Once weekly insulin efsitora alfa leads to HbA1C reduction similar to daily insulin

The results from clinical trials evaluating once weekly insulin efsitora alfa in adults with type 2 diabetes using basal insulin for the first time have been released.

Eli Lilly and Company has also published how once weekly insulin efsitora alfa impacts those who have switched from daily basal insulin injections. 

In these long-term treat-to-target trials, efsitora showed non-inferior HbA1C reduction compared to the most frequently used daily basal insulins globally.

Jeff Emmick, M.D., Ph.D., senior vice president, product development, Lilly said: “Once weekly basal insulins, like efsitora, have the potential to transform diabetes care.

“Many type 2 diabetes patients are reluctant to start insulin because of the burden it places on them.”

He added: “Once-weekly efsitora could potentially make it easier for people with type 2 diabetes to start and manage insulin therapy, while reducing the impact it has on their day-to-day lives.”

QWINT-1 evaluated the efficacy and safety of once weekly efsitora compared to once daily insulin glargine for 52 weeks.

The trial randomised adults with type 2 diabetes who are insulin naïve to receive either efsitora once weekly in a single-use autoinjector or insulin glargine once daily.

Efsitora was titrated across four fixed doses at four-week intervals, as needed for blood glucose control.

All participants treated with efsitora received a starting dose of 100 units followed by a fixed dose escalation to achieve a target fasting blood glucose of 80-130 mg/dL (4.4 – 7.2 mmol/l).

Fasting blood glucose was measured every four weeks and participants escalated to fixed dosages of 150 units, 250 units and 400 units as appropriate.

Participants with fasting blood glucose greater than 130 mg/dL (7.2 mmol/l) on or after 16 weeks were transferred to flexible dosing.

The study’s goal was to provide data supporting real-life applications of fixed dose regimens, which have the potential to make it easier for people living with type 2 diabetes to start and manage insulin therapy.

The trial met its primary endpoint of non-inferior HbA1C reduction with efsitora compared to insulin glargine at week 52.

For the efficacy estimand, efsitora reduced HbA1C by 1.31 per cent compared to 1.27 per cent for insulin glargine, resulting in an HbA1C of 6.92 per cent and 6.96 per cent, respectively.

For the treatment-regimen estimand, efsitora reduced HbA1C by 1.19 per cent compared to 1.16 per cent for insulin glargine, resulting in an HbA1C of 7.05 per cent and 7.08 per cent, respectively.

QWINT-3 evaluated the efficacy and safety of once weekly efsitora compared to once daily insulin degludec for 78 weeks in adults with type 2 diabetes currently treated with basal insulin.

Participants were randomised 2:1 to receive either efsitora once weekly or insulin degludec once daily.

The QWINT-3 trial met its primary endpoint of non-inferior HbA1C reduction with efsitora compared to insulin degludec at week 26.

For the efficacy estimand, efsitora reduced HbA1C by 0.86 per cent compared to 0.75 per cent for insulin degludec resulting in an HbA1C of 6.93 per cent and 7.03 per cent, respectively.

For the treatment-regimen estimand, efsitora reduced HbA1C by 0.81 per cent compared to 0.72 per cent for insulin degludec resulting in an HbA1C of 6.99 per cent and 7.08 per cent, respectively.

Additionally, participants taking efsitora or insulin degludec spent approximately two hours more time in range (glucose 70-180 mg/dL (3.9-10.0 mmol/l)) per day for weeks 22-26 compared to baseline.

For the efficacy estimandx, participants taking efsitora spent 62.8 per cent of time in range compared to 61.3 per cent for insulin degludec for weeks 22-26.

For the treatment-regimen estimand, participants taking efsitora spent 61.4% of time in range compared to 61% for insulin degludec.

Further, for the efficacy estimand, participants taking efsitora spent 38.3 per cent of time in tight range (glucose 70-140 mg/dL (3.9-7.8 mmol/l)) compared to 36.8 per cent for insulin degludec for weeks 22- 26.

In both QWINT-1 and QWINT-3, the overall safety and tolerability profile of efsitora was similar to that of daily basal insulin therapies for the treatment of type 2 diabetes.

In QWINT-1, estimated combined rates of severe or clinically significant (blood glucose <54 mg/dL (<3 mmol/l)) hypoglycaemic events per patient-year of exposure from weeks 0-52 were 0.50 with efsitora vs. 0.88 with insulin glargine.

In QWINT-3, estimated combined rates of severe or clinically significant (blood glucose <54 mg/dL (<3 mmol/l)) hypoglycaemic events per patient-year of exposure from weeks 0-78 were 0.84 with efsitora vs. 0.74 with insulin degludec.