Trial · NCT05162014
To Assess the Risk of Acute Pancreatitis in Patients With Type 2 Diabetes Mellitus Treated With Empagliflozin
NCT05162014, Completed, Boehringer Ingelheim; results first posted 2024-03-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. To Assess the Risk of Acute Pancreatitis in Patients With Type 2 Diabetes Mellitus Treated With Empagliflozin. Trials, record NCT05162014. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05162014
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- To Assess the Risk of Acute Pancreatitis in Patients With Type 2 Diabetes Mellitus Treated With Empagliflozin
- NCT number
- NCT05162014
- Status
- Completed
- Enrollment
- 494,679 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- empagliflozin, Oral non-incretin/non-sodium glucose co-transporter-2 inhibitors (SGLT2)-containing hypoglycaemic agents
- First posted
- 2021-12-17
- Last updated
- 2024-05-02
- Results first posted
- 2024-03-18
- Limitations and caveats
This was a Non interventional study (NIS) based on existing data. Therefore, the study might be subject to potential residual confounding due to the absence of certain key data.~In November 2021, an initial feasibility assessment was conducted which showed that the therapy cohort Empagliflozin vs. Sulfonylurea (SU) reported the highest number of empagliflozin initiators and was the only adequately powered line of therapy.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence Rate of Acute Pancreatitis | From August 2014 to March 2021 (the study period). Up to 79 months. | 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)). |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence Rate of Acute Pancreatitis | From August 2014 to March 2021 (the study period). Up to 79 months. | Pooled unmatched and 1:1 propensity scores (PS) matched cohort of patients with type 2 diabetes mellitus (T2DM) and new initiators of empagliflozin or sulfonylureas (SUs), who were enrolled between 1 August 2014 and the latest data-cut available in IBM MarketScan CCAE/MDCR (30 September 2020) and Optum CDM (31 March 2021). Primary analysis represented an 'as treated' approach. | Events per 1,000 person-years | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence Rate of Acute Pancreatitis | Pooled Empagliflozin - PS Matched | 10.30 | 95% Confidence Interval 9.29 to 11.39 | Events per 1,000 person-years | |
| Incidence Rate of Acute Pancreatitis | Pooled Sulfonylureas (SUs) - PS Matched | 11.65 | 95% Confidence Interval 10.59 to 12.77 | Events per 1,000 person-years |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pooled Empagliflozin | 72,661 | |
| Overall Study | STARTED | Pooled Sulfonylureas (SUs) | 422,018 | |
| Overall Study | Pooled- PS Matched | Pooled Empagliflozin | 72,621 | |
| Overall Study | Pooled- PS Matched | Pooled Sulfonylureas (SUs) | 72,621 | |
| Overall Study | COMPLETED | Pooled Empagliflozin | 72,661 | |
| Overall Study | COMPLETED | Pooled Sulfonylureas (SUs) | 422,018 | |
| Overall Study | NOT COMPLETED | Pooled Empagliflozin | 0 | |
| Overall Study | NOT COMPLETED | Pooled Sulfonylureas (SUs) | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pooled Empagliflozin - PS Matched | 0 | 0 |
| Total, all-cause mortality | Pooled Sulfonylureas (SUs) - PS Matched | 0 | 0 |
| Total, other adverse events | Pooled Empagliflozin - PS Matched | 0 | 0 |
| Total, other adverse events | Pooled Sulfonylureas (SUs) - PS Matched | 0 | 0 |
| Total, serious adverse events | Pooled Empagliflozin - PS Matched | 0 | 0 |
| Total, serious adverse events | Pooled Sulfonylureas (SUs) - PS Matched | 0 | 0 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05162014
GET https://conductscience.org/api/trials/v1/NCT05162014/registered