Trial · Observational

CompletedPhase not statedResults postedRegistry data

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

NCTNCT04295005Other id1245-0221

Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

Measures Glucagon, does not give it. It appears in an outcome measure.

Overview

Status: Completed
Phase: Phase not stated
Enrollment: 24,500 participants (actual)
Sponsor: Boehringer Ingelheim · Industry
Design: Not stated
Countries: 1 country
Germany
Start: 16 Nov 2020
Primary completion: 30 Sept 2021
Completion: 30 Sept 2021
First posted: 4 Mar 2020
Last update posted: 30 Aug 2024
Conditions: Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202020212022

Ph –
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
NCT04295005
16 Nov 2020 to 30 Sept 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

EmpagliflozinDrug
DPP-4iDrug
GLP-1-RADrug

Arms3

Other
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.
Other
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.
Other
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.

Primary outcomes2

Outcomes the sponsor listed as primary.

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.
Registry description
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.
Registry description
Healthcare resource utilization includes hospitalizations, hospital stays. outpatient visits, and rehabilitation stays.

Secondary outcomes(1)

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.
Registry description
Indirect healthcare costs (including indirect costs of days absent from work) includes indirect costs for hospitalization, outpatient visits, absent from work, and rehabilitation stays.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 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.

Direct Healthcare Cost

Group	Value (Euro / patient-year)
Empagliflozin (Matched to Dipeptidyl Peptidase 4 Inhibitor (DPP-4i))	4247
Dipeptidyl Peptidase 4 Inhibitor (DPP-4i) (Matched)	7009
Empagliflozin (Matched to Sitagliptin (SITA))	4319
Sitagliptin (SITA) (Matched)	6535
Empagliflozin (Matched to Glucagon-like Peptide-1 Receptor Agonist (GLP-1-RA))	4895
Glucagon-like Peptide-1 Receptor Agonist (GLP-1-RA) (Matched)	6851

Primary outcome· 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

Group	Value
Empagliflozin (Matched to Dipeptidyl Peptidase 4 Inhibitor (DPP-4i))	not posted
Dipeptidyl Peptidase 4 Inhibitor (DPP-4i) (Matched)	not posted
Empagliflozin (Matched to Sitagliptin (SITA))	not posted
Sitagliptin (SITA) (Matched)	not posted
Empagliflozin (Matched to Glucagon-like Peptide-1 Receptor Agonist (GLP-1-RA))	not posted
Glucagon-like Peptide-1 Receptor Agonist (GLP-1-RA) (Matched)	not posted

Secondary and other outcome results(1)

Secondary outcome· 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.

Indirect Healthcare Costs (Including Indirect Costs of Days Absent From Work)

Group	Value
Empagliflozin (Matched to Dipeptidyl Peptidase 4 Inhibitor (DPP-4i))	not posted
Dipeptidyl Peptidase 4 Inhibitor (DPP-4i) (Matched)	not posted
Empagliflozin (Matched to Sitagliptin (SITA))	not posted
Sitagliptin (SITA) (Matched)	not posted
Empagliflozin (Matched to Glucagon-like Peptide-1 Receptor Agonist (GLP-1-RA))	not posted
Glucagon-like Peptide-1 Receptor Agonist (GLP-1-RA) (Matched)	not posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
All Patients Who Started an Empagliflozin TherapyAll 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.	0 / 0	0 / 0	0 / 0
All Patients Who Started a DPP-4 Inhibitor (Specifically Sitagliptin) TherapyAll 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.	0 / 0	0 / 0	0 / 0
All Patients Who Started a GLP-1 Receptor Agonist TherapyAll 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.	0 / 0	0 / 0	0 / 0

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: Not stated
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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).

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