Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dapansutrile

    Drug

    Patients receive investigational product.

  • Placebo

    Drug

    Patients receive placebo.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Intervention GroupExperimental treatment 1 intervention
Group B: Control GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change 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

Secondary outcomes

1

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
2

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Marc Donath

Lead sponsor

Kantonsspital Baden

Sponsor institution

European Union (Horizon Europe Programme)

Collaborator

State Secretariat for Education Research and Innovation, Switzerland

Collaborator

Olatec Therapeutics LLC

Collaborator

Departement Klinische Forschung Universität Basel

Collaborator

CTU Kantonsspital Baden

Collaborator

Source ClinicalTrials.gov
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