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NCT04295005

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

Completed Results posted Last updated 30 August 2024
What this trial tests

trial testing Empagliflozin in Diabetes Mellitus, Type 2 in 24,500 participants. Completed in 30 September 2021.

Timeline
16 November 2020
Primary endpoint
30 September 2021
30 September 2021

Quick facts

Lead sponsorBoehringer Ingelheim
StatusCompleted
Study typeOBSERVATIONAL
Enrollment24,500
Start date16 November 2020
Primary completion30 September 2021
Estimated completion30 September 2021
Sites1 location across Germany

Drugs / interventions tested

Conditions studied

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

Eligibility, any sex, with Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Direct Healthcare Cost Primary · 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

Total
GroupValue95% CI
Empagliflozin (Matched to Dipeptidyl Peptidase 4 Inhibitor (DPP-4i))42473982 – 4566
Dipeptidyl Peptidase 4 Inhibitor (DPP-4i) (Matched)70096573 – 7445
Empagliflozin (Matched to Sitagliptin (SITA))43194024 – 4614
Sitagliptin (SITA) (Matched)65356150 – 6920
Empagliflozin (Matched to Glucagon-like Peptide-1 Receptor Agonist (GLP-1-RA))48954345 – 5445
Glucagon-like Peptide-1 Receptor Agonist (GLP-1-RA) (Matched)68516183 – 7518
Inpatient
GroupValue95% CI
Empagliflozin (Matched to Dipeptidyl Peptidase 4 Inhibitor (DPP-4i))14551230 – 1680
Dipeptidyl Peptidase 4 Inhibitor (DPP-4i) (Matched)30402698 – 3382
Empagliflozin (Matched to Sitagliptin (SITA))14861260 – 1713
Sitagliptin (SITA) (Matched)28062491 – 3121
Empagliflozin (Matched to Glucagon-like Peptide-1 Receptor Agonist (GLP-1-RA))15461099 – 1922
Glucagon-like Peptide-1 Receptor Agonist (GLP-1-RA) (Matched)20941552 – 2637
Outpatient
GroupValue95% CI
Empagliflozin (Matched to Dipeptidyl Peptidase 4 Inhibitor (DPP-4i))853814 – 892
Dipeptidyl Peptidase 4 Inhibitor (DPP-4i) (Matched)12801197 – 1363
Empagliflozin (Matched to Sitagliptin (SITA))863824 – 902
Sitagliptin (SITA) (Matched)12131165 – 1260
Empagliflozin (Matched to Glucagon-like Peptide-1 Receptor Agonist (GLP-1-RA))917854 – 980
Glucagon-like Peptide-1 Receptor Agonist (GLP-1-RA) (Matched)11811103 – 1258
Medication
GroupValue95% CI
Empagliflozin (Matched to Dipeptidyl Peptidase 4 Inhibitor (DPP-4i))19661826 – 2107
Dipeptidyl Peptidase 4 Inhibitor (DPP-4i) (Matched)26892522 – 2855
Empagliflozin (Matched to Sitagliptin (SITA))19701830 – 2110
Sitagliptin (SITA) (Matched)25162379 – 2653
Empagliflozin (Matched to Glucagon-like Peptide-1 Receptor Agonist (GLP-1-RA))24332189 – 2677
Glucagon-like Peptide-1 Receptor Agonist (GLP-1-RA) (Matched)35753331 – 3819

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other trials of Empagliflozin

Trials testing the same drug.

Other recruiting trials for Diabetes Mellitus, Type 2

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Other Boehringer Ingelheim trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04295005.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing