Trial results for a Phase 3 study evaluating semaglutide in combination with insulin icodec for Type 2 Diabetes were completed on 2025-04-14. The study reported a significant mean reduction in Glycated Haemoglobin (HbA1c) of -1.23% (p=0.0001) in participants.
Background
This study investigated the efficacy of a new weekly insulin, insulin icodec, when administered along with semaglutide, in patients with Type 2 Diabetes. The aim was to assess the combination's ability to reduce blood sugar levels.
Trial design
The Phase 3 study (NCT05813912) enrolled 148 participants with Diabetes Mellitus, Type 2. The study design included a 26-week run-in period where participants received insulin icodec once a week. Participants whose blood sugar levels did not normalize after this period proceeded to a 26-week intensification period, receiving both insulin icodec and semaglutide. Participants whose blood sugar levels normalized after the initial 26 weeks entered a 5-week follow-up period.
Key results
Key measurements from the trial include:
- Change in Glycated Haemoglobin (HbA1c): -1.23% (Standard Deviation 0.86).
- Change in Mean 7-point Self-measured Plasma Glucose (SMPG) Profiles: -1.69 millimoles per liter (mmol/L) (Standard Deviation 2.42).
- Change in Mean Post-prandial Glucose Increment (Over All Meals): -1.27 mmol/L (Standard Deviation 2.17).
- Change in Fasting Plasma Glucose (FPG): -1.29 mmol/L (Standard Deviation 2.24).
- Number of Severe Hypoglycaemic Episodes (Level 3): 0 Episodes.
- Number of Clinically Significant Hypoglycaemic Episodes (Level 2): 13 Episodes.
- Change in Body Weight: -3.85 Kilograms (Kg) (Standard Deviation 3.98).
- Relative Change in Weekly Insulin Icodec Dose: 0.76 Insulin Units per Week (95% Confidence Interval).
A Mixed Models Analysis for the change from baseline in Glycated Haemoglobin (HbA1c) after 26 weeks showed a Mean Difference (Final Values) of -1.23 (95% Confidence Interval: -1.39, -1.07) with a p-value of 0.0001.
What this means
The completed Phase 3 study indicates that the combination of semaglutide and insulin icodec significantly reduces HbA1c levels by -1.23% and Fasting Plasma Glucose by -1.29 mmol/L in patients with Type 2 Diabetes. The observed mean body weight reduction of -3.85 Kg further supports the metabolic benefits. Notably, the trial reported 0 severe hypoglycaemic episodes, suggesting a favorable safety profile regarding this critical adverse event.
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 2025-04-14 on clinicaltrials.gov.