Study S001633

A 52 Week Study Comparing the Efficacy and Safety of Once Weekly IcoSema and Daily Insulin Glargine 100 Units/mL Combined With Insulin Aspart, Both Treatment Arms With or Without Oral Anti Diabetic Drugs, in Participants With Type 2 Diabetes Inadequately Controlled With Daily Basal Insulin. COMBINE 3

Included trial: extracted data ClinicalTrials.gov record

Registration

Registration: NCT05013229
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: NONE
Status: COMPLETED
Enrollment: 679
Start: 2021-11-30
Primary completion: 2023-11-14
Lead sponsor: Novo Nordisk A/S
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG:IcoSema; DRUG:Insulin glargine; DRUG:insulin aspart
Results posted: FALSE
Secondary identifiers: OTHER:U1111-1260-8295; EUDRACT_NUMBER:2020-005309-18; REGISTRY:jRCT2051210127

Registered primary outcomes

Change in HbA1c [From baseline week 0 (V2) to week 52 (V54)]

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:NCT05013229; 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:NCT05013229; registry reference DERIVED:42306490
R0010915	Once-weekly IcoSema versus multiple daily insulin injections in type 2 diabetes management (COMBINE 3): an open-label, multicentre, treat-to-target, non-inferiority, randomised, phase 3a trial. Billings LK, The lancet. Diabetes & endocrinology	2025	Randomized trial	PMID 40482670 DOI	cites ClinicalTrials.gov:NCT05013229; registry reference DERIVED:40482670