Empa PASS on Urinary Tract Malignancies

An observational study of Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 3 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: empagliflozin and DPP-4 inhibitors
How many people: 344,995 participants
Where: 3 sitesin 3 countries
Study dates: 16 Nov 2016to 11 Mar 2024
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: This is an observational, comparative, cohort safety study based on European healthcare databases and includes databases from the UK, Finland, and Sweden.

Who may be able to join

Diagnosis of type 2 diabetes
Age over 18 years at index date
At least 1 year of membership in the medication database prior to index date

Who cannot join

Patients with any cancer (excluding non-melanoma skin cancer) recorded at any time prior to the index date (i.e. during the available look-back time)
Diagnosis of type 1 diabetes or other specific non-type 2 diabetes
Use of any SGLT-2 inhibitor or any DPP-4 inhibitor (including free and fixed-dose combinations) recorded at any time prior to index date (i.e. during the available look-back time).
Use of fixed-dose combinations of SGLT-2 inhibitors with DPP-4 inhibitors
Diagnosis of end stage renal disease or receipt of renal dialysis recorded at any time prior to index date (i.e. during the available look-back time)

Trial locations and contacts

3 sites in 3 countries.

Country

City, postcode or hospital

3 sites in 3 countries

Finland1 site

The National Register Data
Helsinki

Other trials in Finland

Sweden1 site

The Swedish prescribed drug register
Stockholm

Other trials in Sweden

United Kingdom1 site

United Kingdom Clinical Practice Research Datalink (CPRD)
London

Other trials in United Kingdom

About this study

Official title: Post-authorisation Safety Study to Assess the Risk of Urinary Tract Malignancies in Relation to Empagliflozin Exposure in Patients With Type 2 Diabetes: a Multi-database European Study

Conditions: Diabetes Mellitus, Type 2
Being tested: empagliflozin, DPP-4 inhibitors
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

empagliflozinDrug
empagliflozin
DPP-4 inhibitorsDrug
DPP-4 inhibitors

Study groups in NCT03464045
Study group	Role	What they receive
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). Receives: Drug: empagliflozin
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. Receives: Drug: DPP-4 inhibitors
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. Receives: Drug: empagliflozin
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. Receives: Drug: DPP-4 inhibitors
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. Receives: Drug: empagliflozin
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. Receives: Drug: DPP-4 inhibitors

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Nov 201611 Mar 2024

First posted13 Mar 2018
Study start16 Nov 2016
Primary completion11 Mar 2024
Study completion11 Mar 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 344,995 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03464045
Sponsor's protocol ID: 1245-0097
Status last verified: Apr 2025
First submitted: 7 Mar 2018
Last updated: 20 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes Mellitus, Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post-authorisation Safety Study to Assess the Risk of Urinary Tract Malignancies in Relation to Empagliflozin Exposure in Patients With Type 2 Diabetes: a Multi-database European Study
ClinicalTrials.gov ID: NCT03464045
Acronym / sponsor ID: 1245-0097
Conditions: Diabetes Mellitus, Type 2
Study type: Observational
Recruitment status: Completed
Enrolment: 344,995 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: 16 Nov 2016 (actual)
Primary completion: 11 Mar 2024 (actual)
Study completion: 11 Mar 2024 (actual)
First posted: 13 Mar 2018 (actual)
Results: Posted 28 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 6

Arm	Type	Receives
Empagliflozin initiators - UK	–	Drug: empagliflozinParticipants 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	–	Drug: DPP-4 inhibitorsParticipants 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	–	Drug: empagliflozinParticipants 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	–	Drug: DPP-4 inhibitorsParticipants 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.
Empagliflozin initiators - Finland	–	Drug: empagliflozinParticipants 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	–	Drug: DPP-4 inhibitorsParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: This is an observational, comparative, cohort safety study based on European healthcare databases and includes databases from the UK, Finland, and Sweden.

Key inclusion criteria (3 listed)

Diagnosis of type 2 diabetes
Age over 18 years at index date
At least 1 year of membership in the medication database prior to index date

Key exclusion criteria (5 listed)

Patients with any cancer (excluding non-melanoma skin cancer) recorded at any time prior to the index date (i.e. during the available look-back time)
Diagnosis of type 1 diabetes or other specific non-type 2 diabetes
Use of any SGLT-2 inhibitor or any DPP-4 inhibitor (including free and fixed-dose combinations) recorded at any time prior to index date (i.e. during the available look-back time).
Use of fixed-dose combinations of SGLT-2 inhibitors with DPP-4 inhibitors
Diagnosis of end stage renal disease or receipt of renal dialysis recorded at any time prior to index date (i.e. during the available look-back time)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
empagliflozinempagliflozin	Drug	Empagliflozin initiators - Finland, Empagliflozin initiators - Sweden, Empagliflozin initiators - UK
DPP-4 inhibitorsDPP-4 inhibitors	Drug	DPP4-i initiators - Finland, DPP4-i initiators - Sweden, DPP4-i initiators - UK

Primary outcome

Occurrence of Urinary Tract Cancer
Time frame: 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 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.
Occurrence of Bladder Cancer
Time frame: 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, 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.
Occurrence of Renal Cancer
Time frame: 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 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.

Results and safety

Results posted to the registry on 28 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Empagliflozin Initiators - UK	27,410	27,410
DPP4-i Initiators - UK	123,334	123,334
Empagliflozin Initiators - Sweden	35,954	35,954
DPP4-i Initiators - Sweden	73,623	73,623
Empagliflozin Initiators - Finland	21,942	21,942
DPP4-i Initiators - Finland	62,732	62,732

Primary outcome: Occurrence of Urinary Tract Cancer

Time frame: 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).. Number (95% Confidence Interval). Unit: Events per 1000 patient years

Measure	Empagliflozin Initiators - UK, PS-matched n = 18838	DPP4-i Initiators - UK, PS-matched n = 44838	Empagliflozin Initiators - Sweden, PS-matched n = 20844	DPP4-i Initiators - Sweden, PS-matched n = 25682	Empagliflozin Initiators - Finland, PS-matched n = 15696	DPP4-i Initiators - Finland, PS-matched n = 25157	Empagliflozin Initiators - All Countries, PS-matched n = 55378	DPP4-i Initiators - All Countries, PS-matched n = 95677
Value	0.73 (0.46 to 1.16)	1.07 (0.84 to 1.37)	1.34 (0.95 to 1.89)	1.52 (1.13 to 2.05)	1.27 (0.86 to 1.87)	1.49 (1.13 to 1.96)	1.10 (0.88 to 1.38)	1.29 (1.11 to 1.51)

Empagliflozin Initiators - UK, PS-matched vs DPP4-i Initiators - UK, PS-matched vs Empagliflozin Initiators - Sweden, PS-matched vs DPP4-i Initiators - Sweden, PS-matched vs Empagliflozin Initiators - Finland, PS-matched vs DPP4-i Initiators - Finland, PS-matched: Hazard Ratio (HR): 0.80 (95% CI 0.61 to 1.06), p = 0.122, Regression, Cox
Empagliflozin Initiators - UK, PS-matched vs DPP4-i Initiators - UK, PS-matched vs Empagliflozin Initiators - Sweden, PS-matched vs DPP4-i Initiators - Sweden, PS-matched vs Empagliflozin Initiators - Finland, PS-matched vs DPP4-i Initiators - Finland, PS-matched: Hazard Ratio (HR): 0.89 (95% CI 0.67 to 1.18), p = 0.417, Regression, Cox
Empagliflozin Initiators - UK, PS-matched vs DPP4-i Initiators - UK, PS-matched vs Empagliflozin Initiators - Sweden, PS-matched vs DPP4-i Initiators - Sweden, PS-matched vs Empagliflozin Initiators - Finland, PS-matched vs DPP4-i Initiators - Finland, PS-matched: Hazard Ratio (HR): 0.88 (95% CI 0.66 to 1.17), p = 0.376, Regression, Cox

Population analysed: 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).

Primary outcome: Occurrence of Bladder Cancer

Measure	Empagliflozin Initiators - UK, PS-matched n = 18838	DPP4-i Initiators - UK, PS-matched n = 44838	Empagliflozin Initiators - Sweden, PS-matched n = 20844	DPP4-i Initiators - Sweden, PS-matched n = 25682	Empagliflozin Initiators - Finland, PS-matched n = 15696	DPP4-i Initiators - Finland, PS-matched n = 25157	Empagliflozin Initiators - All Countries, PS-matched n = 55378	DPP4-i Initiators - All Countries, PS-matched n = 95677
Value	0.45 (0.25 to 0.81)	0.67 (0.49 to 0.90)	0.92 (0.61 to 1.40)	1.03 (0.71 to 1.48)	0.51 (0.27 to 0.94)	0.64 (0.42 to 0.98)	0.63 (0.47 to 0.85)	0.74 (0.6 to 0.91)

Empagliflozin Initiators - UK, PS-matched vs DPP4-i Initiators - UK, PS-matched vs Empagliflozin Initiators - Sweden, PS-matched vs DPP4-i Initiators - Sweden, PS-matched vs Empagliflozin Initiators - Finland, PS-matched vs DPP4-i Initiators - Finland, PS-matched: Hazard Ratio (HR): 0.79 (95% CI 0.55 to 1.15), p = 0.220, Regression, Cox
Empagliflozin Initiators - UK, PS-matched vs DPP4-i Initiators - UK, PS-matched vs Empagliflozin Initiators - Sweden, PS-matched vs DPP4-i Initiators - Sweden, PS-matched vs Empagliflozin Initiators - Finland, PS-matched vs DPP4-i Initiators - Finland, PS-matched: Hazard Ratio (HR): 0.91 (95% CI 0.63 to 1.32), p = 0.628, Regression, Cox
Empagliflozin Initiators - UK, PS-matched vs DPP4-i Initiators - UK, PS-matched vs Empagliflozin Initiators - Sweden, PS-matched vs DPP4-i Initiators - Sweden, PS-matched vs Empagliflozin Initiators - Finland, PS-matched vs DPP4-i Initiators - Finland, PS-matched: Hazard Ratio (HR): 0.91 (95% CI 0.63 to 1.33), p = 0.632, Regression, Cox

Primary outcome: Occurrence of Renal Cancer

Measure	Empagliflozin Initiators - UK, PS-matched n = 18838	DPP4-i Initiators - UK, PS-matched n = 44838	Empagliflozin Initiators - Sweden, PS-matched n = 20844	DPP4-i Initiators - Sweden, PS-matched n = 25682	Empagliflozin Initiators - Finland, PS-matched n = 15696	DPP4-i Initiators - Finland, PS-matched n = 25157	Empagliflozin Initiators - All Countries, PS-matched n = 55378	DPP4-i Initiators - All Countries, PS-matched n = 95677
Value	0.24 (0.11 to 0.54)	0.34 (0.22 to 0.52)	0.42 (0.22 to 0.78)	0.50 (0.29 to 0.84)	0.76 (0.46 to 1.26)	0.82 (0.57 to 1.19)	0.45 (0.32 to 0.65)	0.51 (0.4 to 0.65)

Empagliflozin Initiators - UK, PS-matched vs DPP4-i Initiators - UK, PS-matched vs Empagliflozin Initiators - Sweden, PS-matched vs DPP4-i Initiators - Sweden, PS-matched vs Empagliflozin Initiators - Finland, PS-matched vs DPP4-i Initiators - Finland, PS-matched: Hazard Ratio (HR): 0.84 (95% CI 0.54 to 1.29), p = 0.420, Regression, Cox
Empagliflozin Initiators - UK, PS-matched vs DPP4-i Initiators - UK, PS-matched vs Empagliflozin Initiators - Sweden, PS-matched vs DPP4-i Initiators - Sweden, PS-matched vs Empagliflozin Initiators - Finland, PS-matched vs DPP4-i Initiators - Finland, PS-matched: Hazard Ratio (HR): 0.89 (95% CI 0.57 to 1.38), p = 0.606, Regression, Cox
Empagliflozin Initiators - UK, PS-matched vs DPP4-i Initiators - UK, PS-matched vs Empagliflozin Initiators - Sweden, PS-matched vs DPP4-i Initiators - Sweden, PS-matched vs Empagliflozin Initiators - Finland, PS-matched vs DPP4-i Initiators - Finland, PS-matched: Hazard Ratio (HR): 0.89 (95% CI 0.57 to 1.38), p = 0.609, Regression, Cox

Adverse events

Time frame: This study used secondary data only. Hence, reporting of adverse reactions was not required nor possible.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events
Empagliflozin Initiators - UK	0 of 0	0 of 0
DPP4-i Initiators - UK	0 of 0	0 of 0
Empagliflozin Initiators - Sweden	0 of 0	0 of 0
DPP4-i Initiators - Sweden	0 of 0	0 of 0
Empagliflozin Initiators - Finland	0 of 0	0 of 0
DPP4-i Initiators - Finland	0 of 0	0 of 0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pasi Korhonen, 358-50-3652990 principal investigator

pasi.korhonen@epidresearch.com

3 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 3 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Finland, Sweden, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of Urinary Tract Cancer (time frame: 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).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03464045.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2025.