Trial results for a Phase 3 study (NCT04760626) investigating insulin icodec, a new weekly insulin, in people with Type 2 Diabetes were posted on ClinicalTrials.gov on 2025-08-26. The study showed that participants receiving insulin icodec achieved a mean HbA1c reduction of -1.68%, compared to -1.31% for those on once-daily basal insulin analogues. This difference was statistically significant.
Background
Insulin icodec is being developed as a new weekly insulin option for individuals with Type 2 Diabetes. Current basal insulin therapies typically require daily administration. This study aimed to evaluate the efficacy and patient satisfaction of a once-weekly insulin regimen compared to existing daily options.
Trial design
The study (NCT04760626) was a Phase 3 trial that enrolled 1085 participants with Type 2 Diabetes who had not used insulin before. The trial compared insulin icodec, administered once weekly, against once-daily basal insulin analogues, which included insulin glargine 100u/ml, insulin degludec, and insulin glargine 300u/ml. Participants were randomized to receive either the weekly or daily insulin regimen. The study's primary outcomes were not explicitly detailed in the provided data, but key measurements included change in glycated haemoglobin (HbA1c).
Key results
The trial results demonstrated several key differences between the insulin icodec and once-daily basal insulin analogue groups:
- For the "Change in Glycated Haemoglobin (HbA1c)" outcome:
- Participants receiving insulin icodec showed a least squares mean change of -1.68% (Standard Error: 0.09).
- Participants receiving once-daily basal insulin analogue showed a least squares mean change of -1.31% (Standard Error: 0.12).
An ANCOVA analysis for the treatment difference in HbA1c change reported a value of -0.38 (95.0% CI: -0.66 to -0.09) with a p-value of 0.0001, indicating a statistically significant greater reduction with insulin icodec.
- For "Time From Baseline to Treatment Discontinuation or Intensification":
- The median time for insulin icodec was 20.1 Weeks.
- The median time for once-daily basal insulin analogue was 13.9 Weeks.
- Regarding patient satisfaction, measured by "Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in Total Treatment Satisfaction":
- Insulin icodec group showed a least squares mean change of 4.68 (Standard Error: 0.25).
- Once-daily basal insulin analogue group showed a least squares mean change of 3.90 (Standard Error: 0.25).
- For "Treatment Related Impact Measure for Diabetes (TRIM-D) Compliance Domain":
- Insulin icodec group scored 90.42 (Standard Error: 0.64).
- Once-daily basal insulin analogue group scored 87.37 (Standard Error: 0.64).
- Regarding hypoglycaemic episodes:
- There were 0 Episodes of "Severe Hypoglycaemic Episodes (Level 3)" in the insulin icodec group, compared to 5 Episodes in the once-daily basal insulin analogue group.
- For "Clinically Significant Hypoglycaemic Episodes (Level 2)", the insulin icodec group had 104 Episodes, while the once-daily basal insulin analogue group had 76 Episodes.
What this means
The results from this Phase 3 trial suggest that insulin icodec, administered once weekly, offers a significant advantage in glycemic control for individuals with Type 2 Diabetes compared to daily basal insulin analogues, as evidenced by the greater HbA1c reduction. The longer median time to treatment discontinuation or intensification, along with higher scores in treatment satisfaction and compliance, indicates potential benefits for patient adherence and quality of life. Notably, insulin icodec was associated with fewer severe hypoglycemic episodes, which is a critical safety consideration in insulin therapy, although it had more clinically significant (Level 2) episodes. These findings support the potential of a once-weekly insulin regimen to simplify diabetes management and improve patient outcomes.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04760626, titled "A Research Study to Compare a New Weekly Insulin, Insulin Icodec Used With DoseGuide App, and Daily Insulins in People With Type 2 Diabetes Who Have Not Used Insulin Before," were posted on 2025-08-26 on clinicaltrials.gov.