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Study on Dapansutrile for Patients with Type 2 Diabetes Not Well Controlled on Standard Treatment

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called Dapansutrile on people with Type 2 Diabetes Mellitus. Type 2 diabetes is a condition where the body does not use insulin properly, leading to high blood sugar levels. The study will compare the effects of Dapansutrile, which is taken as a tablet, to a placebo, which looks like the real medication but does not contain any active ingredients.

The purpose of the study is to see if Dapansutrile can help lower blood sugar levels, specifically a measure called HbA1c, over a period of 26 weeks. HbA1c is a common test that shows the average level of blood sugar over the past two to three months. Participants will continue their usual diabetes treatment while taking either Dapansutrile or the placebo. The study will involve regular check-ups to monitor changes in blood sugar levels and other health indicators.

Throughout the study, participants will have their blood sugar levels checked at various intervals, and other tests will be conducted to assess how well their bodies are responding to the treatment. The study aims to provide more information on whether Dapansutrile can be an effective additional treatment for managing Type 2 diabetes.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit
The trial begins with an initial visit where eligibility is confirmed. This includes checking age, diabetes diagnosis, HbA1c levels, and other health conditions.
Participants must have a body mass index (BMI) between 18 to 40 kg/m² and fasting glucose levels below 9 mmol/l.
Step 2
Baseline visit
During the baseline visit, participants undergo a mixed-meal tolerance test (MMT) to assess glucose and insulin response.
Participants receive either the active drug, dapansutrile, or a placebo. The placebo looks identical to the active drug but contains no active substance.
Step 3
Treatment phase
Participants take the assigned tablet orally. The dosage and frequency are determined by the study protocol.
The treatment lasts for 26 weeks, with regular monitoring of HbA1c levels and other health indicators.
Step 4
Follow-up visits
Follow-up visits occur at weeks 4, 8, 12, 16, and 20 to monitor changes in HbA1c and fasting plasma glucose.
Additional assessments include insulin sensitivity and β-cell function at weeks 8 and 26.
Step 5
Final assessment
At week 26, a final assessment is conducted to evaluate the overall effect of the treatment on HbA1c and other health parameters.
Participants complete another MMT and continuous glucose monitoring (CGM) to assess glycaemic control.

Who can join the trial?

9 criteria

Adults, both men and women, aged between 18 and 75 years old.
Must have been diagnosed with Type II diabetes mellitus for at least 3 months before starting the study. This is a condition where the body doesn't use insulin properly.
Have an HbA1c level between 7.7% and 11.0% at the initial screening. HbA1c is a blood test that shows average blood sugar levels over the past 2 to 3 months.
Have a high-sensitivity C-reactive protein (hsCRP) level of at least 1.5 mg/L. This is a blood test that measures inflammation in the body.
Have a body mass index (BMI) between 18 and 40 kg/m². BMI is a measure of body fat based on height and weight.
Must be in an overall good medical condition to safely participate in the study, especially concerning heart, kidney, and liver health, as judged by the study doctor.
Must be able and willing to sign a written consent form before starting any study-related activities.
Must be able to understand and follow all study requirements, including using a continuous glucose monitor (CGM) and completing a mixed-meal tolerance test (MMT). The MMT is a test to see how the body handles sugar after eating.
Have fasting glucose levels below 9 mmol/L (162 mg/dL) at the start of the study. Fasting glucose is the blood sugar level after not eating for at least 8 hours.

Who cannot join the trial?

5 criteria

Patients who are not diagnosed with **Type II diabetes mellitus**. This is a condition where the body has trouble using sugar properly, leading to high blood sugar levels.
Patients who are not already receiving standard treatment for their diabetes. This means they should be on regular medication or therapy for their condition.
Patients who are not able to take additional medication along with their current diabetes treatment.
Patients who are not within the age range specified for the study. The study is open to adults, so children and teenagers are not eligible.
Patients who are part of a vulnerable population, which means they might need special protection or care.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Centre hospitalier universitaire de Liege
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Liege, Belgium
Deutsche Diabetes Forschungsgesellschaft e.V.
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Duesseldorf, Germany
Hopital Beaujon
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Clichy, France

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Investigated drugs

Dapansutrile is an oral medication being studied for its potential to help people with Type 2 Diabetes Mellitus. It works by inhibiting a specific part of the body's inflammatory response, which may help in controlling blood sugar levels. This trial is testing how effective dapansutrile is when added to the usual diabetes treatments that patients are already taking.

Dapansutrile

What is already known about the treatment

Dapansutrile – Dapansutrile is administered orally and is currently being studied in clinical trials for its potential use in treating Type 2 diabetes mellitus. It is not yet widely recognized in medical literature as a standard treatment, as it is still under investigation. The main therapeutic indication for dapansutrile is to help lower blood sugar levels in patients with Type 2 diabetes who do not achieve adequate control with existing treatments. At the molecular level, dapansutrile works by inhibiting the NLRP3 inflammasome, which is involved in inflammation processes that can affect insulin sensitivity. It is classified pharmacologically as an NLRP3 inhibitor.

Investigated diseases

Type 2 Diabetes Mellitus – This is a chronic condition that affects the way the body processes blood sugar (glucose). In this disease, the body either resists the effects of insulin, a hormone that regulates the movement of sugar into cells, or doesn't produce enough insulin to maintain normal glucose levels. Over time, high blood sugar levels can lead to various complications. The progression of the disease can result in symptoms such as increased thirst, frequent urination, hunger, fatigue, and blurred vision. It is often associated with obesity and a sedentary lifestyle. Managing blood sugar levels is crucial to prevent further complications.