NCT05162014

To Assess the Risk of Acute Pancreatitis in Patients With Type 2 Diabetes Mellitus Treated With Empagliflozin

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 494,679 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	empagliflozin	empagliflozin
DRUG	Oral non-incretin/non-sodium glucose co-transporter-2 inhibitors (SGLT2)-containing hypoglycaemic agents	Oral non-incretin/non-sodium glucose co-transporter-2 inhibitors (SGLT2)-containing hypoglycaemic agents

Timeline

• Start date: 2021-12-20
• Primary completion: 2022-09-12
• Completion: 2022-09-12
• First posted: 2021-12-17
• Last updated: 2024-05-02
• Results posted: 2024-03-18

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated drug study