Study S000483

Efficacy and Safety of Semaglutide Once-weekly Versus Placebo as add-on to SGLT-2i in Subjects With Type 2 Diabetes Mellitus. A 30-week Randomised, Double-blind, Placebo-controlled Trial

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

Registration

Registration: NCT03086330
Acronym: SUSTAIN 9
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: DOUBLE
Status: COMPLETED
Enrollment: 302
Start: 2017-03-15
Primary completion: 2018-07-04
Lead sponsor: Novo Nordisk A/S
Conditions: Diabetes; Diabetes Mellitus, Type 2
Interventions: DRUG:Semaglutide; DRUG:Placebo
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: EUDRACT_NUMBER:2016-000904-27; OTHER:U1111-1180-1213; REGISTRY:JapicCTI-173542; NIH:2016

Registered primary outcomes

Change in HbA1c [Week 0, week 30]

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
R0020457	Semaglutide once weekly as add-on to SGLT-2 inhibitor therapy in type 2 diabetes (SUSTAIN 9): a randomised, placebo-controlled trial. Zinman B, The lancet. Diabetes & endocrinology	2019	Randomized trial	PMID 30833170 DOI	cites ClinicalTrials.gov:NCT03086330; registry reference RESULT:30833170