The data generated during and/or analysed during the current trial are available from the corresponding author on reasonable request.
This trial and secondary analysis was sponsored and funded by Novo Nordisk (Bagsvaerd, Denmark). JBB received support from The National Institutes of Health (UL1TR001111). The trial sponsor was involved in the design of the trial; the collection, and analysis of data; and writing the clinical report.
Duality of interest
BZ has received grant support from Boehringer Ingelheim, AstraZeneca and Novo Nordisk; and consulting fees from AstraZeneca, Boehringer Ingelheim, Eli Lilly, Janssen, Merck, Novo Nordisk and Sanofi.
SPM has received personal fees from Abbott Vascular, Novo Nordisk, University of Oxford, AstraZeneca and Bristol-Myers Squibb; and research support from Novo Nordisk, The Medicines Company and Terumo Medical.
NRP has received personal fees from Servier, Takeda, Novo Nordisk and AstraZeneca in relation to speakers’ fees and advisory board activities (concerning diabetes mellitus); and research grants for his research group (relating to type 2 diabetes mellitus) from Diabetes UK, National Institute for Health Research Efficacy and Mechanism Evaluation (NIHR EME), Julius Clinical and the British Heart Foundation.
SSE has received personal fees related to Data Monitoring Committees from CTI BioPharma, Arena Pharmaceuticals, SFJ Pharmaceuticals, BioMarin, Medivation, Biom’up, Dynavax, Genentech, GlaxoSmithKline, Janssen Research, Novartis, Novo Nordisk, Pfizer, Roche, Sarepta Therapeutics and Xoma; personal fees related to other statistical consulting from AstraZeneca, Celltrion, Sprout Pharmaceuticals, Sanofi, Collegium Pharmaceutical, Intercept, Coherus BioMedical and Emmaus Life Sciences; and research grant support from National Heart, Lung, and Blood Institute (NHLBI).
TRP has received research support from Novo Nordisk and AstraZeneca (paid directly to the Medical University of Graz); personal fees as a consultant from AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Novo Nordisk and Roche Diabetes Care. TRP is also the Chief Scientific Officer of CBmed (Center for Biomarker Research in Medicine), a public-funded biomarker research company.
REP’s services were paid for directly to Florida Hospital, a non-profit organisation. Consultancy and speaker fees from AstraZeneca, Takeda and Novo Nordisk; consultancy fees from Boehringer Ingelheim, GlaxoSmithKline, Hanmi Pharmaceutical Co. Ltd., Janssen Scientific Affairs LLC, Ligand Pharmaceuticals, Inc., Eli Lilly, Merck, Pfizer, Eisai, Inc.; research grants from Gilead Sciences, Lexicon Pharmaceuticals, Ligand Pharmaceuticals, Inc., Eli Lilly, Merck, Sanofi US LLC and Takeda.
ML, KB-F, AM, AMOF, JBL and KK are full-time employees of, and hold stock in, Novo Nordisk A/S.
JBB reports receiving contracted consulting fees, paid to his institution, and travel support from Novo Nordisk, Eli Lilly, GI Dynamics, Elcylex, Merck, Metavention, vTv Pharma, PhaseBio, AstraZeneca, Dance Biopharm, Sanofi, Lexicon Pharmaceuticals, Orexigen, Takeda, Adocia, Roche, NovaTarg, Shenzen HighTide, Fractyl and Dexcom; grant support from Eli Lilly, Bristol-Myers Squibb, GI Dynamics, Merck, PhaseBio, AstraZeneca, Medtronic Minimed, Sanofi, Johnson & Johnson, Andromeda, Boehringer Ingelheim, GlaxoSmithKline, MacroGenics, Intarcia Therapeutics, Lexicon Pharmaceuticals, Scion NeuroStim, Orexigen, Takeda, Theracos and Bayer; he also reports receiving fees and holding stock options in PhaseBio and Insulin Algorithms; he also reports serving on the board of the AstraZeneca Healthcare Foundation.
All authors confirm that they meet the International Committee of Medical Journal Editors uniform requirements for authorship. Specifically, all authors made substantial contributions to the interpretation of data for the manuscript, drafted and critically revised the manuscript, provided final approval of the version to be published and agreed to be accountable for all aspects of the manuscript. All the authors had access to the final results and vouch for the fidelity of the trial to the protocol. Medical writing and editorial support, under the guidance of the authors, was provided by Watermeadow Medical, an Ashfield company, part of UDG Healthcare plc, funded by Novo Nordisk. All authors are responsible for the integrity of the work as a whole.