Table 2

Complications associated with DFU events

Liraglutide (N = 4,668) (PYO = 17,822)Placebo (N = 4,672) (PYO = 17,741)HR (95% CI)P value
n% of NPatients with DFU (%)ERn% of NPatients with DFU (%)ER
DFU events or related complications
 Patients with DFU event(s)1763.8100.02601.461914.1100.02911.640.92 (0.75, 1.13)0.41
 Patients with DFU event(s) + complication of
  Amputation440.925.0600.34671.435.1780.440.65 (0.45, 0.95)0.03
   Minor340.719.3450.25461.024.1500.280.74 (0.47, 1.15)0.17
   Major110.26.3130.07220.511.5240.140.50 (0.24, 1.02)0.06
   Unknown10.00.620.0140.12.140.02
  Infection1072.360.81460.821312.868.61620.910.81 (0.63, 1.05)0.11
  Involvement of underlying structures641.436.4860.48801.741.9980.550.80 (0.57, 1.11)0.17
  Peripheral revascularization200.411.4240.13230.512.0260.150.87 (0.48, 1.58)0.64
Liraglutide (N = 4,599)Placebo (N = 4,601)
n% of Nn% of NHR (95% CI)P value
Analysis of first DFU-related complications that occurred after 1 year from randomization*
 Amputation320.70581.260.55 (0.36, 0.84)0.006
 Infection751.631012.200.74 (0.55, 0.99)0.044
 Involvement of underlying structures471.02671.460.70 (0.48, 1.01)0.06
 Peripheral revascularization110.24200.430.55 (0.26, 1.14)0.11
  • Analyses based on review of case narratives. P values were based on an analysis of time to first event using a Cox regression model with treatment as fixed factor. Infection is defined as presence of clinical signs of infection, including redness, warmth, pain, purulence, or discharge. Involvement of underlying structures is defined as tendon, joint capsule, or bone. Minor amputations are defined as midtarsal or distal amputation and major amputations as any resection proximal to midtarsal level (18). Unknown amputations are defined as those that could not be classified as major or minor based on the case narratives. E, number of events; N, number of patients in the treatment group; n, number of patients with an event or complication; PYO, patient-years of observation; R, event rate per 100 PYO.

  • *Percentages of patients are of the full-analysis set (liraglutide, N = 4,599; placebo, N = 4,601). This analysis excluded complications occurring within the first year of trial participation.