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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
The aim of the study is to assess the risk of urinary tract malignancies in patients initiating empagliflozin (free or fixed dose combination) compared to patients initiating a dipeptidyl peptidase-4 (DPP-4) inhibitor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Empagliflozin initiators - UK | Participants with Type 2 diabetes mellitus (T2D) initiating (first purchase/prescription) empagliflozin (study drug), in free form or in fixed-dose combination with metformin, between 1-Aug-2014 and 31-Dec-2021 (index date), and with more than 6 months of possible follow-up (index date less than 6 months prior to end of study date). The study population was identified from Clinical Practice Research Datalink (CPRD) (General practitioner Online Data [GOLD], and Aurum) in the United Kingdom (UK). |
| |
| DPP4-i initiators - UK | Participants with T2D initiating (first purchase/prescription) a dipeptidyl peptidase-4 inhibitor (DPP-4i) (comparator), in free form or in fixed-dose combination with metformin, between 1-Aug-2014 and 31-Dec-2021 (index date), and with more than 6 months of possible follow-up (index date less than 6 months prior to end of study date). The study population was identified from CPRD (General practitioner Online Data [GOLD], and Aurum) in the UK. |
| |
| Empagliflozin initiators - Sweden | Participants with T2D initiating (first purchase/prescription) empagliflozin (study drug), in free form or in fixed-dose combination with metformin, between 1-Aug-2014 and 31-Dec-2020 (index date), and with more than 6 months of possible follow-up (index date less than 6 months prior to end of study date). The study population was identified from the nationwide registers in Sweden. |
| |
| DPP4-i initiators - Sweden | Participants with T2D initiating (first purchase/prescription) a dipeptidyl peptidase-4 inhibitor (DPP-4i) (comparator), in free form or in fixed-dose combination with metformin, between 1-Aug-2014 and 31-Dec-2020 (index date), and with more than 6 months of possible follow-up (index date less than 6 months prior to end of study date). The study population was identified from the nationwide registers in Sweden. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| empagliflozin | Drug | empagliflozin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Urinary Tract Cancer | Occurrence of urinary tract cancer, which include malignant neoplasm and carcinoma in situ of the urinary tract, is reported as incidence rates per 1000 patient years. Incidence rates were estimated using Poisson regression and computed as the number of outcome events divided by the total person-time-at-risk (in years), multiplied by 1,000 for easier comparison. The country-level datasets were analyzed separately. Thereafter, pooled incidence rates were estimated using the aggregated number of outcome events and time-at-risk of all study countries using the Poisson regression. | From 181 days after index date until the occurrence of a censoring event or cancer outcome event. Up to 6 (Sweden/Finland) or 7 years (UK). |
| Occurrence of Bladder Cancer | Occurrence of bladder cancer, malignant and carcinoma in situ, is reported as incidence rates per 1000 patient years. Incidence rates were estimated using Poisson regression and computed as the number of outcome events divided by the total person-time-at-risk (in years), multiplied by 1,000 for easier comparison. The country-level datasets were analyzed separately. Thereafter, pooled incidence rates were estimated using the aggregated number of outcome events and time-at-risk of all study countries using the Poisson regression. | From 181 days after index date until the occurrence of a censoring event or cancer outcome event. Up to 6 (Sweden/Finland) or 7 years (UK). |
| Occurrence of Renal Cancer | Occurrence of malignant renal cancer is reported as incidence rates per 1000 patient years. Incidence rates were estimated using Poisson regression and computed as the number of outcome events divided by the total person-time-at-risk (in years), multiplied by 1,000 for easier comparison. The country-level datasets were analyzed separately. Thereafter, pooled incidence rates were estimated using the aggregated number of outcome events and time-at-risk of all study countries using the Poisson regression. | From 181 days after index date until the occurrence of a censoring event or cancer outcome event. Up to 6 (Sweden/Finland) or 7 years (UK). |
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Inclusion Criteria:
Exclusion Criteria:
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This is an observational, comparative, cohort safety study based on European healthcare databases and includes databases from the UK, Finland, and Sweden.
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| Name | Affiliation | Role |
|---|---|---|
| Pasi Korhonen, 358-50-3652990 | pasi.korhonen@epidresearch.com | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The National Register Data | Helsinki | Finland | ||||
| The Swedish prescribed drug register |
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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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Throughout the study, different data extraction timepoints were used, starting from 2016 to 2023, and retrospective data was analyzed. Only subjects that met all inclusion and none of the exclusion criteria were included.
This was a non-interventional, comparative, cohort-based Post-authorisation-safety study (PASS) to assess the risk of urinary tract malignancies in patients affected by type 2 diabetes mellitus initiating empagliflozin or dipeptidyl peptidase-4 inhibitor (DPP-4i) between 1-Aug-2014 and 31-Dec-2021 in the United Kingdom (UK), Sweden, and Finland.
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| ID | Title | Description |
|---|---|---|
| FG000 | Empagliflozin Initiators - UK | Participants with Type 2 diabetes mellitus (T2D) initiating (first purchase/prescription) empagliflozin (study drug), in free form or in fixed-dose combination with metformin, between 1-Aug-2014 and 31-Dec-2021 (index date), and with more than 6 months of possible follow-up (index date less than 6 months prior to end of study date). The study population was identified from Clinical Practice Research Datalink (CPRD) (General practitioner Online Data [GOLD], and Aurum) in the United Kingdom (UK). |
| FG001 | DPP4-i Initiators - UK | Participants with T2D initiating (first purchase/prescription) a dipeptidyl peptidase-4 inhibitor (DPP-4i) (comparator), in free form or in fixed-dose combination with metformin, between 1-Aug-2014 and 31-Dec-2021 (index date), and with more than 6 months of possible follow-up (index date less than 6 months prior to end of study date). The study population was identified from CPRD (General practitioner Online Data [GOLD], and Aurum) in the UK. |
| FG002 | Empagliflozin Initiators - Sweden | Participants with T2D initiating (first purchase/prescription) empagliflozin (study drug), in free form or in fixed-dose combination with metformin, between 1-Aug-2014 and 31-Dec-2020 (index date), and with more than 6 months of possible follow-up (index date less than 6 months prior to end of study date). The study population was identified from the nationwide registers in Sweden. |
| FG003 | DPP4-i Initiators - Sweden | Participants with T2D initiating (first purchase/prescription) a dipeptidyl peptidase-4 inhibitor (DPP-4i) (comparator), in free form or in fixed-dose combination with metformin, between 1-Aug-2014 and 31-Dec-2020 (index date), and with more than 6 months of possible follow-up (index date less than 6 months prior to end of study date). The study population was identified from the nationwide registers in Sweden. |
| FG004 | Empagliflozin Initiators - Finland | Participants with T2D initiating (first purchase/prescription) empagliflozin (study drug), in free form or in fixed-dose combination with metformin, between 1-Aug-2014 and 31-Dec-2020 (index date), and with more than 6 months of possible follow-up (index date less than 6 months prior to end of study date). The study population was identified from the nationwide registers in Finland. |
| FG005 | DPP4-i Initiators - Finland | Participants with T2D initiating (first purchase/prescription) a dipeptidyl peptidase-4 inhibitor (DPP-4i) (comparator), in free form or in fixed-dose combination with metformin, between 1-Aug-2014 and 31-Dec-2020 (index date), and with more than 6 months of possible follow-up (index date less than 6 months prior to end of study date). The study population was identified from the nationwide registers in Finland. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Study population: population before propensity score-matching.
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| ID | Title | Description |
|---|---|---|
| BG000 | Empagliflozin Initiators - UK | Participants with Type 2 diabetes mellitus (T2D) initiating (first purchase/prescription) empagliflozin (study drug), in free form or in fixed-dose combination with metformin, between 1-Aug-2014 and 31-Dec-2021 (index date), and with more than 6 months of possible follow-up (index date less than 6 months prior to end of study date). The study population was identified from Clinical Practice Research Datalink (CPRD) (General practitioner Online Data [GOLD], and Aurum) in the United Kingdom (UK). |
| 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 | Occurrence of Urinary Tract Cancer | Occurrence of urinary tract cancer, which include malignant neoplasm and carcinoma in situ of the urinary tract, is reported as incidence rates per 1000 patient years. Incidence rates were estimated using Poisson regression and computed as the number of outcome events divided by the total person-time-at-risk (in years), multiplied by 1,000 for easier comparison. The country-level datasets were analyzed separately. Thereafter, pooled incidence rates were estimated using the aggregated number of outcome events and time-at-risk of all study countries using the Poisson regression. | Main analysis population: participants that were matched using propensity scores (PS) conditional on variables such as index date, disease progression, comorbidities, treatment history, age, and sex; and who did not have observations of any censoring events or outcome cancer events within the latency period (spanning 180 days after the index date). | Posted | Number | 95% Confidence Interval | Events per 1000 patient years | From 181 days after index date until the occurrence of a censoring event or cancer outcome event. Up to 6 (Sweden/Finland) or 7 years (UK). |
This study used secondary data only. Hence, reporting of adverse reactions was not required nor possible.
This study used secondary data only. Hence, reporting of adverse reactions was not required nor possible.
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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 | Empagliflozin Initiators - UK | Participants with Type 2 diabetes mellitus (T2D) initiating (first purchase/prescription) empagliflozin (study drug), in free form or in fixed-dose combination with metformin, between 1-Aug-2014 and 31-Dec-2021 (index date), and with more than 6 months of possible follow-up (index date less than 6 months prior to end of study date). The study population was identified from Clinical Practice Research Datalink (CPRD) (General practitioner Online Data [GOLD], and Aurum) in the United Kingdom (UK). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 7, 2022 | Mar 7, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 26, 2022 | Mar 7, 2025 | SAP_001.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 |
| D054873 | Dipeptidyl-Peptidase IV Inhibitors |
| ID | Term |
|---|---|
| D011480 | Protease Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
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|
| Empagliflozin initiators - Finland | Participants with T2D initiating (first purchase/prescription) empagliflozin (study drug), in free form or in fixed-dose combination with metformin, between 1-Aug-2014 and 31-Dec-2020 (index date), and with more than 6 months of possible follow-up (index date less than 6 months prior to end of study date). The study population was identified from the nationwide registers in Finland. |
|
| DPP4-i initiators - Finland | Participants with T2D initiating (first purchase/prescription) a dipeptidyl peptidase-4 inhibitor (DPP-4i) (comparator), in free form or in fixed-dose combination with metformin, between 1-Aug-2014 and 31-Dec-2020 (index date), and with more than 6 months of possible follow-up (index date less than 6 months prior to end of study date). The study population was identified from the nationwide registers in Finland. |
|
| DPP-4 inhibitors | Drug | DPP-4 inhibitors |
|
| Stockholm |
| Sweden |
| United Kingdom Clinical Practice Research Datalink (CPRD) | London | United Kingdom |
| BG001 | DPP4-i Initiators - UK | Participants with T2D initiating (first purchase/prescription) a dipeptidyl peptidase-4 inhibitor (DPP-4i) (comparator), in free form or in fixed-dose combination with metformin, between 1-Aug-2014 and 31-Dec-2021 (index date), and with more than 6 months of possible follow-up (index date less than 6 months prior to end of study date). The study population was identified from CPRD (General practitioner Online Data [GOLD], and Aurum) in the UK. |
| BG002 | Empagliflozin Initiators - Sweden | Participants with T2D initiating (first purchase/prescription) empagliflozin (study drug), in free form or in fixed-dose combination with metformin, between 1-Aug-2014 and 31-Dec-2020 (index date), and with more than 6 months of possible follow-up (index date less than 6 months prior to end of study date). The study population was identified from the nationwide registers in Sweden. |
| BG003 | DPP4-i Initiators - Sweden | Participants with T2D initiating (first purchase/prescription) a dipeptidyl peptidase-4 inhibitor (DPP-4i) (comparator), in free form or in fixed-dose combination with metformin, between 1-Aug-2014 and 31-Dec-2020 (index date), and with more than 6 months of possible follow-up (index date less than 6 months prior to end of study date). The study population was identified from the nationwide registers in Sweden. |
| BG004 | Empagliflozin Initiators - Finland | Participants with T2D initiating (first purchase/prescription) empagliflozin (study drug), in free form or in fixed-dose combination with metformin, between 1-Aug-2014 and 31-Dec-2020 (index date), and with more than 6 months of possible follow-up (index date less than 6 months prior to end of study date). The study population was identified from the nationwide registers in Finland. |
| BG005 | DPP4-i Initiators - Finland | Participants with T2D initiating (first purchase/prescription) a dipeptidyl peptidase-4 inhibitor (DPP-4i) (comparator), in free form or in fixed-dose combination with metformin, between 1-Aug-2014 and 31-Dec-2020 (index date), and with more than 6 months of possible follow-up (index date less than 6 months prior to end of study date). The study population was identified from the nationwide registers in Finland. |
| BG006 | 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 |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Empagliflozin Initiators - UK, PS-matched | Participants with Type 2 diabetes mellitus (T2D) initiating (first purchase/prescription) empagliflozin (study drug), in free form or in fixed-dose combination with metformin, between 1-Aug-2014 and 31-Dec-2021 (index date), and with more than 6 months of possible follow-up (index date less than 6 months prior to end of study date). The study population was identified from Clinical Practice Research Datalink (CPRD) (General practitioner Online Data [GOLD], and Aurum) in the United Kingdom (UK). The cohort was propensity scored-matched. |
| OG001 | DPP4-i Initiators - UK, PS-matched | Participants with T2D initiating (first purchase/prescription) a dipeptidyl peptidase-4 inhibitor (DPP-4i) (comparator), in free form or in fixed-dose combination with metformin, between 1-Aug-2014 and 31-Dec-2021 (index date), and with more than 6 months of possible follow-up (index date less than 6 months prior to end of study date). The study population was identified from CPRD (General practitioner Online Data [GOLD], and Aurum) in the UK. The cohort was propensity scored-matched. |
| OG002 | Empagliflozin Initiators - Sweden, PS-matched | Participants with T2D initiating (first purchase/prescription) empagliflozin (study drug), in free form or in fixed-dose combination with metformin, between 1-Aug-2014 and 31-Dec-2020 (index date), and with more than 6 months of possible follow-up (index date less than 6 months prior to end of study date). The study population was identified from the nationwide registers in Sweden. The cohort was propensity scored-matched. As no patients initiated empagliflozin treatment in 2014 in Sweden, DPP-4i initiators in 2014 were excluded from PS matching. |
| OG003 | DPP4-i Initiators - Sweden, PS-matched | Participants with T2D initiating (first purchase/prescription) a dipeptidyl peptidase-4 inhibitor (DPP-4i) (comparator), in free form or in fixed-dose combination with metformin, between 1-Aug-2014 and 31-Dec-2020 (index date), and with more than 6 months of possible follow-up (index date less than 6 months prior to end of study date). The study population was identified from the nationwide registers in Sweden. The cohort was propensity scored-matched. As no patients initiated empagliflozin treatment in 2014 in Sweden, DPP-4i initiators in 2014 were excluded from PS matching. |
| OG004 | Empagliflozin Initiators - Finland, PS-matched | Participants with T2D initiating (first purchase/prescription) empagliflozin (study drug), in free form or in fixed-dose combination with metformin, between 1-Aug-2014 and 31-Dec-2020 (index date), and with more than 6 months of possible follow-up (index date less than 6 months prior to end of study date). The study population was identified from the nationwide registers in Finland. The cohort was propensity scored-matched. As no patients initiated empagliflozin treatment in 2014 in Finland, DPP-4i initiators in 2014 were excluded from PS matching. |
| OG005 | DPP4-i Initiators - Finland, PS-matched | Participants with T2D initiating (first purchase/prescription) a dipeptidyl peptidase-4 inhibitor (DPP-4i) (comparator), in free form or in fixed-dose combination with metformin, between 1-Aug-2014 and 31-Dec-2020 (index date), and with more than 6 months of possible follow-up (index date less than 6 months prior to end of study date). The study population was identified from the nationwide registers in Finland. The cohort was propensity scored-matched. As no patients initiated empagliflozin treatment in 2014 in Finland, DPP-4i initiators in 2014 were excluded from PS matching. |
| OG006 | Empagliflozin Initiators - All Countries, PS-matched | This arm includes all the empagliflozin initiators in the propensity scored-matched cohorts. Participants with T2D initiating (first purchase/prescription) empagliflozin (study drug), in free form or in fixed-dose combination with metformin, between 1-Aug-2014 and 31-Dec-2021 (index date), and with more than 6 months of possible follow-up (index date less than 6 months prior to end of study date). The study population was identified from the CPRD (General practitioner Online Data [GOLD], and Aurum) in the UK, and from the from the nationwide registers in Sweden and Finland. As no patients initiated empagliflozin treatment in 2014 in Sweden and Finland, DPP-4i initiators in 2014 were excluded from PS matching. |
| OG007 | DPP4-i Initiators - All Countries, PS-matched | This arm includes all the DPP4-i initiators in the propensity scored-matched cohorts. Participants with T2D initiating (first purchase/prescription) a DPP-4i (comparator), in free form or in fixed-dose combination with metformin, between 1-Aug-2014 and 31-Dec-2020 (index date), and with more than 6 months of possible follow-up (index date less than 6 months prior to end of study date). The study population was identified from the CPRD (General practitioner Online Data [GOLD], and Aurum) in the UK, and from the from the nationwide registers in Sweden and Finland. As no patients initiated empagliflozin treatment in 2014 in Sweden and Finland, DPP-4i initiators in 2014 were excluded from PS matching. |
|
|
|
| Primary | Occurrence of Bladder Cancer | Occurrence of bladder cancer, malignant and carcinoma in situ, is reported as incidence rates per 1000 patient years. Incidence rates were estimated using Poisson regression and computed as the number of outcome events divided by the total person-time-at-risk (in years), multiplied by 1,000 for easier comparison. The country-level datasets were analyzed separately. Thereafter, pooled incidence rates were estimated using the aggregated number of outcome events and time-at-risk of all study countries using the Poisson regression. | Main analysis population: participants that were matched using propensity scores (PS) conditional on variables such as index date, disease progression, comorbidities, treatment history, age, and sex; and who did not have observations of any censoring events or outcome cancer events within the latency period (spanning 180 days after the index date). | Posted | Number | 95% Confidence Interval | Events per 1000 patient years | From 181 days after index date until the occurrence of a censoring event or cancer outcome event. Up to 6 (Sweden/Finland) or 7 years (UK). |
|
|
|
|
| Primary | Occurrence of Renal Cancer | Occurrence of malignant renal cancer is reported as incidence rates per 1000 patient years. Incidence rates were estimated using Poisson regression and computed as the number of outcome events divided by the total person-time-at-risk (in years), multiplied by 1,000 for easier comparison. The country-level datasets were analyzed separately. Thereafter, pooled incidence rates were estimated using the aggregated number of outcome events and time-at-risk of all study countries using the Poisson regression. | Main analysis population: participants that were matched using propensity scores (PS) conditional on variables such as index date, disease progression, comorbidities, treatment history, age, and sex; and who did not have observations of any censoring events or outcome cancer events within the latency period (spanning 180 days after the index date). | Posted | Number | 95% Confidence Interval | Events per 1000 patient years | From 181 days after index date until the occurrence of a censoring event or cancer outcome event. Up to 6 (Sweden/Finland) or 7 years (UK). |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | DPP4-i Initiators - UK | Participants with T2D initiating (first purchase/prescription) a dipeptidyl peptidase-4 inhibitor (DPP-4i) (comparator), in free form or in fixed-dose combination with metformin, between 1-Aug-2014 and 31-Dec-2021 (index date), and with more than 6 months of possible follow-up (index date less than 6 months prior to end of study date). The study population was identified from CPRD (General practitioner Online Data [GOLD], and Aurum) in the UK. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Empagliflozin Initiators - Sweden | Participants with T2D initiating (first purchase/prescription) empagliflozin (study drug), in free form or in fixed-dose combination with metformin, between 1-Aug-2014 and 31-Dec-2020 (index date), and with more than 6 months of possible follow-up (index date less than 6 months prior to end of study date). The study population was identified from the nationwide registers in Sweden. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | DPP4-i Initiators - Sweden | Participants with T2D initiating (first purchase/prescription) a dipeptidyl peptidase-4 inhibitor (DPP-4i) (comparator), in free form or in fixed-dose combination with metformin, between 1-Aug-2014 and 31-Dec-2020 (index date), and with more than 6 months of possible follow-up (index date less than 6 months prior to end of study date). The study population was identified from the nationwide registers in Sweden. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG004 | Empagliflozin Initiators - Finland | Participants with T2D initiating (first purchase/prescription) empagliflozin (study drug), in free form or in fixed-dose combination with metformin, between 1-Aug-2014 and 31-Dec-2020 (index date), and with more than 6 months of possible follow-up (index date less than 6 months prior to end of study date). The study population was identified from the nationwide registers in Finland. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG005 | DPP4-i Initiators - Finland | Participants with T2D initiating (first purchase/prescription) a dipeptidyl peptidase-4 inhibitor (DPP-4i) (comparator), in free form or in fixed-dose combination with metformin, between 1-Aug-2014 and 31-Dec-2020 (index date), and with more than 6 months of possible follow-up (index date less than 6 months prior to end of study date). The study population was identified from the nationwide registers in Finland. | 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 |
| D020164 | Chemical Actions and Uses |
| D007004 | Hypoglycemic Agents |
| D045505 | Physiological Effects of Drugs |
| Male |
|
| Other |
| Base HRs were calculated using a Cox proportional hazards model by adjusting for variables unbalanced after PS matching. To be included in the Cox model, each covariate is required to have a minimum of 5 events per category level to avoid converge failure. Country-level HRs were analyzed separately. Thereafter, random-effects meta-analyses were conducted to pool the HRs from all countries, accounting for potential heterogeneity between the country-level effect sizes. | Regression, Cox | 0.628 | Hazard Ratio (HR) | 0.91 | 2-Sided | 95 | 0.63 | 1.32 | Base hazard ratio of empagliflozin/DPP-4i | Other |
| Adjusted HRs were calculated using a Cox proportional hazards model by adjusting for variables unbalanced after PS matching, and pre-specified time-varying covariates. To be included in the Cox model, each covariate is required to have a minimum of 5 events per category level. Country-level HRs were analyzed separately. Thereafter, random-effects meta-analyses were conducted to pool the HRs from all countries, accounting for potential heterogeneity between the country-level effect sizes. | Regression, Cox | 0.632 | Hazard Ratio (HR) | 0.91 | 2-Sided | 95 | 0.63 | 1.33 | Adjusted hazard ratio of empagliflozin/DPP-4i | Other |
| Other |
| Base HRs were calculated using a Cox proportional hazards model by adjusting for variables unbalanced after PS matching. To be included in the Cox model, each covariate is required to have a minimum of 5 events per category level to avoid converge failure. Country-level HRs were analyzed separately. Thereafter, random-effects meta-analyses were conducted to pool the HRs from all countries, accounting for potential heterogeneity between the country-level effect sizes. | Regression, Cox | 0.606 | Hazard Ratio (HR) | 0.89 | 2-Sided | 95 | 0.57 | 1.38 | Base hazard ratio of empagliflozin/DPP-4i | Other |
| Adjusted HRs were calculated using a Cox proportional hazards model by adjusting for variables unbalanced after PS matching, and pre-specified time-varying covariates. To be included in the Cox model, each covariate is required to have a minimum of 5 events per category level. Country-level HRs were analyzed separately. Thereafter, random-effects meta-analyses were conducted to pool the HRs from all countries, accounting for potential heterogeneity between the country-level effect sizes. | Regression, Cox | 0.609 | Hazard Ratio (HR) | 0.89 | 2-Sided | 95 | 0.57 | 1.38 | Adjusted hazard ratio of empagliflozin/DPP-4i | Other |