Study S000429

Protocol Title: A Single Arm Study Investigating the Glycaemic Control and Safety of Adding Semaglutide to Insulin Icodec in Participants With Type 2 Diabetes Qualifying for Treatment Intensification Short Title: 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

ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT05813912
Study type: INTERVENTIONAL
Phase: PHASE3
Masking: NONE
Status: COMPLETED
Enrollment: 148
Start: 2023-09-22
Primary completion: 2025-04-14
Lead sponsor: Novo Nordisk A/S
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG:Insulin Icodec; DRUG:Semaglutide
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: EUDRACT_NUMBER:2022-002847-24; OTHER:U1111-1281-4752

Registered primary outcomes

Change in Glycated Haemoglobin (HbA1c) [Baseline (Week 26), Week 52]

Linked records (1)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0003826	Efficacy and Safety of Intensifying Once-Weekly Insulin Icodec Treatment With Once-Weekly Semaglutide in Adults With Type 2 Diabetes: A Single-Arm, Open-Label, Treat-to-Target, Phase 3b Trial (ONWARDS 8). Strojek K, Diabetes, obesity & metabolism	2026	Other trial	PMID 42387310 DOI	cites ClinicalTrials.gov:NCT05813912; registry reference DERIVED:42387310