| Trial ID: | L3504 |
| Source ID: | NCT05162014
|
| Associated Drug: |
Empagliflozin
|
| Title: |
To Assess the Risk of Acute Pancreatitis in Patients With Type 2 Diabetes Mellitus Treated With Empagliflozin
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT05162014/results
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: empagliflozin|DRUG: Oral non-incretin/non-sodium glucose co-transporter-2 inhibitors (SGLT2)-containing hypoglycaemic agents
|
| Outcome Measures: |
Primary: Incidence Rate of Acute Pancreatitis, Incidence rate of acute pancreatitis per number of person-years, defined as an acute pancreatitis diagnosis from any of the inpatient (not restricted to the primary diagnosis), outpatient, or emergency contacts diagnoses (ICD-9-CM 577.0 or ICD-10-CM K85) and a lipase measure within +/- 7 days of the acute pancreatitis diagnosis (using LOINC code of 3040-3 and 2572-6 or CPT code of 83690 for lipase) and an abdominal ultrasound (using CPT codes of 76700 and 76705) within +/- 7 days of the acute pancreatitis diagnosis. The incidence rate was reported as the number of events (counts the first event per patient) divided by the total number of person-years at risk during follow-up (1/(1000\*person-years))., From August 2014 to March 2021 (the study period). Up to 79 months. |
|
| Sponsor/Collaborators: |
Sponsor: Boehringer Ingelheim
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
494679
|
| Study Type: |
OBSERVATIONAL
|
| Study Designs: |
Observational Model: |Time Perspective: p
|
| Start Date: |
2021-12-20
|
| Completion Date: |
2022-09-12
|
| Results First Posted: |
2024-03-18
|
| Last Update Posted: |
2024-05-02
|
| Locations: |
Boehringer Ingelheim International GmbH, Ingelheim am Rhein, 55216, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT05162014
|
