Study S000869

A Study to Demonstrate Bioequivalence Between Semaglutide Formulation 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: NCT05232708
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: NONE
Status: COMPLETED
Enrollment: 18
Start: 2022-01-19
Primary completion: 2022-08-30
Lead sponsor: Novo Nordisk A/S
Conditions: Healthy Volunteers (Diabetes Mellitus, Type 2)
Interventions: DRUG:Semaglutide B, 1.34 mg/mL; DRUG:Semaglutide D, 1.0 mg/mL
Results posted: FALSE
Individual participant data sharing: YES
Secondary identifiers: EUDRACT_NUMBER:2021-003216-25; OTHER:U1111-1266-4076

Registered primary outcomes

AUC0-last,sema 0.5mg: Area under the semaglutide concentration-time curve from time 0 until last quantifiable measurement after single dose of s.c. semaglutide 0.5 mg [0-840 hours after a single dose of s.c. semaglutide 0.5 mg]
Cmax,sema,0.5mg: maximum observed semaglutide concentration-time after single dose of s.c. semaglutide 0.5 mg administration [0-840 hours after a single dose of s.c. semaglutide 0.5 mg]

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