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Description of the real-life treatment of adult patients with type-2 diabetes mellitus (T2DM) receiving Empagliflozin, comparing the characteristics of patients starting Empagliflozin in three time intervals
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients receiving Empagliflozin until mid Sep 2015 | Patients receiving Empagliflozin before the EMPA-REG-OUTCOME study was published time until mid-Sept. 2015; Cohort 1 |
| |
| Patients receiving Empagliflozin until CV Label Change time | Patients receiving Empagliflozin starting from the EMPA-REG-OUTCOME study being published until CV Label Change time from mid-Sept. 2015-mid-Jan. 2017; Cohort 2 |
| |
| Patients receiving Empagliflozin until last available data cut | Patients receiving Empagliflozin starting from mid-Jan. 2017 until last; Cohort 3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin | Drug | drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Previous Occurence of Cardiovascular Comorbidities | Percentage of patients with previous occurence of cardiovascular (CV) comorbidities, including myocardial infarction, stroke, coronary artery disease, peripheral arterial disease, congestive heart failure. | At baseline. |
| Percentage of Participants With Previous Occurence of Other Typical Diabetes Complications | Percentage of participants with previous occurence of other typical diabetes complications, including, Neuropathy, Nephropathy, Chronic Kidney Disease, Microalbuminuria, Macroalbuminuria, estimated glomerular filtration rate (eGFR), diabetic foot syndrome, retinopathy (background and proliferative). | At baseline. |
| Percentage of Participants With Antidiabetic and Cardiovascular Co-medication | Percentage of participants with antidiabetic and cardiovascular co-medication, including lipid-lowering agents, other antihypertensives, antiplatelets and anticoagulants. | At baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants by Age Category | Percentage of participants by age category; younger than 65 (< 65), from 65 to 74 (65 ≤ 75) , from 75 to 80 (75 - 80) , older than 80 (> 80). | At baseline. |
| Percentage of Male Participants |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with Diabetes Mellitus, Type 2, treated with Empagliflozin
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diabetes Agenda 2010 GmbH | Mahlow | 15831 | Germany |
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| Label | URL |
|---|---|
| Related Info | View source |
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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, except for the following exclusions:
Requestors can use the following link http://trials.boehringer-ingelheim.com/
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All patients were screened for eligibility to participate in the trial. Only patients that met all the inclusion and none of the exclusion criteria were included in the trial.
A retrospective real-world evidence study based on existing data to describe the treatment and population characteristics of patients with type-2 diabetes mellitus (T2DM) receiving empagliflozin in thee time intervals.
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| ID | Title | Description |
|---|---|---|
| FG000 | Early Users: Patients Receiving Empagliflozin Until Mid-September 2015 | Data from two german patient registries (Diabetes-Patienten-Verlaufs-Dokumentations (DPV) and Diabetes Versorgungs-Evaluation (DIVE)) on patients with type 2 diabetes mellitus (T2DM), registered between 2014 and 2019, receiving empagliflozin were used. Cohort 1 (early users) included only patients who received empagliflozin before the EMPA-REG OUTCOME study publication in mid-September 2015. |
| FG001 | Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017 | Data from two german patient registries (Diabetes-Patienten-Verlaufs-Dokumentations (DPV) and Diabetes Versorgungs-Evaluation (DIVE)) on patients with T2DM, registered between 2014 and 2019, receiving empagliflozin were used. Cohort 2 (intermediate users) included only patients who started empagliflozin after the EMPA-REG OUTCOME study publication (mid-September 2015), but before the European Medicines Agency label change (mid-January 2017). |
| FG002 | Late Users: Patients Receiving Empagliflozin After Mid-January 2017 | Data from two german patient registries (Diabetes-Patienten-Verlaufs-Dokumentations (DPV) and Diabetes Versorgungs-Evaluation (DIVE)) on patients with T2DM, registered between 2014 and 2019, receiving empagliflozin were used. Cohort 3 (late users) included only patients who started empagliflozin after mid-January 2017 until last available data cut in September 2019. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All patients from the two largest German registries (Diabetes-Patienten-Verlaufs-Dokumentation and Diabetes Versorgungs-Evaluation) with Type-2 Diabetes Mellitus and with empagliflozin treatment were included in the analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Early Users: Patients Receiving Empagliflozin Until Mid-September 2015 | Data from two german patient registries (Diabetes-Patienten-Verlaufs-Dokumentations (DPV) and Diabetes Versorgungs-Evaluation (DIVE)) on patients with type 2 diabetes mellitus (T2DM), registered between 2014 and 2019, receiving empagliflozin were used. Cohort 1 (early users) included only patients who received empagliflozin before the EMPA-REG OUTCOME study publication in mid-September 2015. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Previous Occurence of Cardiovascular Comorbidities | Percentage of patients with previous occurence of cardiovascular (CV) comorbidities, including myocardial infarction, stroke, coronary artery disease, peripheral arterial disease, congestive heart failure. | All patients from the two largest German registries (Diabetes-Patienten-Verlaufs-Dokumentation and Diabetes Versorgungs-Evaluation) with Type-2 Diabetes Mellitus and with empagliflozin treatment were included in the analysis. | Posted | Number | Percentage of participants | At baseline. |
|
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As this is a non-interventional study with secondary use of data retrieved from a US health claims database, safety monitoring and safety reporting on an individual case level is not applicable. "0" total Number of Participants at Risk means "All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed".
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Early Users: Patients Receiving Empagliflozin Until Mid-September 2015 | Data from two german patient registries (Diabetes-Patienten-Verlaufs-Dokumentations (DPV) and Diabetes Versorgungs-Evaluation (DIVE)) on patients with type 2 diabetes mellitus (T2DM), registered between 2014 and 2019, receiving empagliflozin were used. Cohort 1 (early users) included only patients who received empagliflozin before the EMPA-REG OUTCOME study publication in mid-September 2015. |
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The main limitation of the study is that patients were recruited from specialized centers that were participating in diabetes registries, which could bias the results toward patients requiring specialist care. The cross-sectional nature of the study precludes the identification of causal links between findings.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 16, 2019 | Dec 9, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
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The percentage of male participants is reported.
| At baseline. |
| Weight of Participants | Weight of participants. | At baseline. |
| Height of Participants | Height of participants. | At baseline. |
| Glycated Hemoglobin (HbA1c) | Glycated hemoglobin (HbA1c). | At baseline. |
| Duration of Diabetes | Duration of diabetes (time since diagnosis). | At baseline. |
| Percentage of Participants With Previous Glucose-lowering Treatment | Percentage of participants with glucose-lowering treatment prior to empagliflozin initiation. | At baseline. |
| Percentage of Patients Participated in Disease Management Programme (DMP) Type 2 Diabetes | Percentage of patients participated in Disease Management Programme (DMP) Type 2 Diabetes. | At baseline. |
| Number of Participants With Hospitalizations | Number of participants with hospitalizations. | At baseline. |
| Dosage of Empagliflozin | Dosage of empagliflozin. Number of patients on 10 milligram versus patients on 25 milligram empagliflozin. | At baseline. |
| Fasting Plasma Glucose (FPG) | Fasting plasma glucose (FPG). | At baseline. |
| BG001 | Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017 | Data from two german patient registries (Diabetes-Patienten-Verlaufs-Dokumentations (DPV) and Diabetes Versorgungs-Evaluation (DIVE)) on patients with T2DM, registered between 2014 and 2019, receiving empagliflozin were used. Cohort 2 (intermediate users) included only patients who started empagliflozin after the EMPA-REG OUTCOME study publication (mid-September 2015), but before the European Medicines Agency label change (mid-January 2017). |
| BG002 | Late Users: Patients Receiving Empagliflozin After Mid-January 2017 | Data from two german patient registries (Diabetes-Patienten-Verlaufs-Dokumentations (DPV) and Diabetes Versorgungs-Evaluation (DIVE)) on patients with T2DM, registered between 2014 and 2019, receiving empagliflozin were used. Cohort 3 (late users) included only patients who started empagliflozin after mid-January 2017 until last available data cut in September 2019. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 | Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017 | Data from two german patient registries (Diabetes-Patienten-Verlaufs-Dokumentations (DPV) and Diabetes Versorgungs-Evaluation (DIVE)) on patients with T2DM, registered between 2014 and 2019, receiving empagliflozin were used. Cohort 2 (intermediate users) included only patients who started empagliflozin after the EMPA-REG OUTCOME study publication (mid-September 2015), but before the European Medicines Agency label change (mid-January 2017). |
| OG002 | Late Users: Patients Receiving Empagliflozin After Mid-January 2017 | Data from two german patient registries (Diabetes-Patienten-Verlaufs-Dokumentations (DPV) and Diabetes Versorgungs-Evaluation (DIVE)) on patients with T2DM, registered between 2014 and 2019, receiving empagliflozin were used. Cohort 3 (late users) included only patients who started empagliflozin after mid-January 2017 until last available data cut in September 2019. |
|
|
|
| Primary | Percentage of Participants With Previous Occurence of Other Typical Diabetes Complications | Percentage of participants with previous occurence of other typical diabetes complications, including, Neuropathy, Nephropathy, Chronic Kidney Disease, Microalbuminuria, Macroalbuminuria, estimated glomerular filtration rate (eGFR), diabetic foot syndrome, retinopathy (background and proliferative). | All patients from the two largest German registries (Diabetes-Patienten-Verlaufs-Dokumentation and Diabetes Versorgungs-Evaluation) with Type-2 Diabetes Mellitus and with empagliflozin treatment were included in the analysis. | Posted | Number | Percentage of participants | At baseline. |
|
|
|
|
| Primary | Percentage of Participants With Antidiabetic and Cardiovascular Co-medication | Percentage of participants with antidiabetic and cardiovascular co-medication, including lipid-lowering agents, other antihypertensives, antiplatelets and anticoagulants. | All patients from the two largest German registries (Diabetes-Patienten-Verlaufs-Dokumentation and Diabetes Versorgungs-Evaluation) with Type-2 Diabetes Mellitus and with empagliflozin treatment were included in the analysis. | Posted | Number | Percentage of participants | At baseline. |
|
|
|
|
| Secondary | Percentage of Participants by Age Category | Percentage of participants by age category; younger than 65 (< 65), from 65 to 74 (65 ≤ 75) , from 75 to 80 (75 - 80) , older than 80 (> 80). | All patients from the two largest German registries (Diabetes-Patienten-Verlaufs-Dokumentation and Diabetes Versorgungs-Evaluation) with Type-2 Diabetes Mellitus and with empagliflozin treatment were included in the analysis. | Posted | Number | Percentage of participants | At baseline. |
|
|
|
|
| Secondary | Percentage of Male Participants | The percentage of male participants is reported. | All patients from the two largest German registries (Diabetes-Patienten-Verlaufs-Dokumentation and Diabetes Versorgungs-Evaluation) with Type-2 Diabetes Mellitus and with empagliflozin treatment were included in the analysis. | Posted | Number | Percentage of participants | At baseline. |
|
|
|
|
| Secondary | Weight of Participants | Weight of participants. | All patients from the two largest German registries (Diabetes-Patienten-Verlaufs-Dokumentation and Diabetes Versorgungs-Evaluation) with Type-2 Diabetes Mellitus and with empagliflozin treatment were included in the analysis. | Posted | Mean | Standard Deviation | Kilogram (kg) | At baseline. |
|
|
|
|
| Secondary | Height of Participants | Height of participants. | All patients from the two largest German registries (Diabetes-Patienten-Verlaufs-Dokumentation and Diabetes Versorgungs-Evaluation) with Type-2 Diabetes Mellitus and with empagliflozin treatment were included in the analysis. | Posted | Mean | Standard Deviation | Centimeter (cm) | At baseline. |
|
|
|
|
| Secondary | Glycated Hemoglobin (HbA1c) | Glycated hemoglobin (HbA1c). | All patients from the two largest German registries (Diabetes-Patienten-Verlaufs-Dokumentation and Diabetes Versorgungs-Evaluation) with Type-2 Diabetes Mellitus and with empagliflozin treatment were included in the analysis. | Posted | Mean | Standard Deviation | nanomol/mol | At baseline. |
|
|
|
|
| Secondary | Duration of Diabetes | Duration of diabetes (time since diagnosis). | All patients from the two largest German registries (Diabetes-Patienten-Verlaufs-Dokumentation and Diabetes Versorgungs-Evaluation) with Type-2 Diabetes Mellitus and with empagliflozin treatment were included in the analysis. | Posted | Mean | Standard Deviation | Years | At baseline. |
|
|
|
|
| Secondary | Percentage of Participants With Previous Glucose-lowering Treatment | Percentage of participants with glucose-lowering treatment prior to empagliflozin initiation. | All patients from the two largest German registries (Diabetes-Patienten-Verlaufs-Dokumentation and Diabetes Versorgungs-Evaluation) with Type-2 Diabetes Mellitus and with empagliflozin treatment were included in the analysis. | Posted | Number | Percentage of participants | At baseline. |
|
|
|
|
| Secondary | Percentage of Patients Participated in Disease Management Programme (DMP) Type 2 Diabetes | Percentage of patients participated in Disease Management Programme (DMP) Type 2 Diabetes. | All patients from the two largest German registries (Diabetes-Patienten-Verlaufs-Dokumentation and Diabetes Versorgungs-Evaluation) with Type-2 Diabetes Mellitus and with empagliflozin treatment were included in the analysis. | Posted | Number | Percentage of participants | At baseline. |
|
|
|
|
| Secondary | Number of Participants With Hospitalizations | Number of participants with hospitalizations. | All patients from the two largest German registries (Diabetes-Patienten-Verlaufs-Dokumentation and Diabetes Versorgungs-Evaluation) with Type-2 Diabetes Mellitus and with empagliflozin treatment were included in the analysis. | Posted | Number | Participants | At baseline. |
|
|
|
| Secondary | Dosage of Empagliflozin | Dosage of empagliflozin. Number of patients on 10 milligram versus patients on 25 milligram empagliflozin. | All patients from the two largest German registries (Diabetes-Patienten-Verlaufs-Dokumentation and Diabetes Versorgungs-Evaluation) with Type-2 Diabetes Mellitus and with empagliflozin treatment were included in the analysis. | Posted | Count of Participants | Participants | At baseline. |
|
|
|
| Secondary | Fasting Plasma Glucose (FPG) | Fasting plasma glucose (FPG). | All patients from the two largest German registries (Diabetes-Patienten-Verlaufs-Dokumentation and Diabetes Versorgungs-Evaluation) with Type-2 Diabetes Mellitus and with empagliflozin treatment were included in the analysis. | Posted | Mean | Standard Deviation | Milligram / deciliter | At baseline. |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017 | Data from two german patient registries (Diabetes-Patienten-Verlaufs-Dokumentations (DPV) and Diabetes Versorgungs-Evaluation (DIVE)) on patients with T2DM, registered between 2014 and 2019, receiving empagliflozin were used. Cohort 2 (intermediate users) included only patients who started empagliflozin after the EMPA-REG OUTCOME study publication (mid-September 2015), but before the European Medicines Agency label change (mid-January 2017). | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Late Users: Patients Receiving Empagliflozin After Mid-January 2017 | Data from two german patient registries (Diabetes-Patienten-Verlaufs-Dokumentations (DPV) and Diabetes Versorgungs-Evaluation (DIVE)) on patients with T2DM, registered between 2014 and 2019, receiving empagliflozin were used. Cohort 3 (late users) included only patients who started empagliflozin after mid-January 2017 until last available data cut in September 2019. | 0 | 0 | 0 | 0 | 0 | 0 |
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.
| D004700 | Endocrine System Diseases |
| Male |
|
|
| Antplatelet, anticoagulant drugs |
|
| Glucose-lowering therapies |
|
| <0.001 |
| Other |
| Antiplatelet, anticoagulant drugs | Chi-squared | <0.001 | Other |
| Glucose-lowering therapies | Chi-squared | <0.001 | Other |
| Title | Measurements |
|---|---|
|
| 75 - 80 |
|
| > 80 |
|
| 0.001 |
| Other |
| Group: 75 - 80 | Chi-squared | <0.001 | Other |
| Group: > 80 | Chi-squared | <0.002 | Other |
| Title | Measurements |
|---|---|
|
| Acarbose |
|
| Sulfonylurea |
|
| Dipeptidyl peptidase-4 (DPP-4) inhibitors |
|
| Glucagon-like peptide-1 (GLP-1) agonists |
|
| Sodium-glucose transport protein-2 (SGLT2) inhibitors other than empagliflozin |
|
| <0.001 |
| Other |
| Acarbose | Chi-squared | 0.157 | Other |
| Sulfonylurea | Chi-squared | <0.001 | Other |
| Dipeptidyl peptidase-4 (DPP-4) inhibitors | Chi-squared | 0.071 | Other |
| Glucagon-like peptide-1 (GLP-1) agonists | Chi-squared | 0.317 | Other |
| Sodium-glucose transport protein-2 (SGLT2) inhibitors other than empagliflozin | Chi-squared | <0.001 | Other |
| 25 milligram of empagliflozin |
|