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 Clinical Trial

Official title:

Post-authorisation Safety Study in Patients With Type 2 Diabetes Mellitus to Assess the Risk of Acute Liver Injury, Acute Kidney Injury and Chronic Kidney Disease, Severe Complications of Urinary Tract Infection, Genital Infections, and Diabetic Ketoacidosis Among Patients Treated With Empagliflozin Compared to Patients Treated With DPP-4 Inhibitors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02864914
• Other study ID #: 1245.96
• Secondary ID: 1245-0096
• Status: Completed
• Start date: March 15, 2016
• Est. completion date: July 29, 2022

Study information

• Verified date: August 2022
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99000
• Est. completion date: July 29, 2022
• Est. primary completion date: July 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetic Ketoacidosis
• Ketosis

Intervention

Drug:
• Empagliflozin
drug
• DPP-4 inhibitors
drug

Locations

Country	Name	City	State
United Kingdom	RTI health solutions	One Or Multiple Sites

Sponsors (2)

Lead Sponsor	Collaborator
Boehringer Ingelheim	Eli Lilly and Company

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute liver injury (ALI) in patients with no predisposing conditions		up to 5 years
Primary	Acute kidney injury (AKI)		up to 5 years
Primary	Severe complications of urinary tract infections (UTIs)		up to 5 years
Primary	Genital infections		up to 5 years
Primary	Incidence of diabetic ketoacidosis (DKA)		up to 5 years
Secondary	Acute liver injury in patients with or without predisposing conditions		up to 5 years
Secondary	Chronic kidney disease (CKD)		up to 5 years
Secondary	Incidence of severe genital infections		up to 5 years

External Links

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