At a glance
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A Meta-Analysis of Amputation Risk in Empagliflozin Studies (1245.25, 1245.110, 1245.121)
In Brief
An observational study evaluating Placebo and Empagliflozin for Diabetes Mellitus, Type 2. Completed, enrolled 16,746 participants across 1 site.
Detailed Summary
The primary objective of this exploratory meta-analysis is to evaluate the frequencies, incidence rates, and hazard ratios of lower-limb amputation (LLA) events (primary outcome) and of adverse events related to amputation (secondary outcome) in patients treated with empagliflozin compared with placebo in the pooled population of the long-term studies 1245.25, 1245.110, and 1245.121 (SAF-M1), in the pooled population of studies 1245.110 and 1245.121 (SAFM2), and in each of the 3 studies separately.
Study Details
Timeline
Interventions
Placebo
Empagliflozin once daily