PLoS Medicine (Jun 2016)

The Effect of Sitagliptin on Carotid Artery Atherosclerosis in Type 2 Diabetes: The PROLOGUE Randomized Controlled Trial.

  • Jun-Ichi Oyama,
  • Toyoaki Murohara,
  • Masafumi Kitakaze,
  • Tomoko Ishizu,
  • Yasunori Sato,
  • Kazuo Kitagawa,
  • Haruo Kamiya,
  • Masayoshi Ajioka,
  • Masaharu Ishihara,
  • Kazuoki Dai,
  • Mamoru Nanasato,
  • Masataka Sata,
  • Koji Maemura,
  • Hirofumi Tomiyama,
  • Yukihito Higashi,
  • Kohei Kaku,
  • Hirotsugu Yamada,
  • Munehide Matsuhisa,
  • Kentaro Yamashita,
  • Yasuko K Bando,
  • Naoki Kashihara,
  • Shinichiro Ueda,
  • Teruo Inoue,
  • Atsushi Tanaka,
  • Koichi Node,
  • PROLOGUE Study Investigators

DOI
https://doi.org/10.1371/journal.pmed.1002051
Journal volume & issue
Vol. 13, no. 6
p. e1002051

Abstract

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BackgroundExperimental studies have suggested that dipeptidyl peptidase-4 (DPP-4) inhibitors provide cardiovascular protective effects. We performed a randomized study to evaluate the effects of sitagliptin added on to the conventional therapy compared with conventional therapy alone (diet, exercise, and/or drugs, except for incretin-related agents) on the intima-media thickness (IMT) of the carotid artery, a surrogate marker for the evaluation of atherosclerotic cardiovascular disease, in people with type 2 diabetes mellitus (T2DM).Methods and findingsWe used a multicenter PROBE (prospective, randomized, open label, blinded endpoint) design. Individuals aged ≥30 y with T2DM (6.2% ≤ HbA1c ConclusionsIn the PROLOGUE study, there was no evidence that treatment with sitagliptin had an additional effect on the progression of carotid IMT in participants with T2DM beyond that achieved with conventional treatment.Trial registrationUniversity Hospital Medical Information Network Clinical Trials Registry UMIN000004490.