| Trial ID: | L4176 |
| Source ID: | NCT04937816
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| Associated Drug: |
Placebo
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| Title: |
This Study Combines Data From 3 Other Studies Testing Empagliflozin in Patients With Diabetes or With Chronic Heart Failure. The Study Looks at the Numbers of Patients Who Had Lower Limb Amputations
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| Acronym: |
|
| Status: |
COMPLETED
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| Study Results: |
YES
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| Results: |
https://ClinicalTrials.gov/show/NCT04937816/results
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| Conditions: |
Diabetes Mellitus, Type 2
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| Interventions: |
DRUG: Placebo|DRUG: Empagliflozin
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| Outcome Measures: |
Primary: Incidence Rate of Lower Limb Amputation (LLA), Incidence rate of lower limb amputation (LLA). Incidence rate were provided as rate per 100 patients-years (pt-yrs) calculated as the observed number of patients with event divided by observed time-at-risk over all patients. Time at risk was derived as followed: Patient with event: time at risk in days = date of start of first event - treatment start date + 1. Patients without event: time at risk in days = last date on treatment + 7 days - treatment start date + 1. Abbreviation: pt-yrs = patient-years., From first to last dose of study medication plus 7 days to account for the residual drug effect, up to 1639 days. | Secondary: Incidence Rate of Adverse Events Related to Amputation, Incidence rate of adverse events (AEs) related to amputation. Incidence rate were provided as rate per 100 patients-years (pt-yrs) calculated as the observed number of patients with event divided by observed time-at-risk over all patients. Time at risk was derived as followed: Patient with event: time at risk in days = date of start of first event - treatment start date + 1. Patients without event: time at risk in days = last date on treatment + 7 days - treatment start date + 1. A search with a pre-defined list of MedDRA preferred terms was performed to identify all AEs related to amputation. These AE included vascular disorders, diabetic-foot-related events, wound/infections, nervous system disorders and volume depletion events. Abbreviation: pt-yrs = patient-years., From first to last dose of study medication plus 7 days to account for the residual drug effect, up to 1639 days.
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| Sponsor/Collaborators: |
Sponsor: Boehringer Ingelheim
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
|
| Enrollment: |
16746
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| Study Type: |
OBSERVATIONAL
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| Study Designs: |
Observational Model: |Time Perspective: p
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| Start Date: |
2021-06-01
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| Completion Date: |
2021-07-13
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| Results First Posted: |
2024-02-08
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| Last Update Posted: |
2024-02-08
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| Locations: |
Boehringer Ingelheim, Ingelheim am Rhein, 55218, Germany
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| URL: |
https://clinicaltrials.gov/show/NCT04937816
|
