Diabetes Mellitus, Type 2Phase 2Dapan-DiaNCT06047262
Dapansutrile in Diabetes and Diabetes-Related Complications - Dapan-Dia
A Phase 2 study testing Dapansutrile in people with Diabetes Mellitus, Type 2, run by Marc Donath at 6 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Dapansutrile
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 9 Jul 2024to 31 Jul 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 4 countries
France2 sites, 2 recruiting
- Recruiting
Hopital Lariboisiere
Paris, Île-de-France Region, 75010
Jean-Francois Gautier, Prof. Dr. med. Dr. sci. nat., +33 1 49 95 90 73, jean-francois.gautier@aphp.fr
- Recruiting
Hopital Bichat
Paris, Île-de-France Region, 75018
Louis Potier, ass. Prof., +33 1 40 25 82 42, louis.potier@aphp.fr
Switzerland2 sites, 1 recruiting
- Terminated
University Hospital Basel
Basel, Basel, 4031
- Recruiting
Kantonsspital Olten
Olten, Canton of Solothurn, 4600
Thomas Züger, Prof. Dr. med., +41 62 311 41 11, thomas.zueger@spital.so.ch
Belgium1 site, 1 recruiting
- Recruiting
CHU de Liege
Liège, 4000
Nathalie Esser, ass. Prof., +32 4 323 72 37, nathalie.esser@chuliege.be
Germany1 site, 1 recruiting
- Recruiting
Deutsches Zentrum für Diabetesforschung Düsseldorf
Düsseldorf, Nordrhein-Westphalen, 40225
Michael Roden, Prof. Dr. med., +49 211 3382-0, kontakt@ddz.de
About this study
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
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Dapansutrile, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapansutrileDrug
Also called 3-methanesulfonyl-propionitrile, OLT1177
Patients receive investigational product.
PlaceboDrug
Patients receive placebo.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c in blood of patients for dapansutrile compared to placebo
Comparison of change in HbA1c for dapansutrile and placebo
Measured: two time assessment at baseline and week 26
Secondary outcomes (2)
Change in HbA1c in blood of patients for dapansutrile compared to placebo
Comparison of change in HbA1c for dapansutrile and placebo
Measured: six time assessment at baseline and week 4, 8, 12, 16, 20
Change in fasting plasma glucose for dapansutrile compared to placebo
Comparison of change in fasting plasma glucose for dapansutrile and placebo
Measured: seven time assessement at baseline and week 4, 8, 12, 16, 20, 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start9 Jul 2024
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomised controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marc Donath
- Sponsor type
- University, hospital or other
- Collaborators
- European Union, State Secretariat for Education Research and Innovation, Switzerland, Olatec Therapeutics, Inc., Departement Klinische Forschung Universität Basel, CTU Kantonsspital Baden
- Responsible party
- Sponsor-investigator, Marc Donath, Kantonsspital Baden
- Investigators
- Marc Y. Donath, Prof., Study chair, Kantonsspital Baden, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06047262
- Sponsor's protocol ID
- 2023-01387; kt23Donath
- Other IDs
- 2023
- Acronym
- Dapan-Dia
- Status last verified
- Feb 2026
- First submitted
- 14 Sep 2023
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Donath MY, Drucker DJ. Obesity, diabetes, and inflammation: Pathophysiology and clinical implications. Immunity. 2025 Oct 14;58(10):2373-2382. doi: 10.1016/j.immuni.2025.09.011. Epub 2025 Oct 3.
PubMed 41045922
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06047262
- Acronym / sponsor ID
- Dapan-Dia / 2023-01387; kt23Donath
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Marc DonathUniversity, hospital or other
- Collaborators
- European Union, State Secretariat for Education Research and Innovation, Switzerland, Olatec Therapeutics, Inc., Departement Klinische Forschung Universität Basel, CTU Kantonsspital Baden
- Study start
- 9 Jul 2024 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Drug: Dapansutrile1000 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. |
| Control Group | Placebo comparator | Drug: PlaceboMatching 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DapansutrileAlso: 3-methanesulfonyl-propionitrile, OLT1177Patients receive investigational product. | Drug | Intervention Group |
| PlaceboPatients receive placebo. | Drug | Control Group |
Primary outcome
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
2 secondary outcomes
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Derived from this study: PubMed 41045922Donath MY, Drucker DJ. Obesity, diabetes, and inflammation: Pathophysiology and clinical implications. Immunity. 2025 Oct 14;58(10):2373-2382. doi: 10.1016/j.immuni.2025.09.011. Epub 2025 Oct 3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marc Y. Donath, Prof. study chair
Kantonsspital Baden, Switzerland
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dapansutrile in people with Diabetes Mellitus, Type 2, run by Marc Donath at 6 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France, Switzerland, Belgium, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marc Y. Donath, Prof. (+41 61 265 50 78, marc.donath@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c in blood of patients for dapansutrile compared to placebo (time frame: two time assessment at baseline and week 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06047262, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.