Recruiting
Dapansutrile in Diabetes and Diabetes-Related Complications - Dapan-Dia
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.
ClinicalTrials.gov IDNCT06047262
PhasePHASE2
Enrollment300
SponsorMarc Donath
Age18 Years
SexALL
Conditions studied
Diabetes Mellitus, Type 2
About this study
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.
Interventions
- Drug: Dapansutrile — Patients receive investigational product.
- Drug: Placebo — Patients receive placebo.
Primary outcomes
- Change in HbA1c in blood of patients for dapansutrile compared to placebo (two time assessment at baseline and week 26)
Eligibility information
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
Study locations
- CHU de Liege, Liège, 4000 Belgium
- Hopital Lariboisiere, Paris, Île-de-France Region 75010 France
- Hopital Bichat, Paris, Île-de-France Region 75018 France
- Deutsches Zentrum für Diabetesforschung Düsseldorf, Düsseldorf, Nordrhein-Westphalen 40225 Germany
- University Hospital Basel, Basel, Basel 4031 Switzerland
- Kantonsspital Olten, Olten, Canton of Solothurn 4600 Switzerland
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.