Once-weekly basal insulin cuts HbA1c for adults with type 2 diabetes in two phase 3 trials
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Key takeaways:
- Once-weekly insulin efsitora alfa was noninferior to once-daily insulins in reducing HbA1c in type 2 diabetes.
- HbA1c reductions were seen for insulin-naive adults and those receiving multiple daily injections.
A once-weekly basal insulin conferred noninferior reductions in HbA1c among insulin-naive adults with type 2 diabetes and those who receive multiple daily insulin injections, according to top-line results from two phase 3 trials.
Insulin efsitora alfa (Eli Lilly) is a once-weekly basal insulin currently being investigated as part of the QWINT phase 3 trial program for adults with type 1 and type 2 diabetes. In both the QWINT-2 and QWINT-4 treat-to-target trials, once-weekly efsitora met the trials’ primary endpoints of noninferior HbA1c reductions when compared with once-daily insulins.
In QWINT-2, adults with type 2 diabetes who had not previously taken insulin were randomly assigned to once-weekly efsitora or once-daily insulin degludec for 52 weeks. From baseline to 52 weeks, adults receiving efsitora lowered their HbA1c by 1.34 percentage points compared with a 1.26 percentage point decrease for the insulin degludec group. The efsitora group had 45 minutes greater time in range without any additional time spent in hypoglycemia compared with the insulin degludec group. Efsitora was noninferior to insulin degludec for lowering HbA1c among adults using GLP-1 receptor agonists and those not using a GLP-1.
In QWINT-4, adults with type 2 diabetes receiving multiple daily basal insulin injections with at least two injections per day of mealtime insulin at baseline were randomly assigned to once-weekly efsitora or once-daily insulin glargine for 26 weeks. All participants received their assigned insulin along with insulin lispro. From baseline to 26 weeks, adults in both groups had an HbA1c reduction of 1.07 percentage points.
Efsitora was well tolerated in both trials. The estimated rate of severe or clinically significant hypoglycemic events in the QWINT-2 trial was 0.58 per patient-year of exposure with efsitora compared with 0.45 events per patient-year of exposure with insulin degludec. In QWINT-4, the rate of severe or clinically significant hypoglycemic events was 6.6 per patient-year of exposure with efsitora vs. 5.9 events per patient-year of exposure with insulin glargine.
“The results of QWINT-2 and QWINT-4 are a significant milestone for the diabetes community and demonstrate that efsitora as a weekly insulin provides blood sugar control equivalent to daily basal insulins,” Jeff Emmick, MD, PhD, senior vice president of product development for Lilly, said in a press release. “With efsitora, we have an opportunity to provide an innovative once-weekly solution that safely achieves and maintains HbA1c control, reduces treatment burden of traditional daily injections and potentially improves adherence for people with diabetes.”
Detailed results from QWINT-2 will be presented at the European Association for the Study of Diabetes annual meeting in September. Top-line results from the QWINT-1, QWINT-3 and QWINT-5 trials are expected later in 2024, according to the press release.
Perspective
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Susan Cornell, PharmD, CDE, FAPhA, FAADE
It has been stated that medication adherence can have a more direct impact on patient outcomes than the specific treatment itself. Medication adherence is a very real concern that impacts the quality and length of life, health outcomes and overall health care costs (Brown MT, et al. Mayo Clin Proc. 2011;doi:10.4065/mcp.2010.0575). Nonadherence to medication can account for up to 50% of treatment failures and up to 25% of hospitalizations each year in the United States (DiMatteo MR, et al. Med Care. 2002;doi:10.1097/00005650-200209000-00009).
Many patients struggle with complex medication regimens. This pill or injection burden often leads to medication nonadherence. Although a once-daily basal injection does not sound laborious, any decrease in the number of pills or injection a person takes on a daily basis can be a welcome reprieve.
The use of once-weekly basal insulin can decrease a person’s injection burden from seven shots per week to one per week. Based on the data from the QWINT-2 and QWINT-4 phase 3 clinical trials, efsitora alfa showed non-inferior HbA1c reductions comparable to once-daily basal insulins. In addition, people using efsitora alfa spent 45 minutes more time in range with no additional time below range with glucose of less than 54mg/dL. Though 45 minutes does not seem like much time, for a person with diabetes, it can make a big difference.
Having a once-weekly basal insulin option for people with diabetes can certainly reduce injection burden, while providing effective, efficacious treatment with no additional adverse effects. This can be a nice option to offer our patients, especially those that struggle with adherence.
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