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New treatment option for Type2diabetes
Official title SGLT2 Inhibition in Addition to Lifestyle Intervention and Risk for Complications in Subtypes of Patients With Prediabetes
ClinicalTrials.gov ID: NCT06054035
What this study is testing
What is Dapagliflozin (Forxiga®)?
Dapagliflozin (Forxiga®) is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for type2diabetes.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 35 to 75
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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 people' safety or well-being
- 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...
- 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 \>...
- 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...
- Current participation in other treatment 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 people' 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
The study team makes the final eligibility decision.
Where it's taking place
- Berlin, Germany
- Dresden, Germany
- Düsseldorf, Germany
- Heidelberg, Germany
- Leipzig, Germany
- Lübeck, Germany
- München, Germany
- Tübingen, Germany
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, 35 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Berlin, Germany; Dresden, Germany; Düsseldorf, Germany; Heidelberg, Germany; Leipzig, Germany; Lübeck, Germany and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.