RecruitingPhase 2NCT06047262

Dapansutrile in Diabetes and Diabetes-Related Complications - Dapan-Dia

A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of the Oral NLRP3 Inhibitor Dapansutrile in Subjects With Type 2 Diabetes Mellitus


Sponsor

Marc Donath

Enrollment

300 participants

Start Date

Jul 9, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The aim of the study is to determine whether NLRP3 inhibition with dapansutrile represents a new pharmacological option for diabetes management with potential as an anti-inflammatory agent to also address micro- and macro-vascular risk and complications from diabetes.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests dapansutrile — a drug that blocks a specific inflammation-causing protein (called NLRP3) — in people with type 2 diabetes who have high levels of inflammation. The hope is that reducing this specific kind of inflammation may improve blood sugar control and reduce diabetes complications. **You may be eligible if...** - You are 18 or older with a type 2 diabetes diagnosis for at least 3 months - Your HbA1c is between 7.7% and 11.0% - Your blood inflammation marker (hsCRP) is elevated (≥1.5 mg/L) - Your BMI is between 25 and 40 kg/m² - Your heart, kidney, and liver are in acceptable condition **You may NOT be eligible if...** - You have type 1 diabetes or other types of diabetes - You have had a recent heart attack or stroke - You have severe kidney or liver disease - You are currently using immunosuppressive medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDapansutrile

Patients receive investigational product.

DRUGPlacebo

Patients receive placebo.


Locations(6)

CHU de Liege

Liège, Belgium

Hopital Lariboisiere

Paris, Île-de-France Region, France

Hopital Bichat

Paris, Île-de-France Region, France

Deutsches Zentrum für Diabetesforschung Düsseldorf

Düsseldorf, Nordrhein-Westphalen, Germany

University Hospital Basel

Basel, Basel, Switzerland

Kantonsspital Olten

Olten, Canton of Solothurn, Switzerland

View Full Details on ClinicalTrials.gov

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NCT06047262


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