| Trial ID: | L7005 |
| Source ID: | NCT03464045
|
| Associated Drug: |
Empagliflozin
|
| Title: |
Empa PASS on Urinary Tract Malignancies
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT03464045/results
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: empagliflozin|DRUG: DPP-4 inhibitors
|
| Outcome Measures: |
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., 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). |
|
| Sponsor/Collaborators: |
Sponsor: Boehringer Ingelheim | Collaborators: Eli Lilly and Company
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
344995
|
| Study Type: |
OBSERVATIONAL
|
| Study Designs: |
Observational Model: |Time Perspective: p
|
| Start Date: |
2016-11-16
|
| Completion Date: |
2024-03-11
|
| Results First Posted: |
2025-03-28
|
| Last Update Posted: |
2025-03-28
|
| Locations: |
The National Register Data, Helsinki, Finland|The Swedish prescribed drug register, Stockholm, Sweden|United Kingdom Clinical Practice Research Datalink (CPRD), London, United Kingdom
|
| URL: |
https://clinicaltrials.gov/show/NCT03464045
|
