RecruitingPhase 4interventionalRules rewrite

Phase 4: testing Dapagliflozin (Forxiga®) for Type2diabetes

Q: Is NCT06054035 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

Q: What phase is NCT06054035?

Phase 4. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Q: Can PlainTrials tell me if I qualify for NCT06054035?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

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.

Official registry: https://clinicaltrials.gov/study/NCT06054035 · University Hospital Tuebingen · enrollment listed as 170

What this phase means

Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Dapagliflozin (Forxiga®), Placebo matching Dapaglifolzin, or Lifestyle Intervention. The registry lists allocation as randomized. More than 50% of patients with type 2 diabetes develop micro- and/or macrovascular complications during the course of the disease.

They plan to enroll about 170 people at 9 sites. Taking part typically means taking a study drug (or dummy pill), following a program (exercise, therapy, diet, or an app) plus check-ins.

Official title (unrewritten)

SGLT2 Inhibition in Addition to Lifestyle Intervention and Risk for Complications in Subtypes of Patients With Prediabetes - a Randomized, Placebo Controlled, Multi-center Trial

Interventions: Dapagliflozin (Forxiga®), Placebo matching Dapaglifolzin, Lifestyle Intervention

Primary outcome (registry wording): Frequency of remission of hyperglycemia

Who it is for (from inclusion criteria)

Ages 35 Years to 75 Years
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)
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)

Who the registry excludes

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

Public study contact (from the registry)

Andreas Birkenfeld, Prof. Dr.

0049707129

andreas.birkenfeld@med.uni-tuebingen.de

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

9 listed

Charité Universitätsmedizin Berlin, Klinik für Endokrinologie und Stoffwechselmedizin — Berlin, Germany (recruiting)
Universitätsstudienzentrum für Stoffwechselerkrankungen , Medizinische Klinik und Poliklinik III — Dresden, Germany (recruiting)
German Diabetes Center, Leibniz-Center for Diabetes Research at the Heinrich-Heine-University Duesseldorf — Düsseldorf, Germany (recruiting)
Heidelberg University Hospital - Department of Endocrinology and Metabolism — Heidelberg, Germany (recruiting)
Medizinische Klinik und Poliklinik III - Bereich Endokrinologie — Leipzig, Germany (recruiting)
Medizinische Klinik I, UKSH Campus LübeckAG Meyhöfer - Endocrinology, Diabetes & Metabolism — Lübeck, Germany (recruiting)
Diabetes Center Med. Klinik und Poliklinik IV, Klinikum der Universität München, LMU — München, Germany (recruiting)
Institut für Ernährungsmedizin, Technische Universität München — München, Germany (recruiting)
University Hospital Tuebingen, Otfried-Mueller Str. 10 — Tübingen, Germany (recruiting)

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FAQ about this NCT record

Is NCT06054035 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06054035?

Phase 4. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06054035?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary