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

RecruitingPhase 2Ages 18 Years - 75 YearsAllMarc Donath
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Diagnosis of type 2, Diabetes mellitus as defined by the criteria of the American Diabetes Association (ADA) Expert Committee on the Diagnosis and Classification of Diabetes Mellitus (see Appendix 1) and recognized by the World Health Organization (WHO, 2019), for at least 3 months prior to the Baseline Visit/Day 1 * HbA1c value of ≥ 7.7% to ≤ 11.0% at the Screening Visit. * High-sensitivity C-reactive protein (hsCRP) ≥ 1.5 mg/L at the Screening Visit. * Body mass index (BMI) ≥25 to ≤ 40 kg/m2 at the Screening Visit * Acceptable overall medical condition to safely participate in the study and complete all study procedures (particularly with regard to cardiovascular, renal, and hepatic conditions), in the opinion of the Investigator Exclusion Criteria: * Diagnosis of type 1 diabetes mellitus * HbA1c value of ≤ 7.5% or ≥ 10.5% at the Baseline Visit/Day 1, as determined at point of care (local laboratory) * Use of thiazolidinediones (glitazones), pramlintide, or short-acting insulin/insulin analogues (as bolus or premixed insulin) within 12 weeks prior to the Screening Visit * Less than 80% compliance in taking investigational medicinal product by pill count during the Run-In Period, as assessed at the Baseline Visit/Day 1 * Significant weight loss (\> 5 kg) in the 12 weeks prior to the Screening Visit * Systolic blood pressure (BP) ≥ 160 mmHg, diastolic BP ≥ 100 mmHg, or resting heart rate (HR) ≥ 100 beats/minute at the Screening Visit * Previous myocardial infarction, any cardiac surgery
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What it tests

  • Dapansutrile
  • Placebo
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Where

6 sites
CHU de Liege
Liège, Belgium
Hopital Lariboisiere
Paris, France
Hopital Bichat
Paris, France
Deutsches Zentrum für Diabetesforschung Düsseldorf
Düsseldorf, Germany
University Hospital Basel
Basel, Switzerland
Kantonsspital Olten
Olten, Switzerland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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