Study S001161

Efficacy and Safety of Once-weekly Semaglutide S.C. 2.0 mg as Add-on to Dose-reduced Insulin Glargine vs Titrated Insulin Glargine in Participants With Type 2 Diabetes and Overweight

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

Registration

Registration: NCT05514535
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: NONE
Status: COMPLETED
Enrollment: 573
Start: 2022-08-29
Primary completion: 2025-03-05
Lead sponsor: Novo Nordisk A/S
Conditions: Diabetes Mellitus, Type 2; Obesity
Interventions: DRUG:Semaglutide; DRUG:Insuline glargine U100 (reduced); DRUG:Insuline glargine U100 (titrated)
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:U1111-1267-0312; EUDRACT_NUMBER:2021-004392-13

Registered primary outcomes

Change in Glycated Haemoglobin (HbA1c) [Noninferiority] [From baseline (week 0) to end of treatment (week 40)]

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