Study S000522

China Multi-regional Clinical Trial: Efficacy and Safety of Oral Semaglutide Versus Sitagliptin in Subjects With Type 2 Diabetes Mellitus Treated With Metformin

Included trial: extracted data ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT04017832
Acronym: PIONEER 12
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 1441
Start: 2019-07-29
Primary completion: 2021-10-27
Lead sponsor: Novo Nordisk A/S
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG:Oral semaglutide; DRUG:Sitagliptin; DRUG:Placebo (oral semaglutide); DRUG:Placebo (sitagliptin)
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:U1111-1188-1256; REGISTRY:2018-002589-38; NIH:2018

Registered primary outcomes

Change From Baseline to Week 26 in Glycated Haemoglobin (HbA1c) (%) [From baseline to week 26]

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
R0019776	Efficacy and safety of oral semaglutide vs sitagliptin in a predominantly Chinese population with type 2 diabetes uncontrolled with metformin: PIONEER 12, a double-blind, Phase IIIa, randomised trial. Ji L, Diabetologia	2024	Randomized trial	PMID 38985161 DOI	cites ClinicalTrials.gov:NCT04017832; registry reference DERIVED:38985161