Halberg, Inge B.
Lyby, Karsten
Wassermann, Karsten
Heise, Tim
Plum-Mörschel, Leona
Zijlstra, Eric
Funding for this research was provided by:
Novo Nordisk
Article History
First Online: 16 May 2019
Compliance with Ethical Standards
:
: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. Informed consent was obtained from all individual participants included in the study.
: This trial was funded by Novo Nordisk.
: Inge B. Halberg, Karsten Lyby and Karsten Wassermann are employees and shareholders of Novo Nordisk. Tim Heise is a shareholder of Profil, which has received research funds from Adocia, Boehringer Ingelheim, Dance Pharmaceuticals, Eli Lilly, Johnson & Johnson, MedImmune, Merck Sharp and Dohme, Mylan, Nordic Bioscience, Novo Nordisk, Poxel, Roche Diagnostics, Saniona, Sanofi, Senseonics and Zealand Pharma. In addition, Tim Heise is member of advisory panels for Novo Nordisk and Mylan and received speaker honoraria and travel grants from Dexcom, Eli Lilly, Mylan, Novo Nordisk, Sanofi and Zealand Pharma. Leona Plum-Mörschel has received speaker honoraria and travel grants from Eli Lilly and Novo Nordisk. Eric Zijlstra has received speaker honoraria and travel grants from Novo Nordisk, Roche Diabetes Care and Senseonics.
: The trial was registered at ClinicalTrials.gov (trial identifier: NCT02304627).
: Individual participant data will be shared in datasets in a de-identified/anonymised format with bona fide researchers submitting a research proposal requesting access to data for use as approved by the Independent Review Board (IRB) according to the IRB Charter (see ExternalRef removed). Datasets from Novo Nordisk-sponsored clinical research completed after 2001 for product indications approved in both the EU and USA and study protocol and redacted Clinical Study Report (CSR) will be available according to Novo Nordisk data-sharing commitments. The data will be available permanently after research completion and approval of product and product use in both the EU and USA (no end date). The access request proposal form and the access criteria can be found at ExternalRef removed. The data will be made available on a specialised SAS<sup>®</sup> data platform.