Status:
RECRUITING
SGLT2 Inhibition in Addition to Lifestyle Intervention and Risk for Complications in Subtypes of Patients With Prediabetes
Lead Sponsor:
University Hospital Tuebingen
Collaborating Sponsors:
German Federal Ministry of Education and Research
German Center for Diabetes Research
Conditions:
Type2diabetes
PreDiabetes
Eligibility:
All Genders
35-75 years
Phase:
PHASE4
Brief Summary
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 metabolicall...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Male, female or intersexualpatients aged between 35 and 75 years (including)
- Prediabetes (defined by one of the following: FG ≥ 100 mg/dL or 2h OGTT glucose ≥ 140 mg/dL)
- BMI ≥20 kg/m2
- TSH within normal range
- Ability to understand and follow study-related instructions
- Negative pregnancy test for premenopausal women (blood)
- Patients who are receiving thyroid replacement therapy must be on a stable treatment regimen for at least 3 months prior to the screening visit (V-1)
- Patients who are receiving antihypertensive medication such as mineralocorticoid receptor antagonists must be on a stable treatment regimen for at least 6 weeks prior to the screening visit (V-1)
- Patients who are treated antihypertensive medication such as ACE inhibitors and AT1receptor antagonists, thiazides as well as loop diuretics must be on stable treatment for at least 2 weeks
- Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures.
- Patients will not be included in the study if, in the opinion of the investigator participation will lead to an unacceptable risk to the subjects' safety or well-being
- Exclusion Criteria
- Manifest diabetes mellitus
- eGFR (as calculated by the CKD-EPI equation) \< 60 ml/min/1.73 m2
- all glucose altering medications (including current therapy with dapagliflozin or empagliflozin or any other SGLT2-Inhibitor)
- Symptomatic chronic congestive heart disease
- New diuretic or antihypertensive medication or dosing changes within the last 2 weeks, for aldosterone antagonists within the last 6 weeks
- known or suspected orthostatic proteinuria
- any acute severe or chronic severe illness, including the following: malignant disease ongoing or \< 5 years ago, unstable cardiovascular disease or procedure within 3 months prior to enrolment or expected to require coronary revascularisation procedure
- history of or current therapy for congestive heart failure (NYHA III and IV), pacemaker or aortic stenosis \> II°
- acute pancreatic disease (i.e. elevated lipase 3x ULN)
- rapidly progressing renal disease or anuria
- known HIV infection or positive HIV test at screening
- history of or planned organ transplantation
- history or presence of inflammatory bowel disease or other severe gastrointestinal diseases, particularly those which may impact gastric emptying, such as gastroparesis or pyloric stenosis
- relevant hepatic disease, including, but not limited to, acute hepatitis, chronic active hepatitis, or severe hepatic insufficiency, including patients with alanine aminotransferase and/or aspartate aminotransferase \> 3 x upper limit of normal and/or total bilirubin (TB) \> 2 mg/dL (\> 34.2 μmol/L) (patients with TB \> 2 mg/dL \[\> 34.2 μmol/L\] and documented Gilbert's syndrome will be allowed to participate).
- treatment with glucocorticoids
- antibiotic treatment within the last 4 weeks
- History of ketoacidosis
- history of repeated urogenital infection
- hemoglobinopathies, haemolytic anaemia, or chronic anaemia (haemoglobin concentration \<12.0 g/dL)
- presence of psychiatric disorder or new intake of antidepressant or antipsychotic agents(start within last 3 months)
- Positive Screening for a severe depression (BDI ≥29)
- history of hypersensitivity to the study drug or its ingredients
- more than 5% weight loss in the last 3 months
- Pregnant or breastfeeding women
- Subject (male, female or intersexual) is not willing to use highly effective contraceptive methods during treatment and for 14 days (male or female) after the end of treatment (highly effective methods are defined as: combined hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner, sexual abstinence).
- Vasectomized partner is a highly effective birth control method provided that partner is the sole sexual partner of the trial participant and that the vasectomized partner has received medical assessment of the surgical success.
- Current participation in other interventional clinical trials or treatment with other IMPs within five times the half-life of the drug
- Previous therapy with dapagliflozin or other drugs that can potentially lead to overlapping toxicities within five times the half-life of the drug
- Patients who do not want to be informed about accidental findings
- Any other clinical condition that would jeopardize subjects' safety or well-being while participating in this clinical trial
- Patients will not be included in the study if, in the opinion of the investigator, participation leads to an unacceptable risk to their safety and well-being
Exclusion
Key Trial Info
Start Date :
October 26 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT06054035
Start Date
October 26 2023
End Date
September 30 2027
Last Update
July 24 2025
Active Locations (9)
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1
Charité Universitätsmedizin Berlin, Klinik für Endokrinologie und Stoffwechselmedizin
Berlin, Germany
2
Universitätsstudienzentrum für Stoffwechselerkrankungen , Medizinische Klinik und Poliklinik III
Dresden, Germany
3
German Diabetes Center, Leibniz-Center for Diabetes Research at the Heinrich-Heine-University Duesseldorf
Düsseldorf, Germany, 40225
4
Heidelberg University Hospital - Department of Endocrinology and Metabolism
Heidelberg, Germany, 69120