Trial Outcomes & Findings for To Assess the Risk of Acute Pancreatitis in Patients With Type 2 Diabetes Mellitus Treated With Empagliflozin (NCT NCT05162014)
NCT ID: NCT05162014
Last Updated: 2024-05-02
Results Overview
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)).
COMPLETED
494679 participants
From August 2014 to March 2021 (the study period). Up to 79 months.
2024-05-02
Participant Flow
A Post-authorization safety study based on existing data between 1-Aug-2014 and the latest data-cut available in IBM MarketScan (30-Sep-2020) and Optum Clinformatics® Data Mart (CDM) 31-Mar-2021. The study aimed to assess the risk of acute pancreatitis in type 2 diabetes mellitus (T2DM) patients newly initiated in empagliflozin to that of newly initiated in other oral non incretin/non-sodium glucose co-transporter-2 inhibitors (SGLT2i)-based glucose lowering drugs. More details in Limitations.
Every patient who fulfilled inclusion and exclusion criteria was selected until the required sample size was achieved.
Participant milestones
| Measure |
Pooled Empagliflozin
Patients with type 2 diabetes mellitus (T2DM) and new initiators of empagliflozin on a background of metformin, between 1-Aug-2014 and the latest data-cut available in IBM MarketScan Commercial Claims and Encounters (CCAE)/ Medicare Supplemental (MDCR) 30-Sep-2020 and Optum Clinformatics® Data Mart (CDM) 31-Mar-2021, who were enrolled for a minimum of 6 months in the US claims databases before index treatment initiation
|
Pooled Sulfonylureas (SUs)
Patients with type 2 diabetes mellitus (T2DM) and new initiators of Sulfonylureas (SUs) on a background of metformin, between 1-Aug-2014 and the latest data-cut available in IBM MarketScan Commercial Claims and Encounters (CCAE)/ Medicare Supplemental (MDCR) 30-Sep-2020 and Optum Clinformatics® Data Mart (CDM) 31-Mar-2021, who were enrolled for a minimum of 6 months in the US claims databases before index treatment initiation
|
|---|---|---|
|
Overall Study
STARTED
|
72661
|
422018
|
|
Overall Study
Pooled- PS Matched
|
72621
|
72621
|
|
Overall Study
COMPLETED
|
72661
|
422018
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Pooled Empagliflozin - PS Matched
n=72621 Participants
Patients with type 2 diabetes mellitus (T2DM) and new initiators of empagliflozin on a background of metformin, between 1-Aug-2014 and the latest data-cut available in IBM MarketScan Commercial Claims and Encounters (CCAE)/ Medicare Supplemental (MDCR) 30-Sep-2020 and Optum Clinformatics® Data Mart (CDM) 31-Mar-2021, who were enrolled for a minimum of 6 months in the US claims databases before index treatment initiation and matched on propensity scores.
|
Pooled Sulfonylureas (SUs) - PS Matched
n=72621 Participants
Patients with type 2 diabetes mellitus (T2DM) and new initiators of Sulfonylureas (SUs) on a background of metformin, between 1-Aug-2014 and the latest data-cut available in IBM MarketScan Commercial Claims and Encounters (CCAE)/ Medicare Supplemental (MDCR) 30-Sep-2020 and Optum Clinformatics® Data Mart (CDM) 31-Mar-2021, who were enrolled for a minimum of 6 months in the US claims databases before index treatment initiation and matched on propensity scores
|
Total
n=145242 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.67 Years
STANDARD_DEVIATION 11.53 • n=72621 Participants
|
56.77 Years
STANDARD_DEVIATION 11.73 • n=72621 Participants
|
56.7 Years
STANDARD_DEVIATION 12 • n=145242 Participants
|
|
Sex: Female, Male
Female
|
30253 Participants
n=72621 Participants
|
30442 Participants
n=72621 Participants
|
60695 Participants
n=145242 Participants
|
|
Sex: Female, Male
Male
|
42368 Participants
n=72621 Participants
|
42179 Participants
n=72621 Participants
|
84547 Participants
n=145242 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: From August 2014 to March 2021 (the study period). Up to 79 months.Population: 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.
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)).
Outcome measures
| Measure |
Pooled Empagliflozin - PS Matched
n=72621 Participants
Patients with type 2 diabetes mellitus (T2DM) and new initiators of empagliflozin on a background of metformin, between 1-Aug-2014 and the latest data-cut available in IBM MarketScan Commercial Claims and Encounters (CCAE)/ Medicare Supplemental (MDCR) 30-Sep-2020 and Optum Clinformatics® Data Mart (CDM) 31-Mar-2021, who were enrolled for a minimum of 6 months in the US claims databases before index treatment initiation and matched on propensity scores.
|
Pooled Sulfonylureas (SUs) - PS Matched
n=72621 Participants
Patients with type 2 diabetes mellitus (T2DM) and new initiators of Sulfonylureas (SUs) on a background of metformin, between 1-Aug-2014 and the latest data-cut available in IBM MarketScan Commercial Claims and Encounters (CCAE)/ Medicare Supplemental (MDCR) 30-Sep-2020 and Optum Clinformatics® Data Mart (CDM) 31-Mar-2021, who were enrolled for a minimum of 6 months in the US claims databases before index treatment initiation and matched on propensity scores
|
|---|---|---|
|
Incidence Rate of Acute Pancreatitis
|
10.30 Events per 1,000 person-years
Interval 9.29 to 11.39
|
11.65 Events per 1,000 person-years
Interval 10.59 to 12.77
|
Adverse Events
Pooled Empagliflozin - PS Matched
Pooled Sulfonylureas (SUs) - PS Matched
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER