Ignite Creation Date:
2024-05-06 @ 8:56 AM
Last Modification Date:
2024-10-26 @ 12:07 PM
Study NCT ID:
NCT02864914
Status:
COMPLETED
Last Update Posted:
2022-08-03
First Post:
2016-05-13
Brief 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
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1245-0096 | OTHER | Boehringer Ingelheim | None |