Study S000217

A Phase III, Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Pegylated Exenatine Injection (PB-119) in Drug-naïve T2DM 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: NCT04504370
Acronym: PB119
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 273
Start: 2020-04-27
Primary completion: 2022-03-30
Lead sponsor: PegBio Co., Ltd.
Conditions: Type 2 Diabetes Mellitus (T2DM)
Interventions: DRUG:GLP-1 receptor agonist; DRUG:Placebo
Results posted: FALSE
Individual participant data sharing: NO

Registered primary outcomes

Change in HbA1c [week 1, week 25]

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
R0011471	Efficacy and safety of visepegenatide, a long-acting weekly GLP-1 receptor agonist as monotherapy in type 2 diabetes mellitus: a randomised, double-blind, parallel, placebo-controlled phase 3 trial. Yan X, The Lancet regional health. Western Pacific	2024	Randomized trial	PMID 38948164 DOI	cites ClinicalTrials.gov:NCT04504370; registry reference DERIVED:38948164
R0037302	770-P: Efficacy and Safety of Once-Weekly PB-119 Monotherapy vs. Placebo in Chinese Patients with Type 2 Diabetes in a Randomized Controlled Trial PEGBIO STUDY GROUP, Diabetes	2023	Randomized trial	DOI	cites ClinicalTrials.gov:NCT04504370