Dapagliflozin for Prediabetes

Inclusion criteria

• {"criterion_text":"- Male, female or intersexualpatients aged between 35 and 75 years (including)"}
• {"criterion_text":"- Understand and voluntarily sign an informed consent document prior to any studyrelated assessments/procedures."}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Prediabetes (defined by one of the following: FG ≥ 100 mg/dL or 2h OGTT glucose ≥ 140mg/dL)"}
• {"criterion_text":"- BMI ≥20 kg/m2"}
• {"criterion_text":"- TSH within normal range"}
• {"criterion_text":"- Ability to understand and follow study-related instructions"}
• {"criterion_text":"- Negative pregnancy test for premenopausal women (blood)"}
• {"criterion_text":"- Patients who are receiving thyroid replacement therapy must be on a stable treatmentregimen for at least 3 months prior to the screening visit (V-1)"}
• {"criterion_text":"- Patients who are receiving antihypertensive medication such as mineralocorticoidreceptor antagonists must be on a stable treatment regimen for at least 6 weeks prior tothe screening visit (V-1)"}
• {"criterion_text":"- Patients who are treated antihypertensive medication such as ACE inhibitors and AT1receptor antagonists, thiazides as well as loop diuretics must be on stable treatment forat least 2 weeks"}

Exclusion criteria

• {"criterion_text":"- Manifest diabetes mellitus"}
• {"criterion_text":"- rapidly progressing renal disease or anuria"}
• {"criterion_text":"- known HIV infection or positive HIV test at screening"}
• {"criterion_text":"- history of or planned organ transplantation"}
• {"criterion_text":"- history or presence of inflammatory bowel disease or other severe gastrointestinal diseases,particularly those which may impact gastric emptying, such as gastroparesis or pyloricstenosis"}
• {"criterion_text":"- relevant hepatic disease, including, but not limited to, acute hepatitis, chronic activehepatitis, or severe hepatic insufficiency, including patients with alanine aminotransferaseand/or aspartate aminotransferase > 3 x upper limit of normal and/or total bilirubin (TB) > 2mg/dL (> 34.2 μmol/L) (patients with TB > 2 mg/dL [> 34.2 μmol/L] and documented Gilbert’ssyndrome will be allowed to participate)"}
• {"criterion_text":"- treatment with glucocorticoids"}
• {"criterion_text":"- antibiotic treatment within the last 4 weeks"}
• {"criterion_text":"- History of ketoacidosis"}
• {"criterion_text":"- history of repeated urogenital infection"}
• {"criterion_text":"- hemoglobinopathies, haemolytic anaemia, or chronic anaemia (haemoglobin concentration <12.0 g/dL)"}
• {"criterion_text":"- eGFR (as calculated by the CKD-EPI equation) < 60 ml/min/1.73 m2"}
• {"criterion_text":"- presence of psychiatric disorder or new intake of antidepressant or antipsychotic agents(start within last 3 months)"}
• {"criterion_text":"- Positive Screening for a severe depression (BDI ≥29)"}
• {"criterion_text":"- history of hypersensitivity to the study drug or its ingredients"}
• {"criterion_text":"- more than 5% weight loss in the last 3 months"}
• {"criterion_text":"- Pregnant or breastfeeding women"}
• {"criterion_text":"- Subject (male, female or intersexual) is not willing to use highly effective contraceptivemethods during treatment and for 14 days (male or female) after the end of treatment(highly effective methods are defined as: combined hormonal contraception associated withinhibition of ovulation, progestogen-only hormonal contraception associated with inhibitionof ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubalocclusion, vasectomized partner, sexual abstinence)"}
• {"criterion_text":"- Current participation in other interventional clinical trials or treatment with other IMPswithin five times the half-life of the drug"}
• {"criterion_text":"- Previous therapy with dapagliflozin or other drugs that can potentially lead to overlappingtoxicities within five times the half-life of the drug"}
• {"criterion_text":"- Patients who do not want to be informed about accidental findings"}
• {"criterion_text":"- Any other clinical condition that would jeopardize subjects’ safety or well-being whileparticipating in this clinical trial"}
• {"criterion_text":"- all glucose altering medications (including current therapy with dapagliflozin or empagliflozinor any other SGLT2-Inhibitor)"}
• {"criterion_text":"- Symptomatic chronic congestive heart disease"}
• {"criterion_text":"- New diuretic or antihypertensive medication or dosing changes within the last 2 weeks, foraldosterone antagonists within the last 6 weeks"}
• {"criterion_text":"- known or suspected orthostatic proteinuria"}
• {"criterion_text":"- any acute severe or chronic severe illness, including the following: malignant disease ongoingor < 5 years ago, unstable cardiovascular disease or procedure within 3 months prior toenrolment or expected to require coronary revascularisation procedure"}
• {"criterion_text":"- history of or current therapy for congestive heart failure (NYHA III and IV), pacemaker oraortic stenosis > II°"}
• {"criterion_text":"- acute pancreatic disease (i.e. elevated lipase 3x ULN)"}

Primary endpoints

• {"endpoint_text":"- Frequency of remission of hyperglycemia in patients in highand low risk for CKD with prediabetes at EoT in thedapagliflozin versus the placebo group defined as a fastingglucose <100 mg/dl and 2 h glucose <140 mg/dl (Objective1)","definition_or_measurement_approach":"Defined as a fasting glucose <100 mg/dl and 2 h glucose <140 mg/dl at End of Treatment (EoT); comparison between dapagliflozin and placebo in high and low risk for CKD groups."}

Germany

Earliest CTIS Part Ii Submission Date

01-03-2024

Latest Decision Or Authorization Date

13-05-2026

Processing Time Days

804

Number Of Sites

9

Number Of Participants

182

Primary sponsor

Full Name

Universitaetsklinikum Tuebingen AöR

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Germany