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

ConditionDiabetes Mellitus, Type 2

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-75

SponsorMarc Donath

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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