Trial Outcomes & Findings for 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 (NCT NCT04295005)
NCT ID: NCT04295005
Last Updated: 2024-08-30
Results Overview
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.
COMPLETED
24500 participants
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.
2024-08-30
Participant Flow
This retrospective study was to compare healthcare cost associated with different antidiabetic drug treatments among the incident users of Empagliflozin (EMPA), any Dipeptidyl peptidase 4 inhibitor (DPP-4i) (specifically Sitagliptin) or any Glucagon-like peptide-1 receptor agonist (GLP-1-RA), based on data covering 2015 - 2018 from Gesellschaft für Qualität und Wirtschaftlichkeit bei Krankenkassen (GWQ) dataset.
All subjects who strictly met all inclusion and none of the exclusion criteria were included in the study.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
3285
|
19433
|
1747
|
|
Overall Study
Patients Who Started a Sitagliptin Therapy
|
0
|
18382
|
0
|
|
Overall Study
COMPLETED
|
3285
|
19433
|
1747
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
All Patients Who Started an Empagliflozin Therapy
n=3285 Participants
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.
|
All Patients Who Started a DPP-4 Inhibitor (Specifically Sitagliptin) Therapy
n=19433 Participants
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.
|
All Patients Who Started a GLP-1 Receptor Agonist Therapy
n=1747 Participants
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.
|
Total
n=24465 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
60.0 Years
STANDARD_DEVIATION 11.0 • n=3285 Participants
|
63.3 Years
STANDARD_DEVIATION 12.6 • n=19433 Participants
|
55.0 Years
STANDARD_DEVIATION 12.0 • n=1747 Participants
|
62.3 Years
STANDARD_DEVIATION 13.4 • n=24465 Participants
|
|
Sex: Female, Male
Female
|
1110 Participants
n=3285 Participants
|
7705 Participants
n=19433 Participants
|
754 Participants
n=1747 Participants
|
9569 Participants
n=24465 Participants
|
|
Sex: Female, Male
Male
|
2175 Participants
n=3285 Participants
|
11728 Participants
n=19433 Participants
|
993 Participants
n=1747 Participants
|
14896 Participants
n=24465 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 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: 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.
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.
Outcome measures
| Measure |
Empagliflozin (Matched to Dipeptidyl Peptidase 4 Inhibitor (DPP-4i))
n=3100 Participants
Matched 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 before this study start from the Gesellschaft für Qualität und Wirtschaftlichkeit bei Krankenkassen (GWQ) dataset.
This cohort includes participants prescribed empagliflozin and who were matched to Dipeptidyl peptidase 4 inhibitor (DPP-4i) cohort via propensity score matching adjusting for potential differences in patient characteristics and prior disease and treatment history between the two cohorts.
|
Dipeptidyl Peptidase 4 Inhibitor (DPP-4i) (Matched)
n=3100 Participants
Matched 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) between 2015 - 2018 before this study start from the Gesellschaft für Qualität und Wirtschaftlichkeit bei Krankenkassen (GWQ) dataset.
This cohort includes participants prescribed DPP-4i and who were matched to Empagliflozin cohort via propensity score matching adjusting for potential differences in patient characteristics and prior disease and treatment history between the two cohorts.
|
Empagliflozin (Matched to Sitagliptin (SITA))
n=3102 Participants
This cohort includes participants prescribed empagliflozin and who were matched to Sitagliptin (SITA) cohort via propensity score matching adjusting for potential differences in patient characteristics and prior disease and treatment history between the two cohorts.
|
Sitagliptin (SITA) (Matched)
n=3102 Participants
Matched 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 Sitagliptin between 2015 - 2018 before this study start from the Gesellschaft für Qualität und Wirtschaftlichkeit bei Krankenkassen (GWQ) dataset.
This cohort includes participants prescribed SITA and who were matched to Empagliflozin cohort via propensity score matching adjusting for potential differences in patient characteristics and prior disease and treatment history between the two cohorts.
|
Empagliflozin (Matched to Glucagon-like Peptide-1 Receptor Agonist (GLP-1-RA))
n=1346 Participants
This cohort includes participants prescribed empagliflozin and who were matched to Glucagon-like peptide-1 receptor agonist (GLP-1-RA) cohort via propensity score matching adjusting for potential differences in patient characteristics and prior disease and treatment history between the two cohorts.
|
Glucagon-like Peptide-1 Receptor Agonist (GLP-1-RA) (Matched)
n=1346 Participants
Matched 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 before this study start from the Gesellschaft für Qualität und Wirtschaftlichkeit bei Krankenkassen (GWQ) dataset.
This cohort includes participants prescribed GLP-1-RA and who were matched to Empagliflozin cohort via propensity score matching adjusting for potential differences in patient characteristics and prior disease and treatment history between the two cohorts.
|
|---|---|---|---|---|---|---|
|
Direct Healthcare Cost
Total
|
4247 Euro / patient-year
Interval 3982.0 to 4566.0
|
7009 Euro / patient-year
Interval 6573.0 to 7445.0
|
4319 Euro / patient-year
Interval 4024.0 to 4614.0
|
6535 Euro / patient-year
Interval 6150.0 to 6920.0
|
4895 Euro / patient-year
Interval 4345.0 to 5445.0
|
6851 Euro / patient-year
Interval 6183.0 to 7518.0
|
|
Direct Healthcare Cost
Inpatient
|
1455 Euro / patient-year
Interval 1230.0 to 1680.0
|
3040 Euro / patient-year
Interval 2698.0 to 3382.0
|
1486 Euro / patient-year
Interval 1260.0 to 1713.0
|
2806 Euro / patient-year
Interval 2491.0 to 3121.0
|
1546 Euro / patient-year
Interval 1099.0 to 1922.0
|
2094 Euro / patient-year
Interval 1552.0 to 2637.0
|
|
Direct Healthcare Cost
Outpatient
|
853 Euro / patient-year
Interval 814.0 to 892.0
|
1280 Euro / patient-year
Interval 1197.0 to 1363.0
|
863 Euro / patient-year
Interval 824.0 to 902.0
|
1213 Euro / patient-year
Interval 1165.0 to 1260.0
|
917 Euro / patient-year
Interval 854.0 to 980.0
|
1181 Euro / patient-year
Interval 1103.0 to 1258.0
|
|
Direct Healthcare Cost
Medication
|
1966 Euro / patient-year
Interval 1826.0 to 2107.0
|
2689 Euro / patient-year
Interval 2522.0 to 2855.0
|
1970 Euro / patient-year
Interval 1830.0 to 2110.0
|
2516 Euro / patient-year
Interval 2379.0 to 2653.0
|
2433 Euro / patient-year
Interval 2189.0 to 2677.0
|
3575 Euro / patient-year
Interval 3331.0 to 3819.0
|
PRIMARY outcome
Timeframe: 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: 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.
Healthcare resource utilization includes hospitalizations, hospital stays. outpatient visits, and rehabilitation stays.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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: 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.
Indirect healthcare costs (including indirect costs of days absent from work) includes indirect costs for hospitalization, outpatient visits, absent from work, and rehabilitation stays.
Outcome measures
Outcome data not reported
Adverse Events
All Patients Who Started an Empagliflozin Therapy
All Patients Who Started a DPP-4 Inhibitor (Specifically Sitagliptin) Therapy
All Patients Who Started a GLP-1 Receptor Agonist Therapy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER