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Article History

Received: 2 April 2021

Accepted: 9 July 2021

First Online: 19 July 2021

Declarations

:

: <i>Ethics approval</i>The study has been approved by the Slovene National Medical Ethics Committee. It is registered at the ExternalRef removed NCT04263415.It will be carried out under the surveillance and guidelines of the Good Clinical Practice and in accordance with the Helsinki Declaration.<i>Consent</i>Written consent was obtained by the principal investigators A.J. and M.J. Sufficient time will be given before written informed consent is obtained by the investigators. They will be fully informed of their rights as well as responsibilities while participating in the trial. An English translation of the informed consent form is provided in supplementary file InternalRef removed.<i>Confidentiality</i>Personal information about potential and enrolled participants will be collected, shared and maintained in accordance with GDPR in order to protect confidentiality before, during and after the trial.<i>Harms</i>All AEs will be collected from the first drug administration and in all following contacts with participants throughout the trial. All AEs will be noted in the CRF and recorded in the end-of-trial form to the Slovenian Medicines Agency and in the report to the ethics committee (if requested) no later than 90 days after trial completion. In case of a SAE, the report will be immediately (and no later than 2 days after becoming aware) sent to the Slovenian Medicines Agency and the ethics committee.

: Patient consent for publication is not required.

: M.J., T.B., S.B., D.S. A.V. and J.K. declare that they have no competing interests in this work. S.F. received lecture fees from NovoNordisk. A.J. is a member of the Advisory Boards of Novo Nordisk on insulin. None of the authors has any significant competing financial, professional or personal interests that might have influenced the performance or presentation of the work described in this manuscript.