Study S001943

Dose-response, Safety and Efficacy of Oral Semaglutide Versus Placebo and Versus Liraglutide, All as Monotherapy in Japanese Subjects With Type 2 Diabetes

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

Registration

Registration: NCT03018028
Acronym: PIONEER 9
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: DOUBLE
Status: COMPLETED
Enrollment: 243
Start: 2017-01-10
Primary completion: 2018-01-09
Lead sponsor: Novo Nordisk A/S
Conditions: Diabetes; Diabetes Mellitus, Type 2
Interventions: DRUG:Semaglutide; DRUG:Placebo; DRUG:Liraglutide
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:U1111-1181-4048; OTHER:JapicCTI-173489

Registered primary outcomes

Change in HbA1c (Week 26) [Week 0, week 26]

Linked records (4)

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
R0007971	Efficacy, safety and cardiovascular outcomes of once-daily oral semaglutide in patients with type 2 diabetes: The PIONEER programme. Thethi TK, Diabetes, obesity & metabolism	2020	Randomized trial	PMID 32267058 DOI	cites ClinicalTrials.gov:NCT03018028; registry reference DERIVED:32267058
R0015952	Dose-response, efficacy, and safety of oral semaglutide monotherapy in Japanese patients with type 2 diabetes (PIONEER 9): a 52-week, phase 2/3a, randomised, controlled trial. Yamada Y, The lancet. Diabetes & endocrinology	2020	Randomized trial	PMID 32333875 DOI	cites ClinicalTrials.gov:NCT03018028; registry reference DERIVED:32333875
R0018529	Effects of semaglutide on risk of cardiovascular events across a continuum of cardiovascular risk: combined post hoc analysis of the SUSTAIN and PIONEER trials. Husain M, Cardiovascular diabetology	2020	Randomized trial	PMID 32998732 DOI	cites ClinicalTrials.gov:NCT03018028; registry reference DERIVED:32998732
R0018857	Semaglutide (SUSTAIN and PIONEER) reduces cardiovascular events in type 2 diabetes across varying cardiovascular risk. Husain M, Diabetes, obesity & metabolism	2020	Other	PMID 31903692 DOI	cites ClinicalTrials.gov:NCT03018028; registry reference DERIVED:31903692