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Semaglutide

Ozempic, Rybelsus, Wegovy

Quick Stats
Studies 78
Trials 100
Completed PHASE3 INTERVENTIONAL NCT05813912

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

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

This study looks at how a new medicine insulin icodec helps in reducing blood sugar levels when given along with semaglutide in patients with type 2 diabetes. Participants will get the medicine insulin icodec once a week in the first part of the study (run-in period-26 weeks). Participants will only enter the second part of the study if the blood sugar levels have not reduced to normal. If blood sugar levels are normal after the first 26 weeks, participants will continue in a 5-week follow up period. In the second part of the study (intensification period-26 weeks), participants will get both insulin icodec and semaglutide once weekly after which they will continue in a 5-week follow up period. Participants will have to inject the study medicines once a week on the same day of the week in a skin fold in the thigh, upper arm or stomach. The study will last for about 13 months. Participants will get a blood glucose meter to check blood sugar levels. In addition, participants will be asked to enter blood sugar levels in the study phone. In addition, Participants will be asked to enter selected few blood sugar values (three times during the study) in a paper diary that will be provided to participants. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.

Interventions

Name: Insulin Icodec
Type: DRUG
Description: Participants will receive subcutaneously insulin icodec once weekly for 52 weeks.
Name: Semaglutide
Type: DRUG
Description: Participants will receive once weekly semaglutide subcutaneously starting from 0.25 mg and dose increased up to 1 mg for 26 weeks.

Primary Outcomes

Measure: Change in glycated haemoglobin (HbA1c)
TimeFrame: From baseline (time of insulin icodec and semaglutide initiation [week 26, visit 28]) to week 52 (visit 54)
Description: Measured in percentage (%) points.

Trial Information

NCT ID

NCT05813912

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE3

Sponsor

Novo Nordisk A/S

Last Updated

December 15, 2025