Study S000309

A Trial to Demonstrate Bioequivalence Between Semaglutide D Formulations for the DV3396 Pen-Injector and the Formulation for 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: NCT04152915
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: NONE
Status: COMPLETED
Enrollment: 68
Start: 2019-11-25
Primary completion: 2020-05-25
Lead sponsor: Novo Nordisk A/S
Conditions: Healthy Volunteers; Diabetes Mellitus, Type 2
Interventions: DRUG:Semaglutide
Results posted: FALSE
Individual participant data sharing: YES
Secondary identifiers: OTHER:U1111-1235-3506; REGISTRY:2019-002588-92; NIH:2019

Registered primary outcomes

AUC0-last,sema,1mg: Area under the semaglutide concentration time curve from time 0 until last quantifiable measurement after one dose of s.c. semaglutide 1 mg administration following a 6-week dose escalation period [0-840 hours after one dose of s.c. semaglutide 1 mg]
Cmax,sema,1mg: Maximum observed semaglutide concentration after one dose of s.c. semaglutide 1 mg administration following a 6-week dose escalation period [0-840 hours after one dose of s.c. semaglutide 1 mg]

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