Patient-reported outcomes are superior in patients with Type 2 diabetes treated with liraglutide as compared with exenatide, when added to metformin, sulphonylurea or both: results from a randomized, open-label study

Abstract

Aims: The Liraglutide Effect and Action in Diabetes 6 trial was an open-label trial comparing liraglutide with exenatide as an 'add-on' to metformin and/or sulphonylurea.

Methods: Patients with Type 2 diabetes were randomized to liraglutide 1.8 mg once daily or exenatide 10 μg twice daily for 26 weeks. This was followed by a 14-week extension phase, in which all patients received liraglutide 1.8 mg once daily.

Results: Patient-reported outcomes were measured in 379 patients using Diabetes Treatment Satisfaction Questionnaire status (DTSQs) and DTSQ change (DTSQc). The change in overall treatment satisfaction (DTSQs score) from baseline at week 26 with liraglutide was 4.71 and with exentaide was 1.66 [difference between groups 3.04 (95% CI 1.73-4.35), P<0.0001]. Five of the six items on the DTSQs improved significantly more with liraglutide than with exenatide (differences: current treatment 0.37, P=0.0093; convenience 0.68, P<0.0001; flexibility 0.57, P=0.0002; recommend 0.49, P=0.0003; continue 0.66, P=0.0001). Patients perceived a greater reduction in hypoglycaemia at week 26 with liraglutide than with exenatide [difference in DTSQc score 0.48 (0.08-0.89), P=0.0193] and a greater reduction in perceived hyperglycaemia [difference 0.74 (0.31-1.17), P=0.0007]. During the extension phase, when all patients received liraglutide, DTSQs scores remained stable in patients who continued on liraglutide and increased significantly (P=0.0026) in those switching from exenatide.

Conclusions: These results demonstrate significant improvements in patients' treatment satisfaction with liraglutide compared with exenatide.

Trial registration: ClinicalTrials.gov NCT00518882.

© 2011 The Authors. Diabetic Medicine © 2011 Diabetes UK.

Figures

FIGURE 1

Study design of Liraglutide Effect and Action in Diabetes 6 (LEAD 6).

FIGURE 2

Patient disposition from screening until the end of the randomization phase (26 weeks) in Liraglutide Effect and Action in Diabetes 6 (LEAD 6). *Intention-to-treat (ITT), per-protocol (PP) and safety populations in the liraglutide treatment group were 233, 193 and 235, respectively. †ITT, PP and safety populations in the exenatide treatment group were 231, 172 and 232, respectively. PROMs, patient-reported outcome measures.

FIGURE 3

Overall treatment satisfaction, as measured by the Diabetes Treatment Satisfaction Questionnaire status version (DTSQs), in patients initially receiving liraglutide 1.8 mg once daily or exenatide 10 μg twice daily for 26 weeks, and then receiving liraglutide 1.8 mg once daily for 14 weeks (patient-reported outcome analysis population with data in extension phase of trial). *Comparison of liraglutide vs. exenatide change from baseline. †Comparison of week 40 vs. week 26 in the exenatide to liraglutide group.