Study S001403

Investigation on Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of a Long-acting GLP-1 Analogue (Semaglutide) in an Oral Formulation in Healthy Male Subjects

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

ClinicalTrials.gov record

Registration

Registration: NCT01866748
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: DOUBLE
Status: COMPLETED
Enrollment: 170
Start: 2013-05
Primary completion: 2014-04
Lead sponsor: Novo Nordisk A/S
Conditions: Diabetes; Diabetes Mellitus, Type 2; Healthy
Interventions: DRUG:semaglutide; DRUG:placebo
Results posted: FALSE
Secondary identifiers: EUDRACT_NUMBER:2012-003199-38; OTHER:U1111-1132-4190

Registered primary outcomes

Part A: Number of treatment emergent adverse events (TEAEs) [Day -1 to Day 24]
Part B: Number of treatment emergent adverse events (TEAEs) [Recorded from the time of first dosing (Visit 3, Day -1 to day +2) and until completion of the post treatment follow-up visit (Visit 18, Day 90-104)]

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