Status:
RECRUITING
Dapansutrile in Diabetes and Diabetes-Related Complications - Dapan-Dia
Lead Sponsor:
University Hospital, Basel, Switzerland
Collaborating Sponsors:
European Union (Horizon Europe Programme)
State Secretariat for Education Research and Innovation, Switzerland
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 add...
Detailed Description
To date, no other oral NLRP3 inhibitor has sufficiently advanced in development to be tested in a chronic low-grade inflammatory disease such as type 2 diabetes mellitus over a period of 3 to 4 months...
Eligibility Criteria
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) ≥18 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
- 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
Key Trial Info
Start Date :
July 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06047262
Start Date
July 9 2024
End Date
July 31 2026
Last Update
August 14 2024
Active Locations (1)
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1
University Hospital Basel
Basel, Switzerland, 4031