2256-PUB: Fixed-Ratio Insulin Degludec/Liraglutide (IDegLira) vs. Basal-Bolus Treatment in Type 2 Diabetic (T2DM) Patients with Diabetic Foot Ulcers (DFU) and Critical Limb Ischemia (CLI)

We report results from the clinical use of IDegLira compared to basal-bolus (BB) insulin regimen in T2DM patients admitted to our department because of DFU and CLI. We retrospectively identified 44 consecutive T2DM patients admitted to our diabetes ward because of DFU (M/F: 24/20; age: 67.3±9.5 years; BMI: 30.6±5.2 Kg/m²; diabetes duration (DD): 23.5±9.9 years; HbA1c 71.7±24.5 mmol/mol). During hospitalization, 28 patients (Group A: M/F: 15/13; age: 65.7±8.9 years; BMI: 32.6±4.8 Kg/m²; DD: 21.1±9.9 years; HbA1c 76.1±25.2 mmol/mol) previously on BB (63.7±33.9 U/day), were started on IDegLira (IDeg 22.8±7.8 U/day, liraglutide 0.82±0.3 mg/day) while the remaining 16 (Group B; M/F: 9/7; age: 70.4±10.1 years; BMI: 30.3±2.2 Kg/m²; DD: 27±9.2 years; HbA1c 63.9±22.0 mmol/mol; all p=NS vs. Group A) continued BB (43±18 U/day), allowing comparison over a mean follow-up period of 3 months. Patients were comparable with respect to distal lesions, pain-relieving, antibiotic therapies, revascularization procedures and surgical treatments performed. In Group A, BMI, HbA1c and LDL-C improved significantly (26.4±10.1 Kg/m²; 54±11 mmol/mol; 61.5±32 mg/dl; p<0.05 vs. baseline) during the follow-up period. No change occurred in Group B whereas Group A also had significant improvement of inflammatory markers (Fibrinogen: 635±178 vs. 437±121 mg/dl; ESR: 74±34 vs. 48±13 mm/h; CRP: 5.2±1.7 vs. 0.8±1.0 mg/dl; all p<0.05 vs. baseline). Ulcer healing was achieved in 17 patients in Group A (61%), and in 3 patients (19%) in Group B (p<0.05). These data suggest that treatment with IDegLira can have positive effects on metabolic and inflammatory parameters of complicated T2DM patients with DFU and CLI, probably contributing to greater ulcer healing observed in this category of patients.