Trial · NCT02864914
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
NCT02864914, Completed, Boehringer Ingelheim; results first posted 2024-11-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT02864914. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02864914
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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
- NCT number
- NCT02864914
- Status
- Completed
- Enrollment
- 333,580 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Empagliflozin, DPP-4 inhibitors
- First posted
- 2016-08-12
- Last updated
- 2024-11-15
- Results first posted
- 2024-11-15
- Limitations and caveats
In the outcome measure ALI1, the number of patients after trimming belonging to the Danish Registries and treated with Empagliflozin, as well as with DPP-4 inhibitors and ≥ 3 glucose-lowering drugs, cannot be reported since the number of events in Danish Registries was 1 to 4, and the total cannot be given to avoid back-calculation of values due to the Danish small cell count policy.
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence Rates of Acute Liver Injury (ALI) in Patients With no Predisposing Conditions (ALI1) in Propensity Score-trimmed Cohort for ALI1 | up to 5 years | Incidence rates (IRs) of acute liver injury (ALI) in patients with no predisposing conditions (ALI1) in propensity score-trimmed study cohorts for ALI1 are reported. Unadjusted IRs were computed as the number of events divided by the total person-years at risk in the empagliflozin and DPP-4 inhibitors cohorts overall and for subgroups with and without insulin use at the index date. IRs adjusted for propensity score decile were generated for empagliflozin and DPP-4 inhibitor cohorts overall (not stratified by any other variable). These estimates with corresponding 95% confidence interval (CIs) were generated using a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model. |
| Primary | Incidence Rates of Acute Kidney Injury (AKI) in Propensity Score-trimmed Cohort for AKI | up to 5 years | Incidence rates (IRs) of acute kidney injury (AKI) in propensity score-trimmed cohort for AKI are reported. Unadjusted IRs were computed as the number of events divided by the total person-years at risk in the empagliflozin and DPP-4 inhibitors cohorts overall and for subgroups with and without insulin use at the index date. IRs adjusted for propensity score decile were generated for empagliflozin and DPP-4 inhibitor cohorts overall (not stratified by any other variable). These estimates with corresponding 95% CIs were generated through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model. |
| Primary | Incidence Rates of Diabetic Ketoacidosis (DKA) in Propensity Score-trimmed Cohort for DKA | up to 5 years | Incidence rates (IRs) of diabetic ketoacidosis (DKA) in propensity score-trimmed cohort for DKA are reported. Unadjusted IRs were computed as the number of events divided by the total person-years at risk in the empagliflozin and DPP-4 inhibitors cohorts overall and for subgroups with and without insulin use at the index date. IRs adjusted for propensity score decile were generated for empagliflozin and DPP-4 inhibitor cohorts overall (not stratified by any other variable). These estimates with corresponding 95% CIs were generated through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model. |
| Primary | Incidence Rates of Severe Complications of Urinary Tract Infections (UTIs) in Propensity Score-trimmed Cohort for UTI - CPRD Only | up to 5 years | Incidence rates (IRs) of severe complications of urinary tract infections (UTIs) in propensity score-trimmed cohort for UTI among CPRD participants are reported. Unadjusted IRs were computed as the number of events divided by the total person-years at risk in the empagliflozin and DPP-4 inhibitors cohorts overall and for subgroups with and without insulin use at the index date. IRs adjusted for propensity score decile were generated for empagliflozin and DPP-4 inhibitor cohorts overall (not stratified by any other variable). These estimates with corresponding 95% CIs were generated through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model. |
| Primary | Incidence Rates of Genital Infections in Males (GIM) in Propensity Score-trimmed Cohort for GIM - CPRD Only | up to 5 years | Incidence rates (IRs) of genital infections in males (GIM) in propensity score-trimmed cohorts for GIM among CPRD participants are reported. Unadjusted IRs were computed as the number of events divided by the total person-years at risk in the empagliflozin and DPP-4 inhibitors cohorts overall and for subgroups with and without insulin use at the index date. IRs adjusted for propensity score decile were generated for empagliflozin and DPP-4 inhibitor cohorts overall (not stratified by any other variable). These estimates with corresponding 95% CIs were generated through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model. |
| Primary | Incidence Rates of Genital Infections in Females (GIF) in Propensity Score-trimmed Cohort for GIF - CPRD Only | up to 5 years | Incidence rates (IRs) of genital infections in females (GIF) in propensity score-trimmed cohort for GIF among CPRD participants are reported. Unadjusted IRs were computed as the number of events divided by the total person-years at risk in the empagliflozin and DPP-4 inhibitors cohorts overall and for subgroups with and without insulin use at the index date. IRs adjusted for propensity score decile were generated for empagliflozin and DPP-4 inhibitor cohorts overall (not stratified by any other variable). These estimates with corresponding 95% CIs were generated through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model. |
| Secondary | Incidence Rates of Acute Liver Injury (ALI) in Patients With or Without Predisposing Conditions (ALI2) in Propensity Score-trimmed Cohort for ALI2 | up to 5 years | Incidence rates (IRs) of acute liver injury (ALI) in patients with or without predisposing conditions (ALI2) in propensity score-trimmed cohort for ALI2 are reported. Unadjusted IRs were computed as the number of events divided by the total person-years at risk in the empagliflozin and DPP-4 inhibitors cohorts overall and for subgroups with and without insulin use at the index date. IRs adjusted for propensity score decile were generated for empagliflozin and DPP-4 inhibitor cohorts overall (not stratified by any other variable). These estimates with corresponding 95% CIs were generated through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model. |
| Secondary | Incidence Rates of Chronic Kidney Disease (CKD) in Propensity Score-trimmed Cohort for CKD - CPRD Only | up to 5 years | Incidence rates (IRs) of chronic kidney disease (CKD) in propensity score-trimmed cohort for CKD among CPRD participants are reported. Unadjusted IRs were computed as the number of events divided by the total person-years at risk in the empagliflozin and DPP-4 inhibitors cohorts overall and for subgroups with and without insulin use at the index date. IRs adjusted for propensity score decile were generated for empagliflozin and DPP-4 inhibitor cohorts overall (not stratified by any other variable). These estimates with corresponding 95% CIs were generated through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model. |
| Secondary | Incidence Rates of Severe Genital Infections in Males (GIMH) in Propensity Score-trimmed Cohort for GIM - CPRD Only | up to 5 years | Incidence rates (IRs) of severe genital infections in males (GIMH) in propensity score-trimmed cohort for GIM among CPRD participants are reported. Unadjusted IRs were computed as the number of events divided by the total person-years at risk in the empagliflozin and DPP-4 inhibitors cohorts overall and for subgroups with and without insulin use at the index date. IRs adjusted for propensity score decile were generated for empagliflozin and DPP-4 inhibitor cohorts overall (not stratified by any other variable). These estimates with corresponding 95% CIs were generated through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model. |
| Secondary | Incidence Rates of Severe Genital Infections in Females (GIFH) in Propensity Score-trimmed Cohort for GIF - CPRD Only | up to 5 years | Incidence rates (IRs) of severe genital infections in females (GIFH) in propensity score-trimmed cohort for GIF among CPRD participants are reported. Unadjusted IRs were computed as the number of events divided by the total person-years at risk in the empagliflozin and DPP-4 inhibitors cohorts overall and for subgroups with and without insulin use at the index date. IRs adjusted for propensity score decile were generated for empagliflozin and DPP-4 inhibitor cohorts overall (not stratified by any other variable). These estimates with corresponding 95% CIs were generated through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence Rates of Acute Liver Injury (ALI) in Patients With no Predisposing Conditions (ALI1) in Propensity Score-trimmed Cohort for ALI1 | up to 5 years | All eligible subjects who strictly met all inclusion and none of the exclusion criteria, and with non-missing ALI results and with no predisposing conditions (ALI1) were included. The cohort after propensity score trimming (extreme values of propensity score were trimmed) was used. A ALI1-specific propensity score model was used for the propensity score including all ALI1-related variables. Due to the Danish small cell count policy, some cohorts were not reported (see limits \& caveats). | Events per 1000 person-years | NUMBER |
| PRIMARY | Incidence Rates of Acute Kidney Injury (AKI) in Propensity Score-trimmed Cohort for AKI | up to 5 years | All eligible subjects who strictly met all inclusion and none of the exclusion criteria. The cohort after propensity score trimming (extreme values of propensity score were trimmed) was used. A AKI-specific propensity score model was used for the propensity score including all AKI-related variables. | Events per 1000 person-years | NUMBER |
| PRIMARY | Incidence Rates of Diabetic Ketoacidosis (DKA) in Propensity Score-trimmed Cohort for DKA | up to 5 years | All eligible subjects who strictly met all inclusion and none of the exclusion criteria. The cohort after propensity score trimming (extreme values of propensity score were trimmed) was used. A DKA-specific propensity score model was used for the propensity score including all DKA-related variables. | Events per 1000 person-years | NUMBER |
| PRIMARY | Incidence Rates of Severe Complications of Urinary Tract Infections (UTIs) in Propensity Score-trimmed Cohort for UTI - CPRD Only | up to 5 years | All eligible subjects who strictly met all inclusion and none of the exclusion criteria. The cohort after propensity score trimming (extreme values of propensity score were trimmed) was used. A UTI-specific propensity score model was used for the propensity score including all UTI-related variables. Because UTI was evaluated only in CPRD database, only participants from CPRD were used. | Events per 1000 person-years | NUMBER |
| PRIMARY | Incidence Rates of Genital Infections in Males (GIM) in Propensity Score-trimmed Cohort for GIM - CPRD Only | up to 5 years | All eligible subjects who strictly met all inclusion and none of the exclusion criteria. The cohort after propensity score trimming (extreme values of propensity score were trimmed) was used. A GIM-specific propensity score model was used for the propensity score including all GIM-related variables. Because genital infection was evaluated only in CPRD database, only participants from CPRD were used. | Events per 1000 person-years | NUMBER |
| PRIMARY | Incidence Rates of Genital Infections in Females (GIF) in Propensity Score-trimmed Cohort for GIF - CPRD Only | up to 5 years | All eligible subjects who strictly met all inclusion and none of the exclusion criteria. The cohort after propensity score trimming (extreme values of propensity score were trimmed) was used. A GIF-specific propensity score model was used for the propensity score including all GIF-related variables. Because genital infection was evaluated only in CPRD database, only participants from CPRD were used. | Events per 1000 person-years | NUMBER |
| SECONDARY | Incidence Rates of Acute Liver Injury (ALI) in Patients With or Without Predisposing Conditions (ALI2) in Propensity Score-trimmed Cohort for ALI2 | up to 5 years | All eligible subjects who strictly met all inclusion and none of the exclusion criteria. The cohort after propensity score trimming (extreme values of propensity score were trimmed) was used. A ALI2-specific propensity score model was used for the propensity score including all ALI2-related variables. | Events per 1000 person-years | NUMBER |
| SECONDARY | Incidence Rates of Chronic Kidney Disease (CKD) in Propensity Score-trimmed Cohort for CKD - CPRD Only | up to 5 years | All eligible subjects who strictly met all inclusion and none of the exclusion criteria. The cohort after propensity score trimming (extreme values of propensity score were trimmed) was used. A CKD-specific propensity score model was used for the propensity score including all CKD-related variables. Because CKD was evaluated only in CPRD database, only participants from CPRD were used. | Events per 1000 person-years | NUMBER |
| SECONDARY | Incidence Rates of Severe Genital Infections in Males (GIMH) in Propensity Score-trimmed Cohort for GIM - CPRD Only | up to 5 years | All eligible subjects who strictly met all inclusion and none of the exclusion criteria. The cohort after propensity score trimming (extreme values of propensity score were trimmed) was used. A GIM-specific propensity score model was used for the propensity score including all GIM-related variables. Because genital infection was evaluated only in CPRD database, only participants from CPRD were used. | Events per 1000 person-years | NUMBER |
| SECONDARY | Incidence Rates of Severe Genital Infections in Females (GIFH) in Propensity Score-trimmed Cohort for GIF - CPRD Only | up to 5 years | All eligible subjects who strictly met all inclusion and none of the exclusion criteria. The cohort after propensity score trimming (extreme values of propensity score were trimmed) was used. A GIF-specific propensity score model was used for the propensity score including all GIF-related variables. Because genital infection was evaluated only in CPRD database, only participants from CPRD were used. | Events per 1000 person-years | NUMBER |
Source ClinicalTrials.gov
Results by group41
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence Rates of Acute Liver Injury (ALI) in Patients With no Predisposing Conditions (ALI1) in Propensity Score-trimmed Cohort for ALI1 | Empagliflozin - CPRD (After Propensity Score Trimming) | 0.60 | 95% Confidence Interval 0.27 to 1.36 | Events per 1000 person-years | |
| Incidence Rates of Acute Liver Injury (ALI) in Patients With no Predisposing Conditions (ALI1) in Propensity Score-trimmed Cohort for ALI1 | Empagliflozin - HIRD (After Propensity Score Trimming) | 1.21 | 95% Confidence Interval 0.79 to 1.86 | Events per 1000 person-years | |
| Incidence Rates of Acute Liver Injury (ALI) in Patients With no Predisposing Conditions (ALI1) in Propensity Score-trimmed Cohort for ALI1 | DPP-4 Inhibitors - CPRD (After Propensity Score Trimming) | 1.09 | 95% Confidence Interval 0.75 to 1.59 | Events per 1000 person-years | |
| Incidence Rates of Acute Liver Injury (ALI) in Patients With no Predisposing Conditions (ALI1) in Propensity Score-trimmed Cohort for ALI1 | DPP-4 Inhibitors - Danish Registries <3 Glucose-lowering Drugs (After Propensity Score Trimming) | NA | 95% Confidence Interval NA to NA | Events per 1000 person-years | |
| Incidence Rates of Acute Liver Injury (ALI) in Patients With no Predisposing Conditions (ALI1) in Propensity Score-trimmed Cohort for ALI1 | DPP-4 Inhibitors - HIRD (After Propensity Score Trimming) | 1.41 | 95% Confidence Interval 1.04 to 1.92 | Events per 1000 person-years | |
| Incidence Rates of Acute Kidney Injury (AKI) in Propensity Score-trimmed Cohort for AKI | Empagliflozin - CPRD (After Propensity Score Trimming) | 4.64 | 95% Confidence Interval 3.51 to 6.12 | Events per 1000 person-years | |
| Incidence Rates of Acute Kidney Injury (AKI) in Propensity Score-trimmed Cohort for AKI | Empagliflozin - Danish Registries <3 Glucose-lowering Drugs (After Propensity Score Trimming) | 3.41 | 95% Confidence Interval 2.31 to 5.02 | Events per 1000 person-years | |
| Incidence Rates of Acute Kidney Injury (AKI) in Propensity Score-trimmed Cohort for AKI | Empagliflozin - Danish Registries ≥3 Glucose-lowering Drugs (After Propensity Score Trimming) | 2.60 | 95% Confidence Interval 1.54 to 4.40 | Events per 1000 person-years | |
| Incidence Rates of Acute Kidney Injury (AKI) in Propensity Score-trimmed Cohort for AKI | Empagliflozin - HIRD (After Propensity Score Trimming) | 10.96 | 95% Confidence Interval 9.61 to 12.49 | Events per 1000 person-years | |
| Incidence Rates of Acute Kidney Injury (AKI) in Propensity Score-trimmed Cohort for AKI | DPP-4 Inhibitors - CPRD (After Propensity Score Trimming) | 11.43 | 95% Confidence Interval 10.21 to 12.79 | Events per 1000 person-years |
1 to 10 of 41Source ClinicalTrials.gov
See all 41 results by groupParticipant flow22
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Empagliflozin | 76,174 | |
| Overall Study | STARTED | DPP-4 Inhibitors | 257,406 | |
| Overall Study | Propensity Score-trimmed Cohort for DKA | Empagliflozin | 64,599 | |
| Overall Study | Propensity Score-trimmed Cohort for DKA | DPP-4 Inhibitors | 203,315 | |
| Overall Study | Propensity Score-trimmed Cohort for AKI | Empagliflozin | 58,393 | |
| Overall Study | Propensity Score-trimmed Cohort for AKI | DPP-4 Inhibitors | 167,823 | |
| Overall Study | Propensity Score-trimmed Cohort for ALI2 | Empagliflozin | 62,917 | |
| Overall Study | Propensity Score-trimmed Cohort for ALI2 | DPP-4 Inhibitors | 197,172 | |
| Overall Study | Propensity Score-trimmed Cohort for CKD - CPRD Only | Empagliflozin | 13,256 | |
| Overall Study | Propensity Score-trimmed Cohort for CKD - CPRD Only | DPP-4 Inhibitors | 62,435 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 participant flowAdverse 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 | Empagliflozin | 0 | 0 |
| Total, all-cause mortality | DPP-4 Inhibitors | 0 | 0 |
| Total, other adverse events | Empagliflozin | 0 | 0 |
| Total, other adverse events | DPP-4 Inhibitors | 0 | 0 |
| Total, serious adverse events | Empagliflozin | 0 | 0 |
| Total, serious adverse events | DPP-4 Inhibitors | 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/NCT02864914
GET https://conductscience.org/api/trials/v1/NCT02864914/results?page=2