Study S000680

A Single-centre, Randomised, Double-blind, Placebo-controlled, Multiple-dose Trial to Assess the Pharmacokinetics, Safety and Tolerability of Semaglutide in Healthy Chinese Subjects

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: NCT03288740
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 36
Start: 2017-09-21
Primary completion: 2018-07-10
Lead sponsor: Novo Nordisk A/S
Conditions: Diabetes; Diabetes Mellitus, Type 2
Interventions: DRUG:Semaglutide 0.5 mg; DRUG:Placebo (semaglutide 0.5 mg); DRUG:Semaglutide 1.0 mg; DRUG:Placebo (semaglutide 1.0 mg)
Results posted: FALSE
Individual participant data sharing: YES
Secondary identifiers: OTHER:U1111-1149-6572

Registered primary outcomes

Area under the semaglutide plasma concentration time curve at steady state (semaglutide 0.5 mg) [0-168 hours after last administration of semaglutide]
Area under the semaglutide plasma concentration time curve at steady state (semaglutide 1.0 mg) [0-168 hours after last administration of semaglutide]

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
R0016699	Pharmacokinetics, Safety and Tolerability of Once-Weekly Subcutaneous Semaglutide in Healthy Chinese Subjects: A Double-Blind, Phase 1, Randomized Controlled Trial. Shi A, Advances in therapy	2021	Randomized trial	PMID 33159658 DOI	cites ClinicalTrials.gov:NCT03288740; registry reference RESULT:33159658
R0045841	941-P: A Trial to Assess the Pharmacokinetics, Safety, and Tolerability of Semaglutide in Healthy Chinese Subjects Aixin Shi, Diabetes	2020	Randomized trial	DOI	cites ClinicalTrials.gov:NCT03288740