Using dapansutrile to manage type 2 diabetes and its complications

A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of the Oral NLRP3 Inhibitor Dapansutrile in Subjects With Type 2 Diabetes Mellitus

This study is testing if a new pill called dapansutrile can help people with type 2 diabetes manage their condition and reduce related health problems.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Kantonsspital Baden (Academic / other)
• Locations: 6 sites (Liège and 5 other locations)
• Trial ID: NCT06047262 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with type 2 diabetes for at least 3 months, with specific HbA1c and hsCRP levels.

Not a fit: Patients with type 1 diabetes or those whose HbA1c levels fall outside the specified range may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new option for managing type 2 diabetes and reducing its complications.

How similar studies have performed: While this approach is novel, it builds on existing preclinical and safety findings, suggesting potential for success.

Eligibility criteria

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 this trial is running

Liège and 5 other locations

• 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)
• University Hospital Basel — Basel, Basel, Switzerland (Terminated)
• Kantonsspital Olten — Olten, Canton of Solothurn, Switzerland (Recruiting)

Study contacts

• Study coordinator: Marc Y. Donath, Prof.

Conditions Diabetes Mellitus, Type 2