Study S001791

China Multi-regional Clinical Trial: Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes Mellitus Treated With Diet and Exercise Only

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

Registration

Registration: NCT04109547
Acronym: PIONEER 11
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 521
Start: 2019-10-01
Primary completion: 2021-09-23
Lead sponsor: Novo Nordisk A/S
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG:Oral semaglutide; DRUG:Placebo
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:U1111-1188-1173; REGISTRY:2018-002590-22; NIH:2018

Registered primary outcomes

Change From Baseline in Glycosylated Haemoglobin (HbA1c) [Baseline (Week 0), 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
R0019663	Efficacy and safety of oral semaglutide monotherapy vs placebo in a predominantly Chinese population with type 2 diabetes (PIONEER 11): a double-blind, Phase IIIa, randomised trial. Wang W, Diabetologia	2024	Randomized trial	PMID 38985162 DOI	cites ClinicalTrials.gov:NCT04109547; registry reference DERIVED:38985162