BMJ open diabetes research & care

Study setup and participant details for adults with type 2 diabetes in the weekly injectable semaglutide trial

Updated

Abstract

A total of 1,278 participants were enrolled in the ongoing SEPRA trial to evaluate the effects of once-weekly subcutaneous semaglutide.

  • 54% of participants were male, with an average age of 57.4 years and a body mass index of 35.7 kg/m².
  • The average duration of diabetes among participants was 7.4 years, with a mean glycated hemoglobin (HbA1c) level of 8.5%.
  • Most participants were using additional antidiabetes medications such as metformin and sulfonylureas at baseline.
  • The majority of participants had comorbid conditions, including hypertension and dyslipidemia.
  • The trial design was assessed as highly pragmatic, scoring 4-5 across all evaluated domains.

Simplified

Key numbers

1278
Enrollment Count
Total participants enrolled in the trial
57.4 years
Mean Age
Mean age of participants at baseline
8.5%
Mean HbA1c
Mean HbA1c level at baseline

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Funding

Competing interests

Competing interests: BPS received support for the present manuscript from Novo Nordisk as a full-time employee. Holds stock or stock options for Novo Nordisk as an employee and Bristol Myers Squibb as a former employee. JBB received support for the present manuscript from Novo Nordisk, funded the study, writing support, and fees to my institution. Received grants from NIH, Dexcom, NovaTarg, Novo Nordisk, Sanofi, Tolerion, and vTv Therapeutics for clinical trials. Consulting fees (personal) from Alkahest, Altimmune, Anji, AstraZeneca, Bayer, Biomea Fusion, Boehringer-Ingelheim, CeQur, Cirius Therapeutics, Dasman Diabetes Center (Kuwait), Eli Lilly, Fortress Biotech, GentiBio, Glycadia, Glyscend, Janssen, MannKind, Mediflix, Medscape, Mellitus Health, Moderna, Pendulum Therapeutics, Praetego, ReachMD, Sanofi, Stability Health, Valo, Zealand Pharma. Consulting fees (funds to institution) from Novo Nordisk. Support for attending meetings and/or travel from AstraZeneca, Boehringer-Ingelheim, Dasman Diabetes Institute, Eli Lilly, Novo Nordisk, Zealand in the context of consulting. Participation on a data safety monitoring board or advisory board from Alkahest, Altimmune, Anji, AstraZeneca, Bayer, Biomea Fusion, Boehringer Ingelheim, CeQur, Cirius Therapeutics, Eli Lilly, GentiBio, Glycadia, Glyscend, Janssen, MannKind, Mellitus Health, Moderna, Pendulum Therapeutics, Praetego, Sanofi, Stability Health, Valo, Zealand Pharma. Leadership or fiduciary role in other board, society, committee, or advocacy group, paid or unpaid from Association for Clinical and Translational Science. Holds stock or stock options for Glyscend, Mellitus Health, Pendulum Therapeutics, PhaseBio, Praetego, and Stability Health. Is a member of the Editorial Board of BMJ Open Diabetes Research & Care. MJC received support for the present manuscript from HealthCore. Employer HealthCore received funding from Novo Nordisk to perform the study services. Holds stock or stock options for Elevance Health as a stockholder in ELV, which is the parent company of HealthCore. EWZ received medical writing support from Spirit Medical Communications. Support for attending meetings and/or travel from Novo Nordisk as an employee. Other financial or non-financial interests from Novo Nordisk as an employee. BJH received support for the present manuscript from Novo Nordisk, as sponsor of the SEPRA trial, contracted with employer, HealthCore, to serve as the data coordinating center for the trial, performing all data collection and analysis, and supporting manuscript writing activities. HNC received support for the present manuscript from Novo Nordisk as an employee. Holds stock or stock options for Novo Nordisk. VW received support for the present manuscript from HealthCore. Employer HealthCore received funding from Novo Nordisk to perform the study services. Holds stock or stock options for Elevance Health as a stockholder in ELV, which is the parent company of HealthCore.
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