Trial results relevant to Liraglutide, from a study comparing weekly insulin icodec with daily insulin degludec for people with Type 1 Diabetes, were posted on ClinicalTrials.gov on 2025-06-12. The Phase 3 study, involving 582 participants, indicated that insulin degludec showed a greater reduction in HbA1c at Week 52 and fewer severe hypoglycemic episodes compared to insulin icodec.
Background
The study investigated treatment options for individuals diagnosed with Diabetes Mellitus, Type 1, comparing a new weekly insulin, insulin icodec, against an available daily insulin, insulin degludec. Both insulins were administered in combination with mealtime insulin.
Trial design
The study (NCT04848480), titled "A Research Study to Compare a New Weekly Insulin, Insulin Icodec, and an Available Daily Insulin, Insulin Degludec, Both in Combination With Mealtime Insulin in People With Type 1 Diabetes (ONWARDS 6)," was a Phase 3 trial. It enrolled 582 participants with Diabetes Mellitus, Type 1. Participants were randomized to receive either insulin icodec once a week or insulin degludec once a day, both in combination with insulin aspart (a mealtime insulin).
Key results
Key measurements from the trial included:
- Change in Glycosylated Haemoglobin (HbA1c) at Week 26:
- Insulin Icodec + Insulin Aspart group: -0.47 Percentage of HbA1c (Standard Error: 0.07)
- Insulin Degludec + Insulin Aspart group: -0.51 Percentage of HbA1c (Standard Error: 0.06)
- Change in Glycosylated Haemoglobin (HbA1c) at Week 52:
- Insulin Icodec + Insulin Aspart group: -0.37 Percentage of HbA1c (Standard Error: 0.05)
- Insulin Degludec + Insulin Aspart group: -0.54 Percentage of HbA1c (Standard Error: 0.05)
- Change in Fasting Plasma Glucose (FPG):
- Insulin Icodec + Insulin Aspart group: -0.84 millimoles per liter (mmol/l) (Standard Error: 0.20)
- Insulin Degludec + Insulin Aspart group: -1.87 millimoles per liter (mmol/l) (Standard Error: 0.20)
- Percentage of Time in Range 3.9-10.0 mmol/L (70-180 Milligrams Per Deciliter [mg/dL]) Using Continuous Glucose Monitoring (CGM) System:
- Insulin Icodec + Insulin Aspart group: 59.10 Percentage of time (Standard Deviation: 15.66)
- Insulin Degludec + Insulin Aspart group: 60.85 Percentage of time (Standard Deviation: 15.03)
- Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in Total Treatment Satisfaction:
- Insulin Icodec + Insulin Aspart group: 1.97 Score on a scale (Standard Error: 0.27)
- Insulin Degludec + Insulin Aspart group: 3.06 Score on a scale (Standard Error: 0.27)
- Number of Severe Hypoglycaemic Episodes (Level 3): From Baseline (Week 0) to Week 26:
- Insulin Icodec + Insulin Aspart group: 47 Episodes
- Insulin Degludec + Insulin Aspart group: 17 Episodes
An ANCOVA analysis for the change from baseline in HbA1c after 26 weeks showed a treatment difference of 0.05 (95.0% CI: -0.13 to 0.23) with a p-value of 0.0065.
What this means
The trial results suggest that insulin degludec, when combined with mealtime insulin, provided a numerically greater reduction in HbA1c and FPG, along with fewer severe hypoglycemic episodes, compared to insulin icodec in people with Type 1 Diabetes. Participants also reported higher treatment satisfaction with insulin degludec. The analysis of HbA1c change at 26 weeks showed a treatment difference of 0.05 (95.0% CI: -0.13 to 0.23) with a p-value of 0.0065.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04848480, titled "A Research Study to Compare a New Weekly Insulin, Insulin Icodec, and an Available Daily Insulin, Insulin Degludec, Both in Combination With Mealtime Insulin in People With Type 1 Diabetes (ONWARDS 6)," were posted on 2025-06-12 on clinicaltrials.gov.