Study S000155

A 52 Week Study Comparing the Efficacy and Safety of Once Weekly IcoSema and Once Weekly Semaglutide, Both Treatment Arms With or Without Oral Anti Diabetic Drugs, in Participants With Type 2 Diabetes Inadequately Controlled With a GLP 1 Receptor Agonist. COMBINE 2

Included trial: extracted data ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT05259033
Acronym: COMBINE 2
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: NONE
Status: COMPLETED
Enrollment: 683
Start: 2022-04-11
Primary completion: 2023-12-13
Lead sponsor: Novo Nordisk A/S
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG:IcoSema; DRUG:Semaglutide 1 mg
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:U1111 1260 8268; EUDRACT_NUMBER:2020 005308 21

Registered primary outcomes

Change From Baseline in Glycosylated Haemoglobin (HbA1c) [Baseline (week 0), (week 52)]

Linked records (2)

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
R0006474	Efficacy and Hypoglycaemia Outcomes With Once-Weekly IcoSema Versus Comparators in Individuals With Type 2 Diabetes by Kidney and Liver Function: A Post Hoc Analysis of the COMBINE 1-3 Trials. Ji L, Diabetes, obesity & metabolism	2026	Other trial	PMID 42557064 DOI	cites ClinicalTrials.gov:NCT05259033; registry reference DERIVED:42557064
R0005851	Once-weekly IcoSema versus once-weekly semaglutide in adults with type 2 diabetes: the COMBINE 2 randomised clinical trial. Lingvay I, Diabetologia	2025	Randomized trial	PMID 39820580 DOI	cites ClinicalTrials.gov:NCT05259033; registry reference DERIVED:39820580