Study S000804

Investigation of Clinical Comparability of Semaglutide Drug Products Based on the Proposed and the Approved Drug Substance Manufacturing Processes in Participants With Type 2 Diabetes

ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT05478252
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: TRIPLE
Status: COMPLETED
Enrollment: 388
Start: 2022-08-03
Primary completion: 2023-08-09
Lead sponsor: Novo Nordisk A/S
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG:Semaglutide J; DRUG:Semaglutide B
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:U1111-1266-2391; EUDRACT_NUMBER:2021-001501-69

Registered primary outcomes

Change in Glycosylated Haemoglobin (HbA1c) [From baseline (week 0) to end of treatment (week 28)]

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