Empa PASS on Urinary Tract Malignancies

Post-authorisation Safety Study to Assess the Risk of Urinary Tract Malignancies in Relation to Empagliflozin Exposure in Patients With Type 2 Diabetes: a Multi-database European Study

The aim of the study is to assess the risk of urinary tract malignancies in patients initiating empagliflozin (free or fixed dose combination) compared to patients initiating a dipeptidyl peptidase-4 (DPP-4) inhibitor and to patients initiating other Sodium glucose co-transporter-2 (SGLT-2) inhibitors (i.e. two comparator groups)

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: empagliflozin; Drug: DPP-4 inhibitors; Drug: SGLT-2 inhibitors

• Study Type: Observational
• Enrollment (Actual): 98000

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland
    • The National Register Data
• Sweden
  • Stockholm, Sweden
    • The Swedish prescribed drug register
• United Kingdom
  • London, United Kingdom
    • United Kingdom Clinical Practice Research Datalink (CPRD)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

This is an observational, comparative, cohort safety study based on European healthcare databases and includes databases from the UK and Sweden.

Description

Inclusion Criteria:

• Diagnosis of type 2 diabetes
• Age over 18 years at index date
• At least 1 year of membership in the medication database prior to index date

Exclusion Criteria:

• Patients with any cancer (excluding non-melanoma skin cancer) recorded at any time prior to the index date (i.e. during the available look-back time)
• Diagnosis of type 1 diabetes or other specific non-type 2 diabetes
• Use of any SGLT-2 inhibitor or any DPP-4 inhibitor (including free and fixed-dose combinations) recorded at any time prior to index date (i.e. during the available look-back time).
• Use of fixed-dose combinations of SGLT-2 inhibitors with DPP-4 inhibitors
• Diagnosis of end stage renal disease or receipt of renal dialysis recorded at any time prior to index date (i.e. during the available look-back time)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
type 2 diabetes patients	Drug: empagliflozin; drug; Drug: DPP-4 inhibitors; drug; Drug: SGLT-2 inhibitors; drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
occurence of urinary tract cancer	first incidence of urinary cancer	up to 60 months
occurence of bladder cancer		up to 60 months
occurence of renal cancer		up to 60 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
occurence of other urinary tract cancers	non-renal, non- urinary bladder, urinary tract cancers	up to 60 months

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim
• Collaborators: Eli Lilly and Company
• Investigators: Principal Investigator: Pasi Korhonen, 358-50-3652990, pasi.korhonen@epidresearch.com

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2016
• Primary Completion (Actual): March 11, 2024
• Study Completion (Actual): March 11, 2024

Study Registration Dates

• First Submitted: March 7, 2018
• First Submitted That Met QC Criteria: March 7, 2018
• First Posted (Actual): March 13, 2018

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Empagliflozin; Sodium-Glucose Transporter 2 Inhibitors; Dipeptidyl-Peptidase IV Inhibitors
• Other Study ID Numbers: 1245-0097

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to: https://www.mystudywindow.com/msw/datatransparency

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No