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Study identifier: NCT06054035 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

SGLT2 Inhibition in Addition to Lifestyle Intervention and Risk for Complications in Subtypes of Patients With Prediabetes

Condition: Type2diabetes · PreDiabetes · Renal Failure  ·  Sponsor: University Hospital Tuebingen

PhasePhase 4
Planned participants170
Who can joinAll sexes, 35 Years to 75 Years
Healthy volunteersNo

About this study

More than 50% of patients with type 2 diabetes develop micro- and/or macrovascular complications during the course of the disease. Additionally, many patients at risk for diabetes develop metabolically driven complications including kidney and heart disease. Thus, it is of utmost importance to improve prevention of T2D and with this complications. Remission of prediabetes, i.e. normalization of hyperglycemia by means of lifestyle intervention is one of the most effective ways to prevent the development of T2D and complications. Novel sub-phenotyping analysis identified clusters of risk for diabetes associated with different complications, opening opportunities to new therapeutic approaches, despite and in addition to lifestyle changes. So far, pharmacological therapy is not indicated for patients with prediabetes. Remission of hyperglycemia associated with prediabetes during lifestyle interventions not only prevents T2D but is also linked with reduced albuminuria and lower microvascular and kidney complications. Thus, reaching normoglycemia (i.e. prediabetes remission) is important for reducing the risk of (pre-)diabetes-associated complications including micro- and even macrovascular disease. In patients with T2D, recent data show that dapagliflozin can improve diabetes remission, and thus, likely complications. However, to date no data have assessed whether or not this is also true in patients with hyperglycemia related to prediabetes which, as outlined above, already cause…

This description comes directly from the study's public registry record.

Talk to the study team

Andreas Birkenfeld, Prof. Dr.  ·  0049707129  ·  andreas.birkenfeld@med.uni-tuebingen.de

Andreas Fritsche, Prof. Dr.  ·  0049707129  ·  andreas.fritsche@med.uni-tuebingen.de

Always discuss trial participation with your own doctor first.

Locations (9)

Charité Universitätsmedizin Berlin, Klinik für Endokrinologie und StoffwechselmedizinBerlin, GermanyRecruiting
Universitätsstudienzentrum für Stoffwechselerkrankungen , Medizinische Klinik und Poliklinik IIIDresden, GermanyRecruiting
German Diabetes Center, Leibniz-Center for Diabetes Research at the Heinrich-Heine-University DuesseldorfDüsseldorf, GermanyRecruiting
Heidelberg University Hospital - Department of Endocrinology and MetabolismHeidelberg, GermanyRecruiting
Medizinische Klinik und Poliklinik III - Bereich EndokrinologieLeipzig, GermanyRecruiting
Medizinische Klinik I, UKSH Campus LübeckAG Meyhöfer - Endocrinology, Diabetes & MetabolismLübeck, GermanyNot Yet Recruiting
Diabetes Center Med. Klinik und Poliklinik IV, Klinikum der Universität München, LMUMünchen, GermanyRecruiting
Institut für Ernährungsmedizin, Technische Universität MünchenMünchen, GermanyNot Yet Recruiting
University Hospital Tuebingen, Otfried-Mueller Str. 10Tübingen, GermanyRecruiting

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Source record: clinicaltrials.gov/study/NCT06054035