Dapansutrile in Diabetes and Diabetes-Related Complications - Dapan-Dia
Recruiting · NCT06047262 · Interventional (participants receive a specific treatment) · Lead sponsor: Marc Donath
View the official record on ClinicalTrials.gov →Interventions studied
DapansutrilePlacebo
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
6 locations listed.
- CHU de Liege - Liège, Belgium
- University Hospital Basel - Basel, Basel, Switzerland
- Kantonsspital Olten - Olten, Canton of Solothurn, Switzerland
- Deutsches Zentrum für Diabetesforschung Düsseldorf - Düsseldorf, Nordrhein-Westphalen, Germany
- Hopital Lariboisiere - Paris, Île-de-France Region, France
- Hopital Bichat - Paris, Île-de-France Region, France