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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
Empagliflozin (Jardiance), a highly potent and selective inhibitor of the sodium-glucose cotransporter 2 (SGLT2), was approved in Europe in May 2014 for the treatment of type 2 diabetes mellitus (T2DM) to improve glycaemic control in adults. As part of the risk management plan, Boehringer Ingelheim International GmbH (BI) has committed to conduct a post-authorisation safety study (PASS) to evaluate the liver and renal safety of empagliflozin. The study will also evaluate the risks of severe complications of urinary tract infections (UTIs) and genital infections. To evaluate the association between empagliflozin use and mentioned outcomes routinely collected health information from the Clinical Practice Research Datalink (CPRD), the Hospital Episodes Statistics, and Office of National Statistic will be used. This PASS will be conducted through an observational cohort study among adult patients with T2DM and at least 12 months of continuous enrolment in the CPRD where new users of empagliflozin will be compared to new users of dipeptidyl peptidase-4 (DPP4) inhibitors. Estimations will be made on the crude and adjusted incidence rates and adjusted incidence rate ratios of the primary and secondary outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Empagliflozin | All eligible patients type 2 diabetes mellitus initiating Empagliflozin treatment within the study period, from existing data of routine medical care in the Clinical Practice Research Datalink (CPRD) in the United Kingdom (UK), HealthCore Integrated Research Database (HIRD) in the United States (US), and Danish Population Registries (Danish Registries) in Denmark. The study period started on 01 August 2014, the date of empagliflozin launch in the UK, US, and Denmark. The study end date was 01 August 2019 in CPRD and Danish Registries and 31 July 2019 in HIRD. |
| |
| DPP-4 inhibitors | All eligible patients with type 2 diabetes mellitus initiating Dipeptidyl peptidase-4 (DPP-4) inhibitors treatment within the study period, existing data of routine medical care in the Clinical Practice Research Datalink (CPRD) in the United Kingdom (UK), HealthCore Integrated Research Database (HIRD) in the United States (US), and Danish Population Registries (Danish Registries) in Denmark. The study period started on 01 August 2014, the date of empagliflozin launch in the UK, US, and Denmark. The study end date was 01 August 2019 in CPRD and Danish Registries and 31 July 2019 in HIRD. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin | Drug | drug |
| |
| DPP-4 inhibitors |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence Rates of Acute Liver Injury (ALI) in Patients With no Predisposing Conditions (ALI1) in Propensity Score-trimmed Cohort for ALI1 | Incidence rates (IRs) of acute liver injury (ALI) in patients with no predisposing conditions (ALI1) in propensity score-trimmed study cohorts for ALI1 are reported. Unadjusted IRs were computed as the number of events divided by the total person-years at risk in the empagliflozin and DPP-4 inhibitors cohorts overall and for subgroups with and without insulin use at the index date. IRs adjusted for propensity score decile were generated for empagliflozin and DPP-4 inhibitor cohorts overall (not stratified by any other variable). These estimates with corresponding 95% confidence interval (CIs) were generated using a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model. | up to 5 years |
| Incidence Rates of Acute Kidney Injury (AKI) in Propensity Score-trimmed Cohort for AKI | Incidence rates (IRs) of acute kidney injury (AKI) in propensity score-trimmed cohort for AKI are reported. Unadjusted IRs were computed as the number of events divided by the total person-years at risk in the empagliflozin and DPP-4 inhibitors cohorts overall and for subgroups with and without insulin use at the index date. IRs adjusted for propensity score decile were generated for empagliflozin and DPP-4 inhibitor cohorts overall (not stratified by any other variable). These estimates with corresponding 95% CIs were generated through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model. | up to 5 years |
| Incidence Rates of Diabetic Ketoacidosis (DKA) in Propensity Score-trimmed Cohort for DKA |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence Rates of Acute Liver Injury (ALI) in Patients With or Without Predisposing Conditions (ALI2) in Propensity Score-trimmed Cohort for ALI2 | Incidence rates (IRs) of acute liver injury (ALI) in patients with or without predisposing conditions (ALI2) in propensity score-trimmed cohort for ALI2 are reported. Unadjusted IRs were computed as the number of events divided by the total person-years at risk in the empagliflozin and DPP-4 inhibitors cohorts overall and for subgroups with and without insulin use at the index date. IRs adjusted for propensity score decile were generated for empagliflozin and DPP-4 inhibitor cohorts overall (not stratified by any other variable). These estimates with corresponding 95% CIs were generated through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model. |
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Inclusion criteria:
Exclusion criteria:
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T2DM eligible patients in CPRD
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RTI health solutions | One Or Multiple Sites | United Kingdom |
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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. 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
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All subjects were screened for eligibility to ensure that they (the subjects) strictly met all inclusion and none of the exclusion criteria.
This was a non-interventional observational cohort study using existing data from routine medical care in the Clinical Practice Research Datalink in the United Kingdom, the Danish Population Registries in Denmark, and the HealthCore Integrated Research Database in the United States investigating safety among patients with type 2 diabetes mellitus treated with empagliflozin versus Dipeptidyl peptidase-4 inhibitors.
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| ID | Title | Description |
|---|---|---|
| FG000 | Empagliflozin | All eligible patients type 2 diabetes mellitus initiating Empagliflozin treatment within the study period, from existing data of routine medical care in the Clinical Practice Research Datalink (CPRD) in the United Kingdom (UK), HealthCore Integrated Research Database (HIRD) in the United States (US), and Danish Population Registries (Danish Registries) in Denmark. The study period started on 01 August 2014, the date of empagliflozin launch in the UK, US, and Denmark. The study end date was 01 August 2019 in CPRD and Danish Registries and 31 July 2019 in HIRD. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 19, 2021 | Sep 17, 2024 |
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| Drug |
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Incidence rates (IRs) of diabetic ketoacidosis (DKA) in propensity score-trimmed cohort for DKA are reported.
Unadjusted IRs were computed as the number of events divided by the total person-years at risk in the empagliflozin and DPP-4 inhibitors cohorts overall and for subgroups with and without insulin use at the index date. IRs adjusted for propensity score decile were generated for empagliflozin and DPP-4 inhibitor cohorts overall (not stratified by any other variable). These estimates with corresponding 95% CIs were generated through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.
| up to 5 years |
| Incidence Rates of Severe Complications of Urinary Tract Infections (UTIs) in Propensity Score-trimmed Cohort for UTI - CPRD Only | Incidence rates (IRs) of severe complications of urinary tract infections (UTIs) in propensity score-trimmed cohort for UTI among CPRD participants are reported. Unadjusted IRs were computed as the number of events divided by the total person-years at risk in the empagliflozin and DPP-4 inhibitors cohorts overall and for subgroups with and without insulin use at the index date. IRs adjusted for propensity score decile were generated for empagliflozin and DPP-4 inhibitor cohorts overall (not stratified by any other variable). These estimates with corresponding 95% CIs were generated through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model. | up to 5 years |
| Incidence Rates of Genital Infections in Males (GIM) in Propensity Score-trimmed Cohort for GIM - CPRD Only | Incidence rates (IRs) of genital infections in males (GIM) in propensity score-trimmed cohorts for GIM among CPRD participants are reported. Unadjusted IRs were computed as the number of events divided by the total person-years at risk in the empagliflozin and DPP-4 inhibitors cohorts overall and for subgroups with and without insulin use at the index date. IRs adjusted for propensity score decile were generated for empagliflozin and DPP-4 inhibitor cohorts overall (not stratified by any other variable). These estimates with corresponding 95% CIs were generated through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model. | up to 5 years |
| Incidence Rates of Genital Infections in Females (GIF) in Propensity Score-trimmed Cohort for GIF - CPRD Only | Incidence rates (IRs) of genital infections in females (GIF) in propensity score-trimmed cohort for GIF among CPRD participants are reported. Unadjusted IRs were computed as the number of events divided by the total person-years at risk in the empagliflozin and DPP-4 inhibitors cohorts overall and for subgroups with and without insulin use at the index date. IRs adjusted for propensity score decile were generated for empagliflozin and DPP-4 inhibitor cohorts overall (not stratified by any other variable). These estimates with corresponding 95% CIs were generated through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model. | up to 5 years |
| up to 5 years |
| Incidence Rates of Chronic Kidney Disease (CKD) in Propensity Score-trimmed Cohort for CKD - CPRD Only | Incidence rates (IRs) of chronic kidney disease (CKD) in propensity score-trimmed cohort for CKD among CPRD participants are reported. Unadjusted IRs were computed as the number of events divided by the total person-years at risk in the empagliflozin and DPP-4 inhibitors cohorts overall and for subgroups with and without insulin use at the index date. IRs adjusted for propensity score decile were generated for empagliflozin and DPP-4 inhibitor cohorts overall (not stratified by any other variable). These estimates with corresponding 95% CIs were generated through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model. | up to 5 years |
| Incidence Rates of Severe Genital Infections in Males (GIMH) in Propensity Score-trimmed Cohort for GIM - CPRD Only | Incidence rates (IRs) of severe genital infections in males (GIMH) in propensity score-trimmed cohort for GIM among CPRD participants are reported. Unadjusted IRs were computed as the number of events divided by the total person-years at risk in the empagliflozin and DPP-4 inhibitors cohorts overall and for subgroups with and without insulin use at the index date. IRs adjusted for propensity score decile were generated for empagliflozin and DPP-4 inhibitor cohorts overall (not stratified by any other variable). These estimates with corresponding 95% CIs were generated through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model. | up to 5 years |
| Incidence Rates of Severe Genital Infections in Females (GIFH) in Propensity Score-trimmed Cohort for GIF - CPRD Only | Incidence rates (IRs) of severe genital infections in females (GIFH) in propensity score-trimmed cohort for GIF among CPRD participants are reported. Unadjusted IRs were computed as the number of events divided by the total person-years at risk in the empagliflozin and DPP-4 inhibitors cohorts overall and for subgroups with and without insulin use at the index date. IRs adjusted for propensity score decile were generated for empagliflozin and DPP-4 inhibitor cohorts overall (not stratified by any other variable). These estimates with corresponding 95% CIs were generated through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model. | up to 5 years |
| FG001 | DPP-4 Inhibitors | All eligible patients with type 2 diabetes mellitus initiating Dipeptidyl peptidase-4 (DPP-4) inhibitors treatment within the study period, existing data of routine medical care in the Clinical Practice Research Datalink (CPRD) in the United Kingdom (UK), HealthCore Integrated Research Database (HIRD) in the United States (US), and Danish Population Registries (Danish Registries) in Denmark. The study period started on 01 August 2014, the date of empagliflozin launch in the UK, US, and Denmark. The study end date was 01 August 2019 in CPRD and Danish Registries and 31 July 2019 in HIRD. |
| Propensity Score-trimmed Cohort for DKA | The propensity score (PS)-trimmed cohort was created by trimming extreme values of PS from a Diabetic ketoacidosis (DKA)-specific PS model including all DKA-related variables. |
|
| Propensity Score-trimmed Cohort for AKI | The propensity score (PS)-trimmed cohort was created by trimming extreme values of PS from a acute kidney injury (AKI)-specific PS model including all AKI-related variables. |
|
| Propensity Score-trimmed Cohort for ALI2 | The propensity score (PS)-trimmed cohort was created by trimming extreme values of PS from a Acute liver injury with or without predisposing conditions (ALI2)-specific PS model including all ALI2-related variables. |
|
| Propensity Score-trimmed Cohort for CKD - CPRD Only | The propensity score (PS)-trimmed cohort was created by trimming extreme values of PS from a Chronic kidney disease (CKD)-specific PS model including all CKD-related variables. CKD was evaluated only in CPRD database. |
|
| Propensity Score-trimmed Cohort for GIM - CPRD Only | The propensity score (PS)-trimmed cohort in males was created by trimming extreme values of PS from a genital infection in males (GIM)-specific PS model including all GIM-related variables. GIM was evaluated only in CPRD database. |
|
| Propensity Score-trimmed Cohort for UTI - CPRD Only | The propensity score (PS)-trimmed cohort was created by trimming extreme values of PS from a Urinary tract infection (UTI)-specific PS model including all UTI-related variables. UTI was evaluated only in CPRD database. |
|
| Propensity Score-trimmed Cohort for GIF - CPRD Only | The propensity score (PS)-trimmed cohort in females was created by trimming extreme values of PS from a genital infection in females (GIF)-specific PS model including all GIF-related variables. GIF was evaluated only in CPRD database. |
|
| Propensity Score-trimmed Cohort for ALI1 | The propensity score (PS)-trimmed cohort was created by trimming extreme values of PS from a Acute liver injury with no predisposing conditions (ALI1)-specific PS model including all ALI1-related variables. The number of participants from the Danish Registries treated with empagliflozin, and treated with DPP-4 inhibitors and ≥ 3 glucose-lowering drugs are not reported due to the Danish small cell count policy. |
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| COMPLETED |
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| NOT COMPLETED |
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All eligible subjects who strictly met all inclusion and none of the exclusion criteria.
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| ID | Title | Description |
|---|---|---|
| BG000 | Empagliflozin | All eligible patients type 2 diabetes mellitus initiating Empagliflozin treatment within the study period, from existing data of routine medical care in the Clinical Practice Research Datalink (CPRD) in the United Kingdom (UK), HealthCore Integrated Research Database (HIRD) in the United States (US), and Danish Population Registries (Danish Registries) in Denmark. The study period started on 01 August 2014, the date of empagliflozin launch in the UK, US, and Denmark. The study end date was 01 August 2019 in CPRD and Danish Registries and 31 July 2019 in HIRD. |
| BG001 | DPP-4 Inhibitors | All eligible patients with type 2 diabetes mellitus initiating Dipeptidyl peptidase-4 (DPP-4) inhibitors treatment within the study period, existing data of routine medical care in the Clinical Practice Research Datalink (CPRD) in the United Kingdom (UK), HealthCore Integrated Research Database (HIRD) in the United States (US), and Danish Population Registries (Danish Registries) in Denmark. The study period started on 01 August 2014, the date of empagliflozin launch in the UK, US, and Denmark. The study end date was 01 August 2019 in CPRD and Danish Registries and 31 July 2019 in HIRD. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| 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 | Incidence Rates of Acute Liver Injury (ALI) in Patients With no Predisposing Conditions (ALI1) in Propensity Score-trimmed Cohort for ALI1 | Incidence rates (IRs) of acute liver injury (ALI) in patients with no predisposing conditions (ALI1) in propensity score-trimmed study cohorts for ALI1 are reported. Unadjusted IRs were computed as the number of events divided by the total person-years at risk in the empagliflozin and DPP-4 inhibitors cohorts overall and for subgroups with and without insulin use at the index date. IRs adjusted for propensity score decile were generated for empagliflozin and DPP-4 inhibitor cohorts overall (not stratified by any other variable). These estimates with corresponding 95% confidence interval (CIs) were generated using a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model. | All eligible subjects who strictly met all inclusion and none of the exclusion criteria, and with non-missing ALI results and with no predisposing conditions (ALI1) were included. The cohort after propensity score trimming (extreme values of propensity score were trimmed) was used. A ALI1-specific propensity score model was used for the propensity score including all ALI1-related variables. Due to the Danish small cell count policy, some cohorts were not reported (see limits & caveats). | Posted | Number | 95% Confidence Interval | Events per 1000 person-years | up to 5 years |
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| Primary | Incidence Rates of Acute Kidney Injury (AKI) in Propensity Score-trimmed Cohort for AKI | Incidence rates (IRs) of acute kidney injury (AKI) in propensity score-trimmed cohort for AKI are reported. Unadjusted IRs were computed as the number of events divided by the total person-years at risk in the empagliflozin and DPP-4 inhibitors cohorts overall and for subgroups with and without insulin use at the index date. IRs adjusted for propensity score decile were generated for empagliflozin and DPP-4 inhibitor cohorts overall (not stratified by any other variable). These estimates with corresponding 95% CIs were generated through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model. | All eligible subjects who strictly met all inclusion and none of the exclusion criteria. The cohort after propensity score trimming (extreme values of propensity score were trimmed) was used. A AKI-specific propensity score model was used for the propensity score including all AKI-related variables. | Posted | Number | 95% Confidence Interval | Events per 1000 person-years | up to 5 years |
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| Primary | Incidence Rates of Diabetic Ketoacidosis (DKA) in Propensity Score-trimmed Cohort for DKA | Incidence rates (IRs) of diabetic ketoacidosis (DKA) in propensity score-trimmed cohort for DKA are reported. Unadjusted IRs were computed as the number of events divided by the total person-years at risk in the empagliflozin and DPP-4 inhibitors cohorts overall and for subgroups with and without insulin use at the index date. IRs adjusted for propensity score decile were generated for empagliflozin and DPP-4 inhibitor cohorts overall (not stratified by any other variable). These estimates with corresponding 95% CIs were generated through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model. | All eligible subjects who strictly met all inclusion and none of the exclusion criteria. The cohort after propensity score trimming (extreme values of propensity score were trimmed) was used. A DKA-specific propensity score model was used for the propensity score including all DKA-related variables. | Posted | Number | 95% Confidence Interval | Events per 1000 person-years | up to 5 years |
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| Primary | Incidence Rates of Severe Complications of Urinary Tract Infections (UTIs) in Propensity Score-trimmed Cohort for UTI - CPRD Only | Incidence rates (IRs) of severe complications of urinary tract infections (UTIs) in propensity score-trimmed cohort for UTI among CPRD participants are reported. Unadjusted IRs were computed as the number of events divided by the total person-years at risk in the empagliflozin and DPP-4 inhibitors cohorts overall and for subgroups with and without insulin use at the index date. IRs adjusted for propensity score decile were generated for empagliflozin and DPP-4 inhibitor cohorts overall (not stratified by any other variable). These estimates with corresponding 95% CIs were generated through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model. | All eligible subjects who strictly met all inclusion and none of the exclusion criteria. The cohort after propensity score trimming (extreme values of propensity score were trimmed) was used. A UTI-specific propensity score model was used for the propensity score including all UTI-related variables. Because UTI was evaluated only in CPRD database, only participants from CPRD were used. | Posted | Number | 95% Confidence Interval | Events per 1000 person-years | up to 5 years |
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| Primary | Incidence Rates of Genital Infections in Males (GIM) in Propensity Score-trimmed Cohort for GIM - CPRD Only | Incidence rates (IRs) of genital infections in males (GIM) in propensity score-trimmed cohorts for GIM among CPRD participants are reported. Unadjusted IRs were computed as the number of events divided by the total person-years at risk in the empagliflozin and DPP-4 inhibitors cohorts overall and for subgroups with and without insulin use at the index date. IRs adjusted for propensity score decile were generated for empagliflozin and DPP-4 inhibitor cohorts overall (not stratified by any other variable). These estimates with corresponding 95% CIs were generated through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model. | All eligible subjects who strictly met all inclusion and none of the exclusion criteria. The cohort after propensity score trimming (extreme values of propensity score were trimmed) was used. A GIM-specific propensity score model was used for the propensity score including all GIM-related variables. Because genital infection was evaluated only in CPRD database, only participants from CPRD were used. | Posted | Number | 95% Confidence Interval | Events per 1000 person-years | up to 5 years |
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| Primary | Incidence Rates of Genital Infections in Females (GIF) in Propensity Score-trimmed Cohort for GIF - CPRD Only | Incidence rates (IRs) of genital infections in females (GIF) in propensity score-trimmed cohort for GIF among CPRD participants are reported. Unadjusted IRs were computed as the number of events divided by the total person-years at risk in the empagliflozin and DPP-4 inhibitors cohorts overall and for subgroups with and without insulin use at the index date. IRs adjusted for propensity score decile were generated for empagliflozin and DPP-4 inhibitor cohorts overall (not stratified by any other variable). These estimates with corresponding 95% CIs were generated through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model. | All eligible subjects who strictly met all inclusion and none of the exclusion criteria. The cohort after propensity score trimming (extreme values of propensity score were trimmed) was used. A GIF-specific propensity score model was used for the propensity score including all GIF-related variables. Because genital infection was evaluated only in CPRD database, only participants from CPRD were used. | Posted | Number | 95% Confidence Interval | Events per 1000 person-years | up to 5 years |
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| Secondary | Incidence Rates of Acute Liver Injury (ALI) in Patients With or Without Predisposing Conditions (ALI2) in Propensity Score-trimmed Cohort for ALI2 | Incidence rates (IRs) of acute liver injury (ALI) in patients with or without predisposing conditions (ALI2) in propensity score-trimmed cohort for ALI2 are reported. Unadjusted IRs were computed as the number of events divided by the total person-years at risk in the empagliflozin and DPP-4 inhibitors cohorts overall and for subgroups with and without insulin use at the index date. IRs adjusted for propensity score decile were generated for empagliflozin and DPP-4 inhibitor cohorts overall (not stratified by any other variable). These estimates with corresponding 95% CIs were generated through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model. | All eligible subjects who strictly met all inclusion and none of the exclusion criteria. The cohort after propensity score trimming (extreme values of propensity score were trimmed) was used. A ALI2-specific propensity score model was used for the propensity score including all ALI2-related variables. | Posted | Number | 95% Confidence Interval | Events per 1000 person-years | up to 5 years |
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| Secondary | Incidence Rates of Chronic Kidney Disease (CKD) in Propensity Score-trimmed Cohort for CKD - CPRD Only | Incidence rates (IRs) of chronic kidney disease (CKD) in propensity score-trimmed cohort for CKD among CPRD participants are reported. Unadjusted IRs were computed as the number of events divided by the total person-years at risk in the empagliflozin and DPP-4 inhibitors cohorts overall and for subgroups with and without insulin use at the index date. IRs adjusted for propensity score decile were generated for empagliflozin and DPP-4 inhibitor cohorts overall (not stratified by any other variable). These estimates with corresponding 95% CIs were generated through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model. | All eligible subjects who strictly met all inclusion and none of the exclusion criteria. The cohort after propensity score trimming (extreme values of propensity score were trimmed) was used. A CKD-specific propensity score model was used for the propensity score including all CKD-related variables. Because CKD was evaluated only in CPRD database, only participants from CPRD were used. | Posted | Number | 95% Confidence Interval | Events per 1000 person-years | up to 5 years |
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| Secondary | Incidence Rates of Severe Genital Infections in Males (GIMH) in Propensity Score-trimmed Cohort for GIM - CPRD Only | Incidence rates (IRs) of severe genital infections in males (GIMH) in propensity score-trimmed cohort for GIM among CPRD participants are reported. Unadjusted IRs were computed as the number of events divided by the total person-years at risk in the empagliflozin and DPP-4 inhibitors cohorts overall and for subgroups with and without insulin use at the index date. IRs adjusted for propensity score decile were generated for empagliflozin and DPP-4 inhibitor cohorts overall (not stratified by any other variable). These estimates with corresponding 95% CIs were generated through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model. | All eligible subjects who strictly met all inclusion and none of the exclusion criteria. The cohort after propensity score trimming (extreme values of propensity score were trimmed) was used. A GIM-specific propensity score model was used for the propensity score including all GIM-related variables. Because genital infection was evaluated only in CPRD database, only participants from CPRD were used. | Posted | Number | 95% Confidence Interval | Events per 1000 person-years | up to 5 years |
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| Secondary | Incidence Rates of Severe Genital Infections in Females (GIFH) in Propensity Score-trimmed Cohort for GIF - CPRD Only | Incidence rates (IRs) of severe genital infections in females (GIFH) in propensity score-trimmed cohort for GIF among CPRD participants are reported. Unadjusted IRs were computed as the number of events divided by the total person-years at risk in the empagliflozin and DPP-4 inhibitors cohorts overall and for subgroups with and without insulin use at the index date. IRs adjusted for propensity score decile were generated for empagliflozin and DPP-4 inhibitor cohorts overall (not stratified by any other variable). These estimates with corresponding 95% CIs were generated through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model. | All eligible subjects who strictly met all inclusion and none of the exclusion criteria. The cohort after propensity score trimming (extreme values of propensity score were trimmed) was used. A GIF-specific propensity score model was used for the propensity score including all GIF-related variables. Because genital infection was evaluated only in CPRD database, only participants from CPRD were used. | Posted | Number | 95% Confidence Interval | Events per 1000 person-years | up to 5 years |
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No applicable.
This study used existing data and adverse events were not planned to be collected and reported. The "0" in the All-cause Mortality, Serious Adverse Events, and Other Adverse Events sections below indicating "Not applicable".
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Empagliflozin | All eligible patients type 2 diabetes mellitus initiating Empagliflozin treatment within the study period, from existing data of routine medical care in the Clinical Practice Research Datalink (CPRD) in the United Kingdom (UK), HealthCore Integrated Research Database (HIRD) in the United States (US), and Danish Population Registries (Danish Registries) in Denmark. The study period started on 01 August 2014, the date of empagliflozin launch in the UK, US, and Denmark. The study end date was 01 August 2019 in CPRD and Danish Registries and 31 July 2019 in HIRD. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | DPP-4 Inhibitors | All eligible patients with type 2 diabetes mellitus initiating Dipeptidyl peptidase-4 (DPP-4) inhibitors treatment within the study period, existing data of routine medical care in the Clinical Practice Research Datalink (CPRD) in the United Kingdom (UK), HealthCore Integrated Research Database (HIRD) in the United States (US), and Danish Population Registries (Danish Registries) in Denmark. The study period started on 01 August 2014, the date of empagliflozin launch in the UK, US, and Denmark. The study end date was 01 August 2019 in CPRD and Danish Registries and 31 July 2019 in HIRD. | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
In the outcome measure ALI1, the number of patients after trimming belonging to the Danish Registries and treated with Empagliflozin, as well as with DPP-4 inhibitors and ≥ 3 glucose-lowering drugs, cannot be reported since the number of events in Danish Registries was 1 to 4, and the total cannot be given to avoid back-calculation of values due to the Danish small cell count policy.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim | 18002430127 | clintriage.rdg@boehringer-ingelheim.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 15, 2022 | Sep 17, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C570240 | empagliflozin |
| D054873 | Dipeptidyl-Peptidase IV Inhibitors |
| ID | Term |
|---|---|
| D011480 | Protease Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D007004 | Hypoglycemic Agents |
| D045505 | Physiological Effects of Drugs |
Not provided
Not provided
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| OG004 | DPP-4 Inhibitors - HIRD (After Propensity Score Trimming) | All eligible patients with type 2 diabetes mellitus initiating Dipeptidyl peptidase-4 (DPP-4) inhibitors treatment within the study period, existing data of routine medical care in the HealthCore Integrated Research Database (HIRD) in the United States (US). This group includes all eligible participants initiating DPP-4 inhibitors after propensity score-trimming, where the model used for propensity score was endpoint-specific including all variables related to the endpoint. |
| Other |
| Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model. | Adjusted incidence rate ratio | 0.55 | 2-Sided | 95 | 0.23 | 1.32 | Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors | Other |
| Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model. | Adjusted incidence rate ratio | 0.86 | 2-Sided | 95 | 0.52 | 1.41 | Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors | Other |
| OG001 | Empagliflozin - Danish Registries <3 Glucose-lowering Drugs (After Propensity Score Trimming) | All eligible patients with type 2 diabetes mellitus initiating Empagliflozin treatment within the study period with <3 glucose-lowering drugs, existing data of routine medical care in the Danish Population Registries (Danish Registries) in Denmark. This group includes all eligible participants initiating Empagliflozin after propensity score-trimming, where the model used for propensity score was endpoint-specific including all variables related to the endpoint. |
| OG002 | Empagliflozin - Danish Registries ≥3 Glucose-lowering Drugs (After Propensity Score Trimming) | All eligible patients with type 2 diabetes mellitus initiating Empagliflozin treatment within the study period with ≥3 glucose-lowering drugs, existing data of routine medical care in the Danish Population Registries (Danish Registries) in Denmark. This group includes all eligible participants initiating Empagliflozin after propensity score-trimming, where the model used for propensity score was endpoint-specific including all variables related to the endpoint. |
| OG003 | Empagliflozin - HIRD (After Propensity Score Trimming) | All eligible patients with type 2 diabetes mellitus initiating Empagliflozin treatment within the study period, existing data of routine medical care in the HealthCore Integrated Research Database (HIRD) in the United States (US). This group includes all eligible participants initiating Empagliflozin after propensity score-trimming, where the model used for propensity score was endpoint-specific including all variables related to the endpoint. |
| OG004 | DPP-4 Inhibitors - CPRD (After Propensity Score Trimming) | All eligible patients with type 2 diabetes mellitus initiating Dipeptidyl peptidase-4 (DPP-4) inhibitors treatment within the study period, existing data of routine medical care in the Clinical Practice Research Datalink (CPRD) in the United Kingdom (UK). This group includes all eligible participants initiating DPP-4 inhibitors after propensity score-trimming, where the model used for propensity score was endpoint-specific including all variables related to the endpoint. |
| OG005 | DPP-4 Inhibitors - Danish Registries <3 Glucose-lowering Drugs (After Propensity Score Trimming) | All eligible patients with type 2 diabetes mellitus initiating Dipeptidyl peptidase-4 (DPP-4) inhibitors treatment within the study period with <3 glucose-lowering drugs, existing data of routine medical care in the Danish Population Registries (Danish Registries) in Denmark. This group includes all eligible participants initiating DPP-4 inhibitors after propensity score-trimming, where the model used for propensity score was endpoint-specific including all variables related to the endpoint. |
| OG006 | DPP-4 Inhibitors - Danish Registries ≥3 Glucose-lowering Drugs (After Propensity Score Trimming) | All eligible patients with type 2 diabetes mellitus initiating Dipeptidyl peptidase-4 (DPP-4) inhibitors treatment within the study period with ≥3 glucose-lowering drugs, existing data of routine medical care in the Danish Population Registries (Danish Registries) in Denmark. This group includes all eligible participants initiating DPP-4 inhibitors after propensity score-trimming, where the model used for propensity score was endpoint-specific including all variables related to the endpoint. |
| OG007 | DPP-4 Inhibitors - HIRD (After Propensity Score Trimming) | All eligible patients with type 2 diabetes mellitus initiating Dipeptidyl peptidase-4 (DPP-4) inhibitors treatment within the study period, existing data of routine medical care in the HealthCore Integrated Research Database (HIRD) in the United States (US). This group includes all eligible participants initiating DPP-4 inhibitors after propensity score-trimming, where the model used for propensity score was endpoint-specific including all variables related to the endpoint. |
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| OG001 | Empagliflozin - Danish Registries <3 Glucose-lowering Drugs (After Propensity Score Trimming) | All eligible patients with type 2 diabetes mellitus initiating Empagliflozin treatment within the study period with <3 glucose-lowering drugs, existing data of routine medical care in the Danish Population Registries (Danish Registries) in Denmark. This group includes all eligible participants initiating Empagliflozin after propensity score-trimming, where the model used for propensity score was endpoint-specific including all variables related to the endpoint. |
| OG002 | Empagliflozin - Danish Registries ≥3 Glucose-lowering Drugs (After Propensity Score Trimming) | All eligible patients with type 2 diabetes mellitus initiating Empagliflozin treatment within the study period with ≥3 glucose-lowering drugs, existing data of routine medical care in the Danish Population Registries (Danish Registries) in Denmark. This group includes all eligible participants initiating Empagliflozin after propensity score-trimming, where the model used for propensity score was endpoint-specific including all variables related to the endpoint. |
| OG003 | Empagliflozin - HIRD (After Propensity Score Trimming) | All eligible patients with type 2 diabetes mellitus initiating Empagliflozin treatment within the study period, existing data of routine medical care in the HealthCore Integrated Research Database (HIRD) in the United States (US). This group includes all eligible participants initiating Empagliflozin after propensity score-trimming, where the model used for propensity score was endpoint-specific including all variables related to the endpoint. |
| OG004 | DPP-4 Inhibitors - CPRD (After Propensity Score Trimming) | All eligible patients with type 2 diabetes mellitus initiating Dipeptidyl peptidase-4 (DPP-4) inhibitors treatment within the study period, existing data of routine medical care in the Clinical Practice Research Datalink (CPRD) in the United Kingdom (UK). This group includes all eligible participants initiating DPP-4 inhibitors after propensity score-trimming, where the model used for propensity score was endpoint-specific including all variables related to the endpoint. |
| OG005 | DPP-4 Inhibitors - Danish Registries <3 Glucose-lowering Drugs (After Propensity Score Trimming) | All eligible patients with type 2 diabetes mellitus initiating Dipeptidyl peptidase-4 (DPP-4) inhibitors treatment within the study period with <3 glucose-lowering drugs, existing data of routine medical care in the Danish Population Registries (Danish Registries) in Denmark. This group includes all eligible participants initiating DPP-4 inhibitors after propensity score-trimming, where the model used for propensity score was endpoint-specific including all variables related to the endpoint. |
| OG006 | DPP-4 Inhibitors - Danish Registries ≥3 Glucose-lowering Drugs (After Propensity Score Trimming) | All eligible patients with type 2 diabetes mellitus initiating Dipeptidyl peptidase-4 (DPP-4) inhibitors treatment within the study period with ≥3 glucose-lowering drugs, existing data of routine medical care in the Danish Population Registries (Danish Registries) in Denmark. This group includes all eligible participants initiating DPP-4 inhibitors after propensity score-trimming, where the model used for propensity score was endpoint-specific including all variables related to the endpoint. |
| OG007 | DPP-4 Inhibitors - HIRD (After Propensity Score Trimming) | All eligible patients with type 2 diabetes mellitus initiating Dipeptidyl peptidase-4 (DPP-4) inhibitors treatment within the study period, existing data of routine medical care in the HealthCore Integrated Research Database (HIRD) in the United States (US). This group includes all eligible participants initiating DPP-4 inhibitors after propensity score-trimming, where the model used for propensity score was endpoint-specific including all variables related to the endpoint. |
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| OG001 | DPP-4 Inhibitors - CPRD (After Propensity Score Trimming) | All eligible patients with type 2 diabetes mellitus initiating Dipeptidyl peptidase-4 (DPP-4) inhibitors treatment within the study period, existing data of routine medical care in the Clinical Practice Research Datalink (CPRD) in the United Kingdom (UK). This group includes all eligible participants initiating DPP-4 inhibitors after propensity score-trimming, where the model used for propensity score was endpoint-specific including all variables related to the endpoint. |
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| OG001 | DPP-4 Inhibitors - CPRD (After Propensity Score Trimming) | All eligible patients with type 2 diabetes mellitus initiating Dipeptidyl peptidase-4 (DPP-4) inhibitors treatment within the study period, existing data of routine medical care in the Clinical Practice Research Datalink (CPRD) in the United Kingdom (UK). This group includes all eligible participants initiating DPP-4 inhibitors after propensity score-trimming, where the model used for propensity score was endpoint-specific including all variables related to the endpoint. |
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| OG001 | DPP-4 Inhibitors - CPRD (After Propensity Score Trimming) | All eligible patients with type 2 diabetes mellitus initiating Dipeptidyl peptidase-4 (DPP-4) inhibitors treatment within the study period, existing data of routine medical care in the Clinical Practice Research Datalink (CPRD) in the United Kingdom (UK). This group includes all eligible participants initiating DPP-4 inhibitors after propensity score-trimming, where the model used for propensity score was endpoint-specific including all variables related to the endpoint. |
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| OG001 | Empagliflozin - Danish Registries <3 Glucose-lowering Drugs (After Propensity Score Trimming) | All eligible patients with type 2 diabetes mellitus initiating Empagliflozin treatment within the study period with <3 glucose-lowering drugs, existing data of routine medical care in the Danish Population Registries (Danish Registries) in Denmark. This group includes all eligible participants initiating Empagliflozin after propensity score-trimming, where the model used for propensity score was endpoint-specific including all variables related to the endpoint. |
| OG002 | Empagliflozin - Danish Registries ≥3 Glucose-lowering Drugs (After Propensity Score Trimming) | All eligible patients with type 2 diabetes mellitus initiating Empagliflozin treatment within the study period with ≥3 glucose-lowering drugs, existing data of routine medical care in the Danish Population Registries (Danish Registries) in Denmark. This group includes all eligible participants initiating Empagliflozin after propensity score-trimming, where the model used for propensity score was endpoint-specific including all variables related to the endpoint. |
| OG003 | Empagliflozin - HIRD (After Propensity Score Trimming) | All eligible patients with type 2 diabetes mellitus initiating Empagliflozin treatment within the study period, existing data of routine medical care in the HealthCore Integrated Research Database (HIRD) in the United States (US). This group includes all eligible participants initiating Empagliflozin after propensity score-trimming, where the model used for propensity score was endpoint-specific including all variables related to the endpoint. |
| OG004 | DPP-4 Inhibitors - CPRD (After Propensity Score Trimming) | All eligible patients with type 2 diabetes mellitus initiating Dipeptidyl peptidase-4 (DPP-4) inhibitors treatment within the study period, existing data of routine medical care in the Clinical Practice Research Datalink (CPRD) in the United Kingdom (UK). This group includes all eligible participants initiating DPP-4 inhibitors after propensity score-trimming, where the model used for propensity score was endpoint-specific including all variables related to the endpoint. |
| OG005 | DPP-4 Inhibitors - Danish Registries <3 Glucose-lowering Drugs (After Propensity Score Trimming) | All eligible patients with type 2 diabetes mellitus initiating Dipeptidyl peptidase-4 (DPP-4) inhibitors treatment within the study period with <3 glucose-lowering drugs, existing data of routine medical care in the Danish Population Registries (Danish Registries) in Denmark. This group includes all eligible participants initiating DPP-4 inhibitors after propensity score-trimming, where the model used for propensity score was endpoint-specific including all variables related to the endpoint. |
| OG006 | DPP-4 Inhibitors - Danish Registries ≥3 Glucose-lowering Drugs (After Propensity Score Trimming) | All eligible patients with type 2 diabetes mellitus initiating Dipeptidyl peptidase-4 (DPP-4) inhibitors treatment within the study period with ≥3 glucose-lowering drugs, existing data of routine medical care in the Danish Population Registries (Danish Registries) in Denmark. This group includes all eligible participants initiating DPP-4 inhibitors after propensity score-trimming, where the model used for propensity score was endpoint-specific including all variables related to the endpoint. |
| OG007 | DPP-4 Inhibitors - HIRD (After Propensity Score Trimming) | All eligible patients with type 2 diabetes mellitus initiating Dipeptidyl peptidase-4 (DPP-4) inhibitors treatment within the study period, existing data of routine medical care in the HealthCore Integrated Research Database (HIRD) in the United States (US). This group includes all eligible participants initiating DPP-4 inhibitors after propensity score-trimming, where the model used for propensity score was endpoint-specific including all variables related to the endpoint. |
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| OG001 | DPP-4 Inhibitors - CPRD (After Propensity Score Trimming) | All eligible patients with type 2 diabetes mellitus initiating Dipeptidyl peptidase-4 (DPP-4) inhibitors treatment within the study period, existing data of routine medical care in the Clinical Practice Research Datalink (CPRD) in the United Kingdom (UK). This group includes all eligible participants initiating DPP-4 inhibitors after propensity score-trimming, where the model used for propensity score was endpoint-specific including all variables related to the endpoint. |
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| OG001 | DPP-4 Inhibitors - CPRD (After Propensity Score Trimming) | All eligible patients with type 2 diabetes mellitus initiating Dipeptidyl peptidase-4 (DPP-4) inhibitors treatment within the study period, existing data of routine medical care in the Clinical Practice Research Datalink (CPRD) in the United Kingdom (UK). This group includes all eligible participants initiating DPP-4 inhibitors after propensity score-trimming, where the model used for propensity score was endpoint-specific including all variables related to the endpoint. |
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| OG001 | DPP-4 Inhibitors - CPRD (After Propensity Score Trimming) | All eligible patients with type 2 diabetes mellitus initiating Dipeptidyl peptidase-4 (DPP-4) inhibitors treatment within the study period, existing data of routine medical care in the Clinical Practice Research Datalink (CPRD) in the United Kingdom (UK). This group includes all eligible participants initiating DPP-4 inhibitors after propensity score-trimming, where the model used for propensity score was endpoint-specific including all variables related to the endpoint. |
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