Trial results for a Phase 3 study comparing insulin efsitora alfa to insulin degludec in participants with Type 2 Diabetes were posted on ClinicalTrials.gov on 2025-06-03. The study found that participants treated with insulin efsitora alfa required a significantly lower weekly insulin dose, with a least squares mean difference of -30.0 units per week compared to insulin degludec.
Background
The study, titled "A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin," aimed to assess the safety and effectiveness of insulin efsitora alfa. Insulin degludec is a basal insulin used in the management of Type 2 Diabetes and is listed as an alias of Liraglutide, indicating its relevance to the broader therapeutic landscape.
Trial design
The Phase 3 study (NCT05275400) was completed with an enrollment of 986 participants diagnosed with Type 2 Diabetes who were already receiving basal insulin. The trial compared insulin efsitora alfa (500 U/mL) against insulin degludec (100 U/mL) over a 78-week treatment period. The study evaluated changes from baseline in Hemoglobin A1c (HbA1c) for noninferiority and superiority, nocturnal hypoglycemia event rates, and other glycemic control parameters.
Key results
The trial reported several key measurements and analyses:
- For "Change From Baseline in Hemoglobin A1c (HbA1c) [Noninferiority]", insulin efsitora alfa showed a least squares mean change of -0.81 percentage of HbA1c (Standard Error: 0.0302), while insulin degludec showed -0.72 percentage of HbA1c (Standard Error: 0.0424). The LS Mean Difference between groups was -0.089 (95.0% CI: -0.191 to 0.013), with an ANCOVA p-value of 0.088.
- The "Nocturnal Hypoglycemia Event Rate" was 0.11 events per year (Standard Error: 0.022) for insulin efsitora alfa and 0.10 events per year (Standard Error: 0.019) for insulin degludec. The relative rate was 1.03 (95.0% CI: 0.62 to 1.74), with a p-value of 0.897.
- "Percentage of Time in Glucose Range Between 70 and 180 mg/dL" was 61.37 percentage of time (Standard Error: 0.676) for insulin efsitora alfa and 60.95 percentage of time (Standard Error: 0.954) for insulin degludec. The LS Mean Difference was 0.42 (95.0% CI: -1.88 to 2.72), with an ANCOVA p-value of 0.722.
- "Change From Baseline in Fasting Glucose" was -30.97 milligrams per deciliter (mg/dL) (Standard Error: 0.943) for insulin efsitora alfa and -30.13 milligrams per deciliter (mg/dL) (Standard Error: 1.323) for insulin degludec. The LS Mean Difference was -0.84 (95.0% CI: -4.01 to 2.33), with an ANCOVA p-value of 0.605.
- Crucially, for "Weekly Insulin Dose at Week 26", insulin efsitora alfa had a least squares mean of 333.20 units per week of insulin (Standard Error: 5.93), compared to 363.20 units per week of insulin (Standard Error: 8.33) for insulin degludec. The LS Mean Difference was -30.0 (95.0% CI: -50.1 to -9.97), with a Mixed Models Analysis p-value of 0.003.
What this means
The results indicate that insulin efsitora alfa achieved comparable glycemic control to insulin degludec across several key metrics, including HbA1c reduction, time in glucose range, and fasting glucose reduction. Importantly, insulin efsitora alfa demonstrated a statistically significant reduction in the required weekly insulin dose compared to insulin degludec. This finding suggests a potential benefit for patients in terms of reduced insulin burden while maintaining similar efficacy in managing Type 2 Diabetes.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05275400, titled "A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin," were posted on 2025-06-03 on clinicaltrials.gov.