inhibitor (DPP-4i), Sitagliptin (SITA) or Glucagon-like peptide-1 receptor agonist (GLP-1-RA) were matched 1:1 based on a propensity score using a nearest-neighbor matching algorithm without replacement and a maximum caliper of 0.001. The propensity scores were derived by logistic regression models estimating the probability of a patient belonging to the different treatment groups (three estimations: EMPA versus DPP-4i, EMPA versus SITA, and EMPA versus GLP-1-RA). The cost per observed patient year is calculated as the sum of the cost/ sum of the observed time [year] over all patients. Final values were rounded to the nearest digit.
Healthcare Resource Utilization
Time frame: Dataset included all adult persons, who were continuously insured between 01 january 2014 until 31 december 2018 (except for death), approximately a 4 year period.
Healthcare resource utilization includes hospitalizations, hospital stays. outpatient visits, and rehabilitation stays.

1 secondary outcome

Indirect Healthcare Costs (Including Indirect Costs of Days Absent From Work)
Time frame: Dataset included all adult persons, who were continuously insured between 01 january 2014 until 31 december 2018 (except for death), approximately a 4 year period.

Results and safety

Results posted to the registry on 30 Aug 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
All Patients Who Started an Empagliflozin Therapy	3,285	3,285
All Patients Who Started a DPP-4 Inhibitor (Specifically Sitagliptin) Therapy	19,433	19,433
All Patients Who Started a GLP-1 Receptor Agonist Therapy	1,747	1,747

Primary outcome: Direct Healthcare Cost

Time frame: Dataset included all adult persons, who were continuously insured between 01 january 2014 until 31 december 2018 (except for death), approximately a 4 year period.. Mean (95% Confidence Interval). Unit: Euro / patient-year

Measure	Empagliflozin (Matched to Dipeptidyl Peptidase 4 Inhibitor (DPP-4i)) n = 3100	Dipeptidyl Peptidase 4 Inhibitor (DPP-4i) (Matched) n = 3100	Empagliflozin (Matched to Sitagliptin (SITA)) n = 3102	Sitagliptin (SITA) (Matched) n = 3102	Empagliflozin (Matched to Glucagon-like Peptide-1 Receptor Agonist (GLP-1-RA)) n = 1346	Glucagon-like Peptide-1 Receptor Agonist (GLP-1-RA) (Matched) n = 1346
Total	4247 (3982 to 4566)	7009 (6573 to 7445)	4319 (4024 to 4614)	6535 (6150 to 6920)	4895 (4345 to 5445)	6851 (6183 to 7518)
Inpatient	1455 (1230 to 1680)	3040 (2698 to 3382)	1486 (1260 to 1713)	2806 (2491 to 3121)	1546 (1099 to 1922)	2094 (1552 to 2637)
Outpatient	853 (814 to 892)	1280 (1197 to 1363)	863 (824 to 902)	1213 (1165 to 1260)	917 (854 to 980)	1181 (1103 to 1258)
Medication	1966 (1826 to 2107)	2689 (2522 to 2855)	1970 (1830 to 2110)	2516 (2379 to 2653)	2433 (2189 to 2677)	3575 (3331 to 3819)

Empagliflozin (Matched to Dipeptidyl Peptidase 4 Inhibitor (DPP-4i)) vs Dipeptidyl Peptidase 4 Inhibitor (DPP-4i) (Matched): p < 0.001, Bang and Tsiatis
Empagliflozin (Matched to Sitagliptin (SITA)) vs Sitagliptin (SITA) (Matched): p < 0.001, Bang and Tsiatis
Empagliflozin (Matched to Glucagon-like Peptide-1 Receptor Agonist (GLP-1-RA)) vs Glucagon-like Peptide-1 Receptor Agonist (GLP-1-RA) (Matched): p < 0.001, Bang and Tsiatis

Population analysed: All eligible participants in this study, with non-missing outcome measures, and matched via propensity score adjusting for potential differences in patient characteristics and prior disease and treatment history among cohorts. The Dipeptidyl peptidase 4 inhibitor (DPP-4i) group and the Sitagliptin group are not mutually exclusive.

Primary outcome: Healthcare Resource Utilization

Time frame: Dataset included all adult persons, who were continuously insured between 01 january 2014 until 31 december 2018 (except for death), approximately a 4 year period.

Population analysed: Relevant data for the outcome measure were not collected in the GMQ dataset because GWQ´s quality assurance decided not to integrate several sub-datasets into GWQ´s dataset due to heterogeneity and low coding-quality of out-patient diagnoses and high variability in size, structure, and quality of specific items in individual sickness funds data.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events
All Patients Who Started an Empagliflozin Therapy	0 of 0	0 of 0
All Patients Who Started a DPP-4 Inhibitor (Specifically Sitagliptin) Therapy	0 of 0	0 of 0
All Patients Who Started a GLP-1 Receptor Agonist Therapy	0 of 0	0 of 0

Limitations and caveats (from the sponsor): Relevant data for the outcome measure were not collected in the GMQ dataset. The general reason for missing data in GWQ´s dataset is insufficient data quality. First, coding-quality of out-patient diagnoses in Germany is heterogenous and generally low. Second, data from GWQ´s individual sickness funds highly differ in size, structure, and quality of specific items. Due to this, GWQ´s quality assurance decided not to integrate several sub-datasets into GWQ´s dataset.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 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 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 3 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 30 Aug 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 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 30 Aug 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?

Direct Healthcare Cost (time frame: Dataset included all adult persons, who were continuously insured between 01 january 2014 until 31 december 2018 (except for death), approximately a 4 year period.). The study lists 2 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 NCT04295005.

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 30 Aug 2024.