Dapansutrile in Diabetes and Diabetes-Related Complications - Dapan-Dia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dapansutrile, Placebo.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus, Type 2. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium, France, Germany, Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Detailed description
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.
Interventions
- Drug Dapansutrile
Patients receive investigational product. - Drug Placebo
Patients receive placebo.
Primary outcome measures
- Change in HbA1c in blood of patients for dapansutrile compared to placebo [Time frame: two time assessment at baseline and week 26]
Secondary outcome measures (2)
- Change in HbA1c in blood of patients for dapansutrile compared to 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 [Time frame: seven time assessement at baseline and week 4, 8, 12, 16, 20, 26]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
France · 2 centers
- Hopital Lariboisiere — Paris
- Hopital Bichat — Paris
Switzerland · 2 centers
- University Hospital Basel — Basel
- Kantonsspital Olten — Olten
Belgium · 1 center
- CHU de Liege — Liège
Germany · 1 center
- Deutsches Zentrum für Diabetesforschung Düsseldorf — Düsseldorf
Identifiers
NCT: NCT06047262 · 2023-01387; kt23Donath