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.
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 as proposed in this trial. Based on the publicly available information, dapansutrile is the most advanced oral NLRP3 inhibitor in development. The rationale is built upon dapansutrile's clinical and extensive preclinical and safety findings, and from data in chronic animal toxicology studies to date, which together enable and support its investigation in select chronic low-grade inflammatory diseases. Therefore, the investigators have selected type 2 diabetes mellitus and its complications, including risk for cardiovascular disease, as a disease with clinical features of low-grade inflammation to further investigate the therapeutic potential of NLRP3 inhibition with dapansutrile.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
300
Patients receive investigational product.
Patients receive placebo.
University Hospital Basel
Basel, Switzerland
RECRUITINGChange in HbA1c in blood of patients for dapansutrile compared to placebo
Comparison of change in HbA1c for dapansutrile and placebo
Time frame: two time assessment at baseline and week 26
Change in HbA1c in blood of patients for dapansutrile compared to placebo
Comparison of change in HbA1c for dapansutrile and placebo
Time frame: six time assessment at baseline and week 4, 8, 12, 16, 20
Change in fasting plasma glucose for dapansutrile compared to placebo
Comparison of change in fasting plasma glucose for dapansutrile and placebo
Time frame: seven time assessement at baseline and week 4, 8, 12, 16, 20, 26
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