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CompletedResults posted

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

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

Asset

GLP-1 / incretin class catch-all

Subcutaneous

Listed sites

1

Recruiting sites

Enrollment

24,500

actual

Study population

Type 2 diabetes

Key I/E criterion

Primary endpoints

Direct Healthcare CostHealthcare Resource Utilization (All-cause hospitalization)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04295005
Org study ID1245-0221

Timeline

Milestones

Study first posted2020-03-04actual
Study start2020-11-16actual
Primary completion2021-09-30actual
Study completion2021-09-30actual
Last update posted2024-08-30actual
Results first posted2024-08-30actual

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

SexAll
Healthy volunteersNot accepted
Sampling methodProbability sample

Study population text

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).

Inclusion criteria

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)

Exclusion criteria

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).

Endpoints (3)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other clinical outcomes
2
Other (unclassified)
1

Other clinical outcomes

2 endpoints
Primary/protocol endpoint

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.

descriptive

Posted result

GroupValue (mean), Euro / patient-year95% CI
Empagliflozin (Matched to Dipeptidyl Peptidase 4 Inhibitor (DPP-4i))Total42473982 – 4566
Inpatient14551230 – 1680
Outpatient853814 – 892
Medication19661826 – 2107
Dipeptidyl Peptidase 4 Inhibitor (DPP-4i) (Matched)Total70096573 – 7445
Inpatient30402698 – 3382
Outpatient12801197 – 1363
Medication26892522 – 2855
Empagliflozin (Matched to Sitagliptin (SITA))Total43194024 – 4614
Inpatient14861260 – 1713
Outpatient863824 – 902
Medication19701830 – 2110
Sitagliptin (SITA) (Matched)Total65356150 – 6920
Inpatient28062491 – 3121
Outpatient12131165 – 1260
Medication25162379 – 2653
Empagliflozin (Matched to Glucagon-like Peptide-1 Receptor Agonist (GLP-1-RA))Total48954345 – 5445
Inpatient15461099 – 1922
Outpatient917854 – 980
Medication24332189 – 2677
Glucagon-like Peptide-1 Receptor Agonist (GLP-1-RA) (Matched)Total68516183 – 7518
Inpatient20941552 – 2637
Outpatient11811103 – 1258
Medication35753331 – 3819
p< 0.001Bang and Tsiatis

Total cost comparison.

p< 0.001Bang and Tsiatis

Total cost comparison.

p< 0.001Bang and Tsiatis

Total cost comparison.

p< 0.001Bang and Tsiatis

Inpatient cost comparison

p< 0.001Bang and Tsiatis

Inpatient cost comparison.

p0.126Bang and Tsiatis

Inpatient cost comparison

p< 0.001Bang and Tsiatis

Outpatient cost comparison.

p< 0.001Bang and Tsiatis

Outpatient cost comparison.

p< 0.001Bang and Tsiatis

Outpatient cost comparison.

p< 0.001Bang and Tsiatis

Medication cost comparison.

p< 0.001Bang and Tsiatis

Medication cost comparison.

p< 0.001Bang and Tsiatis

Medication cost comparison.

Primary/protocol endpoint/low confidence

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.

descriptive

componentsAll-cause hospitalization

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

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.

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.