As Novo Nordisk stares down an FDA adcomm later this month to discuss its once-weekly insulin, Eli Lilly is working on its own, sharing positive topline data from two Phase 3 studies for its insulin candidate named efsitora.
In the first trial dubbed QWINT-2, once-weekly efsitora hit the primary endpoint of non-inferior A1C reduction compared to the daily insulin degludec at week 52 in insulin-naïve adults with type 2 diabetes, with the dataset including some adults who were taking a GLP-1.
Efsitora also hit a secondary endpoint of non-inferiority versus degludec in blood sugar level change among both patients on and not on GLP-1s.
Lilly senior VP of product development Jeff Emmick told Endpoints News that about half of the patients in QWINT-2 were on a GLP-1 and Lilly “didn’t have a lot of trouble” accruing that proportion of participants. Lilly wanted to make sure patients on GLP-1s were included to test the safety and efficacy of its insulin when in combination.
In the second trial, dubbed QWINT-4, efsitora also met the primary endpoint of non-inferior blood sugar reduction compared to a daily insulin called glargine after 26 weeks in patients with type 2 diabetes. This study included patients previously treated with basal insulin and at least two injections each day of mealtime insulin.
Basal insulin is a longer-acting insulin that patients can take between meals or before bed to control blood sugar outside of eating.
“In the future, patients will probably try an oral, and that could be an oral GLP-1 or an oral incretin moving forward,” Emmick said. “But if they’re on an incretin and they’re still not achieving the control they need and they have to move to an insulin, then your next step is a basal insulin.”
More detailed data are set to be revealed, with QWINT-2 results to be presented at the European Association for the Study of Diabetes in September in Madrid.
Novo is further along into bringing the first approved weekly insulin to market in the US. Its insulin candidate, icodec, is under review by the FDA and will be scrutinized in a May 24 meeting with the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee.
In March, the EU recommended an approval for icodec based on Phase 3 data showing the weekly candidate was superior compared to daily insulin at reducing blood sugar and keeping it in an acceptable range. If approved, icodec would be marketed in Europe as Awiqli.