Table 1

HRs associated with DFU events in the LEADER trial

LiraglutidePlaceboHR (95% CI)P value
DFU events
 Time to first DFU event, n (%)*176 (3.8) [FAS = 4,668]191 (4.1) [FAS = 4,672]0.92 (0.75, 1.13)0.41
 Time to first DFU event after 1 year, n (%)127 (2.8) [FAS = 4,599]149 (3.2) [FAS = 4,601]0.85 (0.67, 1.07)0.16
 Time to all DFU events (including recurrent events), n of events2602910.97 (0.82, 1.16)0.76
By background characteristics, n (%)
 Time to first DFU event in patients with history of DFU71 (34.1) [FAS = 208]69 (35.2) [FAS = 196]0.97 (0.69, 1.35)0.84
 Time to first DFU event in patients with no history of DFU105 (2.4) [FAS = 4,460]122 (2.7) [FAS = 4,476]0.86 (0.66, 1.11)0.25
 Time to first DFU event in patients at high risk of DFU101 (5.8) [FAS = 1,747]110 (6.2) [FAS = 1,787]0.93 (0.71, 1.22)0.60
  • DFU event is defined as reporting of an incident DFU or worsening of an existing DFU. Cox regression model with treatment as a fixed factor. High risk of DFU is defined as a patient with type 2 diabetes who at baseline did not have an active foot ulcer but had peripheral neuropathy or presence of peripheral artery disease or history of DFU. FAS, full-analysis set.

  • *n, number of patients with a first DFU between randomization and follow-up dates.

  • n, number of patients with first foot ulcer after 1 year from randomization date and before follow-up date (i.e., excludes event occurring within the first year of trial participation).