An observational study in Diabetes Mellitus, Type 2, sponsored by Boehringer Ingelheim. Completed at 1 site in Germany. Per ClinicalTrials.gov, last updated 2024-08-30.
Sponsored by Boehringer Ingelheim · Observational
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
9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.
This study's enrollment of 24,500 is above the median of 300 across 1,622 observational studies indexed under Diabetes Mellitus, Type 2.
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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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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)
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.
Drug: Empagliflozin
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.
Drug: DPP-4i
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.
Drug: GLP-1-RA
film coated tablet
film coated tablets, specifically Sitagliptin
subcutaneous injection or tablet
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.
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
Healthcare resource utilization includes hospitalizations, hospital stays. outpatient visits, and rehabilitation stays.
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.
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.
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.
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.
| Milestone | 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 |
|---|---|---|---|
| Started | 3285 | 19433 | 1747 |
| Patients who started a sitagliptin therapy | 0 | 18382 | 0 |
| Completed | 3285 | 19433 | 1747 |
| Not completed | 0 | 0 | 0 |
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.
| Euro / patient-year | Empagliflozin (Matched to Dipeptidyl Peptidase 4 Inhibitor (DPP-4i)) | Dipeptidyl Peptidase 4 Inhibitor (DPP-4i) (Matched) | Empagliflozin (Matched to Sitagliptin (SITA)) | Sitagliptin (SITA) (Matched) | Empagliflozin (Matched to Glucagon-like Peptide-1 Receptor Agonist (GLP-1-RA)) | Glucagon-like Peptide-1 Receptor Agonist (GLP-1-RA) (Matched) |
|---|---|---|---|---|---|---|
| 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) |
Healthcare resource utilization includes hospitalizations, hospital stays. outpatient visits, and rehabilitation stays.
No measurements were reported for this outcome.
Indirect healthcare costs (including indirect costs of days absent from work) includes indirect costs for hospitalization, outpatient visits, absent from work, and rehabilitation stays.
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 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 | — | — | — |
All eligible participants in this study.
| Age, Continuous(Years) | 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 | Total |
|---|---|---|---|---|
| Mean | 60.0 ± 11.0 | 63.3 ± 12.6 | 55.0 ± 12.0 | 62.3 ± 13.4 |
| Sex: Female, Male(Participants) | 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 | Total |
|---|---|---|---|---|
| Female | 1110 | 7705 | 754 | 9569 |
| Male | 2175 | 11728 | 993 | 14896 |
| Race and Ethnicity Not Collected(Participants) | 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 | Total |
|---|---|---|---|---|
| Count of participants | — | — | — | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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