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

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ClinicalTrials.gov Identifier: NCT06047262
Recruitment Status : Not yet recruiting
First Posted : September 21, 2023
Last Update Posted : April 24, 2024
Sponsor:
Collaborators:
European Union (Horizon Europe Programme)
State Secretariat for Education Research and Innovation, Switzerland
Olatec Therapeutics LLC
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Dapansutrile Drug: Placebo Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomised controlled trial
Masking: Double (Participant, Investigator)
Masking Description: double-blind
Primary Purpose: Treatment
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
Estimated Study Start Date : May 2024
Estimated Primary Completion Date : June 2026
Estimated Study Completion Date : June 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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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:
  • 3-methanesulfonyl-propionitrile
  • OLT1177
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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in HbA1c in blood of patients for dapansutrile compared to placebo [ Time Frame: two time assessment at baseline and week 26 ]
    Comparison of change in HbA1c for dapansutrile and placebo


Secondary Outcome Measures :
  1. 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 ]
    Comparison of change in HbA1c for dapansutrile and placebo

  2. 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 ]
    Comparison of change in fasting plasma glucose for dapansutrile and placebo


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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) ≥18 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06047262


Contacts
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Contact: Marc Y. Donath, Prof. +41 61 265 50 78 Marc.Donath@usb.ch
Contact: Matthias Hepprich, Dr. +41 61 265 50 78 matthias.hepprich@usb.ch

Locations
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Switzerland
University Hospital Basel
Basel, Switzerland, 4031
Contact: Marc Y. Donath, Prof.    +41 61 265 5078    marc.donath@usb.ch   
Contact: Matthias Hepprich, Dr.    +41 61 265 50 78    matthias.hepprich@usb.ch   
Principal Investigator: Marc Y. Donath, Prof.         
Sponsors and Collaborators
University Hospital, Basel, Switzerland
European Union (Horizon Europe Programme)
State Secretariat for Education Research and Innovation, Switzerland
Olatec Therapeutics LLC
Investigators
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Principal Investigator: Marc Y. Donath, Prof. University Hospital, Basel, Switzerland
More Information
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT06047262    
Other Study ID Numbers: 2023-01387; kt23Donath
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: April 24, 2024
Last Verified: April 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Dapansutrile
Anti-Inflammatory Agents