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

PHASE4RecruitingINTERVENTIONAL
Enrollment

170

Participants

Timeline

Start Date

October 26, 2023

Primary Completion Date

June 30, 2027

Study Completion Date

September 30, 2027

Conditions
Type2diabetesPreDiabetesRenal Failure
Interventions
DRUG

Dapagliflozin (Forxiga®)

Dapagliflozin 10 mg once daily for 6 months. Route of administration: oral.

DRUG

Placebo matching Dapaglifolzin

Placebo matching Dapaglifolzin once daily for 6 months. Route of administration: oral.

BEHAVIORAL

Lifestyle Intervention

Patients receive a conventional lifestyle intervention (one in depth individual session at the beginning and standard care information on a healthy lifestyle at every visit thereafter).

Trial Locations (9)

23562

NOT_YET_RECRUITING

Medizinische Klinik I, UKSH Campus LübeckAG Meyhöfer - Endocrinology, Diabetes & Metabolism, Lübeck

40225

RECRUITING

German Diabetes Center, Leibniz-Center for Diabetes Research at the Heinrich-Heine-University Duesseldorf, Düsseldorf

69120

RECRUITING

Heidelberg University Hospital - Department of Endocrinology and Metabolism, Heidelberg

72076

RECRUITING

University Hospital Tuebingen, Otfried-Mueller Str. 10, Tübingen

Unknown

RECRUITING

Charité Universitätsmedizin Berlin, Klinik für Endokrinologie und Stoffwechselmedizin, Berlin

RECRUITING

Universitätsstudienzentrum für Stoffwechselerkrankungen , Medizinische Klinik und Poliklinik III, Dresden

RECRUITING

Medizinische Klinik und Poliklinik III - Bereich Endokrinologie, Leipzig

RECRUITING

Diabetes Center Med. Klinik und Poliklinik IV, Klinikum der Universität München, LMU, München

NOT_YET_RECRUITING

Institut für Ernährungsmedizin, Technische Universität München, München

All Listed Sponsors
collaborator

German Federal Ministry of Education and Research

OTHER_GOV

collaborator

German Center for Diabetes Research

OTHER

collaborator

AstraZeneca

INDUSTRY

lead

University Hospital Tuebingen

OTHER