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

Diabetes Mellitus, Type 2 Clinical Trial

— Dapan-Dia  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06047262
• Other study ID #: 2023-01387; kt23Donath
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 2024
• Est. completion date: June 2026

Study information

• Verified date: April 2024
• Source: University Hospital, Basel, Switzerland
• Contact: Marc Y. Donath, Prof.
• Phone: +41 61 265 50 78
• Email: Marc.Donath[@]usb.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Dapansutrile
Patients receive investigational product.
• Placebo
Patients receive placebo.

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	European Union (Horizon Europe Programme), Olatec Therapeutics LLC, State Secretariat for Education Research and Innovation, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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