Study S001241

REALYSE - Comparative Effectiveness of Once-daily Oral Semaglutide Versus Any Other Oral Glucose-lowering Medication in a Real-world Adult Population With Type 2 Diabetes on Metformin Monotherapy in US Based Health Care Systems - a Pragmatic Randomized Trial

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

Registration

Registration: NCT05035082
Acronym: REALYSE
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE4
Masking: NONE
Status: COMPLETED
Enrollment: 1018
Start: 2021-09-01
Primary completion: 2025-06-18
Lead sponsor: Novo Nordisk A/S
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG:semaglutide; DRUG:oral glucose-lowering medications (commercially available)
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:U1111-1253-2577

Registered primary outcomes

Change in Glycated Haemoglobin (HbA1c) [Week 0, year 1]

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