Post-authorisation Safety Study in Patients With Type 2 Diabetes to Assess the Risk of Liver Inju… (NCT02864914) | Clinical Trial Compass
CompletedNot Applicable
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
United Kingdom333,580 participantsStarted 2016-03-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study compared empagliflozin to DPP-4 inhibitors and tracked serious side effects like acute kidney injury, diabetic ketoacidosis, and genital infections — based on what this study found, how does empagliflozin's safety profile compare to the DPP-4 inhibitor I might be taking or considering?
2Since this trial specifically measured the risk of diabetic ketoacidosis in people taking empagliflozin, is my personal situation — such as my kidney function or any history of low carbohydrate dieting — something that would make that risk higher for me?
3The study tracked urinary tract and genital infections as real safety outcomes — given that these were serious enough to study formally, how likely are they in practice, and are there warning signs I should watch for if I'm on empagliflozin?
4This was a post-authorisation safety study, meaning it looked at real-world patients already using the drug — does the data from this kind of large observational study change your thinking about whether empagliflozin or a DPP-4 inhibitor would be a better fit for managing my type 2 diabetes?
5Since the study also looked at acute liver injury in patients without pre-existing liver conditions, should I have my liver function checked before starting or while taking empagliflozin, and are there any existing health issues I have that would make that risk more relevant to me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence Rates of Acute Liver Injury (ALI) in Patients With no Predisposing Conditions (ALI1) in Propensity Score-trimmed Cohort for ALI1
Timeframe: up to 5 years
2
Incidence Rates of Acute Kidney Injury (AKI) in Propensity Score-trimmed Cohort for AKI
Timeframe: up to 5 years
3
Incidence Rates of Diabetic Ketoacidosis (DKA) in Propensity Score-trimmed Cohort for DKA
Timeframe: up to 5 years
4
Incidence Rates of Severe Complications of Urinary Tract Infections (UTIs) in Propensity Score-trimmed Cohort for UTI - CPRD Only
Timeframe: up to 5 years
5
Incidence Rates of Genital Infections in Males (GIM) in Propensity Score-trimmed Cohort for GIM - CPRD Only
Timeframe: up to 5 years
6
Incidence Rates of Genital Infections in Females (GIF) in Propensity Score-trimmed Cohort for GIF - CPRD Only