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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT06047262

Run by

Marc Donath

People needed

300

Starts

2024-07-09

Expected to finish

2028-07-31

Last updated by the study team

2026-02-25

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

• CHU de Liege — Liège, Belgium (enrolling)
• Hopital Lariboisiere — Paris, Île-de-France Region, France (enrolling)
• Hopital Bichat — Paris, Île-de-France Region, France (enrolling)
• Deutsches Zentrum für Diabetesforschung Düsseldorf — Düsseldorf, Nordrhein-Westphalen, Germany (enrolling)
• Kantonsspital Olten — Olten, Canton of Solothurn, Switzerland (enrolling)
• University Hospital Basel — Basel, Basel, Switzerland

Full record on ClinicalTrials.gov

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