Study S001424

A Trial to Compare Pharmacokinetic Properties of Semaglutide Following Subcutaneous Administration of Semaglutide 1 mg by the DV3372 Device and by the PDS290 Semaglutide Pen-injector

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: NCT03611322
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 54
Start: 2018-08-08
Primary completion: 2019-01-07
Lead sponsor: Novo Nordisk A/S
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG:Semaglutide, 0.25 mg; DRUG:Semaglutide, 0.5 mg; DRUG:Semaglutide, 1.0 mg; DEVICE:DV3372; DEVICE:PDS290 pen-injector
Results posted: FALSE
Individual participant data sharing: YES
Secondary identifiers: OTHER:U1111-1206-9372; REGISTRY:2017-005127-25; NIH:2017

Registered primary outcomes

AUC0-last,sema,Week5: the area under the plasma semaglutide concentration-time curve from 0 until last quantifiable measurement after first maintenance dose of subcutaneous semaglutide 1 mg administration following a four week escalation period [0-840 hours (5 weeks)]
Cmax,sema,Week5: the maximum plasma semaglutide concentration after first maintenance dose of subcutaneous semaglutide 1 mg administration following a four week escalation period [0-840 hours (5 weeks)]

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