Using dapansutrile to manage type 2 diabetes and its complications

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of dapansutrile, an oral NLRP3 inhibitor, in managing type 2 diabetes and its related complications. The trial will investigate whether dapansutrile can reduce chronic low-grade inflammation associated with diabetes, potentially improving patient outcomes over a 3 to 4 month period. Participants will be monitored for changes in their diabetes management and related cardiovascular risks. The study is unique as it is one of the first to explore this specific pharmacological approach in a chronic inflammatory disease like type 2 diabetes.

Why it matters

Who can join: the full rules

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's running

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

Study contacts

• Study coordinator: Marc Y. Donath, Prof.
• Email: marc.donath@umontreal.ca
• Phone: +41 61 265 50 78

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.