Actively Recruiting
Dapansutrile in Diabetes and Diabetes-Related Complications - Dapan-Dia
Led by Marc Donath · Updated on 2026-02-25
300
Participants Needed
6
Research Sites
211 weeks
Total Duration
On this page
Sponsors
M
Marc Donath
Lead Sponsor
E
European Union (Horizon Europe Programme)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Dapansutrile in Diabetes and Diabetes-Related Complications - Dapan-Dia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of type 2 diabetes mellitus according to ADA and WHO criteria for at least 3 months before the baseline visit
- HbA1c value between 7.7% and 11.0% at screening
- High-sensitivity C-reactive protein (hsCRP) of at least 1.5 mg/L at screening
- Body mass index (BMI) between 25 and 40 kg/m2 at screening
- Overall acceptable medical condition to safely participate, especially regarding cardiovascular, kidney, and liver health, as judged by the investigator
You will not qualify if you...
- Diagnosis of type 1 diabetes mellitus
- HbA1c value of 7.5% or less, or 10.5% or more at baseline
- Use of thiazolidinediones, pramlintide, or short-acting insulin within 12 weeks before screening
- Less than 80% compliance with study medication during run-in period
- Significant weight loss over 5 kg in the 12 weeks before screening
- High blood pressure (systolic ≥160 mmHg or diastolic ≥100 mmHg) or resting heart rate of 100 beats/min or more at screening
- Previous heart attack or any cardiac surgery
AI-Screening
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Trial Site Locations
Total: 6 locations
1
CHU de Liege
Liège, Belgium, 4000
Actively Recruiting
2
Hopital Lariboisiere
Paris, Île-de-France Region, France, 75010
Actively Recruiting
3
Hopital Bichat
Paris, Île-de-France Region, France, 75018
Actively Recruiting
4
Deutsches Zentrum für Diabetesforschung Düsseldorf
Düsseldorf, Nordrhein-Westphalen, Germany, 40225
Actively Recruiting
5
University Hospital Basel
Basel, Basel, Switzerland, 4031
Terminated
6
Kantonsspital Olten
Olten, Canton of Solothurn, Switzerland, 4600
Actively Recruiting
Research Team
M
Marc Y. Donath, Prof.
CONTACT
M
Markus Veit
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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