Trial results for a Phase 3 study evaluating insulin icodec when given along with semaglutide for Type 2 Diabetes Mellitus were posted on ClinicalTrials.gov on 2026-06-03. The study reported a mean reduction in glycated haemoglobin (HbA1c) of -1.23% and a mean body weight reduction of -3.85 kg in participants.
Background
The study investigated the combination of a new weekly insulin, insulin icodec, with semaglutide for patients with Type 2 Diabetes Mellitus. Semaglutide is an established medication for managing blood sugar in Type 2 Diabetes, and this trial explored the potential benefits of adding a weekly insulin to its regimen.
Trial design
The Phase 3 study (NCT05813912) enrolled 148 participants with Type 2 Diabetes Mellitus. The study design included an initial 26-week run-in period where participants received insulin icodec once a week. Participants whose blood sugar levels had not normalized after this period proceeded to a second 26-week intensification period, where they received both insulin icodec and semaglutide. If blood sugar levels were normal after the first 26 weeks, participants continued in a 5-week follow-up period.
Key results
The trial reported the following key measurements for the Insulin Icodec + Semaglutide group:
- Mean change in Glycated Haemoglobin (HbA1c) was -1.23% (Standard Deviation: 0.86).
- Mean change in 7-point Self-measured Plasma Glucose (SMPG) Profiles was -1.69 mmol/L (Standard Deviation: 2.42).
- Mean change in Post-prandial Glucose Increment (Over All Meals) was -1.27 mmol/L (Standard Deviation: 2.17).
- Mean change in Fasting Plasma Glucose (FPG) was -1.29 mmol/L (Standard Deviation: 2.24).
- Mean change in Body Weight was -3.85 Kg (Standard Deviation: 3.98).
- The number of severe hypoglycaemic episodes (Level 3) was 0.
- The number of clinically significant hypoglycaemic episodes (Level 2) was 13.
- The total number of clinically significant (Level 2) or severe (Level 3) hypoglycaemic episodes was 13.
- The relative change in weekly insulin icodec dose was a Least Squares Mean of 0.76 Insulin Units per Week, with a 95% Confidence Interval.
A mixed models analysis for the change from baseline in response after 26 weeks showed a mean difference of -1.23 (95% CI: -1.39 to -1.07), with a p-value of 0.0001.
What this means
The results suggest that the combination of insulin icodec and semaglutide can lead to significant reductions in blood sugar markers, including HbA1c, SMPG, post-prandial glucose, and fasting plasma glucose, in patients with Type 2 Diabetes Mellitus who did not achieve normal blood sugar levels with insulin icodec alone. The observed mean body weight reduction of -3.85 kg is also a notable finding, as weight management is often a key challenge in Type 2 Diabetes. The absence of severe hypoglycaemic episodes (Level 3) and a relatively low number of clinically significant hypoglycaemic episodes (Level 2) indicate a potentially favorable safety profile regarding severe hypoglycemia for this combination therapy.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05813912, titled 'A Research Study to See How a New Weekly Insulin, Insulin Icodec When Given Along With Semaglutide Helps in Reducing the Blood Sugar Level in Patients With Type 2 Diabetes', were posted on 2026-06-03 on clinicaltrials.gov.