Study S000363

Effect of Semaglutide Once-weekly Versus Insulin Aspart Three Times Daily, Both as Add on to Metformin and Optimised Insulin Glargine (U100) in Subjects With Type 2 Diabetes A 52-week, Multi-centre, Multinational, Open-label, Active-controlled, Two Armed, Parallel-group, Randomised Trial in Subjects With Type 2 Diabetes

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

Registration

Registration: NCT03689374
Acronym: SUSTAIN 11
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: NONE
Status: COMPLETED
Enrollment: 2274
Start: 2018-10-01
Primary completion: 2021-02-22
Lead sponsor: Novo Nordisk A/S
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG:Semaglutide; DRUG:Insulin aspart; DRUG:Insulin glargine U100
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:U1111-1200-0164; REGISTRY:2017-003219-20; NIH:2017

Registered primary outcomes

Change From Baseline in Glycated Haemoglobin (HbA1c) [Baseline (week 0), week 52]

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
R0022346	Effect of once-weekly semaglutide versus thrice-daily insulin aspart, both as add-on to metformin and optimized insulin glargine treatment in participants with type 2 diabetes (SUSTAIN 11): A randomized, open-label, multinational, phase 3b trial. Kellerer M, Diabetes, obesity & metabolism	2022	Randomized trial	PMID 35546450 DOI	cites ClinicalTrials.gov:NCT03689374; registry reference RESULT:35546450