Study S001221

A Thorough QTc Evaluation of the Effect of Semaglutide on Cardiac Repolarisation in Healthy Subjects: A Randomised, Double-Blind,Placebo-Controlled, Three-Arm Parallel Trial With a Nested Cross-Over Design for Positive Control With Moxifloxacin Administration

Included trial: extracted data ClinicalTrials.gov record

Registration

Registration: NCT02064348
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: DOUBLE
Status: COMPLETED
Enrollment: 168
Start: 2014-02-26
Primary completion: 2015-04-23
Lead sponsor: Novo Nordisk A/S
Conditions: Diabetes; Healthy
Interventions: DRUG:semaglutide; DRUG:placebo; DRUG:moxifloxacin
Results posted: FALSE
Secondary identifiers: EUDRACT_NUMBER:2012-005073-31; OTHER:U1111-1136-6455

Registered primary outcomes

QTcI, (Individual heart rate corrected QT (Interval in the ECG: from the start of the QRS complex to the end) interval) based on ECG recordings obtained at 11 time points [0-48 hours after the fourth dose of semaglutide/semaglutide placebo at the 1.5 mg dose level]

Linked records (1)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0018853	No QTc Prolongation with Semaglutide: A Thorough QT Study in Healthy Subjects. Demmel V, Diabetes therapy : research, treatment and education of diabetes and related disorders	2018	Randomized trial	PMID 29799100 DOI	cites ClinicalTrials.gov:NCT02064348; registry reference RESULT:29799100