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Clinical Trials in Germany / NCT06047262
Recruiting Phase 2

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

NCT06047262 · tracked via the Priya Life Science Germany tracker
Sponsor
Marc Donath
Phase
Phase 2
Started
2024-07-09
Last updated
2026-02-25

Condition(s) studied

Diabetes Mellitus, Type 2

Investigational drug(s) / intervention(s)

Dapansutrile →Placebo

Dapansutrile: Patients receive investigational product.

Placebo: Patients receive placebo.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (6)

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

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06047262 on ClinicalTrials.gov ↗ ← All trials in Germany