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Study on the Effects of Empagliflozin on Blood Sugar Levels in Patients with HNF1A-MODY Diabetes

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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 empagliflozin on a specific type of diabetes known as Maturity-onset diabetes of the young type 3 (HNF1A-MODY). This form of diabetes is caused by a genetic change in the HNF1A gene, which affects how the body controls blood sugar levels. The medication being tested, Jardiance 25 mg film-coated tablets, contains the active ingredient empagliflozin, which is taken orally as a tablet. The study also involves a comparison with a placebo tablet, which looks like the medication but does not contain any active ingredients.

The purpose of the study is to investigate how well empagliflozin can lower blood sugar levels in patients with HNF1A-MODY. Participants in the study will receive both the medication and the placebo at different times, without knowing which one they are taking, to compare the effects. This type of study is called a "double-blind, crossover trial," meaning neither the participants nor the researchers know who is receiving the medication or the placebo at any given time, and participants will switch between the two during the study.

The study will last for several months, during which participants will have their blood sugar levels monitored using a method called continuous glucose monitoring (CGM). This involves wearing a small device that tracks blood sugar levels throughout the day and night. The study aims to see if there is a significant difference in blood sugar control when taking empagliflozin compared to the placebo. Other factors, such as body weight and the occurrence of low blood sugar events, will also be observed to understand the overall impact of the medication.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the trial
Upon joining the trial, you will be asked to provide informed consent. This means you agree to participate after understanding the trial's purpose and procedures.
You must have diabetes caused by a specific genetic mutation and meet other criteria such as being 18 years or older and having stable glucose-lowering treatment for at least 60 days.
Step 2
Initial assessment
An initial assessment will be conducted to confirm eligibility. This may include reviewing your medical history and current treatments.
Step 3
Treatment period 1
You will begin the first treatment period, where you will take either Jardiance 25 mg film-coated tablets or a placebo tablet once daily. The treatment is taken orally.
This period will last for a specified duration, during which your blood glucose levels will be monitored using a device that measures glucose continuously.
Step 4
Washout period
After the first treatment period, there will be a washout period. During this time, you will not take any trial medication. This allows the effects of the first treatment to clear from your body before starting the next phase.
Step 5
Treatment period 2
You will begin the second treatment period, where you will switch to the other treatment option (either the Jardiance 25 mg film-coated tablets or the placebo tablet).
This period will also involve daily oral administration and continuous glucose monitoring.
Step 6
Final assessment
At the end of the trial, a final assessment will be conducted. This may include reviewing your glucose monitoring data and any other health measurements taken during the trial.

Who can join the trial?

6 criteria

Provide informed consent, which means you agree to participate after understanding the study details.
Have diabetes caused by a specific change in the HNF1A-gene. This change is known as a heterozygous mutation, which means there is a change in one of the two copies of the gene.
Be at least 18 years old.
Have a Hemoglobin A1c level of at least 48 mmol/mol. Hemoglobin A1c is a blood test that shows your average blood sugar level over the past 2 to 3 months.
Have been on a stable treatment to lower blood sugar for at least 60 days before the first study visit.
Be taking at least one medication to lower blood sugar, and the dose of this medication should not change.

Who cannot join the trial?

3 criteria

Patients who do not have **Maturity-onset diabetes of the young type 3 (HNF1A-MODY)** cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who belong to a vulnerable population, which means they might need special protection or care, cannot participate.

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Region Midtjylland
Aarhus, Denmark

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Investigated drugs

Empagliflozin is a medication used to help lower blood sugar levels in people with certain types of diabetes. In this clinical trial, it is being tested to see how well it can reduce blood sugar in patients with a specific genetic form of diabetes called HNF1A-MODY. This medication works by helping the kidneys remove sugar from the body through urine, which can help keep blood sugar levels more balanced. Participants in the trial will take this medication once a day to see if it effectively lowers their blood sugar levels.

Empagliflozin

What is already known about the treatment

Empagliflozin – Empagliflozin is a medication taken orally in the form of a tablet, typically administered once daily. It is currently being studied for its effects on lowering blood sugar levels in patients with a specific type of diabetes known as maturity-onset diabetes of the young type 3 (HNF1A-MODY). The main therapeutic use of empagliflozin is to help control blood sugar levels in individuals with this condition. At the molecular level, empagliflozin works by inhibiting a protein in the kidneys called SGLT2, which reduces the reabsorption of glucose back into the blood, thereby lowering blood sugar levels. It is classified as an SGLT2 inhibitor in pharmacology.

Investigated diseases

Maturity-onset diabetes of the young type 3 (HNF1A-MODY) – This is a form of diabetes caused by a genetic mutation affecting the HNF1A gene, which plays a role in insulin production. It typically manifests in adolescence or early adulthood and is characterized by high blood sugar levels. The disease progresses as the body's ability to produce insulin diminishes, leading to increased blood glucose levels. Over time, individuals may experience symptoms such as increased thirst, frequent urination, and fatigue. The condition is often inherited in an autosomal dominant pattern, meaning a single copy of the altered gene in each cell is sufficient to cause the disorder. As the disease advances, it may require monitoring and management to maintain blood sugar levels within a normal range.