Study S000976

A Multiple-dose, Single-centre, Randomised, Double-blind, Placebo-controlled Trial to Investigate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Oral 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/

ClinicalTrials.gov record

Registration

Registration: NCT04016974
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 32
Start: 2019-10-08
Primary completion: 2021-01-23
Lead sponsor: Novo Nordisk A/S
Conditions: Healthy Volunteers; Diabetes Mellitus, Type 2
Interventions: DRUG:Oral semaglutide; DRUG:Placebo
Results posted: FALSE
Individual participant data sharing: YES
Secondary identifiers: OTHER:U1111-1186-6753

Registered primary outcomes

AUC0-24h,sema,SS, area under the semaglutide concentration-time curve during a dosing interval (0-24 hours) at steady state [After the last dose of oral semaglutide at dose levels of 3 mg on day 28 and 7 mg on day 56, and after the last 3 daily doses of oral semaglutide at dose level 14 mg on day 82, 83 and 84]

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
R0006125	A phase 1, randomized, double-blind, placebo-controlled trial investigating the pharmacokinetics, pharmacodynamics, safety and tolerability of oral semaglutide in healthy Chinese subjects. Xie P, Diabetes, obesity & metabolism	2024	Randomized trial	PMID 38808476 DOI	cites ClinicalTrials.gov:NCT04016974; registry reference RESULT:38808476