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

NCT06047262 | Recruiting Phase 2 DMC

• 1 other identifier: 2023-01387; kt23Donath
• Study Type: interventional
• Target: 300
• Locations: 4 countries
• Sites: 6

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in HbA1c in blood of patients for dapansutrile compared to placebo

  six time assessment at baseline and week 4, 8, 12, 16, 20

• Change in fasting plasma glucose for dapansutrile compared to placebo

  seven time assessement at baseline and week 4, 8, 12, 16, 20, 26

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

PLACEBO COMPARATOR

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

Interventions

Dapansutrile DRUG

Patients receive investigational product.

Also known as: 3-methanesulfonyl-propionitrile, OLT1177

Intervention Group

Placebo DRUG

Patients receive placebo.

Control Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Olatec Therapeutics LLC: collaborator
• Departement Klinische Forschung Universität Basel: collaborator
• Marc Donath: lead
• European Union (Horizon Europe Programme): collaborator
• State Secretariat for Education Research and Innovation, Switzerland: collaborator
• CTU Kantonsspital Baden: collaborator

Study Sites (6)

CHU de Liege

Liège, 4000, Belgium

RECRUITING

Hopital Lariboisiere

Paris, Île-de-France Region, 75010, France

RECRUITING

Hopital Bichat

Paris, Île-de-France Region, 75018, France

RECRUITING

Deutsches Zentrum für Diabetesforschung Düsseldorf

Düsseldorf, Nordrhein-Westphalen, 40225, Germany

RECRUITING

University Hospital Basel

Basel, Basel, 4031, Switzerland

TERMINATED

Kantonsspital Olten

Olten, Canton of Solothurn, 4600, Switzerland

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dapansutrile

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Marc Y. Donath, Prof.

  Kantonsspital Baden, Switzerland

  STUDY CHAIR

Central Study Contacts

Marc Y. Donath, Prof.

CONTACT

+41 61 265 50 78; marc.donath@umontreal.ca

Markus Veit

CONTACT

+41 56 486 25 14; markus.veit@ksb.ch

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med.

Model Details: randomised controlled trial

Study Record Dates

• First Submitted: September 14, 2023
• First Posted: September 21, 2023
• Study Start: July 9, 2024
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: February 25, 2026

Record last verified: 2026-02

Locations

DE (1); BE (1); FR (2); CH (2)