N/A
N=333,580
Post-authorisation Safety Study in Patients With Type 2 Diabetes to Assess the Risk of Liver Injury, Kidney Injury, Urinary Tract and Genital Infections, and Diabetic Ketoacidosis in Patients Treated With Empagliflozin, Compared to DPP-4 Inhibitors
Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT02864914 ↗Enrolled (actual)
333,580
Serious AEs
—
Results posted
Nov 2024
Primary outcome: Primary: Incidence Rates of Acute Liver Injury (ALI) in Patients With no Predisposing Conditions (ALI1) in Propensity Score-trimmed Cohort for ALI1 — 0.60; 1.21; 1.09; NA Events per 1000 person-years
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Empagliflozin (Drug); DPP-4 inhibitors (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence Rates of Acute Liver Injury (ALI) in Patients With no Predisposing Conditions (ALI1) in Propensity Score-trimmed Cohort for ALI1 |
0.60; 1.21; 1.09; NA; 1.41 | — |
| PRIMARY Incidence Rates of Acute Kidney Injury (AKI) in Propensity Score-trimmed Cohort for AKI |
4.64; 3.41; 2.60; 10.96; 11.43; 4.96 | — |
| PRIMARY Incidence Rates of Diabetic Ketoacidosis (DKA) in Propensity Score-trimmed Cohort for DKA |
2.57; 1.50; NA; 3.62; 0.92; 0.70 | — |
| PRIMARY Incidence Rates of Severe Complications of Urinary Tract Infections (UTIs) in Propensity Score-trimmed Cohort for UTI - CPRD Only |
3.32; 6.47 | — |
| PRIMARY Incidence Rates of Genital Infections in Males (GIM) in Propensity Score-trimmed Cohort for GIM - CPRD Only |
47.23; 11.70 | — |
| PRIMARY Incidence Rates of Genital Infections in Females (GIF) in Propensity Score-trimmed Cohort for GIF - CPRD Only |
79.65; 24.58 | — |
| SECONDARY Incidence Rates of Acute Liver Injury (ALI) in Patients With or Without Predisposing Conditions (ALI2) in Propensity Score-trimmed Cohort for ALI2 |
1.33; 1.23; NA; 4.19; 2.67; 1.86 | — |
| SECONDARY Incidence Rates of Chronic Kidney Disease (CKD) in Propensity Score-trimmed Cohort for CKD - CPRD Only |
9.32; 17.73 | — |
| SECONDARY Incidence Rates of Severe Genital Infections in Males (GIMH) in Propensity Score-trimmed Cohort for GIM - CPRD Only |
43.35; 10.72 | — |
| SECONDARY Incidence Rates of Severe Genital Infections in Females (GIFH) in Propensity Score-trimmed Cohort for GIF - CPRD Only |
58.42; 17.48 | — |
Summary
Empagliflozin (Jardiance), a highly potent and selective inhibitor of the sodium-glucose cotransporter 2 (SGLT2), was approved in Europe in May 2014 for the treatment of type 2 diabetes mellitus (T2DM) to improve glycaemic control in adults. As part of the risk management plan, Boehringer Ingelheim International GmbH (BI) has committed to conduct a post-authorisation safety study (PASS) to evaluate the liver and renal safety of empagliflozin. The study will also evaluate the risks of severe complications of urinary tract infections (UTIs) and genital infections. To evaluate the association between empagliflozin use and mentioned outcomes routinely collected health information from the Clinical Practice Research Datalink (CPRD), the Hospital Episodes Statistics, and Office of National Statistic will be used. This PASS will be conducted through an observational cohort study among adult patients with T2DM and at least 12 months of continuous enrolment in the CPRD where new users of empagliflozin will be compared to new users of dipeptidyl peptidase-4 (DPP4) inhibitors. Estimations will be made on the crude and adjusted incidence rates and adjusted incidence rate ratios of the primary and secondary outcomes.
Eligibility Criteria
Inclusion criteria
- Patients will have T2DM, be initiating treatment with a study medication, and have at least 12 months of continuous registration in CPRD.
- Further inclusion criteria apply
Exclusion criteria
- Patients will not have T1DM, will have no prior use of an SGLT2 inhibitor or DPP4 inhibitor, and will not be initiating a SGLT2-DPP4 fixed-dose combination.
- Additional different exclusion criteria will be applied according to each outcomes of interest.
Data sourced from ClinicalTrials.gov (NCT02864914). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.