Diabetes, obesity & metabolism

Heart safety of oral semaglutide in people with type 2 diabetes: Study plan and patient details from the PIONEER 6 trial

Updated

Abstract

A total of 3183 patients have been enrolled in the PIONEER 6 trial assessing the cardiovascular safety of oral semaglutide.

  • Participants are aged 66.1 years on average, with 31.6% being female.
  • The mean duration of diabetes among participants is 14.9 years.
  • The average glycated hemoglobin concentration at baseline is 66 mmol/mol (8.2%).
  • 84.6% of patients have established cardiovascular disease or moderate chronic kidney disease.
  • The primary outcome focuses on the time to the first occurrence of cardiovascular death, non-fatal heart attack, or non-fatal stroke.

Simplified

Key numbers

3183
Patient Enrollment
Total number of patients randomized in the trial.
66.1 years
Mean Age
Mean age of participants at baseline.
14.9 years
Mean Diabetes Duration
Average duration of diabetes among participants.

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Funding

Competing interests

S.C.B. has received honoraria, teaching and research sponsorship/grants from Abbott, AstraZeneca, Boehringer Ingelheim, BMS, Cellnovo, Diartis, Eli Lilly, GlaxoSmithKline, Merck Sharp & Dohme, Novartis, Novo Nordisk, Pfizer, Roche, Sanofi‐Aventis, Schering‐Plough, Servier and Takeda, has received funding for educational programmes from Cardiff University, Doctors.net, Elsevier, Onmedica, Omnia‐Med and Medscape, and has an ownership interest in Gycosmedia (a diabetes on‐line news service). O.M. has received honoraria for advisory boards for Novo Nordisk, Eli Lilly, Sanofi, Merck Sharp & Dohme, Boehringer Ingelheim, Jansen and Jansen, Novartis and AstraZeneca, is on Speaker's Bureau for AstraZeneca, Bristol‐Myers Squibb, Novo Nordisk, Eli Lilly, Sanofi, Novartis, Merck Sharp & Dohme, Boehringer Ingelheim, has grants paid to her institution as study physician by AstraZeneca and Bristol‐Myers Squibb, and has received research grant support through Hadassah Hebrew University Hospital from Novo Nordisk. R.A. has received honoraria for advisory boards for Novo Nordisk, Eli Lilly, Merck Sharp & Dohme, Sanofi, speaking fees from AstraZeneca, Novo Nordisk, Eli Lilly, Merck Sharpe & Dohme, Sanofi, and research support from AstraZeneca, Novo Nordisk, Eli Lilly, Merck Sharpe & Dohme, Sanofi. Ab.C. has served as an advisory panel/board member for Novo Nordisk, Sanofi, Eli Lilly, Merck Sharp & Dohme and AstraZeneca, has received research support from Novo Nordisk, AstraZeneca, Novartis, MSD and Boehringer Ingelheim, and has served on the Speaker's Bureau for Novo Nordisk, Sanofi, Eli Lilly, AstraZeneca and Merck Sharp & Dohme. Ag.C. has received lecture fees and fees for serving on advisory boards from Novo Nordisk, Eli Lilly, AstraZeneca, Sanofi Aventis, Merck Sharp & Dohme and Takeda, and grant support to his institution from AstraZeneca, Eli Lilly and Novo Nordisk. K.D. has received consulting fees from GlaxoSmithKline and Sanofi, research support from AstraZeneca, GlaxoSmithKline, Novo Nordisk, and Sanofi, and participated in CME‐sponsored events funded by Novo Nordisk, Sanofi, Merck, Eli Lilly and AstraZeneca. M.C.F. has received consultancy fees from advisory boards for Novo Nordisk, Sanofi, AstraZeneca, Boehringer Ingelheim, Servier and Pfizer, and honoraria for speaking from Novo Nordisk, Sanofi, AstraZeneca, Boehringer Ingelheim and Servier. M.E.F. has received research support from Amgen and Novo Nordisk. D.R.F. has received honoraria from advisory boards for Sanofi, Eli Lilly, Abbott and Pfizer, and speaking engagements for Sanofi, Novo Nordisk, Eli Lilly, Merk Sharp & Dohme and Medtronic, and has received research grants from Novo Nordisk, AstraZeneca, Bristol‐Myers Squibb, Eli Lilly, Sanofi, Novartis, Merck Sharp & Dohme, Boehringer Ingelheim, Amgen and OPKO. C.G. has participated in scientific advisory boards and received consulting/speaking fees from AstraZeneca, Bayer AG, Boehringer Ingelheim, Eli Lilly, Merck KGaA, Merck Sharp & Dohme, Novo Nordisk, and Sanofi. J.G. has received research funding from Merck Sharp & Dohme, Sanofi Aventis, Eli Lilly, and Novo Nordisk. P.J. has received consultancy fees from advisory boards for Novo Nordisk, Sanofi, AstraZeneca, Boehringer Ingelheim, Servier, Pfizer, Bayer, Eli Lilly, GlaxoSmithKline and Novartis, and honoraria for speaking from Novo Nordisk, Sanofi, Pfizer, Roche, Boehringer Ingelheim and Servier. R.M. has received speaker fees and advisory board honoraria from Novo Nordisk. J.F.M.‐T. has participated in advisory panels for Merck, AstraZeneca and Novo Nordisk, has received research support from Merck, Novo Nordisk, Abbott, Nutricia and Vegenat, and is on the speakers' bureau for Merck, Novo Nordisk, Sanofi, AstraZeneca and Menarini. M.A.N. is a member of advisory boards or has consulted with AstraZeneca, Boehringer Ingelheim, Eli Lilly & Co., Fractyl, GlaxoSmithKline, Intarcia, Menarini/Berlin Chemie, Merck, Sharp & Dohme and Novo Nordisk, has served on the speakers' bureau of AstraZeneca, Boehringer Ingelheim, Eli Lilly & Co., GlaxoSmithKline, Menarini/Berlin Chemie, Merck, Sharp & Dohme, and Novo Nordisk A/S, and his institution has received grant support from AstraZeneca, Boehringer Ingelheim, Eli Lilly & Co., GlaxoSmithKline, Intarcia, Menarini/Berlin‐Chemie, Merck, Sharp & Dohme, Novartis and Novo Nordisk A/S. S.D.P has received consulting fees and honoraria for speaking from Novo Nordisk, AstraZeneca, Boehringer Ingelheim, Merck, Sanofi, Abbott, Eli Lilly, Valeant and Janssen. R.J.S. has received consultancy fees from Novo Nordisk and is on the Speaker's Bureau for AstraZeneca, Eli Lilly and Novo Nordisk. W.H.‐H.S. has received advisor and/or speaker fees from AstraZeneca, Bayer HealthCare, Boehringer Ingelheim Pharmaceuticals, Daiichi‐Sankyo, Eli Lilly and Company, Merck Sharp & Dohme, Mitsubishi Tanabe Pharma Corporation, Novartis, Novo Nordisk, Pfizer, Sanofi‐Aventis and Takeda Pharmaceutical Company. C.J.T. (or the institute with which he is associated) has received research grants, served as a consultant for, or gave lectures organised by Merck, AstraZeneca and Novo Nordisk. M.H. has received investigator‐initiated research grants on projects related to GLP‐1 biology from AstraZeneca, Merck, Novo Nordisk, has received consulting fees or honoraria from AstraZeneca, Boehringer‐Ingelheim, Eli Lilly, Janssen, Merck, Novo Nordisk and Roche, and is co‐inventor of two provisional patents related to GLP‐1. M.T., M.S. and O.K.J. are employees of Novo Nordisk A/S. P.B., C.D. and N.T. have no competing interests. AUTHOR CONTRIBUTIONS: S.C.B., O.M., R.A., P.B., Ab.C., Ag.C., C.D., K.D., M.C.F., M.E.F., D.R.F., J.G., C.G., P.J., J.F.M.‐T., M.A.N., S.D.P., W.H.‐H.S., R.S., C.J.T., N.T. and M.H. were principal study investigators (S.C.B. and M.H. were signatory investigators) involved in the conduct of the trial, interpreting the data and in writing, critically reviewing and approving the final manuscript. O.K.J. was the trial statistician and was involved in analysing the data and in writing, critically reviewing and approving the final manuscript. M.T. was involved in the design and conduct of the trial, interpreting the data, and in writing, critically reviewing and approving the final manuscript. M.S. was involved in the coordination and conduct of the trial, interpreting the data and in writing, critically reviewing and approving the final manuscript.
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