Study S001319

A Multi-centre, Prospective, Non-interventional Single-arm Study Investigating Clinical Parameters and Safety Associated With the Use of Once-daily Oral Semaglutide in a Real-world Adult Population With Type 2 Diabetes in Japan

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: NCT04878393
Acronym: PIONEER REAL
Study type: OBSERVATIONAL
Status: COMPLETED
Enrollment: 650
Start: 2021-04-30
Primary completion: 2023-02-09
Lead sponsor: Novo Nordisk A/S
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG:Oral semaglutide
Results posted: FALSE
Individual participant data sharing: YES
Secondary identifiers: OTHER:U1111-1247-5339

Registered primary outcomes

Change in glycated haemoglobin (HbA1c) [From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)]
Number of adverse event (AEs) [From baseline (week 0) to End of Study visit (Visit 3) (week 34-44)]

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
R0019966	PIONEER REAL Japan: Baseline characteristics of a multicenter, prospective, real-world study of oral semaglutide in adults with type 2 diabetes in clinical practice in Japan. Suzuki R, Journal of diabetes investigation	2024	Nonrandomized study	PMID 38711208 DOI	registry reference RESULT:38711208