PREVAIL was a 20-week, open-label, parallel-arm trial wherein patients aged 30–80 years with T2DM of ≤ 7 years duration were randomized (1:1:1) to 8-weeks treatment with insulin glargine, glargine + thrice-daily lispro, or glargine + twice-daily exenatide, followed by 12-weeks washout. The study protocol and primary outcome have been described in detail previously [9 (link)]. The study was approved by the Mount Sinai Hospital Research Ethics Board and registered at ClinicalTrials.Gov (NCT02194595). All participants provided written informed consent. While the primary and metabolic outcomes have been reported recently [9 (link)], the current report presents the pre-specified ancillary outcome of endothelial function and associated vascular measures.
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