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Could an Anti-Inflammatory pill help control diabetes?

NCT ID NCT06047262

Disease control Sponsor: Marc Donath Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 2 trial tests dapansutrile, an oral drug that reduces inflammation, in 300 adults with type 2 diabetes. The goal is to see if it improves blood sugar control and lowers the risk of diabetes-related complications. Participants are randomly assigned to receive either the drug or a placebo for comparison.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dapansutrile (an oral anti-inflammatory drug)
What this could lead to
If successful, this could offer a new way to manage type 2 diabetes by reducing inflammation, potentially lowering blood sugar and risk of complications.
What could go wrong
This is an early Phase 2 trial with 300 people, so results are not yet proven. The drug may not improve blood sugar control or could have side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes mellitus type 2

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHU de Liege

    RECRUITING

    Liège, 4000, Belgium

  • Deutsches Zentrum für Diabetesforschung Düsseldorf

    RECRUITING

    Düsseldorf, Nordrhein-Westphalen, 40225, Germany

  • Hopital Bichat

    RECRUITING

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

  • Hopital Lariboisiere

    RECRUITING

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

  • Kantonsspital Olten

    RECRUITING

    Olten, Canton of Solothurn, 4600, Switzerland

  • University Hospital Basel

    TERMINATED

    Basel, Basel, 4031, Switzerland

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