Two phase 3 trials demonstrated that once-weekly insulin efsitora is as effective as daily insulin in lowering HbA1c in both type 1 (T1D) and type 2 diabetes (T2D).
Once-weekly dosing of insulin efsitora alfa (efsitora) has been shown to deliver comparable results to daily insulin in reducing hemoglobin A1c (HbA1c) levels in adults with type 1 diabetes (T1D) and type 2 diabetes (T2D), announced Eli Lilly and Company in dual news releases.1,2 This weekly dosing option has the potential to simplify diabetes management for either condition.
Insulin vials / Sherry Young - stock.adobe.com
The announcements come on behalf of positive results from the QWINT-5 (NCT05463744) and QWINT-2 (NCT05362058) trials, which are part of Lilly's larger QWINT phase 3 global clinical development program. Whereas the QWINT-5 trial evaluated once-weekly insulin efsitora compared to once-daily insulin degludec in adults with T1D who require daily basal and multiple daily mealtime insulin injections,1 QWINT-2 evaluated once-weekly insulin efsitora compared to once-daily insulin degludec in adults with T2D who are insulin naïve.2
About QWINT-5
Trial Name: A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 1 Diabetes Treated With Multiple Daily Injection Therapy (QWINT-5)
Clinicaltrials.gov Identifier: NCT05463744
Sponsor: Eli Lilly and Company
Summary: The main purpose of this study is to measure the safety and efficacy of insulin efsitora alfa (LY3209590) compared with insulin degludec in participants with type 1 diabetes treated with multiple daily injection therapy.
Data were presented at the European Association for the Study of Diabetes Annual Meeting 2024.
Speaking to the QWINT-5 trial, Jeff Emmick, MD, PhD, senior vice president of product development at Lilly, said: “When we commercialized insulin more than 100 years ago, it marked the beginning of our commitment to people living with type 1 diabetes—today’s announcement continues that legacy. These results underscore the potential of efsitora to help some people living with type 1 diabetes lower their A1c with only 1 basal insulin injection per week, while also highlighting the complexity of treating this chronic disease.”1
The multicenter, treat-to-target, randomized, parallel-design, open-label QWINT-5 study recruited 692 participants across the US, Argentina, Japan, Poland, Puerto Rico, Slovakia and Taiwan.3 During the 52-week treatment period, participants were randomized to receive insulin efsitora once weekly or insulin degludec once daily administered subcutaneously.
The primary endpoint was the change in HbA1c from baseline to week-26.
Insulin efsitora successfully met its primary endpoint of reducing HbA1c levels as effectively as daily insulin after 26 weeks of treatment. Analyses demonstrated that insulin efsitora was able to lower HbA1c by 0.53%, compared to 0.59% for insulin degludec, resulting in final HbA1c levels of 7.37% and 7.32%, respectively.
About QWINT-2
Trial Name: A Study of Insulin Efsitora Alfa (LY3209590) Compared to Degludec in Adults With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time (QWINT-2)
Clinicaltrials.gov Identifier: NCT05362058
Sponsor: Eli Lilly and Company
Summary: The purpose of this study is to determine the effect and safety of insulin efsitora alfa (LY3209590) compared to degludec in adult participants with type 2 diabetes who are starting basal insulin for the first time. Additional participants will continue to be enrolled in a maximum extended enrollment cohort.
In a key secondary endpoint, insulin efsitora and insulin degludec showed comparable results in time in range, as measured by continuous glucose monitoring (CGM), during the 4 weeks leading up to week 26.
Additionally, the estimated combined rates of patient-reported severe or clinically significant (blood glucose <54 mg/dL) nocturnal hypoglycemic events per patient-year of exposure were similar between insulin efsitora and insulin degludec over the 52-week study period, measuring at 14.03 with insulin efsitora and 11.59 with insulin degludec. There was no evidence of increased duration of hypoglycemia with efsitora compared to insulin degludec based on CGM data.
Estimated rates of severe hypoglycemic events per patient-year of exposure through week 52 were 0.14 with insulin efsitora and 0.04 with insulin degludec. More than half (64%) of the reported severe hypoglycemic events with insulin efsitora took place during the initial 12 weeks of the trial’s treatment period. Incidence of severe hypoglycemia in both treatment groups declined after week 12.
READ MORE: FDA Clears New Disposable Insulin Patch Pump for Patients With T1D and T2D
On QWINT-2, Emmick said, “For the past century, we’ve been searching for the next scientific breakthrough that would alleviate the complexity that comes with starting insulin treatment. With these results, we believe we’re headed towards a future where people with type 2 diabetes who use basal insulin can achieve their desired results with a simple treatment option like efsitora."2
The parallel-design, open-label, treat-to-target, randomized controlled clinical trial QWINT-2 study recruited 928 participants across the US, Brazil, Canada, China, Czech Republic, Germany, Greece, Japan, Korea, Mexico, and Puerto Rico.4 Participants were randomized to receive insulin efsitora once weekly or insulin degludec once daily administered subcutaneously during the 52-week treatment period.
The primary endpoint was to demonstrate non-inferiority in reducing HbA1c at week 52 with insulin efsitora compared to insulin degludec. The study also assessed efficacy and safety for patients using and not using glucagon-like peptide-1 receptor agonists (GLP-1s).
In QWINT-2, insulin efsitora met its primary endpoint of non-inferior HbA1c reduction. Compared to insulin degludec, insulin efsitora reduced HbA1c by 1.34% versus 1.26%, resulting in an HbA1c of 6.87% for insulin efsitora and 6.95% for insulin degludec at 52 weeks.
Additionally, participants using insulin efsitora experienced 45 minutes more time in range per day compared to insulin degludec, without additional time in hypoglycemia compared to insulin degludec.
Further, insulin efsitora demonstrated a safety profile similar to daily insulin. No severe hypoglycemic events were reported with insulin efsitora, while 6 occurred with insulin degludec. Overall, hypoglycemia rates were low, with estimated combined rates of severe or clinically significant events per patient-year of exposure being 0.58 for insulin efsitora and 0.45 for insulin degludec.
Both insulin efsitora and insulin degludec had similar rates of severe or clinically significant nocturnal hypoglycemia, estimated at 0.08 events per patient-year of exposure. Hypoglycemia rates were also comparable among people using GLP-1s and those not using them.
Reducing the frequency of insulin injections with the development of a once-weekly insulin has the potential to simplify treatment for diabetes, ease the burden of care for people with diabetes and their caregivers, and improve adherence and glycemic outcomes. For those who administer insulin daily, a once-weekly insulin could lower the number of insulin injections from about 365 to 52 per year.3
The QWINT phase 3 global clinical development program for insulin efsitora in diabetes launched in 2022 and has enrolled over 4000 people living with T1D or T2D across 5 global registration studies.1,2
“With the data we have seen from our phase 3 program so far, we are confident in efsitora’s potential to transform diabetes care and will continue to pursue new treatment options until we can eliminate the disease entirely,” said Emmick.1
READ MORE: Diabetes Resource Center
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