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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Dapansutrile; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Marc Y. Donath, Prof.; Phone Number: +41 61 265 50 78; Email: marc.donath@umontreal.ca
• Study Contact Backup: Name: Markus Veit; Phone Number: +41 56 486 25 14; Email: markus.veit@ksb.ch

Study Locations

• Belgium
  • Liège, Belgium, 4000
    • Recruiting
    • CHU de Liege
    • Contact: Nathalie Esser, ass. Prof.; Phone Number: +32 4 323 72 37; Email: nathalie.esser@chuliege.be
• France
  • Île-de-France Region
    • Paris, Île-de-France Region, France, 75010
      • Recruiting
      • Hôpital Lariboisière
      • Contact: Jean-Francois Gautier, Prof. Dr. med. Dr. sci. nat.; Phone Number: +33 1 49 95 90 73; Email: jean-francois.gautier@aphp.fr
    • Paris, Île-de-France Region, France, 75018
      • Recruiting
      • Hôpital Bichat
      • Contact: Louis Potier, ass. Prof.; Phone Number: +33 1 40 25 82 42; Email: louis.potier@aphp.fr
• Germany
  • Nordrhein-Westphalen
    • Düsseldorf, Nordrhein-Westphalen, Germany, 40225
      • Recruiting
      • Deutsches Zentrum für Diabetesforschung Düsseldorf
      • Contact: Michael Roden, Prof. Dr. med.; Phone Number: +49 211 3382-0; Email: kontakt@ddz.de
• Switzerland
  • Basel
    • Basel, Basel, Switzerland, 4031
      • Terminated
      • University Hospital Basel
  • Canton of Solothurn
    • Olten, Canton of Solothurn, Switzerland, 4600
      • Recruiting
      • Kantonsspital Olten
      • Contact: Thomas Züger, Prof. Dr. med.; Phone Number: +41 62 311 41 11; Email: thomas.zueger@spital.so.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; 1000 mg dapansutrile (2 × 500mg tablets) administered twice a day from day 1 through the week 26 visit, inclusive. All tablets will be self-administered by mouth with water, with or without food.	Drug: Dapansutrile; Patients receive investigational product.; Other Names: OLT1177; 3-methanesulfonyl-propionitrile
Placebo Comparator: Control Group; Matching placebo (2 tablets) administered twice a day from day 1 through the Week 26 visit, inclusive. All tablets will be self-administered by mouth with water, with or without food.	Drug: Placebo; Patients receive placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HbA1c in blood of patients for dapansutrile compared to placebo	Comparison of change in HbA1c for dapansutrile and placebo	two time assessment at baseline and week 26

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in fasting plasma glucose for dapansutrile compared to placebo	Comparison of change in fasting plasma glucose for dapansutrile and placebo	seven time assessement at baseline and week 4, 8, 12, 16, 20, 26
Change in HbA1c in blood of patients for dapansutrile compared to placebo	Comparison of change in HbA1c for dapansutrile and placebo	six time assessment at baseline and week 4, 8, 12, 16, 20

Collaborators and Investigators

• Sponsor: Marc Donath
• Collaborators: Olatec Therapeutics LLC; State Secretariat for Education Research and Innovation, Switzerland; European Union (Horizon Europe Programme); Departement Klinische Forschung Universität Basel; CTU Kantonsspital Baden
• Investigators: Study Chair: Marc Y. Donath, Prof., Kantonsspital Baden, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2024
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028

Study Registration Dates

• First Submitted: September 14, 2023
• First Submitted That Met QC Criteria: September 14, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Anti-Inflammatory Agents; dapansutrile
• Other Study ID Numbers: 2023-01387; kt23Donath

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No