New data on patient treatment satisfaction from the LEAD(TM) 6 trial presented on the 22nd October at the 20th World Diabetes Congress (International Diabetes Federation) shows that patients have higher overall treatment satisfaction with liraglutide than they do with exenatide.(1)
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Specifically, among the 379 patients who completed the Diabetes Treatment Satisfaction Questionnaires (DTSQ) during the LEAD(TM) 6 trial, those taking liraglutide perceived less hypoglycaemia (abnormally low blood sugar levels) or hyperglycaemia (abnormally high blood sugar levels) compared to those on exenatide.
"Liraglutide has shown here in a convincing study that it is associated with less nausea, less perceived hypoglycaemia and definitely higher patient satisfaction compared to exenatide," said Dr Wolfgang Schmidt, professor and chair of the Department of Medicine at St. Josef-Hospital and one of the principal investigators in the trial.
"Patient-reported outcomes data is an important extension of the efficacy data. If a patient is satisfied with his or her treatment, then they are much more likely to really stick to the treatment over the long term, which is necessary in type 2 diabetes," Dr Schmidt noted.
Treatment satisfaction was also evaluated during an open-label extension of the LEAD(TM) 6 trial, in which patients were either switched from exenatide to liraglutide or continued on liraglutide for another 14 weeks. These results show that switching patients from exenatide to liraglutide further improves patient satisfaction, as evidenced by the larger rise in DTSQs scores for switched patients compared to those who continued on liraglutide from weeks 26-40.
Other key liraglutide data at IDF Congress
Two separate meta-analyses of all six LEAD(TM) (Liraglutide Effect and Action in Diabetes) trials were also presented at the congress. Meta-analyses are a type of statistical analysis that summarise the results for a given treatment from several different studies in order to evaluate its overall effect on a specific outcome.
The meta-analyses presented at the congress documented:
1) Liraglutide's positive effect on lipid profile in patients with type 2 diabetes(2) and 2) liraglutide's ability to lower both HbA1C and weight without inducing hypoglycaemia versus that of the other active comparators in the LEAD(TM) programme including exenatide, glimepiride, rosiglitazone and insulin glargine.(3) Each of the meta-analyses comprised 3,967 people with type 2 diabetes.
In the lipid meta-analysis, total cholesterol, low density lipoprotein, free fatty acids and triglycerides were all statistically significantly reduced from baseline with liraglutide over 26 weeks of treatment. Furthermore, total cholesterol and low density lipoproteins were significantly reduced with liraglutide treatment compared to rosiglitazone, glimepiride or insulin glargine.
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.
Why hypoglycemia-induced glucagon secretion becomes impaired in diabetes