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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

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ClinicalTrials.gov Identifier: NCT02864914
Recruitment Status : Completed
First Posted : August 12, 2016
Last Update Posted : August 3, 2022
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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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.

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 Drug: Empagliflozin Drug: DPP-4 inhibitors

Study Design
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Study Type : Observational
Actual Enrollment : 99000 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Actual Study Start Date : March 15, 2016
Actual Primary Completion Date : July 29, 2022
Actual Study Completion Date : July 29, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Empagliflozin
Patients initiating Empagliflozin treatment within the study period
 Drug: Empagliflozin
drug
DPP-4 inhibitors
Patients initiating DPP-4 inhibitor treatment within the study period
 Drug: DPP-4 inhibitors
drug


Outcome Measures
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Primary Outcome Measures :
  1. Acute liver injury (ALI) in patients with no predisposing conditions [ Time Frame: up to 5 years ]
  2. Acute kidney injury (AKI) [ Time Frame: up to 5 years ]
  3. Severe complications of urinary tract infections (UTIs) [ Time Frame: up to 5 years ]
  4. Genital infections [ Time Frame: up to 5 years ]
  5. Incidence of diabetic ketoacidosis (DKA) [ Time Frame: up to 5 years ]

Secondary Outcome Measures :
  1. Acute liver injury in patients with or without predisposing conditions [ Time Frame: up to 5 years ]
  2. Chronic kidney disease (CKD) [ Time Frame: up to 5 years ]
  3. Incidence of severe genital infections [ Time Frame: up to 5 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
T2DM eligible patients in CPRD
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02864914


Locations
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United Kingdom
RTI health solutions
One Or Multiple Sites, United Kingdom
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
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Additional Information:

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02864914    
Other Study ID Numbers: 1245.96
1245-0096 ( Other Identifier: Boehringer Ingelheim )
First Posted: August 12, 2016    Key Record Dates
Last Update Posted: August 3, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Ketosis
Diabetic Ketoacidosis
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Acidosis
Acid-Base Imbalance
 Diabetes Complications
Empagliflozin
Dipeptidyl-Peptidase IV Inhibitors
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs
Protease Inhibitors
Enzyme Inhibitors