BridgeMD
SGLT2 inhibition in addition to lifestyle intervention and risk for complications in subtypes of patients with prediabetes - a randomized, placebo controlled, multi-center trial
EU CTIS ID: 2024-512179-11-00
What this study is testing
To test if hyperglycemia in patients with prediabetes can be normalized by a treatment with the sodium-glucose co- transporter-2 (SGLT2) inhibitor dapagliflozin (10mg/day) and lifestyle counselling compared to placebo and lifestyle counselling for six months
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male, female or intersexualpatients aged between 35 and 75 years (including)
- Understand and voluntarily sign an informed consent document prior to any studyrelated 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
- Prediabetes (defined by one of the following: FG ≥ 100 mg/dL or 2h OGTT glucose ≥ 140mg/dL)
- BMI ≥20 kg/m2
- TSH within normal range
You likely can't join if
- Manifest diabetes mellitus
- 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 pyloricstenosis
- 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)
See the full eligibility criteria
Who can join
- Male, female or intersexualpatients aged between 35 and 75 years (including)
- Understand and voluntarily sign an informed consent document prior to any studyrelated 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
- Prediabetes (defined by one of the following: FG ≥ 100 mg/dL or 2h OGTT glucose ≥ 140mg/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 treatmentregimen for at least 3 months prior to the screening visit (V-1)
- 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)
- 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
What rules you out
- Manifest diabetes mellitus
- 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 pyloricstenosis
- 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)
- 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)
- eGFR (as calculated by the CKD-EPI equation) < 60 ml/min/1.73 m2
- 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 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)
- Current participation in other interventional clinical trials or treatment with other IMPswithin five times the half-life of the drug
- Previous therapy with dapagliflozin or other drugs that can potentially lead to overlappingtoxicities 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 whileparticipating in this clinical trial
- all glucose altering medications (including current therapy with dapagliflozin or empagliflozinor any other SGLT2-Inhibitor)
- Patients will not be included in the study if, in the opinion of the investigator, participationleads to an unacceptable risk to their safety and well-being
- Symptomatic chronic congestive heart disease
- New diuretic or antihypertensive medication or dosing changes within the last 2 weeks, foraldosterone antagonists within the last 6 weeks
- known or suspected orthostatic proteinuria
- 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
- history of or current therapy for congestive heart failure (NYHA III and IV), pacemaker oraortic stenosis > II°
- acute pancreatic disease (i.e. elevated lipase 3x ULN)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.