Testing dapansutrile for type 2 diabetes in adults
Tests dapansutrile, a pill, against placebo in adults with type 2 diabetes.
Plain-language title generated from the registry record
Registry title: Dapansutrile in Diabetes and Diabetes-Related Complications - Dapan-Dia
Key facts
- Where
- Duesseldorf, GermanySee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06047262, who can take part
Where in Germany
- Deutsche Diabetes Forschungsgesellschaft e.V.Duesseldorf, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Marc Donath
- Trial code
- NCT06047262EU 2024-511828-14-00
- Record updated
- 25 February 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Use of thiazolidinediones (glitazones), pramlintide, or short-acting insulin/insulin analogues (as bolus or premixed insulin) within 12 weeks prior to the Screening Visit; Significant weight loss (> 5 kg) in the 12 weeks prior to the Screening Visit; Previous myocardial infarction, any cardiac surgery; Diagnosis of type 1 diabetes mellitus; Systolic blood pressure (BP) ≥ 160 mmHg, diastolic BP ≥ 100 mmHg, or resting heart rate (HR) ≥ 100 beats/minute at the Screening Visit; HbA1c value of ≤ 7.5% or ≥ 10.5% at the Baseline Visit/Day 1, as determined at point of care (local laboratory); 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.