Study S000221

Efficacy and Safety of Oral Semaglutide Versus Placebo Both in Combination With Metformin and/or Basal Insulin in Children and Adolescents With Type 2 Diabetes

ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT04596631
Acronym: PIONEER TEENS
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 132
Start: 2020-11-02
Primary completion: 2025-04-29
Lead sponsor: Novo Nordisk A/S
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG:Oral semaglutide; DRUG:Placebo (semaglutide)
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:U1111-1218-1527; REGISTRY:2018-002952-34; NIH:2018

Registered primary outcomes

Change From Baseline (Week 0) to Week 26 in Glycosylated Haemoglobin (HbA1c)- Percentage Point [Baseline (Week 0), Week 26]
Change From Baseline (Week 0) in HbA1c to Week 26- Millimoles Per Mole (mmol/Mol) [Baseline (Week 0), Week 26]

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