RecruitingRare disease

Increasing the dose of glimepiride for patients with HNF1A-MODY or HNF4A-MODY diabetes

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What is this trial about?

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

This study focuses on people living with Maturity-onset diabetes of the young type 3, also known as HNF1A-MODY, and Maturity-onset diabetes of the young type 1, known as HNF4A-MODY. These are rare forms of diabetes caused by specific genetic changes rather than the more common types. The research aims to evaluate how increasing the dose of a medication called glimepiride affects blood sugar levels in these individuals.

The medication used, glimepiride, belongs to a group of drugs called sulfonylureas. During the study, participants will undergo a process where their medication dose is gradually increased to find an effective amount. Blood sugar levels will be tracked using continuous glucose monitoring, which is a method that involves a small device to measure sugar levels in the body continuously over time. The study will look at how well the sugar levels stay within a healthy target range and how the medication affects overall sugar stability.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Baseline assessment
Initial measurements are taken to establish a starting point. this includes using continuous glucose monitoring, which is a device that tracks blood sugar levels automatically over time.
Measurements of haemoglobin A1c, which represents the average blood sugar over the past few months, are recorded.
Step 2
Medication titration phase
The glimepiride medication is started. this is a type of sulfonylurea, a medicine used to lower blood sugar. the dosage is 3 mg taken by oral use (swallowing a pill).
The dose of glimepiride is gradually increased, or up-titrated, to find the most effective amount for managing blood sugar levels.
Step 3
Maintenance phase
Once the appropriate dose is determined, a maintenance phase begins to keep blood sugar levels stable.
During the final two weeks of this period, blood sugar metrics are measured using the continuous glucose monitoring device to evaluate the effectiveness of the medication.

Who can join the trial?

4 criteria

You must have a specific type of diabetes known as HNF1A-MODY or HNF4A-MODY, which are caused by a change or mistake in a specific gene (called a heterozygous mutation).
Your HbA1c level, which is a measure of your average blood sugar levels over the past two to three months, must be 48 mmol/mol or higher, or you must currently be using insulin to manage your blood sugar.
You must be 18 years of age or older.
You must be able to provide informed consent, which means you agree to participate in the study after understanding all the details and risks.

Who cannot join the trial?

6 criteria

Women who are pregnant, breastfeeding, or not using effective contraception (methods to prevent pregnancy) cannot participate.
People with nephropathy, which is a type of kidney disease, cannot join. This includes having a very low eGFR (a measure of how well the kidneys filter blood) or albuminuria (excess protein in the urine).
People with end-stage liver disease, which is a severe condition where the liver can no longer function properly, are excluded.
Individuals who cannot use the continuous glucose monitoring (CGM) device, which is a tool used to track blood sugar levels constantly, due to skin reactions or other substances that interfere with the sensor.
Anyone with a known allergic reaction to the study medication, glimepiride, or other sulphonamides (a group of medications).
People who have taken SU (sulfonylureas, a class of diabetes medication) or glinides (another type of diabetes medicine) within the last 30 days.

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Verified sites

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Aarhus University Hospital
Aarhus, Denmark

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Investigated drugs

Glimepiride is a medication taken by mouth that helps lower blood sugar levels in people with certain types of diabetes. In this study, it is being used to see how increasing the amount of this medicine affects blood sugar control in people with specific genetic forms of diabetes.

Glimepiride

What is already known about the treatment

Glimepiride - This medication is taken by mouth in tablet form and is commonly used to help manage high blood sugar levels. It belongs to a group of drugs called sulfonylureas and is currently a standard treatment used to improve blood sugar control in certain types of diabetes. At a molecular level, it works by stimulating the pancreas to release more insulin into the bloodstream, which helps the body lower sugar levels.

Investigated diseases

Maturity-onset diabetes of the young type 3 (HNF1A-MODY)
This is a genetic condition that affects how the body regulates blood sugar. It is caused by a mutation in a specific gene that helps control insulin production. The condition typically appears in young adulthood and involves a gradual decline in the ability of the pancreas to release enough insulin. As the disease progresses, blood sugar levels become increasingly difficult to maintain within a normal range.
Maturity-onset diabetes of the young type 1 (HNF4A-MODY)
This is a rare form of diabetes caused by a mutation in a gene responsible for regulating pancreatic function. It leads to a progressive reduction in the secretion of insulin by the pancreas. The condition often presents in younger individuals and results in rising blood sugar levels over time. As the disease advances, the body's natural ability to manage glucose levels diminishes.