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A registry-based ra...
A registry-based randomised trial comparing an SGLT2 inhibitor and metformin as standard treatment of early stage type 2 diabetes (SMARTEST): Rationale, design and protocol
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- Sundström, Johan, Professor, 1971- (författare)
- Uppsala University,Uppsala universitet,Klinisk epidemiologi,Univ New South Wales, George Inst Global Hlth, Sydney, NSW, Australia.
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- Kristofi, Robin (författare)
- Uppsala University,Uppsala universitet,Klinisk diabetologi och metabolism
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- Jansson, Stefan P. O., 1959- (författare)
- Örebro University,Uppsala University,Uppsala universitet,Örebro universitet,Institutionen för medicinska vetenskaper,Region Örebro län,Institution of Medical Sciences, University Health Care Research Center, Örebro University, Örebro, Sweden; Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden,Uppsala kliniska forskningscentrum (UCR),Allmänmedicin och preventivmedicin,Örebro Univ, Univ Hlth Care Res Ctr, Inst Med Sci, Örebro, Sweden.
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- Bennet, Louise (författare)
- Lund University,Lunds universitet,Allmänmedicin och samhällsmedicin,Forskargrupper vid Lunds universitet,Family Medicine and Community Medicine,Lund University Research Groups
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- Eliasson, Björn, 1959 (författare)
- University of Gothenburg,Gothenburg University,Göteborgs universitet,Institutionen för medicin,Institute of Medicine,Institute of Medicine, University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden,Univ Gothenburg, Sahlgrenska Univ Hosp, Inst Med, Gothenburg, Sweden.
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Jansson, S. (författare)
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- Leksell, Janeth, 1955- (författare)
- Uppsala University,Uppsala universitet,Klinisk diabetologi och metabolism
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- Almby, Kristina E. (författare)
- Uppsala University,Uppsala universitet,Klinisk diabetologi och metabolism
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- Lundqvist, Martin H. (författare)
- Uppsala University,Uppsala universitet,Klinisk diabetologi och metabolism
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- Eriksson, Jan (författare)
- Uppsala University,Uppsala universitet,Klinisk diabetologi och metabolism
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SMARTEST study group, - (bidragsgivare)
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(creator_code:org_t)
- Elsevier BV, 2021
- 2021
- Engelska.
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Ingår i: Journal of Diabetes and Its Complications. - : Elsevier BV. - 1056-8727 .- 1873-460X. ; 35:10
- Relaterad länk:
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https://doi.org/10.1...
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https://doi.org/10.1...
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https://uu.diva-port... (primary) (Raw object)
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http://dx.doi.org/10... (free)
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https://gup.ub.gu.se...
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https://doi.org/10.1...
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https://urn.kb.se/re...
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https://urn.kb.se/re...
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https://lup.lub.lu.s...
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Abstract
Ämnesord
Stäng
- Aim: SGLT2 inhibitors have been shown to reduce cardiovascular and renal complications in type 2 diabetes (T2D) patients at high cardiovascular risk. Metformin is currently widely used as initial monotherapy in T2D but lacks convincing data to show that it reduces risk of complications. We aim to compare the SGLT2 inhibitor dapagliflozin and metformin as first-line T2D medication with regard to development of complications in a registry-based randomised controlled trial. Methods: The SGLT2 inhibitor or metformin as standard treatment of early stage type 2 diabetes (SMARTEST) trial will enrol 4300 subjects at 30-40 study sites in Sweden who will be randomised 1:1 to either metformin or dapagliflozin. Participants must have T2D duration <4 years, no prior cardiovascular disease, and be either drug-naive or on monotherapy for T2D. Results: The primary endpoint is a composite of all-cause death, major adverse cardiovascular events and occurrence or progression of microvascular complications (retinopathy, nephropathy, diabetic foot lesions). Secondary endpoints include individual components of the primary endpoint, start of insulin therapy, risk factor biomarkers, patient-reported outcome measures, and cost-effectiveness analysis. Outcomes will primarily be assessed using nationwide healthcare registries. Conclusions: The SMARTEST trial will investigate whether dapagliflozin is superior to metformin in preventing complications in early stage T2D. (Clinicaltrials.gov identifier NCT03982381, EudraCT 2019-001046-17).
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Endokrinologi och diabetes (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Endocrinology and Diabetes (hsv//eng)
Nyckelord
- Type 2 diabetes
- Metformin
- SGLT2 inhibitors
- Diabetes complications
- Registry-based randomised controlled trials
- glucose-lowering drugs
- mortality
- empagliflozin
- retinopathy
- outcomes
- disease
- events
- Endocrinology & Metabolism
- Diabetes complications
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
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Till lärosätets databas
- Av författaren/redakt...
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Sundström, Johan ...
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Kristofi, Robin
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Jansson, Stefan ...
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Bennet, Louise
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Eliasson, Björn, ...
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Jansson, S.
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Leksell, Janeth, ...
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Almby, Kristina ...
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Lundqvist, Marti ...
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Eriksson, Jan
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SMARTEST study g ...
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- Av lärosätet
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Göteborgs universitet
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Örebro universitet
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Uppsala universitet
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Lunds universitet