Study S001189

A Trial to Demonstrate Bioequivalence Between Semaglutide Formulations for the DV3372 Device 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: NCT03598621
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 68
Start: 2018-07-23
Primary completion: 2019-01-17
Lead sponsor: Novo Nordisk A/S
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG:Semaglutide, 0.5 mg/mL; DRUG:Semaglutide, 1.0 mg/mL; DRUG:Semaglutide, 1.34 mg/mL; DRUG:Semaglutide, 2.0 mg/mL; DEVICE:DV3372, 0.5 mg/mL; DEVICE:DV3372, 1.0 mg/mL; DEVICE:PDS290; DEVICE:NovoPen®4
Results posted: FALSE
Individual participant data sharing: YES
Secondary identifiers: OTHER:U1111-1200-8075; REGISTRY:2017-003437-29; NIH:2017

Registered primary outcomes

AUC0-last,sema,SD, the area under the plasma semaglutide concentration curve from time 0 until last quantifiable measurement after a single dose subcutaneous semaglutide administration [0-840 hours (5 weeks)]
Cmax,sema,SD, the maximum plasma semaglutide concentration after a single dose subcutaneous semaglutide administration [0-840 hours (5 weeks)]

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