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)
Change in HbA1c in blood of patients for dapansutrile compared to placebo — two time assessment at baseline and week 26 Comparison of change in HbA1c for dapansutrile and placebo
Trial sites (6)
Facility
City
Region
Status
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
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.
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