Study S001682

A Study Investigating the Pharmacokinetic Properties of a Single Dose of IcoSema Compared With Insulin Icodec and Semaglutide Given Separately in Chinese Participants With Type 2 Diabetes

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

Included trial: extracted data ClinicalTrials.gov record

Registration

Registration: NCT05435677
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 20
Start: 2022-06-22
Primary completion: 2023-04-25
Lead sponsor: Novo Nordisk A/S
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG:IcoSema; DRUG:insulin icodec; DRUG:semaglutide
Results posted: FALSE
Individual participant data sharing: YES
Secondary identifiers: OTHER:U1111-1262-1959

Registered primary outcomes

AUCIco,0-tz:Area under the serum insulin icodec concentration-time curve after a single dose [From 0 hours to tz hours after IMP administration (day 1) where tz is the time of the last quantifiable concentration]
Dose-normalised AUCSema,0-tz: Area under the plasma semaglutide concentration-time curve after a single dose divided by dose [From 0 hours to tz hours after IMP administration (day 1) where tz is the time of the last quantifiable concentration]

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
R0003268	Pharmacokinetic Characteristics of a Once-Weekly Combination Therapy of Insulin Icodec and Semaglutide Versus Its Separate Components in Chinese Individuals with Type 2 Diabetes. Wang F, Diabetes therapy : research, treatment and education of diabetes and related disorders	2025	Randomized trial	PMID 41051695 DOI	cites ClinicalTrials.gov:NCT05435677; registry reference DERIVED:41051695