In the meta-analysis evaluating efficacy on combined treatment targets of HbA1c and weight without hypoglycaemia, more patients in the liraglutide group reached HbA1c(less than)7.0% with no weight gain or hypoglycaemia than those on comparator treatments. Patients were more likely to reach these treatment goals without hypoglycaemia on liraglutide compared to other commonly used diabetes treatments.
LEAD(TM) 6 trial, extension and sub-analysis designs
LEAD(TM) 6 was a 26-week, open-label trial of 464 patients with type 2 diabetes and HbA1c levels between 7-11%, who were randomised to once-daily liraglutide or twice-daily exenatide on a metformin plus or minus sulphonylurea therapy background. Results from this direct comparison trial were published in The Lancet.
In the LEAD(TM) 6 extension trial, patients were either switched from exenatide to liraglutide or continued on liraglutide for a period of 14 weeks. All 389 patients who completed the randomised trial entered into the extension phase.
In the patient-reported outcomes analysis, a subgroup of 379 patients had treatment satisfaction evaluated using two versions of the Diabetes Treatment Satisfaction Questionnaire: status (DTSQs) at baseline and week 26, and change (DTSQc) at week 26. Patients had higher overall treatment satisfaction with liraglutide than they did with exenatide and, in particular, their perception of hyperglycaemia and hypoglycaemia was reduced more by liraglutide than by exenatide.
In the 14-week extension, 313 patients answered the DTSQs at weeks 34 and 40 and the DTSQc at week 34. These results showed that switching patients from exenatide to liraglutide further improves patient satisfaction, as evidenced by the larger rise in treatment satisfaction scores for switched patients compared to those who continued on liraglutide from weeks 26-40.
Source: NOVO NORDISK