<scp>SGLT2</scp> inhibitor or metformin as standard treatment in early‐stage type 2 diabetes? Baseline data in <scp>SMARTEST</scp> , a novel, decentralised, register‐based randomised trial on prevention of diabetic complications
This decentralised RRCT in newly onset T2D demonstrates a highly feasible option for large-scale trials in the primary care setting, enabling representative participant recruitment. Blinded interim analyses showed a low risk of MACE or death, but unexpectedly high rates of microvascular complications. Study completion is event-driven and is expected by January 2026. The study will challenge or reinforce the current metformin paradigm in early T2D. (EUDRA-CT number 2019-001046-17; EU number 2024-516228-33-00; ClinicalTrials.gov Identifier: NCT03982381).
Authors
- Stefan Jansson (ORCID: https://orcid.org/0000-0001-6864-4679)
- Vagia Patsoukaki
- Anna Norhammar (ORCID: https://orcid.org/0000-0002-4467-0132)
- Jan W. Eriksson (ORCID: https://orcid.org/0000-0002-2639-9481)
- Annette Nilsson
- Sheyda Sofizadeh (ORCID: https://orcid.org/0000-0003-3701-5065)
- Louise Bennet (ORCID: https://orcid.org/0000-0001-7101-1290)
- M. Lundqvist (ORCID: https://orcid.org/0000-0001-9348-4603)
- Björn Eliasson (ORCID: https://orcid.org/0000-0003-2569-4160)
- Elisabet Granstam (ORCID: https://orcid.org/0000-0003-3164-547X)
- Giovanni Fanni (ORCID: https://orcid.org/0000-0002-7920-8909)
- Daniel Lindholm (ORCID: https://orcid.org/0000-0003-3526-0614)
- Johan Sundström (ORCID: https://orcid.org/0000-0003-2247-8454)
- Olov Rolandsson (ORCID: https://orcid.org/0000-0002-1341-6828)
- Karin Rådholm (ORCID: https://orcid.org/0000-0003-3120-0913)
Institutions
- Linköping University (SE)
- Uppsala University (SE)
- Uppsala University Hospital (SE)
- Lund University (SE)
- Örebro University (SE)
- Karolinska Institutet (SE)
- Department of Medical Sciences (RU)
- Uddevalla sjukhus (SE)
- Södertälje Sjukhus (SE)
- Primary Health Care (QA)
- University of Gothenburg (SE)
- Umeå University (SE)
Publication Details
- Journal
- Diabetes Obesity and Metabolism
- Published
- 2025-11-28
- DOI
- https://doi.org/10.1111/dom.70320
- Citations
- 1
- Primary Topic
- Diabetes Treatment and Management
- Type
- article
- Field-Weighted Citation Impact
- 1.29