At a glance
ClinicalIndex Comparison RecordN/ACompleted· 494,679 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-authorization Safety Study (PASS) to Assess the Risk of Acute Pancreatitis in Type 2 Diabetes Mellitus (T2DM) Patients Newly Initiating Empagliflozin Compared to Other Oral Non-incretin/Non-sodium Glucose Co-transporter-2 Inhibitors (SGLT2)-Containing Glucose Lowering Drugs
In Brief
An observational study evaluating empagliflozin and Oral non-incretin/non-sodium glucose co-transporter-2 inhibitors (SGLT2)-containing hypoglycaemic agents for Diabetes Mellitus, Type 2. Completed, enrolled 494,679 participants across 1 site.
Detailed Summary
To compare the risk of acute pancreatitis in patients with Type 2 diabetes mellitus (T2DM) newly initiating empagliflozin to that of patients newly initiating other oral non-incretin/non-Sodium glucose co-transporter-2 inhibitor (SGLT2i)-containing hypoglycemic agents.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesGermany
Collaborators--
Timeline
N/ACompletedFinished
20222023202420252026
First PostedDec 2021
Enrollment StartDec 2021
Primary CompletionSep 2022
TodayJul 2026
First PostedDec 17, 2021
Enrollment StartDec 20, 2021
Primary CompletionSep 12, 2022
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 4.5 years ago
Interventions
empagliflozindrug
empagliflozin
Oral non-incretin/non-sodium glucose co-transporter-2 inhibitors (SGLT2)-containing hypoglycaemic agentsdrug
Oral non-incretin/non-sodium glucose co-transporter-2 inhibitors (SGLT2)-containing hypoglycaemic agents