Flexibility in timing of lixisenatide (LIXI) once-daily administration (comparing before breakfast (BF) with self-determined main meal (MM)) has been demonstrated, with non-inferiority for HbA1c, in a previously reported randomized controlled trial (NCT01517412) in adults with type 2 diabetes (T2D) with sub-optimal glycaemic control on metformin. Patient-reported treatment satisfaction may, however, vary with timing of administration, and offers a clinically valuable indication of perceived acceptability and likelihood of treatment concordance. We aimed to examine treatment satisfaction of adults with T2D taking LIXI prior to BF or MM over 24 weeks.
A total of 451 participants completed the Diabetes Treatment Satisfaction Questionnaire status (DTSQs) at baseline, 12 and 24 weeks. DTSQs scores were analysed by ANCOVA, with treatment and country as fixed effects and baseline value as covariate. The change in DTSQs total score from baseline (27.09) to Week 24 was 2.84 and 3.30 with LIXI taken prior to MM or BF, respectively (difference between groups -0.53 [-1.609; 0.550]; NS). This overall improvement was observed from Week 12 for both groups and maintained over the study period. The DTSQ total score increased in 60% of participants; perception of frequency of hyperglycaemia decreased in 65%. No difference between groups was observed in perceptions of frequency of hyper- and hypoglycaemia (difference of -0.11 (-0.457; 0.233) and 0.00 (-0.248; 0.257) respectively). Baseline HbA1c and DTSQs total were correlated (r=-0.15; p<0.01). Drivers of the DTSQ total score improvement at Week 24, explaining half of the variance in scores, included lower baseline DTSQs total score and baseline HbA1c, and decrease in HbA1c and weight.
Overall, LIXI once daily is associated with improved treatment satisfaction independent of timing of administration. Improvements appear to be driven partly by lowering of HbA1c and weight, which were the same regardless of timing of LIXI administration.