Simioni, N.
,
Berra, C.
Boemi, M.
Bossi, A. C.
Candido, R.
Di Cianni, G.
Frontoni, S.
Genovese, S.
Ponzani, P.
Provenzano, V.
Russo, G. T.
Sciangula, L.
Lapolla, A.
Bette, C.
Rossi, M. C. http://orcid.org/0000-0001-8696-4238
Funding for this research was provided by:
Novo Nordisk A/S
Article History
Received: 10 January 2018
Accepted: 28 February 2018
First Online: 12 March 2018
Compliance with ethical standards
:
: Simioni N: Consulting fees from Novo Nordisk, Lilly, Boehringer Ingelheim and Abbott; member of advisory boards for Novo Nordisk, Lilly and Boehringer Ingelheim; investigator in clinical trials sponsored by Novo Nordisk. Berra C: consulting fees from Novo Nordisk, Lilly, Boehringer Ingelheim, Sanofi, Johnson & Johnson and Bayer; research support from AstraZeneca and Takeda; member of advisory boards for Novo Nordisk, Lilly, Boehringer Ingelheim, AstraZeneca and Sanofi; investigator in clinical trials sponsored by Lilly and Sanofi. Boemi M: member of advisory boards for Lilly, Boehringer Ingelheim and Sanofi; investigator in clinical trials sponsored by Novo Nordisk, Boehringer Ingelheim and Merck SD. Bossi AC: investigator in clinical trials sponsored by Novo Nordisk, Artsana, Lilly, Bayer and Sanofi; consulting fees from AstraZeneca, Roche, Johnson & Johnson and Takeda; research support from Merck SD and Sigma-Tau; member of advisory board for Boehringer Ingelheim. Candido R: investigator in clinical trials sponsored by Novo Nordisk, Lilly and Merck SD; consulting fees from AstraZeneca, Roche and Johnson & Johnson; member of advisory board for Boehringer Ingelheim. Di Cianni G: investigator in clinical trials sponsored by Novo Nordisk, AstraZeneca and Sanofi; member of advisory boards for Lilly and Sanofi. Frontoni S: member of advisory boards for Novo Nordisk, Lilly, AstraZeneca, Johnson & Johnson, Takeda and Sigma-Tau; investigator in clinical trials sponsored by Novo Nordisk and Boehringer Ingelheim. Genovese S: consulting fees from Novo Nordisk, Lilly, Boehringer Ingelheim, AstraZeneca, Merck SD, Sanofi, Johnson & Johnson, Takeda, Abbott Diabetes Care, Bristol Myers & Squibb, Janssen, Lifescan, Menarini and Novartis; member of advisory boards for Novo Nordisk, Boehringer Ingelheim, AstraZeneca, Merck SD, Sanofi, Johnson & Johnson, Takeda, Abbott Diabetes Care, Bruno Farmaceutici, Janssen, Lifescan and Novartis; research support from Novartis; investigator in clinical trials sponsored by Novo Nordisk, Lilly, Boehringer Ingelheim, AstraZeneca, Merck SD, Takeda, Janssen, Novartis and Sanofi. Ponzani P: investigator in clinical trials sponsored by Boehringer Ingelheim, Sanofi, Johnson & Johnson, Bayer and Novartis; member of advisory boards for Novo Nordisk and AstraZeneca. Provenzano V: consulting fees from Novo Nordisk, Lilly, Boehringer Ingelheim, AstraZeneca, Merck SD, Sanofi and Takeda; member of advisory boards for Novo Nordisk, Lilly, Boehringer Ingelheim, AstraZeneca and Sanofi; investigator in clinical trials sponsored by Novo Nordisk, Lilly, Boehringer Ingelheim, AstraZeneca, Merck SD, Sanofi and Roche. Russo GT: investigator in clinical trials sponsored by Lilly, Boehringer Ingelheim, Merck SD, Sanofi and Johnson & Johnson; member of advisory boards for Novo Nordisk, Lilly and Boehringer Ingelheim, member of advisory boards for, and consulting fees from, Novo Nordisk, Lilly and Boehringer Ingelheim. Sciangula L: member of advisory boards for Novo Nordisk, Lilly, AstraZeneca and Johnson & Johnson; consulting fees from Roche; investigator in clinical trials sponsored by Novo Nordisk. Lapolla A: investigator in clinical trials sponsored by Novo Nordisk, Lilly, Boehringer Ingelheim and Sanofi. Bette C: employee of Novo Nordisk SpA (Rome, Italy). Rossi MC: research grant from Novo Nordisk, Sanofi, Dexcom, AstraZeneca, Sigma-Tau, Eli Lilly, Artsana and Medtronic.
: This study was conducted in accordance with the Declaration of Helsinki and the Guidelines for Good Pharmacoepidemiology Practices. According to Italian law (Italian Republic. Determination of the Italian Medicines Agency of March 20, 2008. Official Gazette of the Italian Republic. General Series No. 76; March 31, 2008), prior to study initiation, the protocol, patient informed consent form and patient enrolment procedures were reviewed and approved by an Independent Ethics Committee (IEC). The study protocol was submitted to the Coordinating Centre IEC in advance, then after its official approval, the study documentation was submitted to the local IECs of all participating centres.
: Informed consent was obtained from all individual participants included in the study.