Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Effects of empagliflozin on plasma glucose in patients with HNF1A-MODY: a randomized, double-blind, crossover trial

This study, called a Phase II trial, is investigating a medication called empagliflozin, also known as Jardiance, for people living with a specific type of diabetes called HNF1A-MODY. Researchers want to understand if this drug can help control blood sugar levels more effectively than a dummy pill (placebo). They will compare how blood sugar levels change in participants while they are taking either the active drug or the placebo. This is a "crossover" study, which means participants will take both the study drug and the placebo at different times, allowing researchers to see the effects of each in the same person. The main goal is to find out if empagliflozin makes a noticeable difference to blood sugar readings.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Steno Diabetes Center Copenhagen

Enrolment target

Start

15 Jun 2023

Maturity-onset diabetes of the young type 3 (HNF1A-MODY)

What is this study about?

This research study is looking into a medication called empagliflozin, known by its brand name Jardiance, for people who have a specific type of diabetes called HNF1A-MODY (Maturity-onset diabetes of the young type 3). This type of diabetes is often diagnosed in younger people and is different from the more common Type 1 or Type 2 diabetes.

The main aim of this study is to see if empagliflozin can help manage blood sugar levels in people with HNF1A-MODY. Researchers will compare the effects of empagliflozin to a "placebo," which is a dummy pill that looks exactly like the study drug but doesn't contain any active medicine. This helps them understand if any changes seen are truly due to the empagliflozin.

To measure blood sugar, participants will wear a continuous glucose monitor (CGM). This is a small device that tracks blood sugar levels throughout the day and night. By comparing the average blood sugar readings while participants are taking empagliflozin versus when they are taking the placebo, the researchers hope to learn if this medication could be a helpful treatment option for people with HNF1A-MODY.

Key takeaways

This study investigates a drug called empagliflozin for HNF1A-MODY diabetes.
It aims to see if the drug helps manage blood sugar better than a dummy pill.
Participants will use a continuous glucose monitor (CGM) to track blood sugar.
Both men and women aged 18 and over with HNF1A-MODY can potentially join.
The study helps researchers understand new ways to treat this specific type of diabetes.

Who may be eligible?

This study is open to both men and women. You must be at least 18 years old to take part; there's no upper age limit.

People taking part will have a specific type of diabetes called HNF1A-MODY. This is important because the study is specifically designed to understand how the medication affects this particular kind of diabetes.

Before you can join, the study team will carefully check your medical history and current health to make sure the study is suitable and safe for you. They will explain everything clearly and answer any questions you have.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you at least 18 years old?
Do you have a diagnosis of HNF1A-MODY (Maturity-onset diabetes of the young type 3)?
Are you able to attend regular clinic visits?
Are you able to wear a continuous glucose monitor (CGM) device?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be asked to take study medication (either empagliflozin or a placebo) in tablet form. This is a "crossover" study, which means you will take one type of tablet for a certain period, and then switch to the other type of tablet for another period. This allows the researchers to see how both the active drug and the placebo affect you.

Throughout the study, you will wear a continuous glucose monitor (CGM) for specific periods. This small device will automatically track your blood sugar levels. You'll also have regular visits to the clinic where the study team will carry out health checks, take blood and urine samples, and ask you to self-measure things like your blood sugar and ketone levels at home before your visits. The total duration of your involvement in the study, including all treatment periods and follow-up, will be explained in detail by the study team.

Potential risks and benefits

Taking part in a clinical trial offers the chance to contribute to medical knowledge and potentially help others with HNF1A-MODY in the future. You might also gain a better understanding of your own condition and potentially benefit from the study medication, though this is not guaranteed as it's still being investigated. However, all medications have potential risks; you may experience side effects, some of which could be unexpected or unpleasant. The study team will explain all known potential risks and monitor you closely for any unwanted effects. You are always free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Denmark

Common questions

What is HNF1A-MODY?

HNF1A-MODY is a specific, often inherited, type of diabetes that usually appears in young adults. It's different from the more common Type 1 and Type 2 diabetes.

What is empagliflozin (Jardiance)?

Empagliflozin is a medication designed to help lower blood sugar levels. It works by causing the kidneys to remove more sugar from the body through urine.

What does 'double-blind' mean?

Double-blind means neither you nor the study doctors will know whether you are receiving the active drug or the dummy pill (placebo). This helps make the study results fair and accurate.

What is a continuous glucose monitor (CGM)?

A CGM is a small device worn on the body that continuously measures and records your blood sugar levels throughout the day and night.

Will I have to pay to join the study?

No, you will not have to pay to participate in the study. All study-related medication and assessments will be provided at no cost, and some studies may also cover travel expenses.