Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-31 @ 1:33 PM
Study NCT ID:
NCT04295005
Status:
COMPLETED
Last Update Posted:
2024-08-30
First Post:
2020-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
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
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C570240', 'term': 'empagliflozin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim Call Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'otherDetails': "Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results.\n\nInvestigators 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.\n\nBI may request a delay of the publication in order to protect BI's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Relevant data for the outcome measure were not collected in the GMQ dataset. The general reason for missing data in GWQ´s dataset is insufficient data quality. First, coding-quality of out-patient diagnoses in Germany is heterogenous and generally low. Second, data from GWQ´s individual sickness funds highly differ in size, structure, and quality of specific items. Due to this, GWQ´s quality assurance decided not to integrate several sub-datasets into GWQ´s dataset.'}}, 'adverseEventsModule': {'description': 'This is a non-interventional study using electronic health care records, with data retrieved from Gesellschaft für Qualität und Wirtschaftlichkeit bei Krankenkassen (GWQ). The adverse events were not planned to be collected and reported. The "0" in the All-Cause Mortality, Serious Adverse Events, and Other (non-serious) Adverse Events sections refers to "not applicable".', 'eventGroups': [{'id': 'EG000', 'title': 'All Patients Who Started an Empagliflozin Therapy', 'description': '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.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'All Patients Who Started a DPP-4 Inhibitor (Specifically Sitagliptin) Therapy', 'description': '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.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'All Patients Who Started a GLP-1 Receptor Agonist Therapy', 'description': '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.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Direct Healthcare Cost', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3100', 'groupId': 'OG000'}, {'value': '3100', 'groupId': 'OG001'}, {'value': '3102', 'groupId': 'OG002'}, {'value': '3102', 'groupId': 'OG003'}, {'value': '1346', 'groupId': 'OG004'}, {'value': '1346', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Empagliflozin (Matched to Dipeptidyl Peptidase 4 Inhibitor (DPP-4i))', 'description': '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.\n\nThis 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.'}, {'id': 'OG001', 'title': 'Dipeptidyl Peptidase 4 Inhibitor (DPP-4i) (Matched)', 'description': '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.\n\nThis 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.'}, {'id': 'OG002', 'title': 'Empagliflozin (Matched to Sitagliptin (SITA))', 'description': '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.'}, {'id': 'OG003', 'title': 'Sitagliptin (SITA) (Matched)', 'description': '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.\n\nThis 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.'}, {'id': 'OG004', 'title': 'Empagliflozin (Matched to Glucagon-like Peptide-1 Receptor Agonist (GLP-1-RA))', 'description': '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.'}, {'id': 'OG005', 'title': 'Glucagon-like Peptide-1 Receptor Agonist (GLP-1-RA) (Matched)', 'description': '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.\n\nThis 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.'}], 'classes': [{'title': 'Total', 'categories': [{'measurements': [{'value': '4247', 'groupId': 'OG000', 'lowerLimit': '3982', 'upperLimit': '4566'}, {'value': '7009', 'groupId': 'OG001', 'lowerLimit': '6573', 'upperLimit': '7445'}, {'value': '4319', 'groupId': 'OG002', 'lowerLimit': '4024', 'upperLimit': '4614'}, {'value': '6535', 'groupId': 'OG003', 'lowerLimit': '6150', 'upperLimit': '6920'}, {'value': '4895', 'groupId': 'OG004', 'lowerLimit': '4345', 'upperLimit': '5445'}, {'value': '6851', 'groupId': 'OG005', 'lowerLimit': '6183', 'upperLimit': '7518'}]}]}, {'title': 'Inpatient', 'categories': [{'measurements': [{'value': '1455', 'groupId': 'OG000', 'lowerLimit': '1230', 'upperLimit': '1680'}, {'value': '3040', 'groupId': 'OG001', 'lowerLimit': '2698', 'upperLimit': '3382'}, {'value': '1486', 'groupId': 'OG002', 'lowerLimit': '1260', 'upperLimit': '1713'}, {'value': '2806', 'groupId': 'OG003', 'lowerLimit': '2491', 'upperLimit': '3121'}, {'value': '1546', 'groupId': 'OG004', 'lowerLimit': '1099', 'upperLimit': '1922'}, {'value': '2094', 'groupId': 'OG005', 'lowerLimit': '1552', 'upperLimit': '2637'}]}]}, {'title': 'Outpatient', 'categories': [{'measurements': [{'value': '853', 'groupId': 'OG000', 'lowerLimit': '814', 'upperLimit': '892'}, {'value': '1280', 'groupId': 'OG001', 'lowerLimit': '1197', 'upperLimit': '1363'}, {'value': '863', 'groupId': 'OG002', 'lowerLimit': '824', 'upperLimit': '902'}, {'value': '1213', 'groupId': 'OG003', 'lowerLimit': '1165', 'upperLimit': '1260'}, {'value': '917', 'groupId': 'OG004', 'lowerLimit': '854', 'upperLimit': '980'}, {'value': '1181', 'groupId': 'OG005', 'lowerLimit': '1103', 'upperLimit': '1258'}]}]}, {'title': 'Medication', 'categories': [{'measurements': [{'value': '1966', 'groupId': 'OG000', 'lowerLimit': '1826', 'upperLimit': '2107'}, {'value': '2689', 'groupId': 'OG001', 'lowerLimit': '2522', 'upperLimit': '2855'}, {'value': '1970', 'groupId': 'OG002', 'lowerLimit': '1830', 'upperLimit': '2110'}, {'value': '2516', 'groupId': 'OG003', 'lowerLimit': '2379', 'upperLimit': '2653'}, {'value': '2433', 'groupId': 'OG004', 'lowerLimit': '2189', 'upperLimit': '2677'}, {'value': '3575', 'groupId': 'OG005', 'lowerLimit': '3331', 'upperLimit': '3819'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Total cost comparison.', 'statisticalMethod': 'Bang and Tsiatis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.'}, {'pValue': '< 0.001', 'groupIds': ['OG002', 'OG003'], 'groupDescription': 'Total cost comparison.', 'statisticalMethod': 'Bang and Tsiatis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.'}, {'pValue': '< 0.001', 'groupIds': ['OG004', 'OG005'], 'groupDescription': 'Total cost comparison.', 'statisticalMethod': 'Bang and Tsiatis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Inpatient cost comparison', 'statisticalMethod': 'Bang and Tsiatis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.'}, {'pValue': '< 0.001', 'groupIds': ['OG002', 'OG003'], 'groupDescription': 'Inpatient cost comparison.', 'statisticalMethod': 'Bang and Tsiatis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.'}, {'pValue': '0.126', 'groupIds': ['OG004', 'OG005'], 'groupDescription': 'Inpatient cost comparison', 'statisticalMethod': 'Bang and Tsiatis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Outpatient cost comparison.', 'statisticalMethod': 'Bang and Tsiatis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.'}, {'pValue': '< 0.001', 'groupIds': ['OG002', 'OG003'], 'groupDescription': 'Outpatient cost comparison.', 'statisticalMethod': 'Bang and Tsiatis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.'}, {'pValue': '< 0.001', 'groupIds': ['OG004', 'OG005'], 'groupDescription': 'Outpatient cost comparison.', 'statisticalMethod': 'Bang and Tsiatis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Medication cost comparison.', 'statisticalMethod': 'Bang and Tsiatis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.'}, {'pValue': '< 0.001', 'groupIds': ['OG002', 'OG003'], 'groupDescription': 'Medication cost comparison.', 'statisticalMethod': 'Bang and Tsiatis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.'}, {'pValue': '< 0.001', 'groupIds': ['OG004', 'OG005'], 'groupDescription': 'Medication cost comparison.', 'statisticalMethod': 'Bang and Tsiatis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.'}], 'paramType': 'MEAN', '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.', '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.', 'unitOfMeasure': 'Euro / patient-year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Healthcare Resource Utilization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Empagliflozin (Matched to Dipeptidyl Peptidase 4 Inhibitor (DPP-4i))', 'description': '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.\n\nThis 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.'}, {'id': 'OG001', 'title': 'Dipeptidyl Peptidase 4 Inhibitor (DPP-4i) (Matched)', 'description': '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.\n\nThis 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.'}, {'id': 'OG002', 'title': 'Empagliflozin (Matched to Sitagliptin (SITA))', 'description': '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.'}, {'id': 'OG003', 'title': 'Sitagliptin (SITA) (Matched)', 'description': '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.\n\nThis 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.'}, {'id': 'OG004', 'title': 'Empagliflozin (Matched to Glucagon-like Peptide-1 Receptor Agonist (GLP-1-RA))', 'description': '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.'}, {'id': 'OG005', 'title': 'Glucagon-like Peptide-1 Receptor Agonist (GLP-1-RA) (Matched)', 'description': '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.\n\nThis 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.'}], '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.', 'description': 'Healthcare resource utilization includes hospitalizations, hospital stays. outpatient visits, and rehabilitation stays.', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Indirect Healthcare Costs (Including Indirect Costs of Days Absent From Work)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Empagliflozin (Matched to Dipeptidyl Peptidase 4 Inhibitor (DPP-4i))', 'description': '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.\n\nThis 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.'}, {'id': 'OG001', 'title': 'Dipeptidyl Peptidase 4 Inhibitor (DPP-4i) (Matched)', 'description': '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.\n\nThis 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.'}, {'id': 'OG002', 'title': 'Empagliflozin (Matched to Sitagliptin (SITA))', 'description': '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.'}, {'id': 'OG003', 'title': 'Sitagliptin (SITA) (Matched)', 'description': '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.\n\nThis 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.'}, {'id': 'OG004', 'title': 'Empagliflozin (Matched to Glucagon-like Peptide-1 Receptor Agonist (GLP-1-RA))', 'description': '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.'}, {'id': 'OG005', 'title': 'Glucagon-like Peptide-1 Receptor Agonist (GLP-1-RA) (Matched)', 'description': '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.\n\nThis 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.'}], '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.', '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.', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Patients Who Started an Empagliflozin Therapy', 'description': '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.'}, {'id': 'FG001', 'title': 'All Patients Who Started a DPP-4 Inhibitor (Specifically Sitagliptin) Therapy', 'description': '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.'}, {'id': 'FG002', 'title': 'All Patients Who Started a GLP-1 Receptor Agonist Therapy', 'description': '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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3285'}, {'groupId': 'FG001', 'numSubjects': '19433'}, {'groupId': 'FG002', 'numSubjects': '1747'}]}, {'type': 'Patients Who Started a Sitagliptin Therapy', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '18382'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3285'}, {'groupId': 'FG001', 'numSubjects': '19433'}, {'groupId': 'FG002', 'numSubjects': '1747'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '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.', 'preAssignmentDetails': 'All subjects who strictly met all inclusion and none of the exclusion criteria were included in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3285', 'groupId': 'BG000'}, {'value': '19433', 'groupId': 'BG001'}, {'value': '1747', 'groupId': 'BG002'}, {'value': '24465', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'All Patients Who Started an Empagliflozin Therapy', 'description': '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.'}, {'id': 'BG001', 'title': 'All Patients Who Started a DPP-4 Inhibitor (Specifically Sitagliptin) Therapy', 'description': '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.'}, {'id': 'BG002', 'title': 'All Patients Who Started a GLP-1 Receptor Agonist Therapy', 'description': '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.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '3285', 'groupId': 'BG000'}, {'value': '19433', 'groupId': 'BG001'}, {'value': '1747', 'groupId': 'BG002'}, {'value': '24465', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '60.0', 'spread': '11.0', 'groupId': 'BG000'}, {'value': '63.3', 'spread': '12.6', 'groupId': 'BG001'}, {'value': '55.0', 'spread': '12.0', 'groupId': 'BG002'}, {'value': '62.3', 'spread': '13.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '3285', 'groupId': 'BG000'}, {'value': '19433', 'groupId': 'BG001'}, {'value': '1747', 'groupId': 'BG002'}, {'value': '24465', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '1110', 'groupId': 'BG000'}, {'value': '7705', 'groupId': 'BG001'}, {'value': '754', 'groupId': 'BG002'}, {'value': '9569', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '2175', 'groupId': 'BG000'}, {'value': '11728', 'groupId': 'BG001'}, {'value': '993', 'groupId': 'BG002'}, {'value': '14896', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}], 'populationDescription': 'All eligible participants in this study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-01-20', 'size': 1165280, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-09-26T04:24', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-08', 'studyFirstSubmitDate': '2020-03-03', 'resultsFirstSubmitDate': '2022-09-26', 'studyFirstSubmitQcDate': '2020-03-03', 'lastUpdatePostDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-08', 'studyFirstPostDateStruct': {'date': '2020-03-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Direct Healthcare Cost', '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.', '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.'}, {'measure': 'Healthcare Resource Utilization', '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.', 'description': 'Healthcare resource utilization includes hospitalizations, hospital stays. outpatient visits, and rehabilitation stays.'}], 'secondaryOutcomes': [{'measure': 'Indirect Healthcare Costs (Including Indirect Costs of Days Absent From Work)', '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.', '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mystudywindow.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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)\n* 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).\n* At least one prescription of Empagliflozin or a DPP-4i /Sitagliptin in the inclusion period (01/01/2015 - 31/12/2016)\n\nExclusion Criteria:\n\n* 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)\n\n * 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).'}, 'identificationModule': {'nctId': 'NCT04295005', 'briefTitle': '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', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'The Empagliflozin vs. DPP-4 Inhibitors and GLP-1 Receptor Agonists Cost of Care Study: a German Claims Data Analysis', 'orgStudyIdInfo': {'id': '1245-0221'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'All patients who started an Empagliflozin therapy', 'description': '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.', 'interventionNames': ['Drug: Empagliflozin']}, {'label': 'All patients who started a DPP-4 inhibitor (specifically Sitagliptin) therapy', 'description': '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.', 'interventionNames': ['Drug: DPP-4i']}, {'label': 'All patients who started a GLP-1 receptor agonist therapy', 'description': '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.', 'interventionNames': ['Drug: GLP-1-RA']}], 'interventions': [{'name': 'Empagliflozin', 'type': 'DRUG', 'description': 'film coated tablet', 'armGroupLabels': ['All patients who started an Empagliflozin therapy']}, {'name': 'DPP-4i', 'type': 'DRUG', 'description': 'film coated tablets, specifically Sitagliptin', 'armGroupLabels': ['All patients who started a DPP-4 inhibitor (specifically Sitagliptin) therapy']}, {'name': 'GLP-1-RA', 'type': 'DRUG', 'description': 'subcutaneous injection or tablet', 'armGroupLabels': ['All patients who started a GLP-1 receptor agonist therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55216', 'city': 'Ingelheim', 'country': 'Germany', 'facility': 'Boehringer Ingelheim', 'geoPoint': {'lat': 49.97078, 'lon': 8.05883}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': '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).\n\nFor more details refer to: https://www.mystudywindow.com/msw/datatransparency'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}