Endocrine Abstracts

Objective: Evaluate the efficacy and safety of adding lixisenatide to uncontrolled type 2 diabetic (T2DM) patients treated with insulin.

Methods: A prospective uncontrolled study was designed. Primary endpoints (measured at 3 and 6 months) were change in HbA1c, weight, and insulin doses. Variables analysed were: HbA1c level, insulin and other hypoglycaemic agents doses, capillary glucose tests, number and type of hypoglycaemias, side effects and body composition analysis (Tanita SC-330).

Results: Data from 42 T2DM patients (55% women; mean age: 57.7±7.4 years; and T2DM duration: 13.5±8.7 years) treated with insulin were analysed. A significant decrease in HbA1c levels (7.6±0.8% vs 7.8±1.1% vs 9.1±1.6%; P<0.001) and weight (95.2±14.8 kg vs 95.8±14.4 kg vs 98.5±13.9 kg) was observed at 3 and 6 months compared to baseline and % of fat mass had also reduced at 6 months (33.9±7.6% vs 38.8±8.1%; P: 0.01). Total insulin doses decreased from baseline (61.2±37.3 UI/day) to 3 (52.5±34.8 UI/day; P: 0.02) and 6 months (49.4±30.5 UI/day; P: 0.021). Low incidence of no serious hypoglycaemias (1.0±1.7 mean episodes/month) was referred. Six patients (14.2%) discontinued lixisenatide treatment due to side effects (four patients for nausea or vomiting, one patients for hypertransaminasemia, and one patient for uncontrolled hyperglycaemia). Three patients (7.1%) were lost to follow-up for unknown reasons.

Conclusions: In our clinical experience, lixisenatide contributes to improving glycaemic control as facilitates weight loss and insulin doses reduction in T2DM patients uncontrolled with insulin.