Study S000458

A 52 Week Study Comparing the Efficacy and Safety of Once Weekly IcoSema and Once Weekly Insulin Icodec, Both Treatment Arms With or Without Oral Anti Diabetic Drugs, in Participants With Type 2 Diabetes Inadequately Controlled With Daily Basal Insulin.

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

Registration

Registration: NCT05352815
Acronym: COMBINE 1
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: NONE
Status: COMPLETED
Enrollment: 1291
Start: 2022-06-01
Primary completion: 2024-03-19
Lead sponsor: Novo Nordisk A/S
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG:IcoSema; DRUG:Insulin icodec
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:U1111-1260-8259; EUDRACT_NUMBER:2020-005281-34

Registered primary outcomes

Change in Glycated Haemoglobin (HbA1c) [Baseline (Week 0), Week 52]

Linked records (3)

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:NCT05352815; registry reference DERIVED:42557064
R0009206	CGM-derived postprandial glucose with IcoSema versus other insulin regimens: a post hoc analysis of COMBINE 1 and 3. De Block C, EClinicalMedicine	2026	Randomized trial	PMID 42306490 DOI	cites ClinicalTrials.gov:NCT05352815; registry reference DERIVED:42306490
R0010555	Once‑weekly IcoSema versus once‑weekly insulin icodec in type 2 diabetes management (COMBINE 1): an open‑label, multicentre, treat‑to‑target, randomised, phase 3a trial. Mathieu C, The lancet. Diabetes & endocrinology	2025	Randomized trial	PMID 40482671 DOI	cites ClinicalTrials.gov:NCT05352815; registry reference DERIVED:40482671