RecruitingPhase 2NCT06047262

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

A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of the Oral NLRP3 Inhibitor Dapansutrile in Subjects With Type 2 Diabetes Mellitus

Sponsor

Marc Donath

Enrollment

300 participants

Start Date

Jul 9, 2024

Study Type

INTERVENTIONAL

Conditions

Diabetes Mellitus, Type 2

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 address micro- and macro-vascular risk and complications from diabetes.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria5

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 Criteria7

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