Empa PASS on Urinary Tract Malignancies

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03464045
• Collaborator: Eli Lilly and Company (Industry)
• Enrollment: 98,000
• Locations: 3
• Anticipated Duration (Months): 70.4
• Patients Per Site: 32666.7
• Patients Per Site Per Month: 463.8

Study Details

Study Description

Brief Summary

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)

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: empagliflozin; Drug: DPP-4 inhibitors; Drug: SGLT-2 inhibitors

Study Design

• Study Type: Observational
• Actual Enrollment: 98000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: 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
• Actual Study Start Date: Nov 16, 2016
• Anticipated Primary Completion Date: Sep 30, 2022
• Anticipated Study Completion Date: Sep 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. occurence of urinary tract cancer [upto 60 months]

   first incidence of urinary cancer

2. occurence of bladder cancer [upto 60 months]

3. occurence of renal cancer [upto 60 months]

Secondary Outcome Measures

1. occurence of other urinary tract cancers [upto 60 months]

   non-renal, non- urinary bladder, urinary tract cancers

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The National Register Data	Helsinki		Finland
2	The Swedish prescribed drug register	Stockholm		Sweden
3	United Kingdom Clinical Practice Research Datalink (CPRD)	London		United Kingdom

Sponsors and Collaborators

• Boehringer Ingelheim
• Eli Lilly and Company

Investigators

• Principal Investigator: Pasi Korhonen, 358-50-3652990, [e-mail]

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT03464045
• Other Study ID Numbers: 1245-0097
• First Posted: Mar 13, 2018
• Last Update Posted: Aug 9, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Diabetes Mellitus, Type 2; Empagliflozin; Sodium-Glucose Transporter 2 Inhibitors; Dipeptidyl-Peptidase IV Inhibitors

Study Results

No Results Posted as of Aug 9, 2022