At a glance
ClinicalIndex Comparison RecordN/ACompleted· 344,995 enrolled
Drug / intervention
empagliflozin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
An observational study evaluating empagliflozin and DPP-4 inhibitors for Diabetes Mellitus, Type 2. Completed, enrolled 344,995 participants across 3 sites in 3 countries.
Detailed 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.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesFinland, Sweden, United Kingdom
CollaboratorsEli Lilly and Company
Timeline
N/ACompletedFinished
2017201820192020202120222023202420252026
Enrollment StartNov 2016
First PostedMar 2018
Primary CompletionMar 2024
TodayJul 2026
First PostedMar 13, 2018
Enrollment StartNov 16, 2016
Primary CompletionMar 11, 2024
TodayJul 2, 2026
Enrollment to primary: 7.3 yearsPosted 8.3 years ago
Interventions
empagliflozindrug
empagliflozin
DPP-4 inhibitorsdrug
DPP-4 inhibitors