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

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What is this study about?

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.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Steno Diabetes Center Copenhagen Herlev Denmark
Atflnu Ujkndnetdn Hptvgwya Aarhus Denmark

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Denmark Denmark
Recruiting
01.03.2026

Trial locations

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.

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.

Trial ID:
2025-524679-22-00
Trial Phase:
Therapeutic exploratory (Phase II)

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    Investigated diseases:
    Investigated drugs:
    Denmark