Trial results comparing insulin icodec to insulin degludec in people with type 2 diabetes were posted on ClinicalTrials.gov on 2025-02-20. The study found that weekly insulin icodec led to a least squares mean change in HbA1c of -0.93% (Standard Error 0.05), demonstrating a greater reduction compared to daily insulin degludec, which showed a change of -0.71% (Standard Error 0.06).
Background
Type 2 diabetes mellitus is a chronic condition requiring careful management, often involving insulin therapy. This trial investigated a new weekly insulin, insulin icodec, against an established daily insulin, insulin degludec. Insulin degludec is sometimes listed as an alias for Liraglutide, a drug also used in the management of type 2 diabetes.
Trial design
This completed Phase 3 study (NCT04770532) enrolled 526 participants with Type 2 Diabetes Mellitus who were already using daily insulin. The trial aimed to compare the efficacy and safety of once-weekly insulin icodec against once-daily insulin degludec. Participants were randomized to receive either weekly insulin icodec or daily insulin degludec. Key outcomes measured included changes in glycated hemoglobin (HbA1c), fasting plasma glucose (FPG), time in target glucose range, and patient satisfaction.
Key results
The trial reported several key measurements:
- Change in Glycated Haemoglobin (HbA1c): The least squares mean change was -0.93% (Standard Error 0.05) for the Insulin Icodec group and -0.71% (Standard Error 0.06) for the Insulin Degludec group. An ANCOVA analysis showed a treatment difference of -0.22 (95.0% CI: -0.37 to -0.08) with a p-value of 0.0001, indicating a statistically significant greater reduction in HbA1c with insulin icodec.
- Change in Fasting Plasma Glucose (FPG): The least squares mean change was -1.58 mmol/L (Standard Error 0.12) for Insulin Icodec and -1.62 mmol/L (Standard Error 0.12) for Insulin Degludec.
- Percentage of Time in Target-range (3.9-10.0 mmol/L) using Continuous Glucose Monitoring (CGM): The mean percentage was 63.13% (Standard Deviation 17.40) for Insulin Icodec and 59.50% (Standard Deviation 18.92) for Insulin Degludec.
- Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in Total Treatment Satisfaction: The least squares mean change was 4.22 (Standard Error 0.30) for Insulin Icodec and 2.96 (Standard Error 0.31) for Insulin Degludec.
- Number of Severe Hypoglycaemic Episodes (Level 3): There were 0 episodes reported in the Insulin Icodec group and 1 episode in the Insulin Degludec group.
- Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by BG Meter): There were 113 episodes in the Insulin Icodec group and 41 episodes in the Insulin Degludec group.
What this means
The results suggest that once-weekly insulin icodec provides superior glycemic control as measured by HbA1c reduction and improved patient satisfaction compared to once-daily insulin degludec in people with type 2 diabetes. While FPG reductions were comparable, insulin icodec also demonstrated a higher percentage of time spent in the target glucose range. An important consideration is the observed difference in clinically significant hypoglycemic episodes, with a higher number reported in the insulin icodec group, despite no severe (Level 3) episodes. This finding highlights a potential safety aspect requiring further evaluation in the context of its benefits.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04770532, titled "A Research Study to Compare Two Types of Insulin, a New Weekly Insulin, Insulin Icodec and an Available Daily Insulin, Insulin Degludec, in People With Type 2 Diabetes Who Use Daily Insulin," were posted on 2025-02-20 on clinicaltrials.gov.