Trial results for a Phase 3 study (NCT05362058) investigating insulin efsitora alfa (LY3209590) compared to insulin degludec in adults with Type 2 Diabetes were posted on ClinicalTrials.gov on 2025-05-16. The study showed that insulin efsitora alfa achieved a statistically significant improvement in the percentage of time in the blood glucose target range compared to insulin degludec, with a difference of 3.09 percentage points.
Background
This study focused on adult participants with Type 2 Diabetes who were initiating basal insulin therapy for the first time. The trial aimed to assess the efficacy and safety of insulin efsitora alfa against an established basal insulin, insulin degludec, in managing blood glucose levels in this population.
Trial design
The study (NCT05362058) was a Phase 3 trial with an enrollment of 928 participants. It investigated insulin efsitora alfa (500 U/mL) compared to insulin degludec (100 U/mL) in adults with Type 2 Diabetes. The trial's purpose was to determine the effect and safety of insulin efsitora alfa versus insulin degludec. The study included a 1-week screening, a 2-week lead-in, a 52-week treatment period, and a 5-week safety follow-up, lasting up to 60 weeks.
Key results
Results for the change from baseline in HbA1c at Week 52 (Noninferiority Analysis) showed:
- Participants receiving insulin efsitora alfa had a least squares mean change of -1.26 Percentage of HbA1c (Standard Error: 0.0470).
- Participants receiving insulin degludec had a least squares mean change of -1.17 Percentage of HbA1c (Standard Error: 0.0473).
The least squares mean difference between insulin efsitora alfa and insulin degludec for HbA1c change at Week 52 was -0.09 (95.0% CI: -0.22 to 0.04).
For the outcome of "Percentage of Time in the Blood Glucose Range Between 70 and 180 mg/dL [3.9 and 10.0 mmol/L] - Week 48 to Week 52":
- Participants receiving insulin efsitora alfa achieved a least squares mean of 64.27 Percentage of time (Standard Error: 1.076).
- Participants receiving insulin degludec achieved a least squares mean of 61.18 Percentage of time (Standard Error: 1.085).
The least squares mean difference between insulin efsitora alfa and insulin degludec for this outcome was 3.09 (95.0% CI: 0.09 to 6.08), with a p-value of 0.043, indicating statistical significance.
Additionally, for the change from baseline in HbA1c at Week 26 (Superiority Analysis):
- Insulin efsitora alfa showed a least squares mean change of -1.37 Percentage of HbA1c (Standard Error: 0.0394).
- Insulin degludec showed a least squares mean change of -1.30 Percentage of HbA1c (Standard Error: 0.0397).
The least squares mean difference was -0.06 (95.0% CI: -0.17 to 0.05), with a p-value of 0.26.
What this means
The trial results suggest that insulin efsitora alfa is comparable to insulin degludec in reducing HbA1c over 52 weeks in adults with Type 2 Diabetes starting basal insulin. Importantly, insulin efsitora alfa demonstrated a statistically significant improvement in the percentage of time participants spent within the target blood glucose range (70-180 mg/dL) compared to insulin degludec. This finding indicates a potential benefit for insulin efsitora alfa in achieving better glycemic control as measured by time in range, which is an increasingly recognized metric for diabetes management.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05362058, titled "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," were posted on 2025-05-16 on clinicaltrials.gov.