Study S001494

A 40-week Study Comparing the Efficacy and Safety of Once Weekly IcoSema and Daily Insulin Glargine 100 Units/mL in Participants With Type 2 Diabetes Inadequately Controlled on Oral Anti Diabetic Drugs COMBINE 4

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

ClinicalTrials.gov record

Registration

Registration: NCT06269107
Acronym: COMBINE 4
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: NONE
Status: COMPLETED
Enrollment: 485
Start: 2024-02-15
Primary completion: 2025-05-27
Lead sponsor: Novo Nordisk A/S
Conditions: Type 2 Diabetes
Interventions: DRUG:IcoSema; DRUG:Insulin glargine
Results posted: FALSE
Individual participant data sharing: YES
Secondary identifiers: OTHER:U1111-1283-8648; OTHER:2022-502484-38-00

Registered primary outcomes

Change in glycated haemoglobin (HbA1c) [From baseline (week 0) to week 40]

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
R0005768	Once-weekly IcoSema versus once-daily insulin glargine U100 in type 2 diabetes management (COMBINE 4): an open-label, multicentre, treat-to-target, randomised, phase 3b trial. Ji L, The lancet. Diabetes & endocrinology	2026	Randomized trial	PMID 42594928 DOI	cites ClinicalTrials.gov:NCT06269107; registry reference DERIVED:42594928