Summary
LEAD-6 was a randomized open label parallel group study conducted at 132 sites in the US and EU, comparing the use of liraglutide and exenatide in type 2 diabetes patients 18-80 years of age. In the extension arm of the study, patients on 1.8 mg of liraglutide continued on the drug for another 14 weeks while patients originally randomized to the exenatide treatment group were switched to 1.8 mg liraglutide therapy for 14 weeks. After 40 weeks, both groups had identical A1c levels.
Analysis
These results indicate that patients switching from exenatide could additionally lower their A1c levels with liraglutide if they move to the highest dose - we do interpret these results with some caution, however, since we think the more typical dose of liraglutide for most patients will be 1.2.
The weight at the end of the extension trial was statistically identical to the weight at 26 weeks, with patients on exenatide losing an additional 1 kg of weight after switching to liraglutide (again, this appears dose-related).
It was suggested that beta cell function may be improved in patients who switched to liraglutide though we believe there would be little change outside dose. Nausea persisted in patients previously treated with exenatide though we believe this can be addressed with better titration. Still, overall, these results continue to be very positive for Novo Nordisk and liraglutide-- the question will be one of preferences and mechanics in whether patients switch over. We do believe the key advantage offered and one that will expand the market is once-daily dosing - that said, for now, liraglutide remains stalled at FDA. Each day it is delayed, of course, is a positive for Amylyn and Eli Lilly, who are waiting for the approval of LAR. The time liraglutide will be on the market ahead of LAR likely narrows each day. In the meantime, the liraglutide delay is also good news for Merck in that once there is an "easier" GLP-1 to switch to, patients could move off Januva more quickly (that said, there is no shortage of patients to go on DPP-4 inhibitors).
The weight at the end of the extension trial was statistically identical to the weight at 26 weeks, with patients on exenatide losing an additional 1 kg of weight after switching to liraglutide (again, this appears dose-related).
It was suggested that beta cell function may be improved in patients who switched to liraglutide though we believe there would be little change outside dose. Nausea persisted in patients previously treated with exenatide though we believe this can be addressed with better titration. Still, overall, these results continue to be very positive for Novo Nordisk and liraglutide-- the question will be one of preferences and mechanics in whether patients switch over. We do believe the key advantage offered and one that will expand the market is once-daily dosing - that said, for now, liraglutide remains stalled at FDA. Each day it is delayed, of course, is a positive for Amylyn and Eli Lilly, who are waiting for the approval of LAR. The time liraglutide will be on the market ahead of LAR likely narrows each day. In the meantime, the liraglutide delay is also good news for Merck in that once there is an "easier" GLP-1 to switch to, patients could move off Januva more quickly (that said, there is no shortage of patients to go on DPP-4 inhibitors).
Kelly Close consults with leading institutions through GLG
Analyses are solely the work of the authors and have not been edited or endorsed by GLG.
